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10.0.6612;}{\info{\title VII}{\author Julie Baher}{\operator Computing Services}{\creatim\yr2006\mo5\dy30\hr15\min11}{\revtim\yr2006\mo5\dy30\hr15\min11}{\version2}{\edmins0}{\nofpages46}{\nofwords20849}{\nofchars118843} {\nofcharsws139414}{\vern16389}}\margl1440\margr1440 \widowctrl\ftnbj\aenddoc\noxlattoyen\expshrtn\noultrlspc\dntblnsbdb\nospaceforul\formshade\horzdoc\dgmargin\dghspace187\dgvspace180\dghorigin1440\dgvorigin1440\dghshow1\dgvshow2 \jexpand\viewkind1\viewscale100\pgbrdrhead\pgbrdrfoot\splytwnine\ftnlytwnine\htmautsp\nolnhtadjtbl\useltbaln\alntblind\lytcalctblwd\lyttblrtgr\lnbrkrule\nobrkwrptbl\snaptogridincell\allowfieldendsel\wrppunct\asianbrkrule\rsidroot9782123 \fet0{\*\ftnsep \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3283162 \chftnsep \par }}{\*\ftnsepc \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 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(And Should FDA Let It?): \par }{\b\fs28\insrsid14901340 An Overview}{\b\fs28\insrsid4598150\charrsid4598150 of the Regulatory Regime (or Lack Thereof) Surrounding \par Functional Foods}{\b\fs28\insrsid4598150 * \par \par }{\b\insrsid4598150 \par \par Julie Melissa Baher \par Class of 2006 \par April 2006 \par }{\b\fs28\insrsid4598150 \par \par \par \par \par \par \par \par \par \par \par \par \par \par \par \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4598150 {\b\fs28\insrsid4598150 \tab \tab \tab \tab \tab \tab \tab \tab }{\b\insrsid4598150 \tab \par }\pard \qj \fi720\li5760\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin5760\itap0\pararsid4598150 {\b\insrsid4598150 \par \par \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4598150 {\b\insrsid4598150 \tab \tab \tab \tab \tab \tab \tab \tab \tab }{\b\insrsid4598150\charrsid4598150 \par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4598150 {\b\insrsid4598150 \par \par \par \par \par \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4598150 {\b\insrsid4598150 \par *This paper is being submitted in satisfaction of the course requirement and the third year written work requirement. \par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid10704998 {\b\insrsid4598150 \page }{\b\insrsid6885256\charrsid6885256 Abstract \par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14901340 {\insrsid10704998 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7691467 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid15206187 Foods that provide a health benefit beyond basic nutrition, otherwise known as }{\insrsid7933711 \'93}{\insrsid15206187 functional foods}{\insrsid917605 ,}{\insrsid7933711 \'94}{\insrsid15206187 may hold the key to better short- and long-te rm health for many Americans. In recent years, American consumers have grown more and more interested in the possibility of using foods}{\insrsid12460905 ,}{\insrsid15206187 along with the traditional healthcare system}{\insrsid12460905 ,}{ \insrsid15206187 to promote well-being, reduce the risks of disease, and lower overall costs of care. In response, the food industry}{\insrsid140498 and, increasin}{\insrsid7933711 gly, the biotechnology industry have}{\insrsid15206187 developed and marketed more and more products purporting to be functional foods of one type or another, making myriad claims as to their effects on health or the human body. The problem is that}{\insrsid7933711 , unlike in Japan where there is a formalized regulatory system for approving the separate category of functional foods,}{\insrsid15206187 the}{\insrsid7933711 United States}{\insrsid15206187 Food and Drug Administration does not }{\insrsid7933711 even }{\insrsid15206187 recog}{\insrsid7933711 nize the term. Instead, the FDA}{\insrsid15206187 ap proves or rejects such products on a case-by-case basis under one of its currently existing regulatory categories, including conventional foods, dietary supplements, medical foods, foods for special dietary use, or, if necessary, drugs.}{\insrsid12460905 The current regime, marked by a multitude of available }{\insrsid140498 labeling claims, all with different substantiation standards, as well as multiple federal agencies exercising regulatory control, lacks consistency}{\insrsid12460905 and promotes both consumer and manufacturer confusion}{\insrsid140498 . Moreover, the l ines between the current regulatory categories are blurry, and some are viewed as more favorable to manufacturers than others, which creates incentives for the marketing of products under regulatory categories to which they do not truthfully belong. This can lead to claims being made directly to consumers that are misleading, inaccurate or unsubstantiated. In order to take advantage of the enormous benefits that foods can provide}{\insrsid7933711 and the potential for a vast amount of quality consumer education through food labeling}{\insrsid140498 , significant changes must be made to the current regulatory system surrounding functional foods.}{\insrsid15206187\charrsid16347480 \par }\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15206187 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6885256\charrsid10704998 \page }{\b\insrsid14566914\charrsid10704998 Table of Contents }{\insrsid14566914\charrsid10704998 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6885256 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14566914 \par }\pard \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\field\fldedit{\*\fldinst {\b0\insrsid14566914\charrsid6885256 TOC \\o "1-3" \\h \\z \\u }}{\fldrslt {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795378"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300370038000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 I. Introduction}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795378 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300370038000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 4}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795379"}{ \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300370039000000}}}{\fldrslt {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 II. Food v. Drug? Definitions and Interpretation} {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795379 \\h }{ \b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300370039000000}}}{\fldrslt { \b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 6}}}}}{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795380"}{ \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380030000000}}}{\fldrslt {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 III. Functional Foods: What Are They?}{ \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795380 \\h }{ \b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380030000000}}}{\fldrslt { \b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 9}}}}}{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795381"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380031000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 A. Basic Definitions of Functional Foods}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795381 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380031000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 9}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795382"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380032000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 B. Lack of Recognition}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795382 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380032000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 11}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795383"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380033000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 C. Functional Food v. Dietary Supplement?}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795383 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380033000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 12}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795384"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380034000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 D. The Future: Biotech Functional Foods?}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795384 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380034000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 16}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795385"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380035000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 IV. Claims That Can Be Made When Marketing Functional Foods}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795385 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380035000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 20}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795386"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380036000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 A. Health Claims}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795386 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380036000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 20}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s22\ql \li480\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin480\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795387"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380037000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 1. The NLEA of 1990}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795387 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380037000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 23}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795388"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380038000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 2. FDAMA of 1997: Health Claims Based on Authoritative Statements}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _To c132795388 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380038000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 24}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795389"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380039000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 3. Qualified Health Claims}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795389 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300380039000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 27}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795390"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390030000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 B. Structure/Function Claims}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795390 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390030000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 32}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795391"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390031000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 C. Dietary Guidance Statements}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795391 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390031000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 34}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795392"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390032000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 D. Too Many Claims, Too Many Agencies, Too Much Confusion?}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795392 \\ h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390032000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 35}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795393"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390033000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 V. Foods for Special Dietary Use}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795393 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390033000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 39}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795394"}{ \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390034000000}}}{\fldrslt {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 VI. A Departure: Medical Foods}{ \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795394 \\h }{ \b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390034000000}}}{\fldrslt { \b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 40}}}}}{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795395"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390035000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 A. Definition and Regulatory Loophole}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795395 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390035000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 40}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795396"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390036000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 B. Case Example: HeartBar}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795396 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390036000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 47}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795397"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390037000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 C. Clarification Efforts and Failure}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795397 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390037000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 50}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795398"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390038000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 D. The Future: Biotechnology and Tax Exemptions?}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795398 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390038000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 53}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795399"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390039000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 VII. Nutraceuticals}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795399 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003300390039000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 55}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795400"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300030000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 A. What is a Nutraceutical?}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795400 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300030000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 55}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795401"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300031000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 B. The Propose d Nutraceutical Research and Education Act}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795401 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300031000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 57}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795402"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300032000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 VIII. International Comparison}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795402 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300032000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 59}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s21\ql \li240\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795403"}{\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{ \ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300033000000}}}{\fldrslt { \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 A. Japan: The FOSHU System}{\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795403 \\h }{\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300033000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden\insrsid16143335 59}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795404"}{ \cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300034000000}}}{\fldrslt {\cs17\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 B. FOSHU\rquote s Weaknesses}{ \lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795404 \\h }{ \lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300034000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden\insrsid16143335 62}}}}}{\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }\pard\plain \s20\qc \li0\ri0\widctlpar\tqr\tldot\tx9350\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field\fldedit{\*\fldinst { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795405"}{\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 } {\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300035000000}}}{\fldrslt { \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 IX. Back to the U.S.: Weaknesses in Federal Controls}{\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst { \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795405 \\h }{\b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300035000000}}}{\fldrslt {\b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 65}}}}}{ \b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795406"}{ \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300036000000}}}{\fldrslt {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 X. Recommendations: The Debate Continues}{ \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795406 \\h }{ \b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300036000000}}}{\fldrslt { \b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 69}}}}}{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 \par }{\field\fldedit{\*\fldinst {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 HYPERLINK \\l "_Toc132795407"}{ \cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 }{\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300037000000}}}{\fldrslt {\cs17\b0\ul\cf2\lang1024\langfe1024\noproof\insrsid10441540\charrsid10441540 XI. Conclusion}{ \b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 \tab }{\field{\*\fldinst {\b0\lang1024\langfe1024\noproof\webhidden\insrsid10441540\charrsid10441540 PAGEREF _Toc132795407 \\h }{ \b0\lang1024\langfe1024\noproof\insrsid11404503\charrsid10441540 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f0054006f0063003100330032003700390035003400300037000000}}}{\fldrslt { \b0\lang1024\langfe1024\noproof\webhidden\insrsid16143335 76}}}}}{\b0\lang1024\langfe1024\noproof\insrsid10441540 \par }\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6885256 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 }}\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6885256 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14566914 \page }{\b\insrsid6370426\charrsid6885256 {\*\bkmkstart _Toc132554700} What Can Your Food Do For You? (And Should FDA Let It?):{\*\bkmkend _Toc132554700} \par }{\b\insrsid15486362\charrsid6885256 {\*\bkmkstart _Toc132554701}A Review of t}{\b\insrsid6370426\charrsid6885256 he Regulatory Regime}{\b\insrsid14620580\charrsid6885256 (or Lack Thereof)}{\b\insrsid6370426\charrsid6885256 Surrounding}{ \b\insrsid14620580\charrsid6885256 {\*\bkmkend _Toc132554701} \par }{\b\insrsid6370426\charrsid6885256 {\*\bkmkstart _Toc132554702}Funct}{\b\insrsid14620580\charrsid6885256 ional Foods}{\b\insrsid6370426 {\*\bkmkend _Toc132554702} \par }{\insrsid6885256 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13920109 {\*\bkmkstart _Toc132795378}I. }{ \insrsid13920109\charrsid14566914 Introduction}{\insrsid13920109 {\*\bkmkend _Toc132795378} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3283042 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3283042 \tab }{\insrsid2888946 I}{\insrsid3283042 s chocolate the new miracle drug? }{\insrsid2587713 Can food manufacturers market a butter-like spread as a dietary supplement that promises to lower one\rquote s cholesterol? }{\insrsid3283042 Are we, as consumers and health-conscious}{\insrsid5655710 Americans, to believe that some (or maybe even all) }{\insrsid3283042 of our health problems can be addr}{\insrsid2587713 essed or solved by simply incorporating}{\insrsid3283042 a few bites}{\insrsid2587713 or a specific combination}{\insrsid3283042 of }{\insrsid2587713 so-called functional}{\insrsid3283042 foods }{\insrsid2587713 into our diets }{\insrsid3283042 each day}{\insrsid2587713 ? Are there some foods that truly posses s the power to help us manage health-related conditions? The concept of food as medicine dates all the way back to ancient times, with t}{\insrsid5655710 he philosopher/scientist}{\insrsid2587713 Hippocrates. According to Hippocrates, men would not }{ \insrsid7933711 have initially sought out}{\insrsid13711398 the concept of}{\insrsid7933711 medicine}{\insrsid2587713 at all if the same kinds of diet had suited them in sickness as in good health. Sai}{\insrsid4284006 d Hippocrates, it is}{ \insrsid2587713 }{\insrsid4284006 \'93}{\insrsid2587713 neces}{\insrsid4284006 sary to every physician to \'85}{\insrsid2587713 strive to know, if he would wish to perform his duties, what man is in relation to the articles of food an d drink, and to his other occupations, and what are the effects of each of them to every one.\'94}{\cs16\super\insrsid2587713 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Rex Pay 200, }{\i\insrsid16143335 Hippocrates}{\insrsid16143335 , }{\i\insrsid16143335\charrsid11432203 at}{\insrsid16143335 http://www.humanistictexts.org/hippocrates.htm. (last visited April 16, 2006), citing }{\scaps\insrsid16143335\charrsid5329700 The Genuine Works of Hippocrates}{\insrsid16143335 (Francis Adams trans., Robert E. Krueger Publishing Co.) (1972) (from 1946 reprint of 1849 original).}}}{\insrsid15675428 }{\insrsid2888946 From this passage, came the familiar Hippocratic phrase, \'93let thy food be thy medicine.\'94}{ \insrsid13925247 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3283042 {\insrsid4284006 \tab In addition, \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7691467 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13925247 [c]ultural beliefs in the mystical powers of foods have been handed down for generatio}{\insrsid2888946 ns \'85}{\insrsid13925247 as scientists unravel the mysteries about specific nutritional needs, it becomes apparent that some dietary components that may not be required for human existence may indeed markedly influence quality of life by modifying one}{\insrsid4284006 or more physiologic processes.}{\cs16\super\insrsid13925247 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 John A. Milner, }{\i\insrsid16143335 Functional Foods: The U.S. Perspective}{\insrsid16143335 , 71 }{\scaps\insrsid16143335\charrsid1141496 Am. J. Clin. Nutr}{\insrsid16143335 ., 1654S, 1654S (2000), }{\i\insrsid16143335 available at}{\insrsid16143335 }{\insrsid16143335\charrsid10437609 http://www.ajcn.org/cgi/content/full/71/6/1654S}{\insrsid16143335 . }}}{\insrsid16218749 }{\insrsid4284006 \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3283042 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid16218749 While in the Western world, functional foods a}{\insrsid2888946 re viewed as a \'93revolution,\'94 }{\insrsid16218749 represent}{\insrsid2888946 ing a fast}{\insrsid16218749 growing segment of the food industry, in the Eastern world, functional foods have been part of the culture for centuries.}{ \cs16\super\insrsid16218749 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See, e.g.,}{\insrsid16143335 Ruth DeBusk, Ph.D., RD, }{\i\insrsid16143335 Functional Foods}{\insrsid16143335 , Vegetarian Nutrition: A Dietetic Practice Group of the American Dietetic Association (excerpted from }{\i\insrsid16143335 Integrative Medicine: Your Quick Reference Guide}{\insrsid16143335 , (1998)), }{\i\insrsid16143335\charrsid11870180 at}{\insrsid16143335 http://www.andrews.edu/NUFS/functionalfoods.html (last edited Sept. 16, 2002) (For example, the Chinese have documented foods with medicinal effects since at least 1000 BC).}}}{\insrsid16218749 }{\insrsid13925247 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11995418 {\insrsid11995418 M}{\insrsid8147007 ore than ever, people are }{\insrsid11995418 currently }{\insrsid8147007 turning to the foods they eat to provide }{\insrsid13925247 health and performance }{\insrsid8147007 benefits beyond those of general nutrition}{\insrsid13925247 , and even to influence risks of acquiring certain kinds of diseases}{\insrsid8147007 . }{ \insrsid2888946 It has been noted that \'93[t]}{\insrsid11995418 he tendency for consumers to view \lquote the kitchen cabinet as the medicine cabinet\rquote was initially identified as a leading trend in the food industry in 1994. This \lquote self-care\rquote phenomenon remains a leading consumer trend today.\'94}{\cs16\super\insrsid11995418 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Clare M. Hasler, }{\i\insrsid16143335 Functional Foods: Benefits, Concerns and Challenges \endash A Position Paper from the American Council on Science and Health}{\insrsid16143335 (2002), 132 }{\scaps\insrsid16143335 J. Nutr.}{\insrsid16143335 3772, 3779 (internal citations omitted), }{\i\insrsid16143335 available at}{\insrsid16143335 }{ \insrsid16143335\charrsid10437609 http://jn.nutrition.org/cgi/content/full/132/12/3772}{\insrsid16143335 . }}}{\insrsid11995418 }{\insrsid5267121 So-called \'93functional foods\'94 are one of the most active areas of research in the nutrition sciences}{ \insrsid2888946 , likely}{\insrsid5267121 due to}{\insrsid2888946 some combination of}{\insrsid5267121 : (1) an emphasis in nutritional and medical research on associations between diet and health benefits; (2) a favorable regulatory environment; (3) the consumer self-care phenomenon, and (4) rapid growth in the market for health and wellness products.}{ \cs16\super\insrsid5267121 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See id}{\insrsid16143335 . at 3773.}}}{\insrsid2888946 Further, it is likely that these factors have grown to be so influential in recent years due to the rising cost of prescription drugs and the difficulties that many Americans face gaining access to the health care system and health insurance.}{\insrsid5267121\charrsid16218749 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13925247 {\insrsid5267121 F}{\insrsid8147007 unctional foods are on the rise in America, following the lead of countries like Japan where they have been prominent on the public agenda for some time. }{\insrsid5655710 However, unlike Japan, }{\insrsid11041561 the United States }{\insrsid5655710 F}{ \insrsid11041561 ood and }{\insrsid5655710 D}{\insrsid11041561 rug }{\insrsid5655710 A}{\insrsid11041561 dministration (FDA)}{\insrsid5655710 has no formal scheme for regulating functional f}{\insrsid12452724 oods (and}{\insrsid5655710 functional foods} {\insrsid12452724 are not recognized in FDA\rquote s}{\insrsid5655710 rules or in the Federal Food, Drug, and Cosmetic Act}{\insrsid12543417 (FDCA)}{\insrsid5655710 ). Instead, the United States system i s characterized by a complicated web of regulations applying to conventional foods}{\insrsid12452724 ,}{\insrsid5655710 with some exceptions for statutorily}{\insrsid12452724 -}{\insrsid5655710 defined medical foods and dietary supplements. }{ \insrsid2888946 This paper will }{\insrsid14890471 untangle}{\insrsid2888946 }{\insrsid14890471 from the regulatory web }{\insrsid2888946 the different approaches available to foods purpor}{\insrsid14890471 ting to be functional foods,}{\insrsid2888946 }{\insrsid14890471 as well as explore}{\insrsid2888946 the problems with the current }{\insrsid14890471 (and confusing) }{\insrsid2888946 system and some possible recommendations}{\insrsid12452724 for improvement}{\insrsid2888946 from }{ \insrsid14890471 myriad sources, including the government, the industry and public interest groups. }{\insrsid13920109\charrsid3283042 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid13779195 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13920109 {\*\bkmkstart _Toc132795379}II. Food v. Drug }{\insrsid13779195 ?}{\insrsid5182657 Definitions and Interpretation}{\insrsid4988548 {\*\bkmkend _Toc132795379} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7221680 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7221680 \tab }{\insrsid13779195 Before discussing the realities of the different types of functional foods and their current regulation (or lack of regulation), it is important to differentiate on a basic definitional level what exactly the terms \'93drug\'94 and \'93food\'94 mean}{ \insrsid9525959 in order to determine }{\i\insrsid9525959\charrsid9525959 which}{\insrsid9525959 set of regulations should even apply. T}{\insrsid13779195 he line }{\insrsid9525959 between foods and drugs }{\insrsid13779195 can often become quite blurry}{\insrsid9525959 both technically and in reality, and whether something is characterized as a food or a drug hold s strong implications for the amount and type of requirements its manufacturers will have to fulfill before it can even be marketed}{\cs16\super\insrsid9525959 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Most signi ficantly, if an item is characterized as a drug, its manufacturers would be required to file a new drug application pursuant to 21 U.S.C. \'a7 355 and wait for FDA approval, whereas this requirement does not apply if the same item is instead characterized as a food.}}}{\insrsid14890471 (i.e., pre-market regulation)}{\insrsid9525959 , as well as after it is already on the market}{ \insrsid14890471 (i.e. post-market regulation)}{\insrsid9525959 .}{\insrsid13779195 }{\insrsid9969817 The primary }{\insrsid12452724 initial }{\insrsid9969817 determinant of the regulatory status of a food or drug is its intended use. }{ \insrsid14890471 This means that, from the beginning, the manufacturer of a new product has tremendous power to shape the regulatory climate of this product, which will greatly affect the ease (or difficulty) with which the product will be approved.}{ \insrsid13859916 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13859916 {\insrsid13779195 The statutory scheme guiding us}{\insrsid9969817 , however,}{\insrsid13779195 is somewhat vague and complicated}{ \insrsid14890471 and has, thus, necessitated much interpretation by the courts}{\insrsid13779195 . }{\insrsid12543417 The FDCA}{\insrsid7221680 provides, in relevant part, that the term \'93drug\'94 means \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7691467 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7221680 (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories.}{\cs16\super\insrsid7221680 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7 321(g)(1) (2002).}}}{\insrsid7221680 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7221680 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7221680 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13779195 {\insrsid7221680 The Act provides that the term \'93food\'94 means \'93(1) articles us ed for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.\'94}{\cs16\super\insrsid7221680 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at\'a7 321(f).}}}{ \insrsid7609851 If a product is determined to be}{\insrsid10034599 long in the }{\insrsid7609851 food}{\insrsid10034599 category}{\insrsid7609851 , it can be regulated as a food in conventional form (which includes foods for special dietary use), }{ \insrsid10034599 as a food additive, }{\insrsid7609851 as a dietary supplement, as a medical food, or as an infant formula.}{\cs16\super\insrsid7609851 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Sharon Ross, }{ \i\insrsid16143335 Functional foods: the Food and Drug Administration perspective}{\insrsid16143335 , 71 }{\scaps\insrsid16143335\charrsid616708 Am. J. Clin. Nutr.}{\insrsid16143335 ; 1735S, 1735S (2000), }{\i\insrsid16143335 available at}{ \insrsid16143335 }{\insrsid16143335\charrsid616708 http://www.ajcn.org/cgi/content/full/71/6/1735S?ijkey=9a846b560f178bf1482e963cdecda78bd715c228}{\insrsid16143335 . }}}{\insrsid4988548 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14818120 {\b\insrsid13779195 \tab }{\insrsid10034599 The FDCA\rquote s definition of the term \'93food,\'94 as an article used for food does not offer much guidance. }{\insrsid13779195 In }{\i\insrsid13779195 Nutrilab v. Schweiker}{\insrsid13779195 , the 7th Circuit, in exploring whether starch blockers were foods or drugs under}{\insrsid12452724 the FDCA}{ \insrsid13779195 , expanded upon the Act\rquote s elusive definition of food. }{\insrsid9525959 The Court first explained that the definitions of food and drug are }{\i\insrsid9525959 not}{\insrsid9525959 mutually exclusive, }{\insrsid6257745 such}{ \insrsid9525959 that something that \'93happens to be a food\'94 but is intended for use in treating a disease fits \'93squarely\'94 within the definition of a drug in \'a7321(g)(1)(B).}{\cs16\super\insrsid9525959 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \insrsid16143335\charrsid616708 Nutrilab, Inc. v. Schweiker}{\insrsid16143335 , 713 F.2d 335, 336 (7th Cir. 1983) (starch blockers derived from kidney beans constitute drugs under the FD&C Act), citing, }{\i\insrsid16143335\charrsid616708 inter alia}{ \insrsid16143335 , }{\insrsid16143335\charrsid616708 National Nutritional Foods Ass\rquote n v. Mathews}{\insrsid16143335 , 557 F.2d 325, 334 (2d Cir. 1977); }{\insrsid16143335\charrsid616708 United States v. Hohensee}{\insrsid16143335 , 243 F.2d 367 (3d Cir. 1957); S. Rep. No. 493, 73d Con. 2d Sess. 2 (1934), reprinted in 2 L.H.F.D.C.A. 721, 722 (provision providing that the definition of food, drug, and cosmetic not be construed as mutually exclusive was deleted because language was superfluous).}}}{\insrsid11296658 The Court then discussed the meaning of food, holding that \'93food\'94 must be defined \'93in terms of its }{\i\insrsid11296658 function}{\insrsid11296658 as food, rather than in terms of its source, biochemical composition or ingestibility.\'94}{\cs16\super\insrsid11296658 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Nutrilab}{\insrsid16143335 , 713 F.2d at 337 (emphasis added).}}}{\insrsid14818120 Further, the Court held that \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7691467 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid11296658 [w]hen the statute defines \lquote food\rquote as \lquote articles for food,\rquote it means that the statutory definition of \lquote food\rquote includes articles used by people in the ordinary way most people use food}{\insrsid10034599 \endash }{\insrsid11296658 }{\i\insrsid11296658\charrsid9252382 primarily}{\insrsid11296658 for ta}{\insrsid14818120 ste, aroma, or nutritive value. To hold \'85 that articles used as food are articles solely for taste, aroma or nutritive value is unduly restrictive since some products such as coffee and prune juice are undoubte dly food but may be consumed on occasion for reasons other than taste, aroma, or nutritive value.}{\cs16\super\insrsid11296658 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 338 (emphasis added).}}}{\insrsid4988548 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid14818120 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14818120 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4988548 {\insrsid10034599 Thus, the court implicitly recognized that foods may be consumed for a variety of reasons}{\insrsid9252382 (other than their primary uses)}{\insrsid10034599 , including }{\insrsid7152305 reasons relating to their perceived beneficial functions, such as the stimulation that coffee provides or the laxative effects stemming from prune juice.}{\insrsid10034599 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10034599 {\insrsid6257745 Just a few months later}{\insrsid7152305 ,}{\insrsid6257745 the United States District Court for the Southern District of New York, again dealing with }{\insrsid10631722 starch blocker}{\insrsid6257745 pills, further clarified the statutory definition of food}{\insrsid7152305 and the standard to be applied in determining whether a product constitutes a food}{\insrsid6257745 .}{\cs16\super\insrsid6257745 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\insrsid16143335\charrsid616708 America}{\insrsid16143335 n Health Prods Co.}{ \insrsid16143335\charrsid616708 , Inc. v. Hayes}{\insrsid16143335 , 574 F.Supp. 1498 (S.D.N.Y. 1983) (starch blocker pills derived from white northern beans are drugs for purposes of FDCA).}}}{\insrsid6257745 The Court held that \'93 [t]he ordinary way in which an article is used, therefore, not any marketing claim on the part of the manufacturer or distributor as to a specific physiological purpose of that use, should determine whether it is a food for purposes of the parenthetical exclusion of section 321(g)(1)(C).\'94}{\cs16\super\insrsid6257745 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \i\insrsid16143335 id.}{\insrsid16143335 at 1505.}}}{\insrsid7152305 Under }{\i\insrsid7152305 American Health Products}{\insrsid7691467 , if something \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7691467 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid288089 aff ects bodily structure or function by way of its consumption as a food, the parenthetical precludes its regulation as a drug notwithstanding a manufacturer\rquote s representations as to physiological effect}{\insrsid14697488 \'85 The presence of the parenthetical in part (C) suggests that Congress did }{\i\insrsid14697488 not}{\insrsid14697488 want to inhibit the dissemination of useful information concerning a food\rquote s physiological properties by subjecting foods to drug regulation on the basis of representations in this regard.}{\cs16\super\insrsid288089 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 1507 (emphasis added).}}}{\insrsid6257745 \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10034599 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7152305 The combination of }{\i\insrsid7152305 Nutrilab}{ \insrsid7152305 and }{\i\insrsid7152305 American Health Products}{\insrsid7152305 seems to point in the direction of }{\insrsid9252382 courts }{\insrsid7152305 accepting the premise that some foods can and do, indeed, serve functions that are unrelated to their taste, aroma or nutritive value, and that, through consumption of such foods, these functions may have effects on the human body. }{\insrsid5182657 Moreover, if the product is ordinarily used as food, then the existence of structural or functional effects on the body through consumption does not mean that it should be regulated as (and, further, negates its regulation as) a drug. }{ \insrsid7152305\charrsid7152305 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13920109 {\*\bkmkstart _Toc132795380} III. Functional Foods: What Are They?{\*\bkmkend _Toc132795380} \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6835030 {\*\bkmkstart _Toc132795381} A. Basic Definitions}{\insrsid4988548 of Functional Foods}{\insrsid13920109 {\*\bkmkend _Toc132795381} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6835030 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6835030 \tab }{\insrsid3700941 The definitions of \'93food\'94 and \'93 drug\'94 be}{\insrsid12452724 ing a little more settled post-}{\i\insrsid3700941\charrsid3700941 Nutrilab}{\insrsid3700941 and }{\i\insrsid3700941\charrsid3700941 American Health Products,}{\insrsid3700941 the }{\insrsid3700941\charrsid3700941 relevant} {\insrsid3700941 question then becomes,}{\insrsid9252382 exactly is a functional food? }{\insrsid3700941 And are functional foods actually foods or do they begin to look more like drugs? }{\insrsid9252382 There is no one, accepted meaning for the term }{\insrsid3700941 functional food}{\insrsid9252382 , although many different institutions have posited their own definitions. }{\insrsid6835030 The Institute of Food Technologists (IFT) Expert Panel defines \'93functional foods\'94 as foods and food components that provide a health benefit beyond basic nutrition (for the intended population), providing essential nutrients often beyond quantities necessary for normal maintena nce, growth and development, and/or other biologically active components that impart health benefits or desirable physiological effects.}{\cs16\super\insrsid6835030 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid5848740 See}{\insrsid16143335 Institute of Food Technologists Expert Report, }{\i\insrsid16143335 Functional Foods: Opportunities and Challenges,}{\insrsid16143335 at 6 (March 2005), }{\i\insrsid16143335\charrsid7691467 available at}{\insrsid16143335 }{ \insrsid16143335\charrsid2898648 http://members.ift.org/IFT/Research/IFTExpertReports/functionalfoods_report.htm}{\insrsid16143335 . [}{\insrsid16143335\charrsid9964205 hereinafter}{\insrsid16143335 IFT Expert Report].}}}{\insrsid6835030 }{ \insrsid13925247 The Food and Nutrition Board (FNB) of the National Academy of Sciences (NAS) defines \'93functional food\'94 as one that encompasses potentially healthful products, including \'93 any modified food or food ingredient that may provide a health benefit beyond that of the traditional nutrients it contains.\'94}{\cs16\super\insrsid13925247 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Milner, }{\i\insrsid16143335 supra}{\insrsid16143335 note 2, at 1655S, citing }{\scaps\insrsid16143335\charrsid9899817 Committee on Opportunities in the Nutrition and Food Sciences, Institute of Medicine}{\insrsid16143335 , }{\scaps\insrsid16143335\charrsid9899817 Opportunities in the nutrit ion and food sciences: research challenges and the next generation of investigators}{\scaps\insrsid16143335 109}{\i\insrsid16143335 }{\insrsid16143335 (P.R. Thomas at al. eds., Nat\rquote l Academy Pres. 1994).}}}{\insrsid3700941 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3700941 {\insrsid11879210 Functional foods}{\insrsid3700941 come in many different varieties. They}{\insrsid11879210 may }{\insrsid1593743 be conventional foods naturally}{\insrsid11879210 containing bioactive components that can be linked to positive health outcomes, or}{\insrsid1593743 fortified or enhanced foods that are}{\insrsid11879210 specifically created to reduce disease risk for certain groups of people}{\insrsid1593743 , or they can be derived from the isolation of elements in nontraditional food sources and subsequent addition to traditional foods}{\insrsid11879210 .}{ \cs16\super\insrsid11879210 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 7.}}}{\insrsid11879210 }{\insrsid6835030 Foods}{\insrsid12142507 and functional food ingredients}{\insrsid3700941 can}{ \insrsid6835030 provide health benefits that can co-exist with traditional medical/pharmaceutical approaches to disease treatment. }{\insrsid1509200 Because functional foods \'93 lie at the low cost, high consumer participation end of the delivery options continuum,\'94 they may be \'93especially advantageous in lieu of a drug regimen.\'94}{\cs16\super\insrsid1509200 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 45.}}}{ \insrsid16218749 It is likely that interest in functional foods is growing due to increased health care costs, changes in legislation (see}{\insrsid9899817 discussion}{\insrsid16218749 }{\i\insrsid9899817 infra }{\insrsid16218749 Section}{ \insrsid9899817 IV.A-B.}{\insrsid16218749 ), and scientific discoveries.}{\cs16\super\insrsid16218749 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 , }{\i\insrsid16143335 e.g.,}{\insrsid16143335 Milner, }{\i\insrsid16143335 supra}{ \insrsid16143335 note 2, at 1655S.}}}{\insrsid16218749 }{\insrsid6835030 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6835030 {\insrsid5267121 \tab What are some examples of functional foods? Of course, all foods are \'93functional\'94 in one sense, }{\insrsid4861520 since they provide nutrients enabling}{\insrsid15157118 functions such as}{\insrsid5267121 growth and maintenance of life}{\insrsid4861520 to occur}{\insrsid5267121 . However, functional foods}{\insrsid12142507 (and foods enhanced or fortified with functional ingredients)}{\insrsid5267121 , as seen from the definitions above, go above and beyond the call of conventional foods}{\insrsid10690479 ; generally, functional foods can be thought of as }{ \insrsid14225467 providing one or more dietary ingredients that can be expected to improve long-term health o}{\insrsid2889676 r reduce the risk of }{\insrsid14225467 certain diseases}{\insrsid5267121 .}{\cs16\super\insrsid14225467 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Steph en H. McNamara, }{\i\insrsid16143335 So You Want to Market a Food and to Make Health-Related Claims \endash How Far Can You Go? What Rules of Law Will Govern the Claims You Want to Make?}{\insrsid16143335 53 }{\scaps\insrsid16143335\charrsid9964205 Food & Drug L.J}{\insrsid16143335 . 421, 421 (1998).}}}{\insrsid5267121 }{\insrsid4725036 Chocolate, for instance, a favorite}{\insrsid8218779 (and sometimes guilty)}{\insrsid4725036 indulg}{\insrsid4861520 ence of many Americans, has been under inves tigation during the past few years}{\insrsid4725036 for its potential benefits to heart health}{\insrsid4861520 ,}{\insrsid5267121 }{\insrsid4725036 due to the fact that it contains flavonoids, which may reduce oxidative stress on LDL cholesterol.}{ \cs16\super\insrsid4725036 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 Hasler, }{\i\insrsid16143335 supra}{\insrsid16143335 note 4, at 3776, citing K. Bruinsma, et al., }{\i\insrsid16143335 Chocolate: food or drug?}{\insrsid16143335 99 }{\scaps\insrsid16143335\charrsid5647136 J. Am. Diet. Assoc}{\insrsid16143335 . 1249-1256 (1999). }{\i\insrsid16143335 S}{\i\insrsid16143335\charrsid5647136 ee}{\i\insrsid16143335 also}{\insrsid16143335 Associated Press, }{\i\insrsid16143335 Candy Makers Target Health Conscious But Experts Warn of Risks}{\insrsid16143335 (Feb. 20, 2006), (discussing the introduction of a new line of products made by Mars, Inc., called CocaVia, which is made with a kind of dark chocolate high in flavanols as well as enriched with vitamins and injected with cholesterol-lowering plant sterols from soy), }{\i\insrsid16143335\charrsid5647136 at}{\insrsid16143335 : http://www.msnbc.msn.com/id/11453538/page/2/print/1/displaymode/1098/.}}}{\insrsid10373778 }{\insrsid15157118 Garlic has been shown to have modest blo}{\insrsid4861520 od pressure-lowering effects,}{\insrsid15157118 due to the presence of numerous physiologically active organosulfur components.}{\cs16\super\insrsid15157118 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid5647136 See}{\insrsid16143335 }{\insrsid16143335\charrsid5647136 Hasler}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 4, at 3775, citing C.A. Silagy, et al., }{\i\insrsid16143335 A meta-analysis of the effect of garlic on blood pressure}{\insrsid16143335 12 }{\scaps\insrsid16143335\charrsid5647136 J. Hypertens}{\insrsid16143335 , 463-468 (1994).}}}{\insrsid15157118 }{\insrsid12142507 Since the 1920\rquote s, iodine has been added to salt so as to prevent goiter, making salt a functional food. }{\insrsid15157118 Cranberries, too, are}{\insrsid8218779 a well-known example of a functional food}{\insrsid15157118 , in that they have been shown to be effective in maintaining urinary tract health in women. }{\insrsid1593743 Additionally, orange juice fortified with calcium to maintain bone density, and butter-like spreads containing stanol esters to reduce cholesterol can be considered functiona l foods. The list goes on and on, as more and more manufacturers, developers and, most importantly, consumers are jumping on the functional foods bandwagon.}{\insrsid5267121\charrsid16218749 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4988548 {\*\bkmkstart _Toc132795382} B. Lack of Recognition{\*\bkmkend _Toc132795382} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4286309 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4286309 \tab While the term \'93functional foods\'94 has become widespread throughout the food industry to describe foods with particular health-related benefits, it is }{\insrsid12543417 not actually recognized in the FDCA}{\insrsid9969817 or in FDA regulations}{\insrsid3958359 .}{\insrsid9969817 As a result, FDA argues that it has no authority to establish a formal regulatory category for such foods.}{\cs16\super\insrsid9969817 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 Ross, }{\i\insrsid16143335 supra }{\insrsid16143335 note 9, at 1735S, 1738S (noting, further, that \'93[t]he FDA believes that available regulatory categories of foods provide flexibility and opportunity in regulating the so-called functional foods\'94).}}}{\insrsid3958359 }{\insrsid4286309 In general,}{\insrsid3958359 FDA applies its existing rules, such as regulations and policies governing }{\insrsid14638439 conventional }{\insrsid3958359 foods}{\insrsid14638439 , food additives}{\insrsid12543417 , dietary supplements, }{\insrsid3958359 medical foods}{ \insrsid13859916 , foods for special dietary use}{\insrsid3958359 and}{\insrsid14638439 even, if necessary,}{\insrsid3958359 drugs, to functional}{\insrsid14638439 foods on a \'93case by case basis,}{\insrsid3958359 \'94}{\insrsid14638439 depending on t}{\insrsid4090920 he intended use of the product,}{\insrsid14638439 how it is marketed}{\insrsid4090920 , and the specific claims that are made on its labels.}{\cs16\super\insrsid3958359 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\cf1\insrsid16143335 Center for Science in the Public Interest Report, }{\i\cf1\insrsid16143335 Functional Foods: Public Health Boon or 21st Century Quackery?}{\cf1\insrsid16143335 (Mar. 1999), }{\i\cf1\insrsid16143335\charrsid5647136 available at}{\cf1\insrsid16143335 http://}{\field\flddirty{\*\fldinst {\insrsid16143335\charrsid9782123 HYPERLINK "http://www.cspinet.org/reports/functional_foods/index.html" }{\insrsid16143335\charrsid9782123 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b0200000017000000340000007700770077002e0063007300700069006e00650074002e006f00720067002f007200650070006f007200740073002f00660075006e006300740069006f006e0061006c005f0066006f006f00640073002f0069006e006400650078002e0068007400 6d006c000000e0c9ea79f9bace118c8200aa004ba90b7600000068007400740070003a002f002f007700770077002e0063007300700069006e00650074002e006f00720067002f007200650070006f007200740073002f00660075006e006300740069006f006e0061006c005f0066006f006f00640073002f0069006e0064 00650078002e00680074006d006c000000}}}{\fldrslt {\cs17\insrsid16143335\charrsid9782123 www.cspinet.org/reports/functional_foods/index.html}}}{\insrsid16143335 [hereinafter CSPI Report]; }{\i\insrsid16143335\charrsid3419455 see also}{\insrsid16143335 American Dietetic Association Reports, }{\i\insrsid16143335 Position of the American Dietetic Association: Functional Foods}{\insrsid16143335 , 104 }{\scaps\insrsid16143335\charrsid3419455 J. Am. Diet. Assn}{\insrsid16143335 . 814, 815 (2004), }{ \i\insrsid16143335 available at}{\insrsid16143335 }{\insrsid16143335\charrsid3419455 http://www.webdietitians.org/Public/GovernmentAffairs/92_adap1099.cfm}{\insrsid16143335 [hereinafter ADA Report].}}}{\insrsid3958359 Thus, }{\insrsid2051014 there is no coherent policy for dealing with functional foods}{\insrsid8218779 , and there are no guidelines telling people how much of a particula r functional food they should be consuming per serving or per day, depending on different factors like age, weight, or overall health status}{\insrsid12142507 , whether functional foods or the ingredients they contain adversely interact with particular drugs, or for what duration functional foods or ingredients should be used}{\insrsid2051014 .}{\cs16\super\insrsid8218779 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 For instance, while chocolate may prove to be a functional food in that it may reduce cholesterol, this doesn\rquote t mean that people should eat ten servings of chocolate per day, as it still contains high amounts of calories, sugar and fat. If chocolate were proven scientifically to aid in the reduction of cholesterol (and thus, to be a functional food), there would be no regulations under the current system, forcing manufacturers to label it with suggested serving sizes in order to obtain these health benefits without going overboard. Moreover, a fortified junk food is still a junk food, even tho ugh it may have one ingredient that is beneficial to one\rquote s health. Ultimately, no functional food is a \'93magic bullet\'94 or a substitute for overall good health habits. }{\i\insrsid16143335\charrsid4946901 See}{\insrsid16143335 Hasler, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 4, at 3779.}}}{\insrsid2051014 And, more importantly, }{\insrsid3958359 whether a manufacturer attempts to market a functional food as a conventional food, }{\insrsid12543417 a food additive}{ \insrsid11941396 , }{\insrsid3958359 a dietary supplement, a drug or a medical food will be crucial in determining how FDA will }{\insrsid14620580 eventually }{\insrsid3958359 regulate it.}{\cs16\super\insrsid3958359 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See, e.g.,}{\insrsid16143335 CSPI Report, } {\i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid3958359 }{\insrsid4286309\charrsid4286309 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid3958359 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13069602 {\*\bkmkstart _Toc132795383}C}{ \insrsid6947795 . Functional Food v. Dietary Supplement?{\*\bkmkend _Toc132795383} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2051014 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3958359 \tab }{\insrsid14620580 One source of confusion in determining how functional foods should be regulated, lacking a regulatory category of their own, is whether a particular product is a conventional food or a dietary supplement. }{\insrsid3958359 Congress enacted the Dietary Supplement Health and Education Act (DSHEA) in 1994}{\insrsid9198561 .}{\insrsid2051014 }{\insrsid11995418 The DSHEA re}{\insrsid13113307 gulates dietary supplements as f}{\insrsid11995418 oods, not as food additives, defining }{\insrsid11941396 a dietary supplement}{\insrsid11995418 as }{\insrsid11941396 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid4946901 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid11941396 a product (other than tobacco) that is intended to supplement the diet and that bears or contains one or more of the following dietary ingredients: a }{\insrsid11995418 vita}{\insrsid11941396 min}{\insrsid11995418 ,}{\insrsid11941396 a mineral}{\insrsid11995418 ,}{\insrsid11941396 an herb}{\insrsid11995418 or other}{\insrsid11941396 botanical, an amino acid, a dietary substance}{\insrsid11995418 for use by man to supplement the diet by increasing the}{\insrsid11941396 total dietary intake, or a concentrate, metabolite, constituent, extract, or }{\insrsid11995418 combination}{\insrsid11941396 s of these ingredients}{\insrsid11995418 .}{\cs16\super\insrsid11995418 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11995418 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7 321(ff) (2002); }{ \i\insrsid16143335 see also}{\insrsid16143335 42 U.S.C. 287c-11 (2002).}}}{\insrsid11995418 }{\insrsid11941396 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid11941396 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid11941396 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12543417 {\insrsid10690479 Dietary supplements are intended for ingestion in pill, capsule, tablet or liquid form, are not represented for use as conventional foods or as the sole item of a meal or diet, and are labeled as dietary supplements. }{\insrsid13113307 Importantly, }{ \insrsid10690479 they}{\insrsid2051014 are}{\insrsid11995418 }{\insrsid2051014 exempted}{\insrsid14620580 under the DSHEA}{\insrsid2051014 from the approval requirements subject to food additives. }{\insrsid12543417 Under the FDCA, manufacturers must obtain pre-market approval for food additives, or demonstrate that such ingredients are Generally Recognized }{\insrsid10631722 as}{\insrsid12543417 Safe (GRAS). Demonstrating that a food ingredient is GRAS means that the manufacturer must publicly document that the product has been consumed, that the range of the consumption is the same historically, and that the literature does not indicate adverse effects. And if a manufacturer does not consider the ingredient to be GRAS or FDA challenges its GRAS determination, the manufacturer must submit a food additive petition establ ishing the ingredient\rquote s safety under the conditions of its expected use before FDA will grant approval (which is usually a quite lengthy process).}{\cs16\super\insrsid12543417 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12543417 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid4946901 See}{ \insrsid16143335 21 U.S.C. \'a7 348 (2002).}}}{\insrsid12543417 }{\insrsid13113307 Instead}{\insrsid4861520 of following these procedures}{\insrsid13113307 , a manufacturer of a dietary supplement }{\insrsid10753150 that contains a new dietary in gredient (meaning one that was not marketed in the US before October 15, 1994) }{\insrsid13113307 must notify FDA seventy-five days before marketing and provide the agency with substantiation demonstrating that the new dietary ingredient can reasonably be expected to be safe.}{\cs16\super\insrsid13113307 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at \'a7 350(b)}}}{\insrsid13113307 }{\insrsid10753150 This submission is a }{\insrsid4946901 pre-market }{\insrsid10753150 notification, rather than a pre}{\insrsid14620580 -}{\insrsid4946901 market authorization}{ \insrsid10753150 as would be the case for a food additive.}{\cs16\super\insrsid10753150 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 190.6 (2005).}}}{\insrsid10753150 }{\insrsid12543417 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12543417 {\insrsid12543417 T}{\insrsid11995418 he labels of dietary supplements }{\insrsid12543417 may}{\insrsid11995418 bear }{\insrsid10690479 certain claims known as }{\insrsid11995418 structure/function claims}{\insrsid10690479 (see}{\insrsid8992321 discussion}{\insrsid10690479 }{\i\insrsid10690479 infra}{\insrsid10690479 }{\insrsid8992321 Section IV.B. }{\insrsid10690479 for a more complete discussion of structure/function claims)}{\insrsid11995418 without FDA }{\insrsid10753150 pre-}{\insrsid11995418 approval (in contrast to health claims which require pre-approval by FDA after significant scientific agreement about a diet-disease relationship), so long as }{\insrsid10753150 the manufactu rer notifies FDA within thirty days of marketing the product that displays the claim and so long as }{\insrsid11995418 these claims are accompanied by a disclaimer}{\cs16\super\insrsid10753150 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Specifically, the claim must be accompanied by the following disclaimer: \'93}{\i\insrsid16143335 This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.}{ \insrsid16143335 \'94}}}{\insrsid11995418 that the statements have not been evaluated by the FDA. }{\insrsid12543417 Moreover, i}{\insrsid10690479 n order to take a dietary supplement}{\insrsid2051014 off t he market, the FDA must establish that the product \'93presents a significant or unreasonable risk of illness or injury\'94 or poses an \'93imminent hazard }{\insrsid12386570 to public health or safety.\'94}{\cs16\super\insrsid12386570 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7\'a7\'a7 342 (f)(1)(A)-(C) (2002). Note that FDA must establish substantial harm to the public health and prevail in court as a result of these statutory requirements.}}}{\insrsid12386570 Thus, with the burden of proof on the FDA, it often takes years before a FDA can have a product taken off the market, and the agency instead issues mere public warnings about dangerous sup}{\insrsid10690479 plements in most cases. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11941396 {\insrsid12386570 Manufacturers, as a result, often try to market functional foods as dietary supplements rather than }{\insrsid6569232 as }{\insrsid12386570 conventional foods with added ingredients}{\insrsid6569232 ,}{\insrsid12386570 in order to take advantage of the more relaxed requirements applicable to dietary supplements. If a manufacturer markets a functional food as a dietary supplement, it will not have to prove that added ingredients are GRAS, and the FDA would have to prove in court that the product was harmful before it could be taken off the market. }{\insrsid4340155 In addition, under current FDA policy, the scope of }{\insrsid10690479 structure/function claims is}{\insrsid4340155 more limited for foods than for dietary supplements. Specifically, str ucture/function claims for foods must relate to the nutritive value of the component which is a subject of a claim, whereas FDA allows structure/function claims for dietary supplements whether or not the relevant component has nutritive value.}{ \cs16\super\insrsid4340155 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 CSPI report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25; }{\i\insrsid16143335\charrsid10027158 see also}{\insrsid16143335 FDA/Center for Food Safety and Applied Nutrition (CFSAN)/Office of Food Labeling, Nutrition & Dietary Supplements, }{\i\insrsid16143335 Structure/Function Claims}{\insrsid16143335 (June 9, 2004), }{\i\insrsid16143335\charrsid10027158 available at}{ \insrsid16143335 }{\insrsid16143335\charrsid15809352 http://www.cfsan.fda.gov/~dms/labstruc.html}{\insrsid16143335 . }}}{\insrsid6569232 Thus}{\insrsid4340155 , diet ary supplement manufacturers have a competitive advantage over food manufacturers in the regulatory process, making marketing as a dietary supplement even more attractive than marketing a product as a conventional food.}{\insrsid6947795\charrsid4340155 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6569232 {\insrsid12386570 \tab Take, for example, the manufactur}{\insrsid14908416 ers of BENECOL\'ae}{\insrsid3824412 and Take Control}{ \insrsid14908416 \'ae}{\insrsid3824412 (}{\insrsid14908416 spreadable }{\insrsid3824412 margarine products promoted for their cholesterol-lowering functional ingredients), who initially attempted to market their products as dietary supplements in order to avoid compliance with the law requiring that ingredients be approved as food additives or GRAS.}{\insrsid12386570 }{\insrsid3824412 FDA put its foot down and said that these products could not be marketed as dietary supplements}{\insrsid14908416 since they resembled}{\insrsid2457483 ,}{ \insrsid14908416 and would be used as}{\insrsid2457483 ,}{\insrsid14908416 conventional foods.}{\cs16\super\insrsid2457483 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Although one of these company\rquote s initial packages identified the product as a dietary supplement, this packaging also included statements promoting the flavor and texture of the product, along with pictures of it in uses common for butter or margarine. }{ \i\insrsid16143335\charrsid10027158 See}{\insrsid16143335 United States General Accounting Office Report to Congressional Committees, }{\i\insrsid16143335 FOOD SAFETY Improvements Needed in Overseeing the Safety of Dietary Supplements and \'93 Functional Foods,\'94}{\insrsid16143335 at 14 (GAO/RCED-00-156 July 2000), }{\i\insrsid16143335\charrsid10027158 available at}{\insrsid16143335 }{\insrsid16143335\charrsid10027158 http://www.nutriwatch.org/20pdfs/gaoff.pdf}{\insrsid16143335 [hereinafter GAO Report]. }}}{\insrsid14908416 }{\insrsid10027158 }{\insrsid14908416 This being the case, the}{\insrsid3824412 plant stanol and sterol esters}{\insrsid14908416 (i.e., the functional ingredients) that they, respectively,}{ \insrsid3824412 contain would be consid}{\insrsid14908416 ered }{\insrsid3824412 unapproved f}{\insrsid14908416 ood additives, }{\insrsid3824412 which require FDA pre-market approval. The manufacturers decided, in response, t}{\insrsid2457483 o market their products as conventional foods after determining that the added ingredients (the stanols/sterols) were GRAS}{\insrsid14908416 .}{\insrsid8218779 The FDA subsequently approved health claims for }{\insrsid7740252 certain foods containing plant sterol or}{\insrsid8218779 plant stanol esters and their roles in reducing the risk of coronary heart disease}{\insrsid4026516 .}{\cs16\super\insrsid7740252 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4026516 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid4026516 See}{ \insrsid16143335\charrsid12403015 }{\insrsid16143335\charrsid4026516 Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease; Interim Final Rule}{\insrsid16143335 , 65 Fed. Reg. 54,685 (September 8, 2000).}}}{\insrsid12403015 }{\insrsid3824412 According to the Center for Science }{\insrsid7602724 in the Public Intere}{\insrsid10027158 st (CSPI), }{\insrsid6569232 \'93}{\insrsid10027158 the extent to which }{\insrsid7602724 FDA will enforce the law and prevent food companies from marketing functional foods as dietary supplements in order to avoid FDA requirements intended to insure the safety of food ingredients and the validity of claims on food labels\'94 is unknown, and \'93\'85 there is no indication that the agency is willing to devote the resources necessary to take enforcement action in cases that raise similar issues [to the }{\insrsid6569232 case of }{\insrsid10027158 BENECOL\'ae/}{\insrsid6569232 }{ \insrsid10027158 TakeControl\'ae].}{\insrsid6569232 \'94}{\cs16\super\insrsid3824412 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI report, }{\i\insrsid16143335\charrsid12403015 supra}{\insrsid16143335 note 25.}}}{\insrsid12218242 }{\insrsid9969817 \tab }{\insrsid7602724 \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10027158 {\insrsid9969817 In sum, }{\insrsid8485047 one author notes that,}{\insrsid9969817 \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7602724 {\insrsid7602724 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12403015 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9969817 [t]here are }{\insrsid10690479 striking differences between dietary supplements and functional foods. Whereas dietary supplements, herbs in particular, are considered time-tested but are in most cases scientifically unpro ven, functional foods are components of the normal human diet that are increasingly shown by rigorous science to be inherently valuable for maintaining human health. Whereas herbal sales skyrocket and feed false public perception of the irrelevance of sc ience to health, the era of functional foods promises to propel nutritional science to the forefront of preventive medicine for the }{\insrsid9969817 most common diseases of humans.}{\cs16\super\insrsid9969817 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Charles H. Halsted, }{\i\insrsid16143335 Dietary supplements and functional foods: 2 sides of a coin?}{\insrsid16143335 77 Am. J. Clin. Nutr.; 1001S, 1006S (2003).}}}{\insrsid10690479 }{\insrsid14620580 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14620580 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14620580 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14620580 {\insrsid10690479 Yet despite these differences}{\insrsid7694468 , and due to}{\insrsid10690479 the lack of recognition for the term \'93 functional food,\'94 many manufacturers are still trying to evade the stricter regulatory requirements of conventional foods by marketing their pr}{\insrsid3028846 oducts as dietary supplements. }{\insrsid5134128 Unless the FDA is prepared to step in to take enforcement action in such cases, it seems necessary to enact more precise regulations specifying the difference between dietary supplements and functional food}{\insrsid9969817 s}{\insrsid5134128 .}{ \insrsid10690479 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2457483 {\insrsid7602724 Certain groups, however, }{\insrsid3028846 take the opposite stance, expressing the sentiment that there should not, in fact, be different safety standards for dietary supplements and functional foods. The Research-based Dietary Ingredient Association, representing a group of large food and supplement companies, including Cargill, Galagen, General Nutrition, Monsanto, and Novartis, believes that \'93 the same ingredient, whether it goes into a dietary supplement or food should meet the same standard of safety.\'94}{\cs16\super\insrsid3028846 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 15. Presumably, this group would prefer that the \'93 same standard of safety\'94 would be the lower standard applicable to dietary supplements.}}}{\insrsid7694468 The American Dietetic Association (ADA) (representing nutrition professionals) and the CSPI (representing consumer interests) share this interest in a single safety standard for dietary supplements and functional foods. Perhaps having one standard would eliminate foods masquerading harmfully a}{\insrsid6569232 s dietary supplements}{\insrsid7694468 . }{\insrsid6569232 However, if the}{ \insrsid10379429 putative}{\insrsid7694468 single s}{\insrsid6569232 afety standard were}{\insrsid7694468 closer to the standard for conventional foods than to the laxer s}{\insrsid6569232 tandard for dietary supplements, then it may undermine the original purpose of the DSHEA as well.}{\insrsid7694468 }{\insrsid6569232 T}{\insrsid7694468 ightening up the standard fo}{\insrsid10379429 r dietary supplements would}{\insrsid7694468 }{ \insrsid10379429 presumably }{\insrsid7694468 harm the dietary supplement manufacturers and }{\insrsid7602724 eliminate the benefits that they lobbied so hard to achieve in the first place through passage of the DSHEA}{\insrsid7694468 . So it seems, in the case of dietary supplements versus functional foods, what\rquote s good for the goose may not be good for the gander. }{\insrsid3028846 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14102768 {\*\bkmkstart _Toc132795384}D}{ \insrsid4988548 . The Future: Biotech Functional Foods?{\*\bkmkend _Toc132795384} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9047468 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9047468 \tab }{\insrsid6569232 Another source of controversy surrounding the future of functional foods stems from the ever-growing field of biotechnology. }{\insrsid11162358 Many people in the United States and around the globe continue to object to genetically modified \'93biotech \'94 foods. To try to get consumers to accept genetically modified products, the }{\insrsid6569232 biotech }{\insrsid11162358 industry is starting to turn to the so-called \'93second generation\'94}{\cs16\super\insrsid8147303 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 The so-called \'93first generation\'94 of genetically engineered crops was developed primarily to benefit the growers.}}}{\insrsid11162358 of genetically modified crops \endash functional foods.}{\cs16\super\insrsid11162358 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Corporate Watch, }{ \i\insrsid16143335 The Industry Strikes Back, Functional Foods: Good for Monsanto\rquote s Health}{\insrsid16143335 , GE Briefing Series (May 2000), }{\i\insrsid16143335\charrsid12403015 available at}{\insrsid16143335 http://www.corporatewatch.org. }}}{ \insrsid11162358 Biotechnology is increasingly being used to deliver the \'93perceived consumer benefit inherent in the functional foods trend.\'94}{\cs16\super\insrsid11162358 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid1520787 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1520787 {\insrsid4946307 Agricultural biotechnology }{\insrsid6569232 h}{\insrsid4946307 as been defined as \'93 the use of living plant organisms, or parts thereof, to produce food and feed products such as insect-resistant corn, to develop processes li ke the manufacturing of biologics by tobacco, and to provide services such as, bioremediation of heavy metal contamination using genetically engineered poplars.\'94}{\cs16\super\insrsid4946307 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Michael C. Falk, et. al., }{\i\insrsid16143335 Food Biotechnology: Benefits and Concerns}{\insrsid16143335 , 132 }{\scaps\insrsid16143335\charrsid12403015 J. Nutr}{\insrsid16143335 . 1384, 1384 (2002).}}}{\insrsid4946307 Modifications can be made to crop plants to either benefit the producer (input traits), or t o benefit the consumer (output traits). Input traits include modifications that protect the crop from either abiotic or biotic stress or increase total crop yiel}{\insrsid16256753 d, whereas output traits include modifications that can confer advantageous health benefits to consumers.}{\cs16\super\insrsid16256753 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id}{\insrsid16143335 . at 1385.}}}{\insrsid16256753 }{\insrsid4605519 Although many publicized examples of applying biotechnology to agriculture have involved insecticides and protection against other biological insults, biotechnology is slowly being used to produce plants with a whole range of output traits, i ncluding increased nutritional value, medicinal properties, industrial utility, and novel taste and esthetic appeal.}{\cs16\super\insrsid4605519 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid4605519 For example, carotenoids (which can be found in papaya, tomatoes, kale and spinach) are a class of nutrients thought to be associated with decreased risk for certain cancers and macular degeneration. Beta-carotene}{\insrsid2629602 , specifically,}{ \insrsid4605519 has been expressed in a genetically engineered rice cultivar called Golden Rice, by addition of genes for three enzymes (two genes from a daffodil and one from the bacteria }{\i\insrsid4605519 Erwinia uredovora}{\insrsid4605519 ).}{ \cs16\super\insrsid11544159 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 1386.}}}{\insrsid4605519 Golden Rice}{\insrsid12930486 supposedly}{\insrsid4605519 has the potential to benefit people in developing countries by decreasing malnutrition and blindness associated with vitamin A deficiency. Yet there are many }{\insrsid12930486 unanswered questions about this product}{\insrsid4605519 , and \'93 there have been questions raised about the effectiveness of this rice because of the many biological, cultural, and dietary barriers that must be overcome.\'94}{\cs16\super\insrsid4605519 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 , citing, M. Nestle, }{\i\insrsid16143335 Genetically engineered \'93golden\'94 rice unlikely to overcome vitamin A deficiency}{\insrsid16143335 . 101 }{\scaps\insrsid16143335\charrsid12403015 J. Am. Diet. Assoc.}{\insrsid16143335 , 289-290 (2001).}}}{\insrsid11544159 Other nutrients found in plants with purp}{\insrsid12930486 orted health benefits could similarly}{\insrsid11544159 be selectively }{\insrsid10631722 over-expressed}{\insrsid11544159 to therapeutic levels.}{ \insrsid9047468 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9047468 {\insrsid11544159 \tab In addition, biotechnology has the potential to produce vaccines in plants by introducing genes that express a protein antigen in crops such as corn, potatoes and bananas that, when eaten, will elicit an immune respo nse and provide protection against a subsequent challenge from pathogens.}{\cs16\super\insrsid11544159 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 , citing S.J. Streatfield. et al., }{\i\insrsid16143335 Plant-based vaccines; unique advantages}{\insrsid16143335 , 19 }{\scaps\insrsid16143335\charrsid12403015 Vaccine}{\insrsid16143335 , 2742-2748 (2001).}}}{\insrsid11544159 }{\insrsid12930486 This c}{\insrsid2629602 ould potentially facilitate }{ \insrsid12930486 protection against serious illness for many people who previously did not have access to expensive vaccinations, if these types of crops}{\insrsid2629602 could be cheaply mass-produced and distributed.}{\insrsid11544159 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11544159 {\insrsid11544159 \tab Biotechnology foods, whether or not considered \'93functional foods,\'94 remain a somewhat controversial area in the eyes of consumers. There are many consumers who are still completely opposed to genetically modified ing redients in their foods, although most are unaware of the extent to which crops derived from biotechnology are already in the marketplace. }{\insrsid10631722 Anti-biotechnology}{\insrsid14444308 sentiments are very strong in Europe, and European import restrictions are one of the biggest barriers facing the acceptance of food biotechnology.}{\cs16\super\insrsid14444308 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Falk, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 44, at 1388 (noting that there are social and cultural reasons for the opposition in Europe (including sensational and negative media coverage, general support for small farms and open spaces, and a general opposition to foreign producers and their products), as well as political and economic reasons (such as past food crises like BSE undermining confidence in the government and the food supply, limited educational outreach by the food industry, public leaders, academia and consumers, and ant i-globalization sentiments and non-tariff trade barriers)).}}}{\insrsid528002 In sharp contrast, countries like China and India are \'93 actively developing this technology, and their support for biotechnology may turn the tide in global political acceptance.\'94}{\cs16\super\insrsid528002 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id}{\insrsid16143335 . at 1389.}}}{ \insrsid11162358 Moreover, even if the people who needed them most both accepted and could afford biotech functional food crops, widespread adoption might}{\insrsid10119235 , as one activist group put it,}{\insrsid11162358 \'93 simply lead to an even bigger dependence on the companies providing them}{\insrsid12930486 }{\insrsid11162358 \'85}{\insrsid12930486 }{\insrsid11162358 [which will] serve to concentrate power still further in the hands of a few giant multinational corporations}{\insrsid12930486 }{\insrsid11162358 \'85}{\insrsid12930486 }{\insrsid11162358 controlling the whole world\rquote s food supply.}{\insrsid10119235 \'94}{ \cs16\super\insrsid10119235 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Corporate Watch, }{\i\insrsid16143335 supra}{\insrsid16143335 note 42.}}}{\insrsid2629602 }{\insrsid11162358 \par }{\insrsid11544159 \tab How will biotechnology }{\insrsid10119235 functional }{\insrsid11544159 foods be regulated? There are }{\insrsid1143130 three}{\insrsid11544159 federal entities that play}{\insrsid7370337 major}{\insrsid11544159 roles in the curr}{\insrsid1143130 ent process, including }{\insrsid11544159 the Animal Plant Health Inspection Serve (APHIS) of the USDA, the FDA, and the Environmental Protection Agency (EPA)}{\insrsid12930486 .}{\cs16\super\insrsid7370337 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 In addition, the National Institutes of Health (NIH) is involved at the laboratory research level; it has published guidelines to specify practice s for working with recombinant DNA and organisms containing it. The NIH Guidelines for Research Involving Recombinant DNA Molecules are widely accepted and followed. (}{\i\insrsid16143335\charrsid12403015 See}{\insrsid16143335 Falk, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 44, at 1387.}}}{\insrsid11544159 }{\insrsid7370337 In short, the }{\insrsid1143130 FDA ensures that foods made through biotechnology are safe for humans and animals to eat, the USDA makes sur e that the plants being genetically engineered are safe to grow, and the EPA ensures that any pesticides introduced into the plants are safe for human and animal consumption and for the environment.}{\cs16\super\insrsid1143130 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1143130 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335\charrsid12403015 See}{\insrsid16143335 Linda Bren, }{\i\insrsid16143335 Genetic Engineering: The Future of Foods?,}{\insrsid16143335 37 }{\scaps\insrsid16143335\charrsid12403015 FDA Consumer Magazine}{\insrsid16143335 No. 6 (Nov.-Dec. 2003).}}}{\insrsid1143130 }{\insrsid8660500 Relevant to this discussion, the FDA treats foods developed via biotechnology like other new foods and bases its safety assessment on the premise that a new food should be \'93as safe as\'94 the food from which it was developed. The FDA does }{\i\insrsid8660500 not}{\insrsid8660500 have a mandatory pre}{\insrsid12930486 -}{\insrsid8660500 market approval system in place for food products developed from biotechnology}{\insrsid8147303 (consultation with FDA is voluntary on the part of developers}{\insrsid1143130 , according to FDA\rquote s statement of policy issued in 1992}{\cs16\super\insrsid1143130 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \insrsid16143335\charrsid16612369 Statement of Policy: Foods Derived from New Plant Varieties}{\insrsid16143335 , 57 Fed. Reg. 22,984 }{\cf1\insrsid16143335 (}{\cf1\insrsid16143335 May 29, 1992). This policy provided guidance to industry on scientific and regulatory issues related to human foods and animal feeds derived from new plant varieties (including those developed using recombinant DNA technology). Further, in June 1996, FDA provided additional guidance to industry on procedures for the voluntary consultations described in the 1992 policy statement. These procedures serve to \'93 describe a process in which a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioe ngineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food; FDA evaluates the submission and responds to the developer by letter.\'94 }{\i\cf1\insrsid16143335\charrsid16612369 See}{\cf1\insrsid16143335 FDA/CFSAN/Office of Food Additive Safety, }{\i\cf1\insrsid16143335 List of Completed Consultations on Bioengineered Foods}{\cf1\insrsid16143335 (Nov. 2005), }{\i\cf1\insrsid16143335\charrsid16612369 available at}{\cf1\insrsid16143335 http://}{ \cf1\insrsid16143335\charrsid7370337 www.cfsan.fda.gov/~lrd/biocon.html}{\i\cf1\insrsid16143335 . }}}{\insrsid8147303 )}{\insrsid8660500 , because it does not consider the method of production of such foods to raise significant safety issues.}{ \cs16\super\insrsid8660500 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 Falk, }{\i\insrsid16143335\charrsid16612369 supra}{\insrsid16143335 note 44, }{\insrsid16143335\charrsid16612369 at}{\insrsid16143335 1388.}}}{\insrsid8660500 However, even though the pre}{\insrsid12930486 -}{ \insrsid8660500 mar}{\insrsid8147303 ket review process is voluntary, the legal requirements that the foods have to meet are not}{\insrsid12930486 .}{\cs16\super\insrsid2895574 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2895574 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Bren, }{\i\insrsid16143335 supra}{\insrsid16143335 note 54.}}}{\insrsid2895574 And}{\insrsid8660500 every company that has commercialized a new }{\insrsid2895574 biotechnologically-developed product has, in fact,}{\insrsid8660500 submi}{ \insrsid8147303 t}{\insrsid2895574 ted its data to FDA for review.}{\cs16\super\insrsid2895574 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Falk, }{\i\insrsid16143335 supra}{\insrsid16143335 note 44, at 1388.}}}{\insrsid2895574 Thus,}{ \insrsid14444308 food}{\insrsid2895574 s derived from biotechnology have been}{\insrsid14444308 more heavily regulated than any other new foods.}{\insrsid1143130 }{\insrsid2895574 }{\insrsid7370337 In January 2001, FDA issued a proposed rule that would require developers to submit a scientific and regulatory assessment of a bioengineered food 120 days before it is marketed; FDA also recommended that developers continue consulting with the agency before submitting this required pre}{\insrsid4916812 -}{\insrsid7370337 market notice.}{\cs16\super\insrsid7370337 \chftn {\footnote \pard\plain \s30\ql \li0\ri0\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2895574 \f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\f0\super\insrsid16143335\charrsid5988281 \chftn }{\f0\insrsid16143335 }{\i\f0\insrsid16143335 See}{\f0\insrsid16143335 }{\f0\insrsid16143335\charrsid12614088 Premarket Notice Concerning Bioengineered Foods}{\insrsid16143335 ,}{\f0\insrsid16143335\charrsid2895574 66 F}{\f0\insrsid16143335 ed. }{\f0\insrsid16143335\charrsid2895574 R}{\f0\insrsid16143335 eg.}{\f0\insrsid16143335\charrsid2895574 4706 (January 18, 2001).}}}{\insrsid7370337 The comment period for the proposed rule ended on April 3, 2001.}{\insrsid4916812 Whether or not pre-market notice is made mandatory, biotechnology functional foods still must comply with all of the regulations applicable to conventional foods, described }{\i\insrsid4916812 infra}{\insrsid4916812 .}{\insrsid4916812\charrsid4916812 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13657848\charrsid13657848 {\*\bkmkstart _Toc132795385 }IV. Claims That Can Be Made When Marketing Functional Foods{\*\bkmkend _Toc132795385} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13657848 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3742409 \tab Because}{\insrsid13657848 }{\insrsid3742409 most functional foods end up being regulated as conventional foods }{\insrsid5335017 in the U.S.}{\insrsid13657848 , there are a variety of different claims that can be made as to their effects on health or the human body.}{\cs16\super\insrsid13657848 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 This section will explore only those claims that are directly related to the \'93functional\'94 aspect of a food, and thus Nutrient Content Claims, while available in general as a type of claim for conventional foods, have been omit ted from the discussion.}}}{\insrsid5335017 Since}{\insrsid13657848 the standards for the different kinds of claims vary, it is important, both as a manufacturer hoping to market a functional food and as a potential consumer}{\insrsid5988281 wanting to get the most out of functional food labeling}{\insrsid13657848 , to}{\insrsid4916812 understand exactly what}{\insrsid13657848 these claims really mean.}{\insrsid5335017 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13657848\charrsid13657848 {\*\bkmkstart _Toc132795386 }A. Health Claims{\*\bkmkend _Toc132795386} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13657848 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13657848 \tab }{\insrsid1402341 Health claims are claims that are made on the label or in the labeling of a food, including a dietary supplement, that expressly or by implication characterize the relationship of any substance to a disease or health-related condition.}{ \cs16\super\insrsid16415285 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.14(a)(1) (2005).}}}{\insrsid1402341 }{\insrsid13657848 According to the FDA, health claims \'93describe a relationship between a food, food componen t, or dietary supplement ingredient, and reducing risk of a disease or health-related condition}{\insrsid6423681 .\'94}{\cs16\super\insrsid6423681 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements, }{\i\insrsid16143335 Claims That Can Be Made for Conventional Foods and Dietary Supplements}{\insrsid16143335 (Sept. 2003), }{\i\insrsid16143335\charrsid12614088 available at}{\insrsid16143335 http://www.cfsan.fda.gov/~dms/hclaims.html [hereinafter FDA }{\i\insrsid16143335 Claims}{\insrsid16143335 ]. }}}{\insrsid6423681 Health claims thus have two essential components \endash a substance and a disease or health-related condition; if either component is missing then the product at issue is not eligible for a health claim. }{\insrsid3824412 Particularly relevant is the idea that \'93FDA\rquote s authority to approve health claims concerning the relationship of }{\insrsid5988281 a nutrient to a disease has []}{\insrsid3824412 been used by some companies as a mechanism to gain approval for what could be characterized as claims for functional foods.\'94}{\cs16\super\insrsid3824412 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid3824412 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3824412 {\insrsid5988281 What is the purpose}{\insrsid9117855 of a health claim? According to FDA, health claims were instituted by Congress \'93so that food manufacturers could voluntarily, by the use of the food label and labeling, let consumers know about important beneficial food components that had the ability to reduce disease risk when integrated into the total daily diet.\'94}{ \cs16\super\insrsid9117855 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN, }{\i\insrsid16143335 Consumer Health Information for Better Nutrition Initiative: Task Force Final Report}{\insrsid16143335 (July 10, 2003), }{\i\insrsid16143335\charrsid12614088 available at}{\insrsid16143335 http://www.cfsan.fda.gov/~dms/nuttftoc.html [hereinafter FDA }{\i\insrsid16143335\charrsid16277974 Task Force Final Report}{\insrsid16143335 ].}}}{\insrsid15075840 Unlike drug claims, which focus on diagnosing, treating, curing or mitigating disease, health claims focus on }{\i\insrsid15075840\charrsid15075840 reduction}{\insrsid15075840 }{\i\insrsid15075840\charrsid5988281 of risk}{\insrsid15075840 as part of one\rquote s total diet.}{\insrsid1329902 In order to avoid more stringent regulation as a drug (including the possibility of the requirement for FDA approval of a new drug application prior to marketing), health claims for foods should not represent th at they are intended to cure, mitigate, treat or prevent any disease.}{\cs16\super\insrsid1329902 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid12614088 See}{\insrsid16143335 IFT Expert Report,}{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 15.}} }{\insrsid3824412 }{\insrsid9117855 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9117855 {\insrsid6423681 FDA\rquote s regulations establish general standards for the use of health claims, including, }{\i\insrsid6423681 inter alia}{\insrsid6423681 : \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5848740 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6423681 (1) limiting authorization of health claims only to those categories for which there is \'93significant scientific agreement\'94 that the relevant diet-disease relationship is supported by the scientific evidence; (2) establishing disqualifying levels for total fat, saturated fat, cholesterol, and sodium, above which foods are disqualified fro m bearing any health claims; (3) for the specific substance that is the subject of a health claim, setting a threshold level for the amount of such substance in the food, that is either sufficiently low or sufficiently high to support the health claim; (4 ) requiring that foods bearing health claims have some minimal nutritional value; and (5) requiring that health claims identify those factors, other than dietary intake of the substance, that affect the diet-disease relationship.}{ \cs16\super\insrsid3100192 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Federal Trade Commission, }{\i\insrsid16143335 Enforcement Policy Statement on Food Advertising}{\insrsid16143335 (May 1994), }{\i\insrsid16143335\charrsid12614088 available at}{\insrsid16143335 http://www.ftc.gov/bcp/policystmt/ad-food.htm (internal citations omitted) [hereinafter FTC Enforcement Policy Statement], citing 21 C.F.R. \'a7 101.14 }{\i\insrsid16143335 et. seq.}{\insrsid16143335 (2005).}}}{\insrsid3100192 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3100192 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3100192 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4465456 {\insrsid9201228 \tab Thus far, health claims have been authorized for the relationship between the following fo}{\insrsid5988281 ods in conventional or dietary supplement form}{\insrsid9201228 and disease or health-related conditions: calcium and osteoporosis}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.72 (2003).}}}{\insrsid9201228 ; dietary lipids and cancer}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.73 (2003).}}}{\insrsid9201228 ; sodium and hypertension}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.74 (2003).}}}{\insrsid9201228 ; dietary saturated fat and cholesterol and risk of coronary heart disease}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid4069121 See}{\insrsid16143335 }{\insrsid16143335\charrsid4069121 21}{\insrsid16143335 C.F.R. \'a7 101.75 (2003). }}}{\insrsid9201228 ; fiber-containing grain products, fruits, and vegetables and cancer}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 21 C.F.R. \'a7 101.76 (2003).}}}{\insrsid9201228 ; fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease;}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.77 (2003).}}}{\insrsid9201228 fruits a}{\insrsid3503566 nd vegetables and cancer}{\cs16\super\insrsid9201228 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.78 (2003).}}}{\insrsid3503566 ;}{\insrsid9201228 }{\insrsid8206979 folate and neural tube defects}{\cs16\super\insrsid8206979 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.79 (2003).}}}{\insrsid3503566 ;}{\insrsid8206979 dietary noncariogenic carbohydrate sweeteners and dental caries}{\cs16\super\insrsid8206979 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.80 (2003).}}}{\insrsid3503566 ;}{\insrsid8206979 soluble fiber from certain foods and risk of coronary heart disease (CHD)}{\cs16\super\insrsid8206979 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.81 (2003).}}}{\insrsid3503566 ;}{\insrsid8206979 soy protein and risk of coronary heart disease (CHD)}{\cs16\super\insrsid8206979 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.82 (2003).}}}{\insrsid3503566 ;}{\insrsid8206979 and plant sterol/stanol esters and risk of coronary heart disease (CHD).}{\cs16\super\insrsid8206979 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.83 (2003).}}}{\insrsid4465456 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3100192 {\insrsid8206979 FDA may go through one}{\insrsid3100192 of the following three routes in order to determine which health claims may be used in labeling for a food: (1) the Nutrition Labeling and Education Act of 19 90 (NLEA); (2) the Food and Drug Administration Modernization Act of 1997 (FDAMA); and (3) the FDA }{\i\insrsid3100192 Consumer Health Information for Better Nutrition Initiative}{\insrsid3100192 of 2003.}{\cs16\super\insrsid3100192 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid16673270 See}{ \insrsid16143335 FDA }{\i\insrsid16143335 Claims}{\insrsid16143335 , }{\i\insrsid16143335\charrsid16673270 supra}{\insrsid16143335 note 62.}}}{\insrsid3100192 \par }\pard\plain \s3\ql \li360\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin360\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3100192\charrsid3100192 {\*\bkmkstart _Toc132795387}1. The NLEA}{\insrsid14637773 of }{\insrsid14637773\charrsid14566914 1990}{\insrsid14637773 {\*\bkmkend _Toc132795387} \par }\pard\plain \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8352250 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6947795 Starting in 1985, FDA began to experiment with allowing health claims for conventional foods without requiring pre-market approval. This led to just a few truthful claims followed by tons of products \'93 claiming to cure almost every ailment under the sun.\'94}{\cs16\super\insrsid6947795 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\cf1\insrsid16143335 CSPI report, }{\i\cf1\insrsid16143335\charrsid16673270 supra}{\cf1\insrsid16143335 note 25.}}}{\insrsid6947795 Congress then passed legislation, }{\insrsid15075840 the 1990 Nutrition Labeling and Education Act}{\insrsid6947795 (NLEA), which permits }{\insrsid3503566 the making of }{\insrsid6947795 health claims that have been approved by the FDA}{\insrsid3958359 .}{\insrsid6947795 Health claims}{\insrsid14637773 may be used on labels to characterize the relationship between a food, food component or dietary ingredient (as well as a dietary supplement) and a disease, so long as the claims meet certain criteria and are authorized by an FDA }{\insrsid3503566 regulation (generally after }{\insrsid14637773 one}{\insrsid3503566 intending to make the health claim}{\insrsid14637773 has submitted a health claim petition). }{\insrsid1329902 In general, an approved health claim will state that in clusion of a substance in the diet on a regular basis \'93may help to reduce the risk of\'94 a particular disease.}{\cs16\super\insrsid1329902 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 , }{\i\insrsid16143335 e.g.}{\insrsid16143335 , IFT Expert Report, }{ \i\insrsid16143335\charrsid16673270 supra}{\insrsid16143335 note 16, }{\insrsid16143335\charrsid16673270 at}{\insrsid16143335 15.}}}{\insrsid1329902 }{\insrsid1402341 An example of a health claim is, \'93 calcium may help reduce the risk of osteoporosis.\'94 }{\insrsid14637773 This type of health claim will be authorized based on FDA\rquote s extensive review of the scientific literature, using the \'93significant scientific agreement\'94 standard to determine that the nutrient/disease relationship is well-established.}{\cs16\super\insrsid14637773 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 }}}{\insrsid738397 Specifically, FDA may promulgate regulations authori}{\insrsid3503566 zing health claims only if FDA \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid3503566 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid738397 determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is a signif icant scientific agreement among experts qualified by scientific training and experience to evaluate such claim}{\insrsid1402341 s, that the claim is supported }{\insrsid738397 by such evidence.}{\cs16\super\insrsid738397 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 U.S.C. \'a7 343(r)(3)(B)(i) (2002).}}}{\insrsid14310024 }{\insrsid3503566 \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3503566 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14310024 This basically means that evidence used to substantiate a claim cannot be chosen selectively to support a particular viewpoint}{\insrsid3503566 . }{\insrsid8352250 Significant}{\insrsid3503566 scientific agreement (SSA) doe}{\insrsid8352250 s }{ \i\insrsid8352250 not}{\insrsid8352250 }{\insrsid3503566 mean }{\insrsid8352250 consensus. Rather, FDA has described SSA according to the following: \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5848740 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid8352250 FDA\rquote s determination of when SSA has been achieved represents the Agency\rquote s best judgment as to whe ther qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confiden c e in the validity of a substance/disease relationship. SSA means that the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined. Application of the SSA standard is intended to be objective, in relying upon a body of sound and relevant scientific data; flexible, in recognizing the variability in the amount and type of data needed to support the validity of different substance/disease relationships; and re s ponsive, in recognizing the need to re-evaluate data over time as research questions and experimental approaches are refined. SSA does not require a consensus or agreement based on unanimous and incontrovertible scientific opinion. However, on the conti nuum of scientific discovery that extends from emerging evidence to consensus, it represents an area on the continuum that lies closer to the latter than to the former.}{\cs16\super\insrsid8352250 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN/Office of Special Nutritionals, }{\i\insrsid16143335 Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements}{\insrsid16143335 (Dec. 22, 1999), }{\i\insrsid16143335\charrsid5848740 available at}{\insrsid16143335 }{ \insrsid16143335\charrsid5988281 http://www.cfsan.fda.gov/~dms/ssaguide.html}{\insrsid16143335 . }}}{\insrsid8352250 \par }\pard\plain \ql \li360\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0\pararsid8352250 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid8352250 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3503566 {\insrsid14381063 It is }{\insrsid3503566 important to emphasize from the above}{\insrsid14381063 excerpt that }{\insrsid3503566 SSA}{ \insrsid14381063 is a }{\i\insrsid14381063 strong }{\insrsid14381063 standard for a manufacturer to have to meet in trying to get a health claim approv}{\insrsid3503566 ed. Consequently, SSA}{\insrsid14381063 has the potential to act as a roadblock to many unsubstantiated claims about foods that purport}{\insrsid3503566 , through the labels on their packaging}{\insrsid14381063 }{\insrsid3503566 and accompanying label information, }{\insrsid14381063 to be functional.}{\insrsid3503566\charrsid8352250 \par }\pard\plain \s3\ql \li360\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin360\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3100192\charrsid14637773 {\*\bkmkstart _Toc132795388}2. FDAMA}{\insrsid14637773\charrsid14637773 of 1997: Health Claims Based on Authoritative Statements{\*\bkmkend _Toc132795388} \par }\pard\plain \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14637773 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14637773 Health claims, under the Food and Drug Administration Modernization Act, ma}{\insrsid8809548 y also be authorized based on a current, published}{\insrsid14637773 \'93authoritative statement\'94 from a scient ific body of the US Government or the National Academy of Sciences.}{\cs16\super\insrsid738397 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 U.S. FDA/CFSAN/Office of Food Labeling, }{\i\insrsid16143335 Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body}{\insrsid16143335 , (June 11, 1998), }{\i\insrsid16143335\charrsid4150183 available at}{\insrsid16143335 http://www.cfsan.fda.govt/~dms/hclmguid.html [hereinafter FDA }{\i\insrsid16143335 Authoritative Statement}{\insrsid16143335 ]. Compare the standard of substantiation for drugs, whose effectiveness in diagnosing, curing, mitigating, treating, or preventing disease must be established by substantial evidence, defined as: \'93 evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qu alified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have u nder the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.\'94 21 U.S.C. \'a7 355(d)(7) (2002).}}}{\insrsid14637773 This does not hold true for dietary supplements.}{\insrsid12785963 Sections 303 and 304 o}{\insrsid12543417 f FDAMA amended the FDCA}{\insrsid12785963 (21 U.S.C. \'a7\'a7 403(r)(3)}{\insrsid8809548 , 403(r)(2)) so as to expedite the process by which scientific basis for health claims is established}{\insrsid12321397 , such that certain health claims may be authorized without approval by an FDA regulation}{\insrsid2241489 if they are based on an authoritative statement of a scientific body with official responsibility for public health protection or r esearch directly relating to human nutrition}{\insrsid8809548 .}{\cs16\super\insrsid4550595 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 U.S.C. \'a7 343(r)(3)(C) (2002).}}}{\insrsid8809548 }{\insrsid2241489 In order for FDA to approve such a claim, manufacturers must also notify FD}{\insrsid14381063 A at least 120 days in advance o}{\insrsid2241489 f marketing a product with the prospective health claim and submit a balanced representation of the s cientific literature on which the claim is based}{\insrsid136634 . }{\insrsid4550595 Importantly,}{\insrsid3503566 FDAMA upholds the SSA}{\insrsid4550595 standard}{\insrsid14381063 \endash }{\insrsid136634 FDA }{\insrsid4550595 will }{ \insrsid14381063 determine}{\insrsid136634 whether significant scientific agreement has been met by a health claim based on an authoritative statement}{\insrsid4550595 , based on the totality of publicly available scientific evidence}{\insrsid136634 .}{ \cs16\super\insrsid16202774 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335\charrsid4150183 See}{\insrsid16143335 FDA }{\i\insrsid16143335 Authoritative Statement}{\insrsid16143335 , }{\i\insrsid16143335\charrsid4150183 supra}{\insrsid16143335 note 85.}}}{\insrsid8809548 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12321397 {\insrsid8809548 Along with the National Academy of Sciences, FDAMA specifically identifies the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) as acceptable scientific bodies the publications of which manufacturers and distributors may rely on as \'93authoritative statements,\'94 and, in addition, FDA believes that the Surgeon General within the Department of Health and Human Services; and the Food and Nutrition Service, the Food and Safety Inspection Service, and the Agricultural Research Service within the Depar}{ \insrsid14381063 tment of Agriculture may also qualify as}{\insrsid8809548 sources of \'93authoritative statements.\'94}{\cs16\super\insrsid8809548 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid8809548 According to FD}{\insrsid14381063 A, an authoritative statement: \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid4150183 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14381063 (1) }{\insrsid1341965 is \'93}{\insrsid8809548 about the relationship between a nutrient and a dise}{\insrsid1341965 ase or health-related condition\'94}{\insrsid8809548 }{\insrsid1341965 for a health claim, or \'93}{\insrsid8809548 identifies the nutrient }{\insrsid1341965 level to which the claim refers\'94}{\insrsid8809548 for a }{\insrsid1341965 nutrient content claim, (2) is \'93}{\insrsid8809548 p}{\insrsid1341965 ublished by the scientific body\'94 (as identified above), (3) is \'93currently in effect,\'94}{ \insrsid8809548 an}{\insrsid1341965 d (4) \'93}{\insrsid8809548 shall not include a statement of an employee of the scientific body made in the indivi}{\insrsid1341965 dual capacity of the employee.\'94}{\insrsid738397 }{\insrsid14381063 [}{ \insrsid136634 Moreover, FDA believes that authoritative statements should}{\insrsid14381063 ] }{\insrsid136634 (5) reflect a consensus within the identified scientific body if published by a subdiv ision of one of the Federal scientific bodies, and (6) be based on a deliberative review by the scientific b}{\insrsid14381063 ody of the scientific evidence.}{\cs16\super\insrsid14381063 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14381063 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid14381063 }{ \insrsid136634 }{\insrsid14381063 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid14381063 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14381063 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1341965 {\insrsid4465456 Claims must be stated so that they are accurate representations of the authoritative statements}{\insrsid136634 to which they refer}{\insrsid4465456 and so that the public can comprehend the information they provide and understand the relative significance of such information in the context of a total daily diet.}{\cs16\super\insrsid4465456 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \i\insrsid16143335 id}{\insrsid16143335 .}}}{\insrsid4465456 }{\insrsid12321397 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12321397 {\insrsid12321397 H}{\insrsid16202774 ealth claims submitted based on authoritative statements must}{\insrsid12321397 also}{ \insrsid16202774 comply with the rest of the provisions of 21 C.F.R. \'a7 101.14.}{\insrsid12321397 For example, foods bearing a health claim must contain \'93 10% of more of the reference daily intake (RDI) or daily reference value (DRV) for vitamin A, vitamin C, iron, calcium, protein or fiber per reference amount customarily consumed (RACC) prior to any nutrient addition, unless otherwise exempted by FDA.\'94 }{\cs16\super\insrsid12321397 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra }{\insrsid16143335 note 16, at 16; }{\i\insrsid16143335 see also}{\insrsid16143335 21 C.F.R. \'a7 101.14 }{\i\insrsid16143335 et seq.}{\insrsid16143335 (2003).}}}{\insrsid12321397 This is known as the }{ \insrsid1341965 \'93}{\insrsid12321397 jellybean rule}{\insrsid1341965 \'94}{\insrsid4550595 , because health claims cannot be made for foods like jellybeans (i.e., candy), soda or other junk foods, no matter what kind of functional ingredients are added to them}{\insrsid12321397 .}{\cs16\super\insrsid8136606 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Notably, the jellybean rule does }{\i\insrsid16143335 not}{\insrsid16143335 apply to claims on dietary supplements.}}}{\insrsid12321397 }{ \insrsid3503566 The }{\insrsid12321397 NLEA }{\insrsid2241851 also allows a health claim to be made only if the food does not contain, as determined by FDA, \'93disqualifying nutrient levels,\'94 i.e., \'93\lquote any nutrient in an amount which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet.\rquote \'94}{ \cs16\super\insrsid2241851 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 16.}}}{\insrsid2241851 For most foods, the disqualifying nutrient levels are 13.0 grams of fat, 4.0 gra ms of saturated fat, 60 milligrams of cholesterol, or 480 milligrams of sodium per RACC, per label serving size, and, only for foods with RACC of 30 grams or less or 2 tablespoons pr less, per 50 grams.}{\cs16\super\insrsid2241851 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 C.F.R. \'a7 101.14(a)(4).}}}{\insrsid2241851 FDA may, however, exempt certain foods from the jellybean rule}{\cs16\super\insrsid2241851 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid4150183 See, e.g.,}{\insrsid16143335 21 C.F.R. \'a7\'a7 101.80(c), 101.83(c) (2003) (exempting non-cariogenic chewing gums and candies, and salad dressings containing plant sterol/stanol esters, respectively).}}}{\insrsid2241851 as well as from the provision stating disqualifying nutrient levels.}{ \cs16\super\insrsid2241851 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335\charrsid4150183 See, e.g}{\insrsid16143335 ., 21 C.F.R. \'a7101.83(c) (2003) (exempting plant sterol/stanol-containing spreads and salad dressings).}}}{\insrsid2241851 }{\insrsid12321397 \par }\pard\plain \s3\ql \li360\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin360\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3100192\charrsid14106867 {\*\bkmkstart _Toc132795389}3. }{\insrsid16088985 Qualified Health Claims}{\insrsid14637773\charrsid14637773 {\*\bkmkend _Toc132795389} \par }\pard\plain \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14637773 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14637773 Finally, FDA}{\insrsid4465456 , through the }{ \i\insrsid4465456\charrsid4465456 Consumer Health Information for Better Nutrition Initiative}{\insrsid4465456 , the final report and recommendations of which were announced on January 16, 2003,}{\insrsid14637773 provides for the use of qualified health claims \'93when there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition.\'94}{\cs16\super\insrsid14637773 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA }{\i\insrsid16143335 Claims}{ \insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 62.}}}{\insrsid14637773 In such a case, the evidence is not yet well-enough established for FDA to actually issue an authorizing regulation}{\insrsid1274807 (i.e., the science supporting the claim does not meet the significant scientific agreement standard)}{\insrsid14637773 , and so qualifying language must be used in the claim}{\insrsid1274807 so as not to mislead consumers}{\insrsid14637773 . }{ \insrsid1274807 Thus, qualified health claims must be accompanied by a disclaimer or qualified in some other way. }{\insrsid14507408 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277974 {\insrsid9459095 FDA}{\insrsid14637773 evaluate}{\insrsid9459095 s}{\insrsid14637773 and rank}{\insrsid9459095 s}{\insrsid14637773 the quality and strength of the totality of the scientific evidence using its enforcement discretion. }{\insrsid14637452 FDA\rquote s evidence-ranking system is described in FDA\rquote s interim guidelines on qualified health claims, from July 10, 2003, such that different levels of scientific evidence will trigger different qualifying language in a claim.}{\cs16\super\insrsid14637452 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN, }{\i\insrsid16143335 Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements}{\insrsid16143335 (July 10, 2003), }{\i\insrsid16143335\charrsid16277974 available at}{ \insrsid16143335 http://www.cfsan.fda.gov/~dms/hclmgui3.html [hereinafter FDA }{\i\insrsid16143335 Interim Guidelines}{\insrsid16143335 ]. }}}{\insrsid14507408 B}{\insrsid14637452 ased on the extent to whi ch the totality of the publicly available evidence supports the claim, this scheme }{\insrsid14106867 provides standardized}{\insrsid14637452 language for qualified health claims based on a \'93grade\'94 of B, C, or D levels for those claims for which the significant scientific agreement standard cannot be met (and a \'93grade\'94 of A }{\insrsid14106867 for}{\insrsid14507408 }{\insrsid14637452 claims that do meet the significant scientific agreement standard}{\insrsid15794236 , and therefore would never be used for a qualified health claim}{\insrsid14637452 ).}{\cs16\super\insrsid14637452 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid14637452 The table below illustrates this grading scheme:}{\insrsid5525288 \line }{\b\insrsid5525288 Table 1. Standardized Qualifying Language for Qualified Health Claims}{\cs16\super\insrsid5525288\charrsid5525288 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{ \insrsid8672933\charrsid14106867 \par }\trowd \irow0\irowband0\ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2726\clshdrawnil \cellx2618\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1756\clshdrawnil \cellx4374\clvertalt\clbrdrt \brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4041\clshdrawnil \cellx8415\pard \ql \li0\ri0\sl480\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid14637452 { \b\fs20\insrsid5525288\charrsid5525288 Scientific Ranking}{\fs20\insrsid5525288\charrsid5525288 *}{\fs20\insrsid14637452\charrsid5525288 \cell }{\b\fs20\insrsid5525288\charrsid5525288 FDA Category}{\b\fs20\insrsid14637452\charrsid5525288 \cell }{ \b\fs20\insrsid5525288\charrsid5525288 Appropriate Qualifying Language}{\fs20\insrsid5525288\charrsid5525288 **}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 { \insrsid14637452 \trowd \irow0\irowband0\ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2726\clshdrawnil \cellx2618\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1756\clshdrawnil \cellx4374\clvertalt\clbrdrt \brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4041\clshdrawnil \cellx8415\row }\pard \ql \li0\ri0\sl480\slmult1 \widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid14637452 {\fs20\insrsid5525288\charrsid5525288 Second Level}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \qc \li0\ri0\sl480\slmult1 \widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 B}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 \'85 \'93although there is scientific evidence supporting the claim, the evidence is not conclusive.\'94}{ \fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\insrsid14637452 \trowd \irow1\irowband1\ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb \brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2726\clshdrawnil \cellx2618\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1756\clshdrawnil \cellx4374\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4041\clshdrawnil \cellx8415\row }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid14637452 {\fs20\insrsid5525288\charrsid5525288 Third Level}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \qc \li0\ri0\sl480\slmult1 \widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 C}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 \'93Some scientific evidence suggests\'85however, FDA has determined that this evidence is limited and not conclusive.\'94}{ \fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\insrsid14637452 \trowd \irow2\irowband2\ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb \brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2726\clshdrawnil \cellx2618\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1756\clshdrawnil \cellx4374\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4041\clshdrawnil \cellx8415\row }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid14637452 {\fs20\insrsid5525288\charrsid5525288 Fourth Level}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \qc \li0\ri0\sl480\slmult1 \widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 D}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 \'93Very limited and preliminary scientific research suggests\'85 FDA concludes that there is little scientific evidence supporting this claim.\'94}{\fs20\insrsid14637452\charrsid5525288 \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\insrsid14637452 \trowd \irow3\irowband3 \ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2726\clshdrawnil \cellx2618\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1756\clshdrawnil \cellx4374\clvertalt\clbrdrt \brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4041\clshdrawnil \cellx8415\row }\trowd \irow4\irowband4\lastrow \ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr \brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth8523\clshdrawnil \cellx8415\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid5525288 {\fs20\insrsid5525288\charrsid5525288 *From Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data \par **The language reflects wording used in qualified health claims as to which the Agency has previously exercised enforcement discretion for certain dietary supplements. During this interim period, the precise language as to which the agency considers exercising enforcement discretion may vary depending on the specific circumstances of each case.\cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\insrsid5525288 \trowd \irow4\irowband4\lastrow \ts19\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh \brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trftsWidthA3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkhdrrows\tbllklastrow\tbllkhdrcols\tbllklastcol \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl \brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth8523\clshdrawnil \cellx8415\row }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15794236 {\insrsid1341965 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15794236 {\insrsid4465456 The }{\i\insrsid4465456\charrsid1341965 Consumer Health Information for Better Nutrition Initiative}{\insrsid4465456 was designed to \'93 encourage the kind of marketplace where healthy foods can compete readily among all foods available; to foster research and better understanding about diet and health; and to protect consumers, and to help consumers protect themselves, from misleading cla ims by producers of foods and dietary supplements about health benefits that are not supported by science.\'94}{\cs16\super\insrsid4465456 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA }{\i\insrsid16143335 Task Force Final Report}{\insrsid16143335 , supra note 63.}}}{\insrsid1402341 }{\insrsid15794236 Indeed, industry response to FDA\rquote s authorization of qualified health claims was quite positive. Sa}{\insrsid7162190 id Alison Kretser, M.S., R.D., Senior D}{\insrsid15794236 irector }{\insrsid7162190 of Scientific and Nutrition P}{ \insrsid15794236 olicy of Grocery Manufacturers of America, Inc.}{\insrsid7162190 (GMA)}{\insrsid15794236 in Washington D.C.}{\insrsid16277974 , \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid16277974 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid15794236 FDA\rquote s regulatory structure for approving qualified health claims will allow the food industry to get the newest health information on the food label and into the hands of the consumer. More importantly, the ability to use qualified health claims by the food industry will provide food manufacturers with new incentives to develop and market }{\insrsid16277974 new healthier-for-you products.}{ \cs16\super\insrsid15794236 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Grocery Manufacturers of America Press Release, }{\i\insrsid16143335 FDA Qualified Health Claim Rules Could Help Consumers Make Informed Food Choices, GMA Urges Agency to Reject Required Language for Claims}{\insrsid16143335 (July 10, 2003), }{ \i\insrsid16143335 available at}{\insrsid16143335 }{\insrsid16143335\charrsid9587937 http://www.gmabrands.com/news/docs/NewsRelease.cfm?DocID=1176}{\insrsid16143335 ; }{\i\insrsid16143335 see also}{\insrsid16143335 Ronald C. Deis, Ph.D., }{ \i\insrsid16143335 What\rquote s in a Claim: Labeling Functional Foods}{\insrsid16143335 , Functional Foods Annual (November 2003), }{\i\insrsid16143335\charrsid16277974 available at}{\insrsid16143335 http://www.foodproductdesign.com/archive/2003/1103FFA_02.html. }}}{\insrsid4465456 \par }\pard\plain \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6583983 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14507408 The history of qualified health claims is}{ \insrsid15794236 , however}{\insrsid14507408 , not without its share of controversy}{\insrsid15075840 . }{\insrsid2241851 In }{\i\insrsid2241851 Pearson v. }{\i\insrsid2241851\charrsid2241851 Shalala}{\cs16\super\insrsid7495308\charrsid7495308 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 164 F.3d 650 (D.C. Cir. 1999).}}}{ \insrsid2241851\charrsid7495308 ,}{\insrsid2241851 }{\insrsid7495308 the United States Court of Appeals for the District of Columbia Circuit held that FDA must consider the possibility of approving health claims}{\insrsid8862790 for dietary supplements} {\insrsid7495308 that incorporate qualified representations or }{\insrsid16088985 \'93}{\insrsid7495308 disclaimers.}{\insrsid16088985 \'94}{\cs16\super\insrsid7495308 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 See IFT Expert Report, }{\i\insrsid16143335 supra }{ \insrsid16143335 note 16, at 16, citing }{\i\insrsid16143335 Pearson,}{\insrsid16143335 164 F.3d 650.}}}{\insrsid7495308 }{\insrsid2241851 }{\insrsid8862790 The court held that the First Amendment does not allow FDA to reject health claims that the agency determines not to be supported by significant scientific agreement unless the FDA also determines that a disclaimer would not cure the potential deception.} {\cs16\super\insrsid14507408 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 Pearson}{\insrsid16143335 , 164 F.3d at 658.}}}{\insrsid8862790 }{\insrsid15075840\charrsid2241851 It}{\insrsid15075840 was only }{\insrsid4090920 as recently as December 18}{\insrsid15075840 , 2002 that the FDA announced its intention in the Federal Register to apply }{\i\insrsid15075840 Pearson}{\insrsid15075840 to conventional human food and, thus, provide for qualified health claims for conventional foods}{\insrsid7495308 so long as the claims were supported by the \'93weight of the evidence.\'94}{\cs16\super\insrsid15075840 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 FDA/CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements, }{\i\insrsid16143335 Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements}{\insrsid16143335 (December 18, 2002), }{\i\insrsid16143335\charrsid16277974 available at}{\insrsid16143335\charrsid16277974 http://www.cfsan.fda.gov/~dms/hclmgui2.html}{\insrsid16143335 . }}}{\insrsid7495308 Soon after, in }{\i\insrsid7495308 Whitaker v. Thompson}{\cs16\super\insrsid7495308\charrsid7495308 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 248 F.Supp. 1 (D.D.C. 2002).}}}{\insrsid7495308\charrsid7495308 , }{\insrsid7495308 the United States District Court for the District of Columbia, interpreting }{\i\insrsid7495308 Pearson}{\insrsid7495308 , found that FDA must apply a \'93credible evidence\'94 standard rather than a \'93weight of the evidence\'94 standard in evaluating qualified health claims.}{\cs16\super\insrsid7495308 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid16277974 See}{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 16.}}}{\insrsid6162849 }{\insrsid14507408 Subsequently, u}{ \insrsid11300084 nde}{\insrsid14507408 r the July interim guidelines}{\insrsid11300084 , FDA stated that the weight of the evidence standard for qualified health claims must be \'93tempered by the test of credible evidence.\'94}{ \cs16\super\insrsid11300084 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA }{ \i\insrsid16143335 Interim Guidelines}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 98.}}}{\insrsid9587937 This}{\insrsid14186394 means that FDA can allow qualified health claims so long as some credible evidence supports them, even where the weight of the evidence does not.}{\insrsid16088985 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14950011 {\insrsid14950011 The CSPI, along with the Public Citizen Health Research Group, filed a c omplaint against the FDA on September 23, 2003, in the District Court for the District of Columbia, alleging that }{\insrsid3227404 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid3227404 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14950011 [t]he [July Interim Guidance] sets forth a new regulatory regime in which the FDA, under the guise of enforcement discretion, will permit cer tain claims about purported health benefits of foods, without following the procedural requirements or meeting the substantive standard of the Nutritional Labeling and Education Act of 1990 (\'93NLEA\'94).}{\cs16\super\insrsid14950011 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\cf1\insrsid16143335 CSPI v. FDA,}{ \cf1\insrsid16143335\charrsid14950011 2}{\cf1\insrsid16143335 003 WL 24209883 (D.D.C. Sep. 23, 2003)}{\cf1\insrsid16143335\charrsid14950011 (NO. 103-CV-01962-RBW)}{\cf1\insrsid16143335 , \'b6 1.}}}{\insrsid14950011 }{\insrsid3227404 \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3227404 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14950011 The plaintiffs in this case alleged that the July Gui dance threatens \'93 irreparable injury to plaintiffs and their members, who will be deprived of the substantive and procedural protections established by Congress to protect them against injuries to their health and the waste of money on foods that make inacc urate or misleading health claims.\'94}{\cs16\super\insrsid14950011 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id}{\insrsid16143335 . at \'b6 37.}}}{\insrsid14950011 However, on August 6, 2004, the court granted FDA\rquote s Motion to Dismiss, since it found the case was not ripe for judicial resolution and the plaintiffs lacked standing.}{\cs16\super\insrsid14950011 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI v. FDA, 2004 WL 2011467 (D.D.C. Aug. 6, 2004) (No. Civ.A.03-1962 RBW).}}}{\insrsid14507408 Thus, through the doctrines of justici}{ \insrsid1341965 ability, the court was}{\insrsid14507408 able to skirt the issue of whether qualified health claims, interpreted under the July Interim Guidance, will actually cause harm to the public.}{\insrsid14950011\charrsid11300084 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6583983 {\insrsid6583983 FDA}{\insrsid9587937 , in any event,}{\insrsid6583983 began considering qualified health claims under the interim procedures described }{\i\insrsid6583983 supra}{\insrsid6583983 on September 1, 2003, and has been preparing for the promulgation of regulations through notice-and-comment rulemaking. }{ \insrsid1341965 In preparation, }{\insrsid6583983 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid3227404 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6583983 FDA published an advance notice of proposed rulemaking (ANPR) on November 25, 2003, requesting comments on thr ee regulatory alternatives for qualified health claims: (1) codify the interim guidelines on procedure and evidence-based ranking through notice-and-comment rulemaking, (2) apply the SSA standard to characterization of the scientific data rather than the s ubstance-disease relationship and subject claims to notice-and-comment rulemaking, and (3) consider the claims outside NLEA and therefore subject only to the post-marketing ban against false or misleading claims, which includes claims lacking substantiati on.}{\cs16\super\insrsid6583983 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 17 (internal citations omitted), citing Advance Notice of Proposed Rulemaking, }{\insrsid16143335\charrsid4026516 Food Labeling: Health Claims; Dietary Guidance}{ \insrsid16143335 , 68 Fed. Reg. 66,040 (Nov. 25, 2003)).}}}{\insrsid6583983 \par }\pard\plain \ql \li360\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0\pararsid6583983 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9459095 \par }\pard \ql \fi360\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3357651 {\insrsid9459095 In response to this ANPR, the American Association of Family and Consumer Sciences, the American Cancer Society, the American College of Preventive Medicine, the Association of American Medical Colleges, the Center for Science in the Public Interest, the Consumer Federation of America, and the National Consumers League}{\insrsid7501846 voice}{\insrsid8862790 d}{\insrsid7501846 their disapproval over the FDA\rquote s authorization of qualified health claims and}{\insrsid9459095 submitted comments to the FDA, stating their belief that the FDA\rquote s policies regarding qualified health claims violate the NLEA}{\cs16\super\insrsid9459095 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Comments to Advance Notice of Proposed Rulemaking}{ \i\insrsid16143335\charrsid9459095 , Food Labeling: Health Claims; Dietary Guidance}{\insrsid16143335 , Dkt. No. 2003N-0496 (February 25, 2004).}}}{\insrsid8862790 }{\insrsid2257780 The American Dietetic Association (ADA) also does not support this approach to functional food labeling, believing instead that the health claims authorized for foods and dietary supplements should not be based on preliminary or speculative evidence.}{ \cs16\super\insrsid2257780 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 ADA Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25, at 818.}}}{\insrsid3357651 }{\insrsid5793672 \par }{\insrsid4792365 Nevertheless, as of November}{\insrsid9190921 2005, FDA has exercised enforcement discretion to allow a whole slew of qualified health claims}{\insrsid4792365 , including claims for: tomatoes or tomato sauce and a variety of cancers, calcium and colon/rectal cancer and recurrent colon/rectal polyps, green tea and cancer, selenium and cancer, antioxidant vitamins and cancer, nuts and heart disease, walnuts and heart disease, omega-3 fatty acids and CHD, B vitamins and vascular disease, monounsaturated fatty acids fr om olive oil and CHD, phosphatidylserine and cognitive dysfunction and dementia, }{\insrsid9190921 folic acid and neural tube birth defects, }{\insrsid4792365 and calcium and hypertension.}{\cs16\super\insrsid4792365 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 FDA/CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements, }{\i\insrsid16143335 Qualified Health Claims Subject to Enforcement Discretion,}{\insrsid16143335 (last updated November 2005), }{\i\insrsid16143335\charrsid3227404 available at }{\insrsid16143335 : }{\insrsid16143335\charrsid4792365 http://www.cfsan.fda.gov/~dms/qhc-sum.html}{\insrsid16143335 . }}}{\insrsid4792365 }{\insrsid6583983 It remains to be seen what the future of the regulatory process surrounding qualified health claims will be.}{\insrsid5525288\charrsid7495308 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid8672933\charrsid12785963 {\*\bkmkstart _Toc132795390} B. Structure/Function Claims{\*\bkmkend _Toc132795390} \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12321397 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid12321397 Not all claims about health are actually health claims. Claims about health can also take the form of structure/function claims, which generally link a nutrient solely to the normal, healthy structure or function of the human body.}{ \cs16\super\insrsid12321397 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See, e.g.,}{\insrsid16143335 IFT Expert Report}{\i\insrsid16143335 , supra}{\insrsid16143335 note 16, at 15. This is appropriate since, under }{\i\insrsid16143335 Nutrilabs}{\insrsid16143335 , a food\rquote s effects n eed not be of a nutritional nature.}}}{\insrsid12321397 }{\insrsid12785963 Structure/function claims have}{\insrsid136634 numerous functions. They may: \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid9587937 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid12785963 describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans\'85[i]n addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function\'85 or they may describe general well-being from consumption of a nutrient or dietary ingredient\'85[or] describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a d}{ \insrsid136634 isease is in the United States.}{\cs16\super\insrsid12785963 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA }{\i\insrsid16143335 Claims}{\insrsid16143335 , }{\i\insrsid16143335\charrsid3227404 supra}{\insrsid16143335 note 62.}}}{\insrsid12785963 }{\insrsid6162849 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6162849 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6162849 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6162849 {\insrsid1402341 An example of a structure/function claim is, \'93calcium helps build strong bones.\'94 }{\insrsid12785963 Structure/function claims are }{\i\insrsid12785963\charrsid12785963 not}{\insrsid12785963 pre-approved by the FDA, but must be truthful and not misleading. }{\insrsid136634 In this vein, it is very important to note that it is the manufacturer itself that is responsible for ensuring the accuracy and truthfulness of a structure/function claim}{\insrsid3824412 , and many manufacturers have resorted to making structure/functio n claims instead of health claims in order to avoid FDA approval requirements.}{\insrsid136634 }{\insrsid9587937 As a result, the public is deprived of a great deal of educational health information that it would have had access to had the manufacturers (of credible products) taken the time to get health claims for their products approved. \par }{\insrsid12785963 Structure/function claims may be used for both foods and dietary supplements (although dietary supplements, if they include such a claim, must also include a disclaimer that the FDA has not evaluated t he claim and that the dietary supplement product is not intended to \'93diagnose, treat, cure or prevent any disease\'94).}{\cs16\super\insrsid12785963 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid12785963 }{\insrsid854033 Immediately, one can see how it might be problematic for dietary supplements to be required to contain disclaimers on labels when they co ntain structure/function claims but for conventional foods containing the very same ingredient and structure/function claim not to be required to contain such disclaimers.}{\cs16\super\insrsid854033 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid3227404 See}{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 24.}}}{\insrsid1402341 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid136634 {\insrsid7819541 Structure/function claims are permissible for foods so long as they do not also rep resent that the food will cure, mitigate, treat or prevent disease (which would create drug status) and provided that the claim does not trigger some other requirement for FDA pre-approval (such as being a health claim in addition).}{ \cs16\super\insrsid7819541 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7819541 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{ \insrsid16143335 }{\i\insrsid16143335\charrsid3227404 See}{\insrsid16143335 IFT }{\insrsid16143335\charrsid12134005 Expert Report}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 16, at 21.}}}{\insrsid7819541 The line between structure/function claim status and drug status or health claim status is, however, often blurry}{\insrsid16530860 , and often depends on slight changes in linguistics}{\insrsid7819541 .}{\cs16\super\insrsid16071004 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Generally, if a disease is mentioned in the claim, the claim must be approved by FDA as a health claim, whereas if a body organ is mentioned, a structure/function claim can be made without FDA pre-market approval.}}}{\insrsid7819541 For example, in the Federal Register of September 23, 1997 (FDA, 1997b), FDA stated: \par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid7819541 {\insrsid7819541 FDA points out that the claim that cranberry juice cocktail prevents the recurrence of urinary tract infections\'85 is a claim that brings the product within the \'93drug\'94 definition\'85because it is a claim that the product will prevent disease. However, a claim that cranberry products help to maintain urinary tract health may be permissible on\'85 cranberry products in conventional food form\'85if it is truthful, not misleading, and derives from the nutritive value of cranberries. If the claim derives from the nutritive value of cranberries, the claim would describe an effect of a food on the structure or function of the body and thus fall under one exception to the definition for the term \'93drug\'94}{\insrsid16530860 \'85 }{\insrsid7819541 The claim is not a health claim because no disease is mentioned explicitly or implicitly.}{\cs16\super\insrsid8352250 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT }{\insrsid16143335\charrsid12134005 Expert Report}{\insrsid16143335 , }{\i\insrsid16143335 supra }{\insrsid16143335 note 16, at 22.}}}{ \insrsid7819541 \par }{\insrsid4023934 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4023934 {\insrsid4023934 In 1 998, FDA issued a proposed rule on structure/function claims to provide some guidance as to the permissible wording for structure/function claims.}{\cs16\super\insrsid4023934 \chftn {\footnote \pard\plain \s30\ql \li0\ri0\widctlpar \tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11217863 \f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\f0\super\insrsid16143335\charrsid11217863 \chftn }{\f0\insrsid16143335\charrsid11217863 }{\i\f0\insrsid16143335\charrsid11217863 See}{\f0\insrsid16143335\charrsid11217863 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body}{\f0\insrsid16143335 ,}{\i\f0\insrsid16143335\charrsid11217863 }{\f0\insrsid16143335\charrsid11217863 63 Fed. Reg. 23,624 (April 29, 1998).}}}{\insrsid4023934 FDA stated, for example, that manufacturers can claim that their products \'93maintain healthy cholesterol\'94 but cannot claim that they \'93lower cholesterol.\'94 However, FDA has not proposed how much scientific evidence is needed to make a permissible structure/function claim, e.g., it is unknown whether companies can continue to make permissible structure/function cl aims based on preliminary scientific studies.}{\insrsid15809352 The current framework for structure/function claims requires only that they be based on \'93appropriate scientific criteria and appropriate endpoints.\'94}{\cs16\super\insrsid15809352 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements, }{\i\insrsid16143335 Discussion of a Conceptual Framework for Structure and Function Claims For Conventional Foods: Meeting Summary}{\insrsid16143335 , (Feb. 16-17, 2000), }{ \i\insrsid16143335\charrsid11217863 available at}{\insrsid16143335 }{\insrsid16143335\charrsid15809352 http://www.cfsan.fda.gov/~dms/labstru2.html}{\insrsid16143335 [hereinafter FDA }{\i\insrsid16143335\charrsid14091128 Structure/Function Claims}{ \insrsid16143335 ]. }}}{\insrsid4023934 Because the substantiation standard for structure}{\insrsid15809352 /function claims remains vague and undefined}{\insrsid4023934 , there is great potential for many structure/function claims to mislead the general public. }{\insrsid16530860 Add to this a public that is overly eager to believe the myriad claims that appear on the thousands of functional food products out there, and the potential for harm greatly increases.}{\insrsid9587937 }{\insrsid7819541 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1402341\charrsid1402341 {\*\bkmkstart _Toc132795391} C. Dietary Guidance Statements{\*\bkmkend _Toc132795391} \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13920109 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1402341 Like structure/function claims, \'93dietary guidance\'94 statements can be made on food labels without FDA review. Such statements focus on general dietary patterns, practices, and recommendations that promote health, rather than targeting specific substances and certain diseases like health claims do.}{ \cs16\super\insrsid1402341 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335\charrsid11217863 See}{\insrsid16143335 FDA }{\i\insrsid16143335 Task Force Final Report, supra}{\insrsid16143335 note 63.}}}{\insrsid1402341 An example of a dietary guidance statement is the National Cancer Institute\rquote s \'93 5-a-Day\'94 program to encourage the consumption of more fruits and vegetables to attain better health.}{\insrsid9587937 This category of statements adds to the complex web of regulatory options facing a manufacturer of a functional food and holds appeal for manufacturers hoping to avoid pre-market approval requirements.}{\insrsid13920109 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4659503 {\*\bkmkstart _Toc132795392} D. Too Many Claims, }{\insrsid3170647 Too Many Agencies, }{\insrsid4659503 Too Much Confusion?}{\insrsid13920109 {\*\bkmkend _Toc132795392} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4659503 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4659503 \tab }{\insrsid873557\charrsid9456206 One problem}{ \insrsid873557 with the current regulatory scheme for }{\insrsid9785262 claims made about functional foods is that the standards of evidence required for each type of claim are vastly different, and, perhaps, co nfusing to both manufacturers and consumers. }{\insrsid9456206 Consumers may not understand the different purposes of health claims and structure/function claims, and, as a result, may incorrectly view structure/function claims as claims to reduce the risk of or treat a disease}{\insrsid4937788 rather than as claims that merely describe how consuming a product affects a struc}{\insrsid9587937 ture or function of the body or }{\insrsid4937788 a person\rquote s general well-being}{\insrsid9456206 .}{\cs16\super\insrsid9456206 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 5, 18. Moreover, consumer s have no clear way of distinguishing between claims that require rigorous scientific support and claims that can be made with less evidence, and, as a result, may make inappropriate dietary choices or attempt to treat a disease with a product not capable of producing this benefit.}}}{\insrsid4937788 The G}{\insrsid13525464 eneral }{\insrsid4937788 A}{\insrsid13525464 ccounting }{\insrsid4937788 O}{\insrsid13525464 ffice}{\insrsid16530860 (GAO)}{\insrsid4937788 found that \'93agencies\rquote efforts and federal laws concerning health-related claims on product labels and in advertising provide limited assistance to consumers in making informed choices and do little to protect them against inaccurate and misleading claims.\'94}{ \cs16\super\insrsid4937788 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4937788 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{ \insrsid16143335 }{\i\insrsid16143335 Id}{\insrsid16143335 . at 5.}}}{\insrsid4937788 }{\insrsid873557 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid873557 {\insrsid9785262 Another}{\insrsid14566914 problem is that there are three different federal agencies}{\insrsid1593743 , operating under different statutes,}{\insrsid14566914 involved in the regulation of claims made by food manufacturers: the FDA, the Federal Trade Commission (FTC), and the United States Department of Agriculture (USDA).}{\cs16\super\insrsid1778707 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 This section will mainly explore the interplay between the FDA and the FTC, but it is of note that USDA, rather than adopting a comprehensive approach to the use of FDA authorized health claims on products containin g meat or poultry, regulates and reviews requests to use health claims on a case-by-case basis. }{\i\insrsid16143335\charrsid11217863 See}{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 23.}}}{\insrsid14566914 FDA\rquote s authority comes, in part, }{\insrsid12543417 from Section 403(a) of the }{\insrsid14566914 F}{\insrsid12543417 DCA}{\insrsid14566914 , which prohibits }{\insrsid6448949 \'93labeling [that] is false or misleading in any particular,\'94}{ \cs16\super\insrsid6448949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7343(a) (2002).}}}{\insrsid6448949 although }{\insrsid7498086 the reach of }{\insrsid6448949 FDA\rquote s authority is broader than simply preventing false and misleading food labeling claims in light of the NLEA of 1990.}{ \cs16\super\insrsid6448949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 The NLEA, besides being designed to prevent deceptive and misleading claims on labels, was also intended to enable nutrient content and health claims to educate consumers in order to assist them in maintaining healthy dietary practices. }{ \i\insrsid16143335\charrsid11217863 See}{\insrsid16143335 FTC, }{\i\insrsid16143335 Enforcement Policy Statement}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 65.}}}{\insrsid6448949 FTC\rquote s authority comes from Section 5 of the Federal Trade Commission Act (FTC Act), which prohibits \'93unfair or deceptive practices,\'94 and, for food products, from Sections 12 and 15 of the FTC Act which prohibit \'93any false advertisement\'94 that is \'93 misleading in a material respect.\'94}{\cs16\super\insrsid6448949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 15 U.S.C. \'a7\'a7 45, 52, 55 (1980).}}}{\insrsid6448949 USDA\rquote s authority comes from the Federal Meat Inspection Act, which prohibits labeling of meat or meat products that is \'93 false or misleading in any particular,\'94}{\cs16\super\insrsid6448949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7 601(n)(1) (2002).}}}{\insrsid6448949 and the Poultry Products Inspection Act, which prohibits labeling of poultry products that is \'93false or misleading in any particular.\'94}{ \cs16\super\insrsid6448949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7 453(h)(1).}}}{\insrsid6448949 }{\insrsid4011646 \par }{\insrsid9198561 The United States}{\insrsid16530860 non-intuitively}{\insrsid9198561 separates regulation of food labeling claims from regulation of food advertising claims and applies different standards to each. }{\insrsid4011646 The FTC and the FDA have operated under a Memorandum of Understanding since 1954, under which the FTC has assumed primary resp}{\insrsid1778707 onsibility for food advertising}{\insrsid542552 (including claims used in television, radio, magazine, newspaper or other forms of advertising)}{\insrsid1778707 ,}{\insrsid4011646 and the FDA has assumed primary responsibility for food labeling.}{\cs16\super\insrsid4011646 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid11217863 See}{ \insrsid16143335 FTC }{\i\insrsid16143335 Enforcement Policy Statement}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 65, citing }{\i\insrsid16143335 Working Agreement Between FTC and Food and Drug Administration}{ \insrsid16143335 , 4 Trade Reg. Rep. (CCH) \'b6 9,850.01 (1971). Note that a \'93label\'94 is defined as \'93a display of written, printed, or graphic matter upon the immediate container\'94 of a product (21 U.S.C. \'a7 321(k) (2002)), and \'93labeling \'94 is defined to include \'93all labels and other written, printed, or graphic matter \'85 upon any product or any of its containers or wrappers, or \'85 accompanying such [product]\'94 (21 U.S.C. \'a7 321(m) (2002)).}}}{\insrsid4011646 }{ \insrsid7498086 In general, the FTC gives great weight to FDA\rquote s scientific determinations in matters of health and nutrition, and for the most part, \'93it is unlikely that the Commission will take action under Sections 5 and 12 of the FTC Act r egarding nutrient content and health claims if they comply with FDA\rquote s regulations.\'94}{\cs16\super\insrsid7498086 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 See FTC }{\i\insrsid16143335 Enforcement Policy Statement}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 65.}}}{ \insrsid7498086 }{\insrsid4214276 In addition, the FTC\rquote s standard for substantiation of health claims in food advertising is similar}{\insrsid9198561 (but not identical)}{\insrsid4214276 to FDA\rquote s \'93significant scientific agreement\'94 approach to health claims in labeling, i.e., the Commission requires that health claims be supported by \'93competent and reliable}{\insrsid16530860 scientific evidence,\'94 meaning \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid11217863 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4214276 tests, analyses, research, studies, or other evidence based on the expertise of professionals in the rel evant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield}{\insrsid16530860 accurate and reliable results.}{\cs16\super\insrsid4214276 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{ \insrsid16143335 , citing }{\insrsid16143335\charrsid7999860 Gracewood Fruit Co}{\i\insrsid16143335 .}{\insrsid16143335 , FTC Dkt. No. C-3470 (Oct. 29, 1993) (consent order); }{\i\insrsid16143335\charrsid7999860 see also}{\insrsid16143335 }{ \insrsid16143335\charrsid7999860 Pompeian Inc}{\i\insrsid16143335 ., }{\insrsid16143335 FTC Dkt. No. C-3402 (Oct. 27, 1992) (consent order).}}}{\insrsid4214276 }{\insrsid16530860 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid16530860 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid16530860 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16530860 {\insrsid16530860 And, while both the FDA and FT}{\insrsid4214276 C look to well-designed studies in evaluating health claims for foods, neither requires the establishment of scientific consensus in support of these claims. Because the FTC regards FDA\rquote s \'93significant scientific agreement\'94 standard as a principal guide of what experts in the field would consider reasonable substantiation for an unqualified health claim, it is \'93 likely that the Commission will reach the same conclusion as to whether an unqualified health claim about the relationship between a nutrient or substance in food and a disease or health-related condition is adequately supported by scientific evidence. \'94}{\cs16\super\insrsid4214276 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FTC }{\i\insrsid16143335 Enforcement Policy Statement}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 65.}}}{\insrsid4214276 Moreover, the FTC looks carefully at health claims specifically not considered by the FDA during the petition process, and this will be a significant factor in the FTC\rquote s determination of the adequacy of substantiation for an advertising claim. } {\insrsid1778707 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 {\insrsid1778707 However, t}{\insrsid4214276 here is one kink in this whole shared}{\insrsid1051322 , seemingly unified}{\insrsid4214276 regulatory scheme. }{\insrsid1778707 Because of the differing substantiation requirements imposed by the FTC and the FDA}{\insrsid6508191 (and the f act that the FTC has a more lenient standard for advertising claims about diet-disease relationships than does the FDA for food labeling)}{\insrsid1778707 , t}{\insrsid4011646 he FTC \'93 recognizes that there may be certain limited instances in which carefully qualified health claims may be per mitted under Section 5 although not yet authorized by the FDA, if the claims are expressly qualified to convey clearly and fully the extent of the scientific support.\'94}{\cs16\super\insrsid4011646 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid4011646 }{\insrsid8743841 One example of this is the Heinz company\rquote s}{\insrsid6508191 advertisement appearing in magazines a few years ago stating that \'93lycopene (found in tomato products) may help reduce the risk of prostate and cervical cancer.\'94}{ \cs16\super\insrsid6508191 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 ADA Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25, at 819.}}}{\insrsid6508191 }{\insrsid8743841 The FTC allowed this advertisement }{\insrsid1051322 in the media, }{\insrsid8743841 although FDA had not yet authorized such a labeling claim, and, in fact, FDA later determined that }{\cf1\insrsid8743841 no credible evidence existed to support Heinz\rquote s claims about}{\cf1\insrsid1051322 consumption of tomato lycopene,}{ \cf1\insrsid8743841 tomatoes and tomato }{\cf1\insrsid1051322 products which contain lycopene,}{\cf1\insrsid8743841 lycopene in tomatoes and tomato products, or lycopene }{\cf1\insrsid1051322 in fruits and vegetables}{\cf1\insrsid8743841 and a reduced risk of prostate cancer.}{\cs16\cf1\super\insrsid8743841 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA/CFSAN/Office of Nutritional Products, Labeling and Dietary Supplements, }{\i\insrsid16143335 Qualified Health Claims: Letter Regarding Tomatoes and Prostate Cancer (Lycopene Health Claim Coalition }{\insrsid16143335 ), (Dkt. No. 2004Q-020,) (Nov. 8, 2005), }{\i\insrsid16143335\charrsid7999860 available at}{\insrsid16143335 : }{\insrsid16143335\charrsid8743841 http://www.cfsan.fda.gov/~dms/qhclyco2.html}{\insrsid16143335 . }}}{\insrsid6508191 \par }{\insrsid9198561 Thus, the FTC has the right to permit claims in advertising that are not permitted on food labels w}{\insrsid16530860 hen it believes those claims }{\insrsid9198561 comply with the FTC Act. }{\insrsid8743841 Manufacturers can capitalize on the lack of unified substantiation, which}{\insrsid1778707 presen ts a real risk of harming consumers, for they are likely to be highly influenced by the advertisements they see in their everyday lives, even if these advertisements are not entirely consistent with what they see on the labels of the foods that they subse quently purchase. In response to this kink, the FTC notes that, }{\insrsid3283042 \'93at the same time}{\insrsid16530860 }{\insrsid3283042 \'85}{\insrsid16530860 }{\insrsid3283042 the Commission believes that qualified claims based on evidence that is inconsistent with the larger body of evidence have the potential to mislead consumers, and, therefore, are like}{\insrsid7999860 ly}{\insrsid3283042 to violate Section 5\'94 anyway.} {\cs16\super\insrsid3283042 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FTC }{ \i\insrsid16143335\charrsid9198561 Enforcement Policy Statement}{\i\insrsid16143335 , supra}{\insrsid16143335 note 65.}}}{\insrsid3283042 }{\insrsid3283042\charrsid16530860 So the potential for harm to consumers exists, but perhaps it is not }{ \insrsid16530860 quite }{\insrsid3283042\charrsid16530860 as significant as it would seem at first glance.}{\insrsid4937788 And, from the industry\rquote s point of view, FDA\rquote s approach to authorizing health claims is ove}{\insrsid1051322 rly restrictive anyway. T}{\insrsid4937788 hus, given FTC\rquote s legal mandate, }{\insrsid1051322 the industry believes }{\insrsid4937788 it is actually appropriate for FTC to take a different approach to claims made in advertising.}{ \cs16\super\insrsid4937788 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 22.}}}{\insrsid6557949 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6557949 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6557949 {\*\bkmkstart _Toc132795393} V. Foods for Special Dietary Use{\*\bkmkend _Toc132795393} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6557949 \tab FDA first defined the term \'93special dietary uses\'94 in 1972 (in regard to food for humans) as \'93uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of disease, convalescence, preg nancy, lactation, allergic hypersensitivity to food, underweight, and overweight.\'94}{\cs16\super\insrsid6557949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 C.F.R. 105.3(a)(1) (2005).}}}{\insrsid6557949 In 1976, the term was added to the statute, which now defines \'93special dietary use\'94 as a particular use for which a food purports or is represented to be used, including but not limited to: \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7999860 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6557949 (A) Supplying a special dietary need that exists by reason of a physical, physiological pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hyper sensitivity to food, underweight, overweight, or the need to control intake of sodium.}{\insrsid7999860 \par }{\insrsid6557949 (B) Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by increasing the total dietary intake. \par (C) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.}{\cs16\super\insrsid6557949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 U.S.C. \'a7 350(c)(3) (2002).}}}{\insrsid6557949 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6557949 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 {\insrsid6557949 \tab Foods for special dietary use are subject to the nutrition labeling requirements and requirements for health and nutrient content claims established for conventional foods under the NLEA of 1990.}{\cs16\super\insrsid6557949 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6557949 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Advance Notice of Proposed Rulemaking: Regulation of Medical Foods, 61 F.R. 60661, 60663 (November 29, 1996).}}}{\insrsid6557949 }{\insrsid5657418 Specific regulations governing foods for special dietary use are codified at 21 C.F.R. \'a7 105(B), however FDA has not updated these provisions in years.}{\cs16\super\insrsid5657418 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid7999860 See}{\insrsid16143335 Center for Science in the Public Interest, }{\i\insrsid16143335 Starvation Diet: FDA Lacks Adequate Resources f or its Nutritional Health and Consumer Protection Missions}{\insrsid16143335 (October 2003) at 15, }{\i\insrsid16143335\charrsid7999860 available at}{\insrsid16143335 http://www.cspinet.org [hereinafter CSPI }{\i\insrsid16143335 Starvation Diet}{ \insrsid16143335 ] (noting that the last update to these regulations occurred in 1996 when FDA revoked regulations for food s used to regulate sodium intake and food labeled for use by diabetics (Revocation of Certain Regulations Affecting Food, 61 Fed. Reg. 27,771, 27,779 (June 3, 1996)). }}}{\insrsid6557949 \par }{\insrsid2889676 \tab FDA has stated that if a claim that would otherwise require FDA approval as a health claim is already authorized by a regulation concerning foods for special dietary use, then it will not require that a new health claim regulation also be issued.}{\cs16\super\insrsid2889676 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid7999860 See}{\insrsid16143335 McNamara, }{\i\insrsid16143335 supra }{\insrsid16143335 note 21, at 434, citing 21 C.F.R. \'a7 105.}}}{\insrsid2889676 Thus, if a company is interested in making a new claim on a product label that would fall within the definition of a health claim, it may be able to petition the agency to }{\insrsid1055019 instead }{\insrsid2889676 issue a special dietary use labeling regulation rather than having to go through the arduous process of petitioning the FDA to issue an approving health claim regulation.}{\cs16\super\insrsid2889676 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 McNamara, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 21, at 434.}}}{\insrsid4550879 However, this is a largely-theoretical option, as FDA has, in practice, avoided issuing new special dietary use regulations and has actually been revoking some of them.}{ \cs16\super\insrsid4550879 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid2889676\charrsid4659503 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13920109 {\*\bkmkstart _Toc132795394}V}{ \insrsid6557949 I}{\insrsid13920109 . A Departure: Medical Foods}{\insrsid8352250 {\*\bkmkend _Toc132795394} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1055019 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1055019 \tab Along with dietary supplements, anot}{\insrsid1051322 her important group of foods is}{\insrsid1055019 exempted from the labeling and substantiation requirements applicable to conventional foods, creating }{\insrsid1051322 yet }{\insrsid1055019 another opportunity for functional food manufacturers to market their products in ways that may be less vulnerable to FDA scrutiny. This category of foods is known as medical foods.}{\insrsid1055019\charrsid1055019 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7867004 {\*\bkmkstart _Toc132795395} A. Definition and Regulatory Loophole}{\insrsid854033 {\*\bkmkend _Toc132795395} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid854033 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3170647 \tab }{\insrsid11412975 Medical foods are a unique category of products for the nutritional medical management of a disease or disease condition.}{\cs16\super\insrsid11412975 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Susan D. Brienza, Esq., }{\i\insrsid16143335 Medical Foods \endash A Unique FDA Product Category}{\insrsid16143335 , }{\scaps\insrsid16143335\charrsid16138979 Aloe Today}{\insrsid16143335 (November 2004), }{\i\insrsid16143335\charrsid16138979 at}{ \insrsid16143335\charrsid16138979 http://www.aloecorp.com/pdfs/Brienza_1104.pdf}{\insrsid16143335 .}}}{\insrsid11412975 }{\insrsid3170647 The term }{\insrsid354981 \'93}{\insrsid3170647 medical food}{\insrsid354981 \'94}{\insrsid3170647 is defined }{ \insrsid947511 under }{\insrsid6557949 \'a75(b)}{\insrsid11883257 (3)}{\insrsid4988548 of }{\insrsid947511 the Orphan Drug Act }{\insrsid3170647 as a food which is }{\insrsid1055019 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12679027 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid3170647 formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requir ements, based on recognized scientific principles, are established by medical evaluation.}{\cs16\super\insrsid3170647 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Orphan Drug Act, 21 U.S.C. \'a7 360ee(b)(3) (2002). The Orphan Drug Act was enacted because of the fact that there are many diseases and conditions which affect such small numbers of people in the United States (i.e., less than 200,000 new cases per year) that they are considered rare, and, as such, adequate drugs for these disea ses and conditions have not been developed. Such drugs are referred to as \'93orphan drugs,\'94 and since so few people are affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may expect to incur a financial loss. T he Orphan Drug Act seeks to provide incentives for the development of orphan drugs by assisting in defraying the costs of developing medical devices, medical foods, and drugs for rare diseases and conditions. }}}{\insrsid3170647 }{\insrsid1055019 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid1055019 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1055019 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1055019 {\insrsid2295499 Thus, medical foods}{\insrsid13859916 are distinguished from foods for special dietary use \endash they are }{ \insrsid2295499 generally prescribed by physicians for patients with special nutritional needs}{\insrsid4220193 that cannot otherwise be met with a conventional diet}{\insrsid2295499 , and their labels must clearly state that the product is intended to be used in order to manage a specific medical disorder or condition.}{\cs16\super\insrsid2295499 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 FDA/CFSAN/Office of Special Nutritionals, }{\i\insrsid16143335 Medical Foods}{\insrsid16143335 (May 1997), }{\i\insrsid16143335\charrsid16138979 available at}{\insrsid16143335 : }{\insrsid16143335\charrsid7867004 http://vm.cfsan.fda.gov/~dms/ds-medfd.html}{\insrsid16143335 . }}}{\insrsid8536272 }{\insrsid2889676 Medical foods are also distinguished from drugs \endash they must n ot claim to cure, mitigate, treat or prevent any disease, but may make claims to address a patient\rquote s special dietary needs that exist }{\i\insrsid2889676\charrsid2889676 because of}{\insrsid2889676 a disease.}{\cs16\super\insrsid2889676 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See, e.g.,}{ \insrsid16143335 McNamara, }{\i\insrsid16143335 supra}{\insrsid16143335 note 21, at 426.}}}{\insrsid2889676 }{\insrsid15953405 Many medical foods are used institutionally in hospitals and nursing homes. }{\insrsid13859916 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13859916 {\insrsid947511 Medical foods are exempted from the labeling requirements for conventional foods}{\insrsid13859916 proscribed under the NLEA}{\insrsid7867004 . That is,}{\insrsid947511 medical foods do not have to include nutrition information on their labels, and their claims}{\insrsid14895032 (both health and nutrient content)}{\insrsid947511 do not need to meet specific standards.}{\cs16\super\insrsid13859916 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 21 U.S.C. \'a7 343(q)(5)(A)(iv) (2002).}}}{\insrsid947511 }{\insrsid11412975 To state it another way, medical fo}{\insrsid7867004 ods and the claims they make}{\insrsid11412975 do not require FDA pre-approval of safety and efficacy before they can be marketed. }{\insrsid15953405 T}{\insrsid2889676 his is because, in theory, medical food}{\insrsid15953405 use is supposed to be authorized by physicians, whose judgment FDA has traditionally deferred to. }{\insrsid2889676 Manufacturers are not even required to notify FDA that they are manufacturing or marketing a \'93medical food.\'94 }{\insrsid947511 However a food is subject to this}{\insrsid15953405 labeling}{\insrsid947511 exemption only if:}{\insrsid3170647 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12679027 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid947511 i. If is a specially formulated and pro cessed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding}{\cs16\super\insrsid11883257 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Enteral nutrition is nutrition provided through the gastrointestinal tract, taken by mouth or provided through a tube or catheter that delivers nutrients beyond the oral cavity, i.e., directly to the stomach or small intestine. }{ \i\insrsid16143335\charrsid16138979 See}{\insrsid16143335 Regulation of Medical Foods, 61 Fed. Reg. at 60,664.}}}{\insrsid947511 by tube; \par ii. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary managemen t of which cannot be achieved by the modification of the normal diet alone; \par iii. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation; \par iv. It is intended to be used under medical supervision; and \par v. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.}{\cs16\super\insrsid947511 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 C.F.R. \'a7 101.9(j)(8) (2005) (internal citation added).}}}{\insrsid947511 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid947511 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid947511 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11412975 {\insrsid11412975 While exempt from the requirements of the NLEA, specific claims may be made about exactly how a medical food product meets the distinctive nutritional requirements of a disease or condition only if the need for the product has been medically established, the product is formulated based on sound science, and the claims for efficacy or effectiveness are based on scientific evidence.}{\cs16\super\insrsid11412975 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 Brienza, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 150.}}}{\insrsid11412975 In addition, all medical f}{\insrsid11941396 ood ingredients must be GRAS}{\insrsid9975129 , and good manufacturing practi ces that apply to sanitary manufacture of processed conventional foods apply to medical foods as well.}{\cs16\super\insrsid9975129 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 Charles Mueller, MS, RD, CNSD, }{\i\insrsid16143335 The Regulatory Status of Medical Foods and Dietary Supplements in the United States}{\insrsid16143335 , 15 }{\scaps\insrsid16143335\charrsid12679027 Nutrition}{\insrsid16143335 249, 250 (1999).}}}{\insrsid11412975 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11412975 {\insrsid16343142 Because medical foods had received little attention in the past, and because the number and types of foods marketed as medical foods began to increase, FDA published an advanced notice of proposed rulemaking (ANPR) entitled \'93Regulation of Medical Foods \'94 on November 29, 1996, soliciting comments to \'93initiate a reevaluation of its approach to the regulation of the broad group of heterogeneous products that are marketed as medical foods.\'94}{\cs16\super\insrsid16343142 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Regulation of Medical Foods, 61 Fed Reg. at 60,661.}} }{\insrsid16343142 }{\insrsid14895032 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5267399 {\insrsid7867004 The ANPR first discusses the history of medical food regulation, noting that o}{\insrsid3366507 ne of the first medical foods developed was Lofenalac\'ae, an infant formula designed for use in the dietary management of phenylketonuria (PKU) b y way of its very limited amount of the amino acid phenylalanine (since PKU-afflicted individuals have an impaired ability to metabolize phenylalanine).}{\cs16\super\insrsid3366507 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 60662.}}}{\insrsid3366507 Before 1972, FDA regulated products like Lofenalac\'ae as drugs under }{\insrsid14895032 \'a7 201(g)(1)(B) of the FDCA}{\insrsid3366507 because they helped to mitigate serious adverse effects of diseases. In 1972, the FDA changed its position and stated that such products would be regulated as \'93foods for special dietary use,\'94 since it was interested both in fostering innovation in development of these types of products, most of which were developed for the dietary management of diseases and conditions that were not widespread, as well as in protecting the general public from inappropriate and }{\insrsid14895032 potentially }{\insrsid3366507 hazardous use of these products via regulation as foods for general use.}{\cs16\super\insrsid3366507 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id}{\insrsid16143335 . }}}{\insrsid3366507 }{\insrsid14895032 Finally, the Orphan Drug Amendments of 1988 enacted a statutory definition of \'93medical food,\'94 described }{\i\insrsid14895032 supra}{\insrsid1051322 , and foods like Lofenalac\'ae began to fall under this new category of regulation.}{ \insrsid14895032 In 1990, the Nutrition Labeling and Education Act incorporated the definition of medical foods from the Orphan Drug Amendments into 21 U.S.C. \'a7 403(q)(5)(A)(iv) and exempted medical foods from the nutrition labeling, health claim, and nutrient content claim requirements applicable to conventional foods. }{\insrsid11883257 \par }{\insrsid7867004 Next, the ANPR notes that, b}{\insrsid5267399 esides PKU, medical foods are administered to manage diseases or conditions such as kidney disease, liver disease, hypermetabolic states such as severe burns or trauma, lung disease, compromised immune function such as in HIV or AIDS, diabetes mellitus, malabsorption, oral rehydration, maple syrup urine disease, hereditary tyrosinemia, homocystinuria, and urea cycle disorders. Enteral nutrition products labeled and marketed as medical foods are generally liqui d or powdered products, including nutritionally complete formulations}{\insrsid13595345 (the majority of medical foods currently in use, which supply all the required protein, fat, carbohydrates, vitamins and minerals in quantities sufficient to maintain nutritional status of individuals receiving no other source of nourishment)}{ \insrsid5267399 , nutritionally incomplete formulations (for use in conjunction with other formulations}{\insrsid13595345 or as supplemental sources of nutrients or calories}{\insrsid5267399 ), formulations for metabolic}{\insrsid13595345 /genetic}{ \insrsid5267399 disorders in patients over 12 months of age}{\insrsid13595345 (for use in providing the nutrient composition necessary for the growth and development of persons afflicted with a specific metabolic disorder)}{\insrsid5267399 , and oral rehydration products}{\insrsid13595345 (for use in replacing water and electrolytes that have been lost from the body)}{\insrsid5267399 .}{\cs16\super\insrsid5267399 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid9141792 See}{\i\insrsid16143335 id. }{\insrsid16143335 at 60664; }{\i\insrsid16143335\charrsid9141792 see also}{\insrsid16143335 }{\insrsid16143335\charrsid9141792 Mary K. Schmidl, Ph.D., }{\i\insrsid16143335\charrsid9141792 Food Products for Special Medical Purposes}{\i\insrsid16143335 , }{\insrsid16143335 }{\insrsid16143335\charrsid3552066 Sandoz Nutrition Corp}{\insrsid16143335 . (last visited April 1, 2006), }{\i\insrsid16143335 at}{\insrsid16143335 }{\insrsid16143335\charrsid9141792 http://faculty.che.umn.edu/fscn/Ted_Labuza/PDF_files/papers/Medical_Trends.PDF}{\insrsid16143335 . }}}{\insrsid5267399 }{\insrsid5267399\charrsid14895032 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid992600 {\insrsid992600 \tab It is important to note Congress\rquote s intention to treat medical foods and}{\insrsid11883257 their predecessors,}{ \insrsid992600 foods for special dietary use}{\insrsid11883257 ,}{\insrsid992600 as separate and distinct categories of products to be regulated separately. While medical foods are statuto rily exempt from the requirements of the NLEA, foods for special dietary use are not \endash they, like conventional foods, must be labeled with nutrition information in a prescribed format}{\insrsid11883257 , and any nutrient content claims or health claims on their labels must be authorized by FDA to ensure that the claims are scientifically valid and are presented so as to be truthful and not misleading.}{\cs16\super\insrsid11883257 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Regulation of Medical Foods, 61 Fed. Reg.}{\i\insrsid16143335 .}{\insrsid16143335 at 60663.}}}{\insrsid11883257 }{\insrsid992600 As indicated in the ANPR, the exemption of medical foods from the requirements of the NLEA of 1990 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid1051322 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid992600 creates a troubling para dox: Medical foods intended for use by sick people are subject to much less scrutiny than virtually all other foods, which are intended for the healthy general population. This lack of scrutiny creates a situation that could have adverse public health co nsequences if these products bear claims that are not scientifically valid, or if their labeling does not disclose nutrition or other information that is necessary for the safe and effective use of the food.}{\cs16\super\insrsid992600 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 60663-4.}}}{\insrsid2777944 }{\insrsid11883257 \tab }{\insrsid11412975 \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5457432 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14102768 Because }{\insrsid7867004 m}{\insrsid5457432 edical foods are given li}{\insrsid14102768 ttle regulatory attention,}{\insrsid5267399 the }{\insrsid14102768 years starting in the }{\insrsid5267399 early 199}{\insrsid14102768 0\rquote s have seen}{\insrsid11883257 a vast increase in both number and variety of products marketed as medical foods, the number and types of claims made for such products, the number of manufacturers marketing medical foods, and the types of ingredients included in them.}{ \cs16\super\insrsid11883257 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 60664.}}}{\insrsid11883257 Due to FDA\rquote s almost complete non-involvement in the regulation of medical foods to be marketed t}{\insrsid2960831 o the public, manufacturers have been}{\insrsid11883257 jumping on the bandwagon left and right, trying to evade the requirements of the NLEA }{\insrsid5457432 and the necessity for FDA approval, }{\insrsid11883257 by characterizing their products as medical foo}{\insrsid14102768 ds, even when their products do}{\insrsid11883257 not necessarily qualify as such under the statutory definition. }{\insrsid7867004 In fact, u}{\insrsid2960831 nder current rules, manufacturers can escape approval requirements for health claims simply by calling a product a medical food and advising consumers on the label that it is to be used under the supervision of a physician.}{\cs16\super\insrsid2960831 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2960831 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 See CSPI }{ \i\insrsid16143335 Starvation Diet}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 146, at 37.}}}{\insrsid790905 }{\insrsid14102768 This creates a significant regulatory loophole. }{\insrsid790905 Even more troubling is the fact that many of the products they are pushing end up being marketed directly to the public rather than administered by a physician. While over-the-counter medical foods can indeed be used under physician }{\i\insrsid790905 supervision}{\insrsid790905 , there is no guarantee that this will happen}{\insrsid9975129 (and often is }{\i\insrsid9975129 not}{\insrsid9975129 the case in practice) when such products}{\insrsid790905 are actually available for consumers to directly purchase them, sometimes without even the knowledge of their physicians, let alone supervision.}{\insrsid14102768 }{\insrsid2777944\charrsid790905 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2777944 {\insrsid790905 In the ANPR, }{\insrsid5267399 FDA expressed its worries over the gr eatly increased number and types of products purporting to be medical foods: }{\insrsid11883257 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid8129778 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid5267399 Medical foods are complex formulated products, generally requiring sophisticated and exacting technology comparable to that used in the manufacture of infant formulas and drugs. Moreover, the populations that consume these products, often as the sole or a major source of nutrition, are extremely vulnerable, e.g., pediatric patients in periods of growth and development, the elderly, patients who have serious illnesses, and patien t s in intensive care units. Although excessive, or conversely, insufficient amounts of particular nutrients may not be a health hazard when consumed by healthy persons, serious adverse consequences (even death) may result when these vulnerable populations consume these products for long, or even short, periods of time.}{\cs16\super\insrsid5267399 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Regulation of Medical Foods, 61 F.R. at 60664}{\i\insrsid16143335 .}}}{\insrsid3475548 \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13326623 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13326623 FDA recognized in the ANPR that it is }{ \i\insrsid13326623 not}{\insrsid13326623 enough that a manufacturer dec}{\insrsid8129778 lare or subjectively intend for}{\insrsid13326623 a purported medical food}{\insrsid8129778 to}{\insrsid13326623 be used for the dietary management of patients with specific diseases or conditions. In order to prevent the medical foods category from becoming a \'93safe harbor for fraudulent claims targeted at those who are most vulnerable,\'94 the product as formulated and consumed must actually meet the distinctive nutritional requirements of the disease/condition it purports to manage.}{\cs16\super\insrsid13326623 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13326623 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 60669.}}}{\insrsid13326623 \par }{\insrsid13709709 Importantly, FDA\rquote s current scheme does not include a regulatory framework to establish quality assurance, to ensure the safety of medical foods under their intended conditions of use, to ensur e that medical foods provide the nutrients they claim to provide within safe ranges, or to ensure that the benefits claimed for medical foods' purported use are supported by adequate scientific evidence.}{\cs16\super\insrsid13709709 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \i\insrsid16143335 id.}{\insrsid16143335 at 60670.}}}{\insrsid13709709 }{\insrsid5457432 While this may create vast opportunities for manuf acturers to enter the market and escape FDA interference, it also creates risks for such manufacturers who take the chance (in the absence of definitive regulations) of investing time and money developing and marketing a medical food only to have the FDA eventually change the landscape and issue final rules that could eliminate their products from the market.}{\cs16\super\insrsid5457432 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Although, as discussed below, it appears the FDA will not be considering the issue of regulation of medical foods anytime in the near future.}} }{\insrsid14102768 Moreover, it would}{\insrsid5457432 be quite risky }{\insrsid14102768 (as far as products liability is concerned) }{\insrsid5457432 for manufacturers to market an unapproved high-risk product to populati ons with life-threatening diseases (as are the focus of many medical foods). Thus, there may be some unanticipated constraints on the marketing of foods that truly do not fulfill the statutory requirements of medical foods, despite the lack of specific r egulation.}{\insrsid2777944 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid2960831 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7867004 {\*\bkmkstart _Toc132795396}B}{ \insrsid2960831 . Case Example: HeartBar{\*\bkmkend _Toc132795396} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2960831 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid2960831 \tab }{\insrsid9975129 The example of HeartBar illustrates}{ \insrsid790905 the}{\insrsid12197354 tensions between medical food manufacturers and those pressing for more stringent pre-approval requirements for medical foods}{\insrsid790905 . HeartBar}{\insrsid9975129 , developed by John Cooke, M.D., Ph.D.,}{ \insrsid790905 was a popular product, looking and tasting like conventional}{\insrsid12197354 chewy}{\insrsid790905 sports and protein bars}{\insrsid12197354 (as well as powders)}{\insrsid790905 available in grocery stores or health food counters. However, HeartBar was instead sold in pharmacies}{\insrsid12197354 (directly to consumers)}{\insrsid790905 as a medical food}{\insrsid9975129 , and its manufacturers advertised}{\insrsid790905 it for}{\insrsid9975129 use in the}{\insrsid790905 diet}{\insrsid9975129 ary management of heart disease.}{\cs16\super\insrsid9975129 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9975129 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 wholehealthmd.com, }{\i\insrsid16143335 New Medical Foods; HeartBar}{\insrsid16143335 (November 7, 2000), }{\i\insrsid16143335\charrsid14318628 at}{\insrsid16143335 http://www.wholehealthmd.com. Strangely, one of HeartBar\rquote s listed drawbacks was that it supplied about 200 calories per bar and 400 calories at two bars a day, a substantial amount considering that many heart disease patients are already struggling with their weight and trying to avoid unnecessary calorie inta ke. }}}{\insrsid9975129 HeartBar consisted of the}{\insrsid790905 active ingredient }{\insrsid9975129 L-A}{\insrsid790905 rginine, an amino }{\insrsid9975129 acid that is supposed to }{\insrsid6163091 promote heart health and}{\insrsid1769691 is required to produce nitric oxide, a potent dilator of blood vessels. L-Arginine is thought to play a direct role in}{\insrsid12197354 reducing the risk of developing heart disease, reversing damage to the heart, reducing or eliminating heart disease patients\rquote need for surgery and medications, and substantially decreasing leg pain in people with cardiovascular disease.}{ \cs16\super\insrsid5524458 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 An article supported by an unrestricted educational grant from Cooke Pharma states that \'93[s]tudies clearly demonstrate the potential of L-arginine supplementation to enhance NO-mediated cardiovascular health.\'94 U.S. Pharmacist, }{ \i\insrsid16143335 The Role of L-Arginine in Cardiovascular Health}{\insrsid16143335 , U.S. Pharmacist Continuing Education (lesson expires November 30, 2001), }{\i\insrsid16143335\charrsid14318628 available at}{\insrsid16143335 http://www.uspharmacist.com/NewLook/CE/larginine/lesson.htm.}}}{\insrsid12197354 }{\insrsid2960831 \par }{\insrsid12197354 \tab While the director of legal affairs at the Center for Science purportedly said that, \'93[b]y marketing this as a medical food, [Cooke Pharma is] just trying to evade FDA regu}{\insrsid15232335 l}{\insrsid12197354 ations that would restrict the health claims the company\rquote s making,\'94 Cooke Pharma\rquote s }{\insrsid6114636 CEO & President, }{\insrsid12197354 Darlene Walley}{\insrsid6114636 ,}{\insrsid12197354 said, \'93 [t]he FDA is aware of this product. It\rquote s not a category that requires preapproval. If they ask us for information, we\rquote re prepared to do that.\'94}{\cs16\super\insrsid12197354 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Richard Haugh, }{\i\insrsid16143335 Label Loophole}{ \insrsid16143335 , hospitalconnect.com (July 1, 2002). }{\i\insrsid16143335 available at}{\insrsid16143335 }{\insrsid16143335\charrsid14318628 http://www.hhnmag.com/hhnmag/hospitalconnect/search/article.jsp?dcrpath=AHA/NewsStory_Article/data/HHNMAG286&domain=HHNMAG}{\insrsid16143335 . }}}{\insrsid12197354 \par }{\insrsid15232335 \tab Soon after developing HeartBar, Cooke Pharma (}{\insrsid4468516 and later}{\insrsid5524458 Unither Pharmaceuticals}{\insrsid12988774 (Unither}{\insrsid7954251 Pharma}{\insrsid12988774 )}{\insrsid5524458 , a wholly owned subsidiary of United Therapeutics Corporation}{\insrsid12988774 (United}{\insrsid7954251 Therapeutics}{\insrsid12988774 )}{\insrsid5524458 , which acquired all of the assets of Cooke Pharma) began to advertise the product extensively.}{ \cs16\super\insrsid5524458 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335\charrsid14318628 See}{\insrsid16143335 Exhibits A-I attached to the Federal Trade Commission complaint, }{\i\insrsid16143335\charrsid14318628 available at}{\insrsid16143335 : http://www.ftc.gov/opa/2003/unither.htm. Th e complaint alleges that advertisements and promotions have appeared on cookepharma.com and unither.com websites, as well as on product packaging and print media since at least 1999. Representative advertisements included claims that HeartBar can improve circulation and heart health, help users feel more active and energetic, reduce painful symptoms such as angina and leg pain, and improve users\rquote stamina. HeartBar was touted as clinically proven to be safe and effective in the dietary management of people with or at risk of developing cardiovascular disease, to be effective in enhancing exercise capacity while decreasing angina, while improving the quality of life in patients with coronary artery disease. Further, the advertisements included memoirs ( \'93patient success stories\'94) from people who supposedly used HeartBar and experienced significant improvements in their cardiovascular health. Some of the advertisements did include the phrase \'93use under the supervision of a physician.\'94}}}{ \insrsid4468516 It wasn\rquote t long bef}{\insrsid8129778 ore the FTC}{\insrsid4468516 brought a }{\insrsid7954251 complaint against Unither Pharma and United Therapeutics}{\insrsid4468516 for allegedly violating the provisions of the FTC Act by representing, expressly or by implication, that they possessed and relied upon a reasonable basi s that substantiated the representations they made (i.e., that HeartBar substantially decreases leg pain for people with cardiovascular disease; that HeartBar reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, or estrog en deficiency; that HeartBar prevents age-related vascular problems, including \'93hardening of the arteries\'94 and plaque formation, and reduces the risk of develo}{\insrsid8129778 ping cardiovascular disease; that}{\insrsid4468516 HeartBar reduces or eliminates the need for surgery, such as cor onary bypass or angioplasty, and medications such as nitroglycerin, in patients with cardiovascular disease; and that HeartBar Sport improves endurance and energy for the general population) when, in fact, they did not possess and rely upon a reasonable b asis to substantiate these representations at the time they were made.}{\cs16\super\insrsid4468516 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 See In the Matter of Unither Pharma, Inc., (Federal Trade Commission 2003), Dkt. No. 022 3036 (Complaint); }{\i\insrsid16143335 available at}{ \insrsid16143335 }{\insrsid16143335\charrsid12991679 http://www.ftc.gov/os/2003/06/unithercmp.htm}{\insrsid16143335 .}}}{\insrsid4468516 }{\insrsid12988774 The FTC thus alleged that these representations were false and misleading. Further, the FTC alleged that }{\insrsid7954251 Unither Pharma and United}{\insrsid12988774 }{\insrsid7954251 Therapeutics }{\insrsid12988774 represented, expressly or by implicatio n, that clinical studies, research, and/or trials showed certain facts (i.e., that HeartBar decreases angina pain, including by as much as 70% within two weeks; that HeartBar decreases leg pain while walking or exercising, including by as much as 66% with i n two weeks, for people with peripheral artery disease; that HeartBar reverses the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart; and that HeartBar Sport improves endurance and energy for the general population) when , in fact, clinical studies, research, and/or trials did not show any of these things. Thus, the FTC alleged that these representations were also false and misleading.}{\cs16\super\insrsid12988774 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid12988774 Finally, FTC alleged that the acts and practices described in its complaint constitute d unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the FTC Act. }{\insrsid15232335 \par }{\insrsid12988774 \tab On June 12, 2003, Unither Pharma and United Therapeutics entered into a proposed settlement agreement with the FTC, prohibiting }{\insrsid7954251 them}{\insrsid12988774 from repeating the kinds of claims they had been making for HeartBar and other L-Arginine products unless they have adequate scientific support and barring them from making any unsubstantiated claims about health bene fits, performance, or efficacy of any food, medical food, or dietary supplement used in or marketed for the treatment, cure, or prevention of cardiovascular disease.}{\cs16\super\insrsid7954251 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \insrsid16143335\charrsid14318628 In the Matter of Unither Pharma, I}{\insrsid16143335 nc}{\i\insrsid16143335 .}{\insrsid16143335 (Federal Trade Commission, June 12, 2003) Dkt. No. 022 3036 (Agreement Containing Consent Order), }{ \i\insrsid16143335\charrsid12991679 available at}{\insrsid16143335 : http://www.ftc.gov/opa/2003/06/unither.htm). }}}{\insrsid12988774 }{\insrsid7954251 The proposed consent agreement also requires Unither Pharma and United Therapeutics to c ontact all of their distributors and sellers and request that they immediately stop using any false or deceptive advertisements for HeartBar, and that they actively notify the FTC of any distributors who continue to make claims that the order prohibits. The proposed settlement does, however, permit Unither Pharma and United Therapeutics to use certain claims for foods that the FDA approved for labels through its regulation under the NLEA and certain claims for drugs that the FDA approved. }{ \insrsid12988774 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7954251 {\insrsid7954251 While FDA never took formal action against the health claims made on HeartBar\rquote s labeling, o}{\insrsid15232335 n January 19, 2006, Unither Pharma poste}{\insrsid12988774 d the following message on its HeartB}{\insrsid15232335 ar website: \'93We regret to inform you that, effective immediately, Unither Pharma is discontinuing its H eartBar line of products. Orders for HeartBar products will no longer be accepted, and no further shipments of HeartBar products will be made.\'94}{\cs16\super\insrsid15232335 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Unither Pharma (January 19, 2006), }{ \i\insrsid16143335\charrsid12991679 at }{\insrsid16143335 http://www.heartbar.net }}}{\insrsid7954251 }{\insrsid3807001 Whether or not HeartBar was taken off the market as an indirect result of the settlement agreement with the F TC, or as a result of general consumer unresponsiveness, or for fear that FDA would crack down on its promot}{\insrsid8129778 ion as a medical food is irrelevant. What is important about}{\insrsid3807001 the HeartBar case}{\insrsid8129778 is that it}{ \insrsid3807001 exemplifies what can happen when manufacturers try to get through the regulatory loophole without adequate scientific substantiation to back up the claims that they make about their purported medical foods. }{\insrsid6835030 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7867004 {\*\bkmkstart _Toc132795397}C}{ \insrsid4988548 . Clarification Efforts and Failure{\*\bkmkend _Toc132795397} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13326623 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13326623 \tab }{\insrsid3148004 With the above concerns in mind, and noting that medical foods fall somewhere between conventional foods and drugs, FDA}{\insrsid6163091 , in its ANPR,}{\insrsid3148004 opined that some level of substantiation for a medical food\rquote s claimed usefulness in the dietary management of disease must be required; it would simply \'93make no sense to establish a standa rd for claims on medical foods that was lower than the standard for health claims that are made for foods sold to healthy people.\'94}{\cs16\super\insrsid3148004 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Regulation of Medical Foods, 61 F.R. at 60669.}}}{ \insrsid3148004 Because of FDA\rquote s growing concern that many claims made for products marketed as medical foods are not actually supported by adequate scientific evidence, and, thus, that these unsupported claims lead to inappropriate use by patients and physicians who rely on them when effective alternative nutritional strategies for disease management are available, FDA called for a strong s t andard of substantiation requiring all pertinent data to be considered in the formulation of the product and in the development of any claims relating to its use. In fact, FDA suggested that, in light of the fact that medical foods are intended for use i n the clinical management of }{\insrsid354981 \tab }{\insrsid3148004 serious diseases and injuries, it may be appropriate to apply a more stringent standard to the scientific evidence used to support claims for medical foods than for conventional foods.}{ \cs16\super\insrsid3148004 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 60670}}}{\insrsid3148004 }{\insrsid11828773 T}{\insrsid3148004 he agency went so far as to state a pre liminary view that the scientific standard contained in the statutory medical food definition \'93may require some of the same types of data for medical foods as are needed to support drug claims (e.g., data from clinical investigations).\'94}{ \cs16\super\insrsid3148004 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 Id.}}}{\insrsid3148004 }{\insrsid11828773 Moreover, FDA sta ted that medical foods are not meant to be used by the general public and may not be available in stores or supermarkets; if medical foods were available over the counter, consumers not under the supervision of a physician would use them, going against th e statutory definition of a medical food, which requires supervision of a physician. }{\insrsid354981 \par }{\insrsid13635441 \tab Amongst those responding to the ANPR was the American Dietetic Association}{\insrsid6557949 (ADA)}{\insrsid13635441 , which represents food and nutritional professionals serving the public in a variety of settings. }{ \insrsid6557949 The ADA stressed the importance of FDA developing regulations to both address the safety and efficacy concerns surrounding the current medical foods regime as well as to more clearly define the difference between medical food and food for specia l dietary use. The ADA recommended }{\insrsid14811165 applying }{\insrsid6557949 more specific definition}{\insrsid14811165 s of medical foods to products (e.g., definitions that spell out the particular kinds of diseases or disorders that medical foods are intended to manage and the needs of patients afflicte d by those diseases or disorders), as well as applying the significant scientific agreement standard in reviews of claims submitted for products meeting the statutory definition of medical foods.}{\cs16\super\insrsid14811165 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 American Di etetic Association, }{\i\insrsid16143335 FDA Proposal on Regulation of Medical Foods}{\insrsid16143335 (April 28, 1997), }{\i\insrsid16143335\charrsid12991679 available at}{\insrsid16143335 http://www.eatright.org/cps/rde/xchg/ada/hs.xsl/advocacy_lg042897_ENU_HTML.htm. The claims must also be truthful and nonmisleading.}}}{\insrsid14811165 }{\insrsid10056101 In addition, because of the growing number of medical food s and similar products in the marketplace that are becoming more and more available directly to consumers, the ADA }{\insrsid6163091 stated its belief}{\insrsid10056101 that medical foods should be labeled with (but not limited to) the following: }{ \insrsid13635441 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12991679 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10056101 \tab designed for\'85 \par \tab route(s) of administration (or \'93for enteral use only\'94) \par \tab use guidelines (such as \'93shake well before opening\'94) \par }\pard \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12991679 {\insrsid10056101 \tab ingredient listing \par }\pard \s32\qj \li1440\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin1440\itap0\pararsid12991679 {\insrsid10056101 nutrient content expressed in appropriate measures (such as per 100 cc or per 100 calories) \par }\pard \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12991679 {\insrsid10056101 \tab adverse effects \par }\pard \s32\qj \li1440\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin1440\itap0\pararsid12991679 {\insrsid10056101 notification requirement: this information sho uld include a system for health care professionals to notify the manufacturer of safety concerns specific to the product as well as any adverse incidence that occurred as a result of administering the product. This system should also be responsive to con sumers and allow them to contact the manufacturer to report any safety and adverse incidence issues. \par use only under medical supervision\'85 \endash or\'85use only as directed by a physician \par }\pard \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12991679 {\insrsid10056101 \tab drug nutrient/drug-drug/drug-food interaction, as appropriate}{\cs16\super\insrsid10056101 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid11412975 \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10056101 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14570954 The Foundation for Innovation in Medicine }{ \insrsid13910789 (FIM) }{\insrsid14570954 (founded by Stephen DeFelice) also responded to the ANPR.}{\insrsid13910789 The FIM \'93congratulate[d]\'94 the FDA for its ANPR, but noted that there was one provision in the proposal that, if implemented, would negate the general good of the ANPR and have a major negative impact on the health of the American people.}{\cs16\super\insrsid13910789 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Stephen L. DeFelice, M.D., }{ \i\insrsid16143335 Where Is the First Nutraceutical Cereal Company?}{\insrsid16143335 43 }{\scaps\insrsid16143335\charrsid12991679 Cereal Foods World}{\insrsid16143335 , Perspective 351, 352 (May 1998); Stephen L. DeFelice, M.D., }{\i\insrsid16143335 The Foundation for Innovation in Medicine\rquote s (FIM) Response to the FDA ANPR on Medical Foods}{\insrsid16143335 : }{\i\insrsid16143335 An Overview of the Nutraceutical Revolution}{\insrsid16143335 (April 10, 1997), }{\i\insrsid16143335 available at} {\insrsid16143335 }{\insrsid16143335\charrsid6031252 http://www.fimdefelice.org/archives/arc.researchact.html}{\insrsid16143335 .}}}{\insrsid13910789 The FIM expressed its belief that dramatically constricting the definition of a medical food}{ \insrsid1383537 , as the FDA proposed,}{\insrsid13910789 would significantly discourage U.S. corporate investment in clinical research, which is necessary to demonstrate reasonable efficacy and safety of medical foods.}{\cs16\super\insrsid13910789 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See FIM \rquote s Response to the FDA ANPR}{\insrsid16143335 , }{\i\insrsid16143335 supra}{\insrsid16143335 note 184 (noting that many companies have developed products as medical foods rather than as dietary su pplements, in order to take advantage of the lack of FDA pre-approval for medical foods, however the FIM saw this is a positive trend. Because of the fact that corporations feel more comfortable with the clear rules applicable to medical food products, t hey have initiated a substantial number of clinical studies to demonstrate the safety and efficacy of many medical food products).}}}{\insrsid1383537 }{\insrsid14570954 \par }{\insrsid5657418 Although FDA }{\insrsid8129778 and certain segments of the population }{\insrsid5657418 clearly recognized the}{\insrsid8129778 importance of re-evaluating the}{\insrsid5657418 regulations i}{\insrsid8129778 n the area of medical foods, FDA }{\insrsid5657418 did not follow its ANPR with a proposed rule. }{\insrsid2777944 Unfortunately, on April 10, 2003, FDA announced its intent to withdraw the ANPR (along with other ANPR\rquote s, proposed rules and proposed actions published in the Federal Register more than five years prior to this notice of intent)}{\insrsid13635441 , claiming that \'93the backlog of pending proposals dilutes [FDA\rquote s] ability to concentrate on higher priority regulations that are mandated by statute or necessary to address current public health issues.\'94}{\cs16\super\insrsid2777944 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\insrsid16143335\charrsid6031252 Withdrawal of Certain Proposed Rules and Other Proposed Actions}{\i\insrsid16143335 ; }{\insrsid16143335\charrsid6031252 Notice of Intent}{\insrsid16143335 , 21 C.F.R. \'a7 1, Dkt. No. 02N-0434 (April 10, 2003).}}}{\insrsid2777944 }{\insrsid10056101 Thus, none of the proposed and suggested requirements/comments were ever implemented. }{\insrsid2777944 FDA}{\insrsid13635441 determined that the proposals it was withdrawing were lower in priority, and that it would not likely have sufficient resources in the foreseeable future to further consider or prioritize them. }{\insrsid5657418 The C}{\insrsid8129778 SPI}{ \insrsid5657418 argues that \'93regulation in this area should be a high priority, not endlessly delayed and then ignored.\'94}{\cs16\super\insrsid4396919 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI, }{\i\insrsid16143335 Starvation Diet,}{\insrsid16143335 }{ \i\insrsid16143335\charrsid6031252 supra}{\insrsid16143335 note 146, at 16.}}}{\insrsid2777944\charrsid354981 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7867004 {\*\bkmkstart _Toc132795398}D}{ \insrsid13595345 . The Future: Biotechnology}{\insrsid4988548 and Tax Exemptions?{\*\bkmkend _Toc132795398} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6163091 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid16733750 \tab }{\insrsid12198162 Even if FDA is not looking to rapidly change the regulatory landscape in the near future, there may be significant changes in the medical foods industry in years to come.}{\insrsid6163091 }{\insrsid12198162 According to some in the industry, biotechnology is likely to have a major impact on the development of medical food products in the future. Potential applications of biotechnology to the medical food industry include:}{\insrsid13595345 \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid6031252 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid12198162 (1) use of genetic manipulation to delete undesirable components (e.g., the gene for gluten in flour) during growth of the plant or animal or to add genes for synthesis of specific therapeutic compounds (thus conve rting normal foods into specialized medical foods), and \par (2) use of enzyme bioreactor systems to convert normal food products into needed medical foods (e.g., conversion of soybean oil into MCT oil).}{\cs16\super\insrsid12198162 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Schmidl, }{\i\insrsid16143335 supra}{\insrsid16143335 note 162}{ \i\insrsid16143335 ,}{\insrsid16143335 citing S.K. Harlander and Ted Labuza, }{\i\insrsid16143335 Biotechnology and Food Processing}{\insrsid16143335 (1986), Noyes Publishing Co., Park Ridge, NJ.}}}{\insrsid12198162 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid12198162 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid6163091 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6163091 {\insrsid6163091 All of the concerns about biotechnology functional foods mentioned, }{\i\insrsid6163091 supra}{\insrsid6163091 , in Section III.D. are applicable in the biotechnology medical foods arena as well, and they would likely be amplified due to the fact that medical foods are supposed to be utilized by populations that are amongst the most physically vulnerable. }{ \insrsid12198162 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4067375 {\insrsid12198162 Another future development may well be a change in the tax treatment applicable to medical foods. }{\insrsid16733750 In 2005, a bill, H.R. 2486, was introduced into the House of Representatives to enact the \'93Dietary Supplement Tax Fairness Act of 2005.}{\cs16\super\insrsid16733750 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 H.R. 2486, 109}{ \super\insrsid16143335\charrsid16733750 th}{\insrsid16143335 Congress 1}{\super\insrsid16143335\charrsid16733750 st}{\insrsid16143335 Session (May 19, 2005) (referred to Committee on Ways and Means).}}}{\insrsid16733750 The purpose of this Act is to \'93amend the Internal Revenue Code of 1986 to provide that amounts paid for foods for special dietary use, dietary supplements, or medical foods shall be treated as medical expenses,\'94 i.e., shall be deductible as medical expenses withou t being subject to regulation as drugs.}{\cs16\super\insrsid16733750 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid16733750 The justification behind this bill is twofold: (1) items such as medical foods have been shown to be a valuable benefit to overall human health and disease prevention, and (2) children born with metabolic disorders or autism, as well as all individuals with diabetes, autoimmune disorders and chronic inflammatory conditions often require daily dietary interventions in addition to medical interventions to manage their conditions such that these dietary interventions can become significant economic burdens on them.}{\cs16\super\insrsid16733750 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid16733750 }{\insrsid3807669 In light of the real and persistent use of items such as medical foods in the management of serious diseases or disorder}{\insrsid8129778 s, it would make no sense to bar}{\insrsid3807669 them from deduction as medical expenses or to continu e to allow them to be deducted but only if they are prescribed drugs (since the very nature of the regulatory scheme surrounding medical foods encourages manufacturers to avoid at all possible costs the idea of their products being considered drugs rather than loosely-controlled medical foods). }{\insrsid16733750 }{\insrsid3807669 It remains to be seen whether this bill will be passed, but if it is eventually enacted into law, it could greatly decrease the tax burdens borne by those people with serious conditions that necessitate large daily dietary expenses akin to what other people with disorders instead treatable by drugs are permitted to deduct.}{\insrsid8129778 This is yet another way in which functional foods (specifically, medical foods) will be able to lower the total costs of health care for those most in need.}{\insrsid992600\charrsid4220193 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4988548 {\*\bkmkstart _Toc132795399}VII}{ \insrsid13920109 . Nutraceuticals}{\insrsid8352250 {\*\bkmkend _Toc132795399} \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid1769691 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1769691 {\*\bkmkstart _Toc132795400} A. What is a Nutraceutical?{\*\bkmkend _Toc132795400} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10690479 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10690479 \tab The term \'93nutraceutical\'94 }{\insrsid16070844 was coined }{\insrsid1315931 in 1989 }{\insrsid16070844 by Dr. Stephen DeFelice, MD, founder and chairman of the }{\insrsid15417942 FIM, from}{\insrsid16070844 a combination of two terms, \'93nutrition\'94 and \'93pharmaceutical.\'94 According to Dr. DeFelice, \'93nutraceutical\'94 }{\insrsid10690479 can be defined as \'93a}{\insrsid16070844 food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease}{\insrsid10690479 .} {\insrsid16070844 \'94}{\cs16\super\insrsid16070844 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{ \insrsid16143335 Vicki Brower, }{\i\insrsid16143335 Nutraceuticals: Poised for a healthy slice of the healthcare market?}{\insrsid16143335 16 }{\scaps\insrsid16143335\charrsid6031252 Nat. Biotech}{\insrsid16143335 . 728, 728 (Aug. 1998).}}}{ \insrsid16070844 As with functional foods,}{\insrsid10690479 the FDA does not r}{\insrsid16070844 ecognize nutraceuticals, however, this term is commonly used in marketing. }{\insrsid10690479 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1315931 {\insrsid1315931 \tab Nutraceutical may, in fact, just be another term for functional}{\insrsid4067375 foods, depending on who}{ \insrsid1315931 is speaking. }{\insrsid9179464 Perhaps th}{\insrsid10512217 e difference is purely one of semantics or, likely, it may have something to do with which term a manufacturer feels has greater market acceptability}{\insrsid9179464 . }{ \insrsid1315931 Like the term \'93functional food,\'94 the term \'93nutraceutical\'94 is a \'93catch-all\'94 that can also include products that are characterized as dietary supplements, or medical foods, or foods for special dietary use. However , there have been attempts to distinguish between }{\insrsid9179464 definitions for }{\insrsid1315931 functional foods and nutraceuticals. }{\insrsid9179464 In one view, a food is a \'93functional food\'94 when it is being cooked or prepared using \'93 scientific intelligence\'94 with or without knowledge of how or why it is being used, whereas a \'93nutraceutical\'94 is a functional food that aids in prevention and/or treatment of disease(s) and/or disorder(s) other than anemia.}{ \cs16\super\insrsid9179464 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See }{\insrsid16143335 Ekta K. Kalra, }{\i\insrsid16143335 Nutraceutical \endash Definition and Introduction}{\insrsid16143335 , 5 AAPS PharmSci Art. 25 (Sept. 3, 2003), }{\i\insrsid16143335\charrsid12656617 available at}{ \insrsid16143335 : http://www.pharmsci.org/view.asp?art=ps050325.}}}{\insrsid9179464 Thus, under this view, functional foods are a broader category and provide the body with the requ ired amount of vitamins, fats, proteins, carbohydrates, etc. needed for healthy survival, whereas nutraceuticals are a subset of functional foods that can be linked to prevention or treatment of health conditions. Further, under this view, \'93 a functional food for one consumer can act as a nutraceutical for another consumer.\'94}{\cs16\super\insrsid10512217 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}}}{\insrsid10512217 }{\insrsid1769691 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1315931 {\insrsid7675202 \tab Under another view, nutraceuticals are less aligned with functional foods, and are instead a subset of dietary supplements. Ste}{\insrsid6446553 ven Zeisel propose}{\insrsid14570954 s}{\insrsid7675202 to define nutraceuticals as \'93thos e diet supplements that deliver a concentrated form of a presumed bioactive agent from a food, presented in a nonfood matrix, and used to enhance health in dosages that exceed those that could be obtained from normal foods.\'94}{ \cs16\super\insrsid6446553 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Steven H. Zeisel, }{\i\insrsid16143335 Regulation of \'93Nutraceuticals}{\insrsid16143335 \'94, 285 }{\scaps\insrsid16143335\charrsid12656617 Science}{\insrsid16143335 1853, 1853 (Sept. 17, 1999).}}}{\insrsid6446553 }{\insrsid14570954 Under this view, }{\insrsid6446553 a good example of a nutraceutical is genistein purified from soybeans and delivered in a pill in dosages greater than could be consumed in soy. }{\insrsid14570954 In contrast, a}{\insrsid6446553 ccording}{\insrsid15417942 to Zeisel, functional foods}{\insrsid6446553 , unlike nutraceuticals, }{\insrsid15417942 are }{\insrsid6446553 similar in appearance to conventional foods and consumed as part of a normal diet, delivering one or more active ingredients (that have physiological effects and perhaps enhance health) within the matrix of a food.}{\cs16\super\insrsid6446553 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid6446553 An example of a functional food would be bread or breakfast cereal with added high-dose folic acid.}{\insrsid14570954 Zeisel proposes creating the category of nutraceuticals for dietary supplements that are administered in large dosages in order to obtain pharmacological effects. Thus, for Zeisel, the benefits and risks of nutraceuticals should be consi dered much more carefully than those for foods, and nutraceuticals seem closer to drugs than to conventional foods.}{\cs16\super\insrsid14570954 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id}{\insrsid16143335 .}}}{\insrsid14570954 Zeisel suggests that FDA could regulate nutraceuticals by requiring similar safety data to those required for over-the-counter medications (like cold remedies).}{\insrsid7757316 }{\insrsid7757316\charrsid1769691 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1769691 {\*\bkmkstart _Toc132795401}B}{ \insrsid4988548 . The Proposed Nutraceutical Research and Education Act{\*\bkmkend _Toc132795401} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1383537 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid1383537 \tab }{\insrsid7757316 The FIM, believing that the one major obstacle to the emergence of true nutraceutical companies is the unclear and confusing rules for making health claims, proposed t}{\insrsid1383537 he }{\insrsid9192842 \'93}{\insrsid1383537 Nut raceutical Research and Education Act}{\insrsid9192842 \'94}{\insrsid1383537 (NREA)}{\insrsid4067375 , which purports}{\insrsid9192842 to}{\insrsid209985 }{\insrsid9192842 \'93 amend the Federal Food, Drug, and Cosmetic Act to promote clinical research and development on dietary supplements and foods for their health benefits; to establish a new legal classificatio n for dietary supplements and foods with health benefits, and for other purposes}{\insrsid7757316 .}{\insrsid9192842 \'94}{\cs16\super\insrsid7757316 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7757316 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 H.R. 3001, 106}{ \super\insrsid16143335\charrsid16733750 th}{\insrsid16143335 Congress 1}{\super\insrsid16143335\charrsid16733750 st}{\insrsid16143335 Session (Oct. 1, 1999) (referred to Subcommittee on Health and Environment).}}}{\insrsid7757316 This bill}{ \insrsid9192842 }{\insrsid1383537 was introduced in Congress by Representat}{\insrsid209985 ive Frank Pallone, Jr. (D-NJ) on October 1, 1999}{\insrsid4067375 and }{\insrsid7757316 modeled after the successful principles of the Orphan Drug Act.}{ \insrsid9192842 }{\insrsid5522132 Co ngress found that, due to the current regulatory and epistemological chaos that exists with regard to health claims for foods, dietary supplements, and medical foods, it is in the national interest to provide a category of products that have recognized he alth benefits but are not drugs and to recognize that these products are safe when used as indicated on the}{\insrsid4067375 ir labeling. In short, the NREA purports}{\insrsid5522132 to promote research into the health benefits of dietary supplements, medical foods and other foods; establis h a simplified process within the FDA for reviewing, on a case by case basis, health claims of health benefits of such nutraceutical products made under a petition under \'a7 403(r)(4) of the Food, Drug and Cosmetic Act; prescribe a period of exclusive market ing protection for a person that demonstrates the health benefits of a dietary supplement, medical food, or other food, and who markets such product in association with approved labeling that describes its contribution to human health}{ \cs16\super\insrsid7698239 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 The NREA proposes an exclusivity period of seven years, whereas the FIM later, in 2002, proposes an extension of this exclusivity period for claims to ten years. }{\i\insrsid16143335\charrsid12656617 See}{\insrsid16143335 Stephen L. DeFelice, M.D., }{ \i\insrsid16143335 FIM Rationale and Proposed Guidelines for the Nutraceutical Research and Education Act (NREA)}{\insrsid16143335 , presented at FIM\rquote s 10}{\super\insrsid16143335\charrsid7698239 th}{\insrsid16143335 Nutraceutical Conference, (November 10-11, 2002), }{\i\insrsid16143335\charrsid12656617 available at}{\insrsid16143335 : http://www.fimdefelice.org/archives/arc.researchact.html. }}}{\insrsid5522132 ; and confirm the hea lth benefits of these products as determined by clinical trials, and disseminate this information to the public and the health care profession.}{\cs16\super\insrsid5522132 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 H.R. 3001.}}}{ \insrsid10119241 }{\insrsid5522132 \tab Important to determining what exactly the term \'93nutraceutical\'94 means, the NREA would amend 21 U.S.C. \'a7 321 by adding the following: \par }\pard\plain \s32\qj \li720\ri720\sa120\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid12656617 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid5522132 (kk) The term \'93nutraceutical\'94 means a dietary supplement, food, or medical food, as respectively defined in paragraphs (f) and (95) and section 5(h)(3) of the Orphan Drug Act (21 U.S.C. \'a7 360ee(b)(3)), that \endash }{\insrsid12656617 \par }{\insrsid5522132 possesses health benefits; and \par }{\insrsid13709709 is safe for human consumption in such quantity, and with such frequency, as required to realize such properties.}{\insrsid5522132 \par (ll) The term \'93health benefit,\'94 when used with reference to a nutraceutical, means a benefit which prevents or reduces the risk of a disease or health condition, including the management of a disease or health condition or the improvement of health. }{\cs16\super\insrsid12656617 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 Id.}}}{\insrsid5522132 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid5522132 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid5522132 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7698239 {\insrsid7698239 According to Dr. DeFelice, the NREA offers a practical solution to the difficulties facing the emerging nutraceutical industry \endash it enables more affordable clinical research costs for nutraceuticals (that are lower than research costs for pharmaceuticals), and it rewards companies that invest in clinical research on their products by allowing them to use their clinical data to make profits.} {\cs16\super\insrsid7698239 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Michael Mannion, }{\i\insrsid16143335 The Current Nutraceutical Health Sector and The Next Phase of the Nutraceutical Revolution}{\insrsid16143335 , Summary of the Foundation for Innovation in Medicine 11th Nutraceutical Conference (Feb. 3-4, 2000), }{ \i\insrsid16143335\charrsid12656617 available at}{\insrsid16143335 : http://www.fimdefelice.org/summary11.html. }}}{\insrsid5522132 \par }{\insrsid15417942 Whether or not nutraceutical is simply a fancy term for functional foods, the fact that it is out th}{\insrsid4144047 ere only informally}{\insrsid3742409 (the NREA has not yet been passed)}{\insrsid4144047 as}{\insrsid3742409 yet}{ \insrsid4144047 another }{\insrsid3742409 way to market}{\insrsid15417942 }{\insrsid4144047 certain dietary supplements, conventional foods and medical foods adds to the regulatory chaos}{\insrsid3742409 in the United States}{\insrsid4144047 . }{ \insrsid15417942\charrsid10512217 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid7675202 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9782123\charrsid13657848 {\*\bkmkstart _Toc132795402} VII}{\insrsid4988548 I}{\insrsid9782123\charrsid13657848 . }{\insrsid7675202 International Comparison}{\insrsid6423681\charrsid13657848 {\*\bkmkend _Toc132795402} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9782123 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid13657848 \tab In evaluating the regulatory system in the United States, it is ins}{\insrsid10512217 tructive to look to the }{\insrsid7675202 much more organized and formalized regulatory regime for functional foods}{\insrsid10512217 }{\insrsid7675202 in Japan for comparison. }{\insrsid13657848\charrsid13657848 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9782123\charrsid13657848 {\*\bkmkstart _Toc132795403} A. Japan: The FOSHU System{\*\bkmkend _Toc132795403} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9780826 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid9782123 \tab In Japan, there is an old saying (reminiscent of}{ \insrsid11802773 Hippocrates\rquote ruminations) that}{\insrsid9782123 \'93[m]edicines and foods are intrinsically the same in nurturing life and health.}{\insrsid6044022 \'94}{\cs16\super\insrsid9782123 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid9782123 FOSHU in Japan}{ \insrsid16143335 , LGG Action at 5 (February 2001), available at http://}{\field\flddirty{\*\fldinst {\insrsid16143335\charrsid9782123 HYPERLINK "http://www.valio.fi/lgg" }{\insrsid16143335\charrsid9782123 {\*\datafield 00d0c9ea79f9bace118c8200aa004ba90b0200000017000000110000007700770077002e00760061006c0069006f002e00660069002f006c00670067000000e0c9ea79f9bace118c8200aa004ba90b3000000068007400740070003a002f002f007700770077002e00760061006c0069006f002e00660069002f006c006700 67000000}}}{\fldrslt {\cs17\insrsid16143335\charrsid9782123 www.valio.fi/lgg}}}{\insrsid16143335 .}}}{\insrsid9782123 }{\insrsid3765063 It thus comes as no surprise that }{\insrsid9782123 Japan\rquote s }{\insrsid15808758 modern-day }{\insrsid9782123 functional food market is highly advanced, and, in fact, Japan is the only nation with legally defined functional foods}{\insrsid15808758 .}{\cs16\super\insrsid9782123 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 However, functional foods are distinguished from both vitamin or mineral-fortified foods and dietary supplements sold in pill or capsule form. }{\i\insrsid16143335 See}{\insrsid16143335 }{\cf1\insrsid16143335 CSPI Report, }{\i\cf1\insrsid16143335 supra }{\cf1\insrsid16143335 note 25.}}}{\insrsid9782123 }{\insrsid13595345 Functional foods have been defined as foods \'93derived from naturally occurring substances, which can and should be consumed as part of the daily diet, and serve[] to regulate or otherwise affect a particular body process when ingested.\'94}{\cs16\super\insrsid13595345 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 Schmidl, }{\i\insrsid16143335 supra}{\insrsid16143335 note 162.}}}{\insrsid13595345 }{\insrsid4018652 In Japan, foods are considered to have three functions- the primary being a nutritional function essential to survival, the secondary being a sensor y function such as flavor or pleasing texture, and the tertiary being a physiological function , such as regulation of biorhythm, the immune system, and body defense.}{\cs16\super\insrsid4018652 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Toshio Shimizu, }{ \i\insrsid16143335 Health Claims on Functional Foods: The Japanese Regulations and an International Comparison}{\insrsid16143335 , 16 }{\scaps\insrsid16143335\charrsid3552066 Nutrition Research Reviews}{\insrsid16143335 241, 241 (2003), }{ \i\insrsid16143335 available at}{\insrsid16143335 }{\insrsid16143335\charrsid3552066 http://www.frescojapan.co.jp/pdf/NRR0312.pdf}{\insrsid16143335 . }}}{\insrsid4018652 }{\insrsid5179166 The concept of functional foods was first }{\insrsid3742409 developed in the 1980\rquote s when Japan\rquote s}{\insrsid5179166 Ministry of Health}{\insrsid3742409 , Labor}{\insrsid5179166 and Welfare}{\insrsid3742409 (MHLW)}{\insrsid5179166 , faced with escalating health care costs, initiated a regulatory system to approve certain foods with documented health benefits.}{\cs16\super\insrsid5179166 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Hasler, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 4, at 3772.}}}{\insrsid5179166 }{\insrsid15808758 Functional foods have become a priority in the areas of science, technology and nutriti on in Japan, especially as lifestyle-related diseases have come to the forefront of many aging consumers\rquote minds. }{\insrsid9780826 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9780826 {\insrsid15808758 Japan\rquote s }{\insrsid9780826 regulatory }{\insrsid15808758 approval system}{\insrsid9780826 for functional foods}{ \insrsid15808758 is called \'93Foods for Specified Use\'94 or \'93FOSHU,\'94 and was instituted in 1991}{\insrsid9780826 to approve statements contained on product labels regarding the effects of food on the human body}{\insrsid15808758 .}{ \cs16\super\insrsid15808758 \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13658474 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{ \fs20\insrsid16143335 }{\i\fs20\insrsid16143335 See }{\fs20\insrsid16143335\charrsid13658474 Nutrition Improvement Law (Law No. 248, July 31, 1952, Amended by Law No. 101, May 24, 1995) and the Nutrition Improvement Law Enfor cement Regulations (Ministerial Ordinance No. 41, July 1991, Amendment to Ministerial Ordinance No. 33, May 25, 1996)}}}{\insrsid15808758 }{\insrsid9780826 FOSHU, being enacted under the Nutrition Improvement Law, is one of five categories of foods for special dietary uses, including: (1) milk powder for pregnant and la ctating women; (2) formulated milk powder for infants; (3) foods for elderly individuals with difficulty chewing or swallowing; (4) medical foods for the ill; and (5) FOSHU.}{\cs16\super\insrsid9780826 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 Shimizu, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 206, at 242.}}}{\insrsid9780826 }{\insrsid4486602 FOSHU foods are classified into five categories, including: (1) foods that enhance the body\rquote s immune system by boosting defense mechanisms, (2) foods that help prevent or control disease like diabetes or heart disease, (3) foods that aid recovery from disease such as lowering high cholesterol levels, (4) foods that regulate body rhyth ms by aiding digestion or enhancing absorption of vitamins and minerals, and (5) foods that suppress aging.}{\cs16\super\insrsid4486602 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 National Centre of Excellence in Functional Foods, }{\i\insrsid16143335\charrsid3552066 Health Claim Regulatory System: Japan}{\insrsid16143335 (2004), }{\i\insrsid16143335\charrsid3552066 available at}{\insrsid16143335 http://www.nceff.com.au/pdf/Japan.pdf. }}}{\insrsid4486602 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4486602 {\insrsid9914950 FOSHU was intended to \'93encourage the development of functional foods that could benefit the public\rquote s health while responding to the concerns of consumer groups (and some leading food companies) about misleading health claims.}{\insrsid6044022 \'94}{\cs16\super\insrsid9914950 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid9914950 }{\insrsid13658474 It focuses on health claims for specific products, rather than}{\insrsid11802773 on claims for}{\insrsid13658474 generalized categories of foods}{\insrsid4486602 or ingredients, and approved products can make express health claims on their labels}{\insrsid13658474 . }{\insrsid3742409 From a manufacturer\rquote s point of view, this seems an advantage over the United States \'93system,\'94 since it does not reward an entire sector of the food industry for the research efforts of just one company. }{\insrsid13658474 Applying for FOSHU approval i s a relatively long and complicated process, typically taking about one year to complete, and requiring extensive supporting information}{\insrsid9780826 relating to effectiveness (based on scientific evidence and clinical studies), product safety (based on studies with human subjects), and analytical determination of the effective components}{\insrsid13658474 .}{\cs16\super\insrsid15293672 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15293672 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See} {\insrsid16143335 Shimizu, }{\i\insrsid16143335 supra}{\insrsid16143335 note 206, at 242; }{\i\insrsid16143335\charrsid3552066 see also}{\insrsid16143335 CSPI Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25}{\i\insrsid16143335 }{ \insrsid16143335 (noting that information required includes a full list of the ingredients and functional compo nents and the basis for the recommended dose of the functional ingredient. Those seeking approval must also provide an explanation of the health benefits and the way in which they are brought about, an explanation of how the product will benefit the popu l ation as a whole, information demonstrating the safety of the ingredient, relevant test methods, a compositional analysis, physical and chemical characteristics of the product and its functional component, and documentary proof of all clinical and nutriti onal benefits and the safety and stability of the product. All of this information is expected to be accompanied by scientific papers (in the fields of medicine and/or nutrition) to substantiate the health claim).}}}{\insrsid15293672 FOSHU applications are reviewed and eventually approved by}{\insrsid9780826 }{\insrsid10377258 local}{\insrsid9780826 prefectures and}{\insrsid3742409 the }{\insrsid13247926 MH}{\insrsid2380391 L}{\insrsid3742409 W}{\insrsid15293672 . }{ \insrsid9782123 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9782123 {\insrsid15293672 \tab FOSHU products must be labeled with the approved health claim, recommended daily intake of the food, nutrition information, guidance on healthy eating, a warning against excessive intake if necessary, and any other special precautions that are needed}{\insrsid13982775 . Domestic FOSHU products}{\insrsid2163854 carry an \'93Approved\'94 mark from th}{\insrsid13247926 e MH}{\insrsid2380391 L}{\insrsid13247926 W}{\insrsid11338105 and the seal of approval, pictured below}{\insrsid2163854 .}{\cs16\super\insrsid15293672 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 Shimizu, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 206.}}}{\insrsid2163854 }{\insrsid11338105 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9782123 {\insrsid11338105 }{\insrsid11338105 {\*\shppict {\pict{\*\picprop\shplid1025{\sp{\sn shapeType}{\sv 75}}{\sp{\sn fFlipH}{\sv 0}}{\sp{\sn fFlipV}{\sv 0}}{\sp{\sn pibFlags}{\sv 2}}{\sp{\sn fLine}{\sv 0}}{\sp{\sn fLayoutInCell}{\sv 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claim.}{\cs16\super\insrsid10377258 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See id.}{\insrsid16143335 at 245.}}}{ \insrsid10377258 }{\insrsid15293672 \par }\pard\plain \s2\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid4067375 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4067375 {\*\bkmkstart _Toc132795404}B. FOSHU\rquote s Weaknesses{\*\bkmkend _Toc132795404} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7013972 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid5795571 \tab While the Japanese}{\insrsid2163854 system seems to be much more proactive than the}{\insrsid5795571 regulatory system in the United States, which is characterized by a}{\insrsid2163854 lack of specific recognition of funct}{\insrsid5795571 ional foods, there}{\insrsid2163854 still}{ \insrsid5795571 exist}{\insrsid2163854 some significant glitches. Most importantly, the FOSHU approval system is entirely voluntary, meaning that companies wishing to avoid the cumbersome regulatory process can market what are known as \'93health foods \'94 without obtaining FOSHU approval, so long as they do not make express claims that the product can reduce the risk of a disease or health-related condition.}{\cs16\super\insrsid2163854 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid3552066 See}{\insrsid16143335 CSPI report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid2163854 }{\insrsid12853192 Significantly, there is no law in Japan that defines health foods, and so manufacturers are relatively free to market an y foods they like as health foods. }{\insrsid5795571 Because of this weakness, changes to the system were implemented in 1998}{\insrsid2163854 , in order to promote}{\insrsid5795571 increased}{\insrsid2163854 voluntary par}{\insrsid5795571 ticipation in FOSHU approval. }{\insrsid2163854 Such changes include: (1) reduction of the amount of scientific document ation that manufacturers must submit during the application process (which previously was often quite large), (2) replacement of the requirement that manufacturers had to submit a certificate that all submitted scientific documentation had bee}{ \insrsid13982775 n reviewed by outside experts with}{\insrsid2163854 a requirement that studies instead be published in a scientific journal (note that industry-sponsored journals have been deemed acceptable), (3) elimination of the requirement that products be tested by the National Health and Nutriti on Laboratory such that the manufacturer\rquote s own analytical tests are instead acceptable, and (4)}{\insrsid5795571 elimination of the limiting four year duration of FOSHU approvals subsequent lack of expiration date.}{\cs16\super\insrsid5795571 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{ \insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid5795571 }{\insrsid13982775 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13982775 {\insrsid5795571 Yet, the fact still remains that the FO}{\insrsid13982775 SHU system is si mply voluntary. While the above changes might work effectively}{\insrsid5795571 to increase participation, they also make it easier for potentially lower-q}{\insrsid4990198 uality, less- substantiated claim}{\insrsid5795571 s to obtain }{ \insrsid13982775 FOSHU }{\insrsid5795571 approval. Regardless of the fact that the approval criteria have been weakened, it does seem preferable to have more functional foods actually re}{\insrsid13247926 viewed }{\i\insrsid13247926\charrsid7013972 formally}{\insrsid13247926 by the MH}{\insrsid2380391 L}{\insrsid13247926 W }{\insrsid5795571 before entering the market to }{\insrsid13247926 make health }{\insrsid8261048 claims instead of a}{\insrsid13247926 }{\insrsid6044022 plethora of health foods }{\insrsid8261048 }{\insrsid7013972 being }{\insrsid8261048 intentionally}{\insrsid7013972 (and legally)}{\insrsid8261048 screened off from review in order to avoid the deterrent effects of a more stringent regulatory}{\insrsid5795571 process. }{ \insrsid9914950 But}{\insrsid12853192 perhaps the system needs to be made completely mandatory in order to meet its}{\insrsid7013972 goals,}{\insrsid12853192 }{\insrsid8261048 in light of the fact that there are still tons of functional foods being marketed w}{\insrsid12853192 ithout FOSHU approval (simply lacking express health claims on their labels) even }{\i\insrsid12853192\charrsid12853192 after}{ \i\insrsid8261048\charrsid12853192 }{\insrsid8261048 the relaxatio}{\insrsid12853192 n of the standards}{\insrsid8261048 .}{\insrsid12853192 }{\insrsid7013972 Perhaps instead of maintaining the relaxed standards to encourage voluntary participating in the system, Japan should move towards a mandatory FOSHU system, with more stringent requirements to obtain approval.}{\insrsid2163854 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9914950 {\insrsid11802773 Another weakness of the}{\insrsid6044022 Japanese}{\insrsid11802773 system is that, unlike in the United States, the level of substantiation required for FOSHU approvals is not precisely known, a}{\insrsid13247926 s the MH}{\insrsid2380391 L}{\insrsid13247926 W}{\insrsid11802773 has not announ ced what standards it will apply.}{\cs16\super\insrsid6044022 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid11802773 Additionally, }{\insrsid13247926 it seems that the health food industry has undue influence in the regulatory approval process, }{ \insrsid11802773 as hinted above by the fact that the 1998 Amendments}{\insrsid15153777 both}{\insrsid4018652 : (1)}{\insrsid11802773 }{\insrsid13247926 allow FOSHU approvals conditioned on the require ment that studies supplied by companies be published in an academic journal, including industry-sponsored journals (replacing the former requirement that companies certify that scientific evidence in a FOSHU application was reviewed by outside experts)}{ \insrsid4018652 ,}{\insrsid15153777 and }{\insrsid4018652 (2) }{\insrsid15153777 accept the product manufacturer\rquote s own analytical tests in place of products being tested by }{\insrsid4018652 the }{\insrsid15153777 National Health and Nutrition Laboratory}{\insrsid13247926 .}{\cs16\super\insrsid13247926 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid13247926 }{\insrsid4018652 \par Prior to the change in regulatory requirements}{\insrsid12853192 , all scientific evidence in}{\insrsid2649138 an application had been}{\insrsid13247926 reviewed by outsid}{\insrsid2649138 e experts. }{\insrsid12853192 }{\insrsid2649138 T}{ \insrsid13247926 he Japan Health Food & Nutrition Food Association (JHNFA) established its own separate but parallel approval system to review research on new functional ingredients, summarize the scientific evidence, and make recommendations}{ \insrsid2649138 based on an evaluation of the available information}{\insrsid12853192 }{\insrsid2649138 (these recommendations}{\insrsid5252777 were}{\insrsid12726121 considered highly}{\insrsid5252777 influential with the MH}{\insrsid2380391 L}{ \insrsid5252777 W)}{\insrsid2649138 ,}{\insrsid13247926 which helped companies to obtain their }{\insrsid2649138 required certificates in order to obtain approval from the Ministry}{\insrsid13247926 . Since the changes in 1998 were implemented, the JHNFA created a publication called the }{\i\insrsid13247926 Journal of Nutritional Food}{\insrsid13247926 to help companies get their studies published, but the rules for submission to this journal are pretty lax, a}{\insrsid5252777 nd it seems that it}{\insrsid13247926 was created basically to help its members meet the publication requirement instituted by the MH}{\insrsid2380391 L}{\insrsid13247926 W.}{\cs16\super\insrsid13247926 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid5252777 }{\insrsid2649138 If industries can submit publications from journals that they}{\insrsid13635449 themselves}{\insrsid2649138 have sponsored}{\insrsid4018652 , and if manufacturers can submit analytical product data that has not been reviewed by an outside authority}{\insrsid2649138 , o}{\insrsid5252777 ne must }{\insrsid2649138 stop and }{\insrsid5252777 question the trustworthiness of}{\insrsid13635449 the} {\insrsid2649138 resultant}{\insrsid5252777 scientific evidence}{\insrsid13635449 that reaches the Ministry}{\insrsid4018652 ; it is no secret that}{\insrsid5252777 industries have as their primary obligations }{\insrsid12726121 (and interests) }{ \insrsid5252777 profit-maximization and loyalty to shareholder interests}{\insrsid15153777 .}{\cs16\super\insrsid12726121 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335\charrsid3552066 See, generally}{\insrsid16143335 , Sheldon Krimsky, Ph.D., }{\i\insrsid16143335 The Funding Effect in Science and Its Implications for the Judiciary}{\insrsid16143335 , 13 }{\scaps\insrsid16143335\charrsid14091128 Brook. }{\scaps\lang9\langfe1033\langnp9\insrsid16143335\charrsid14091128 J. L. & Pol\rquote y}{ \lang9\langfe1033\langnp9\insrsid16143335 43 (2005).}}}{\insrsid5252777 If the }{\i\insrsid5252777 Journal of Nutritional Food}{\insrsid14239719 is}{\insrsid2649138 a product}{\insrsid5252777 of regulatory capture, it may be of little help to a system that strives to put on the market not only foods that will generate profits for the industry but functional foods that provide truthful and accurate health claims to ensure the safety}{ \insrsid7013972 and improve the health}{\insrsid5252777 of the Japanese consumers. }{\insrsid13635449 Yet, unlike in the United States, where only a select subset of agency publications can actually count as an \'93authoritative statement,\'94 the MHLW does regard the Journal as a generally reliable academic publication.}{\cs16\super\insrsid13635449 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid11802773 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7675202 {\insrsid15153777 Finally, the JHNFA offers its own seal of approval for health foods, which may be confusing to consumers, especially since many junk foods with functional ingredients added to them are actually marketed as \'93health foods.\'94}{ \cs16\super\insrsid15153777 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 , }{\i\insrsid16143335\charrsid14091128 see also}{\insrsid16143335 National Centre for Excellence in Functional Foods, }{\i\insrsid16143335\charrsid14091128 supra}{ \insrsid16143335 note 210.}}}{\insrsid14239719 The bottom line is that, although Japan does have a formal system for evaluating and approving functional foods, there are significant weaknesses to this system that must be remedied before it can serve as an adequate role model for the United States.}{ \insrsid13657848 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid4468092 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4468092 {\*\bkmkstart _Toc132795405}IX. }{ \insrsid14239719 Back to the U.S.: }{\insrsid4468092 Weaknesses in Federal Controls{\*\bkmkend _Toc132795405} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4468092 \tab }{\insrsid14239719 Despite the}{\insrsid4067375 weaknesses in Japan\rquote s FOSHU system, at least Japan }{\insrsid14239719 actually }{\i\insrsid4067375\charrsid14239719 has}{\insrsid4067375 a formal system in place for regulation of functional foods. This is more than can be said for the United States, where, as can be seen from the sections above, }{\insrsid4546970 a manufacturer wanting to develop and market a potential functional food (and a consumer wanting to buy one) is confronted by regulatory chaos. }{\insrsid4468092 In its 2005 Expert Report, the Institute of Food Technologists (IFT ) Expert Panel recognizes some limitations of the cu}{\insrsid14239719 rrent FDA policies involving functional}{\insrsid4468092 foods. First, in order to avoid drug classification, some claims may not accurately convey the actual effects of the food on which they are represented and may confuse consumers. Thus, \'93 [s]ometimes compliance with the regulations results in misleading (if not outright false) statements of the underlying science.\'94}{\cs16\super\insrsid4468092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra }{ \insrsid16143335 note 16,at 27.}}}{\insrsid14239719 }{\insrsid4468092 \par \tab Further, current policy requires that the health benefits attributed to a food be derived from its \'93nutritive value.\'94 }{\insrsid5793672 This is particularly pertinent to uncovering the weaknesses underlying the current approach to regulation of structure/function claims. }{\insrsid4468092 FDA has stated that \'93 nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.\'94}{\cs16\super\insrsid4468092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 21 C.F.R. \'a7 101.14(a)(3) (2005).}}}{ \insrsid4468092 }{\insrsid5793672 However, FDA has repeatedly modified and adjusted the definition of \'93nutritive value\'94 and recognizes that its efforts have not succeeded in developing a clear framework for regulating this kind of claim.}{ \cs16\super\insrsid5793672 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See }{\insrsid16143335 FDA}{\i\insrsid16143335 Structure/Function Claims, supra}{\insrsid16143335 note 124.}}}{\insrsid5793672 S}{\insrsid4468092 ince there is currently no consensus among legislation, regulations and other FDA }{ \insrsid5793672 documents on the meaning of FDA\rquote s definition, it is hard for manufacturers to}{\insrsid4468092 effectively tie health benefits of food components to nutritive value, which creates a \'93 major impediment to providing appropriate health information and/or new products to consumers.\'94}{\cs16\super\insrsid4468092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 IFT Expert Report, }{\i\insrsid16143335 supra }{\insrsid16143335 note 16, at 28.}}}{\insrsid5793672 }{\insrsid4468092 \par \tab The United States General Accounting Office (GAO) also recognized some weaknesses in current FDA policies (and lack of current regulations) surrounding functional foods in its July 2000 Report to Congressional Committees, stating that \'93FDA\rquote s efforts and federal laws provide limited assurances of the safety of functional foods and dietary supplements.\'94}{\cs16\super\insrsid4468092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{ \insrsid16143335 note 35, at 4.}}}{\insrsid4468092 The GAO assessed weaknesses i n three areas of the regulatory system including: (1) the fact that potentially unsafe products may reach consumers for a variety of reasons, (2) the fact that some products do not have safety-related information on their labels, since FDA has not issued regulations or guidance on the information required (and this could endanger some consumers), and (3) the fact that FDA cannot effectively assess whether a functional food is adversely affecting consumers\rquote health because, among other things, it does not investigate most reports it receives of health problems potentially caused by these products.}{\cs16\super\insrsid4468092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4468092 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \i\insrsid16143335 id.}{\insrsid16143335 at 4-5.}}}{\insrsid4468092 \par }{\insrsid2457483 \tab Regarding the first point, the GAO enumerated several ways in which weaknesses in controls could allow potentially unsafe products to reach }{\insrsid12543417 consumers. First, since the FDCA}{\insrsid2457483 allows companies to market a product if they determine its ingredients are GRAS, this means that they don\rquote t need to notify FDA before selling that product to consumers. FDA may only then become aware of the product after it enters the market, l earning of it through complaints from individuals or other companies when it is already t}{\insrsid14239719 o}{\insrsid2457483 o late to prevent the harms caused. And if FDA wanted to remove such a product from the market and the company did not do so voluntarily, then FDA would have to initiate enforcement actions. \par }{\insrsid4808987 \tab Regarding the second point, the GAO stated that the main}{\insrsid14239719 problem is that FDA has not pre}{\insrsid4808987 scribed by regulation}{\insrsid14239719 ,}{\insrsid4808987 or provided guidance on}{\insrsid14239719 ,}{ \insrsid4808987 when or if manufacturers of functional foods must include certain safety information on the ir product labels, like information on the maximum safe dosage of the ingredients in the product, possible interactions between the ingredients and drugs that a consumer may concurrently be taking, or the need for certain groups, such as pregnant women, t o avoid ingesting them. Producers of such products subsequently do not include important safety information in their labeling}{\insrsid14239719 , which poses significant health}{\insrsid4808987 risks to some consumers. \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7418655 {\insrsid10095036 \tab Finally, regarding the third point, the GAO expressed concern over the purely voluntary nature of FDA\rquote s adverse event monitoring system for functional foods. FDA will }{\insrsid14239719 only become aware of the}{\insrsid10095036 health problems potentially associated with a functional food on the market when consumers, health professionals or other companies contact it to report a problem, and health problems in such a system are generally significantly underreported.}{ \cs16\super\insrsid10095036 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10095036 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{ \insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 16-17.}}}{\insrsid10095036 Moreover, FDA does not necessarily know whether any reports of health problems justify taking action, since such reports are subjective and do not necessarily establish clear links between an adverse event and a product or ingredient. GAO noted that \'93resource limitations allow [FDA officials] to perform detailed reviews of only some of the most significant reports, or less than 40 percent of the total reported health problems.\'94}{\cs16\super\insrsid10095036 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 17.}}}{ \insrsid1593743 }{\insrsid4468092 \par }{\insrsid10247378 \tab The FIM has also expressed its beliefs that the current regime for regulating functional foods and nutraceuticals contains significant weaknesses. The NLEA grants the right to make a health claim on a specific food or category of foods to all companies and not just the company that sponsored the research; i.e., there is no exclusivity once a health claim has been approved.}{\cs16\super\insrsid10247378 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 DeFelice, }{ \i\insrsid16143335 FIM\rquote s Response to the FDA ANPR on Medical Foods}{\insrsid16143335 , at 353.}}}{\insrsid10247378 This}{\insrsid4990198 , according to the FIM,}{\insrsid10247378 discourages research, since the rewards to be gained must be shared with all other companies, and a manufacturer might prefer to wait and see what other companies have done and \'93free-ride\'94 on their efforts instead of investing in costly research to develop new products itself. Companies will instead spend their money on promotion, rather than devote time and money to helping to support their competitors. }{\insrsid4990198 The }{ \insrsid14239719 FIM attempted to alleviate this problem through the proposed NREA, but, as noted above, this act has not yet been passed into law.}{\insrsid10247378 \par }{\insrsid14749318 \tab Other weaknesses that exist, as discussed, }{\i\insrsid14749318 supra}{\insrsid14749318 , include: the fact that the exemption of medical foods from the requirements of the NLEA creates a significant incentive for functional food manufacturers to market their products as medical foods even if they are not; the fact that food adv ertising and food labeling are controlled by two separate government agencies (the FTC and the FDA, respectively); and the fact that there are many different kinds of claims that can be made for functional foods with different substantiation standards, th us leading to both manufacturer and consumer confusion.}{\insrsid7687831 Moreover}{\insrsid5793672 ,}{\insrsid7687831 subtle changes in linguistics and format between the different kinds of claims can lead to consumer confusion.}{\insrsid7822488 }{ \insrsid10710836 I}{\insrsid5793672 t}{\insrsid10710836 has been noted that it}{\insrsid5793672 is \'93difficult to clearly distinguish health claims, which are about the relationship between a nutrient or a food component and a disease, from structure and function claims, which are about supporting or maintaining a healthy structure or function in the body.\'94}{\cs16\super\insrsid5793672 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA }{\i\insrsid16143335 Structure/Function Claims, supra }{\insrsid16143335 note 124.}}}{\insrsid14749318\charrsid14749318 \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid14566914 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4988548 {\*\bkmkstart _Toc132795406}X}{ \insrsid13920109 . Recommendations}{\insrsid16581649 : The Debate Continues}{\insrsid13920109 {\*\bkmkend _Toc132795406} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4396919 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4396919 \tab }{\insrsid16534034 Th ere have been a plethora of recommendations}{\insrsid4990198 as to what should be done to improve}{\insrsid16534034 the current regulatory approach (or lack of approach) to functional foods. Different interest groups predictably have different ideas about what is the best way to proceed, h owever all can be influential in trying to strike a balance between protecting and educating consumers of functional foods, eliminating confusion as to the proper regulatory standards, and stimulating manufacturers to do the research necessary to come up with innovative new products and truthful and non-misleading claims for their labels. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16534034 {\insrsid16534034 The GAO, after reviewing applicable laws and FDA regulations, as well as interviewing a wide range of organizations regarding safety concerns related to functional foods and dietary supplements, came up with specific ways in which the regulation of functional foods could be improved. }{\insrsid4396919 In }{\insrsid13721124 the }{\insrsid4396919 GAO\rquote s report, it }{\insrsid14946713 made two sets of recommendations \endash one to Congress, and one to the FDA. First, GAO recommended that Congress: \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard\plain \s32\qj \fi-360\li1440\ri720\sa120\widctlpar\jclisttab\tx1440\aspalpha\aspnum\faauto\ls12\adjustright\rin720\lin1440\itap0\pararsid6367462 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14946713 amen d the Federal Food, Drug, and Cosmetic Act to require makers of functional foods to meet the same requirements that currently apply to dietary supplements: (1) advance notification to FDA regarding ingredients that companies have determined are safe, (2) notification to FDA regarding the use of structure/function claims, and (3) disclaimers of FDA approval on product labels containing structure/function claims. \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab}establish an expert panel to reexamine the current approach to labeling, which distinguishes heal th claims from structure/function claims, to determine whether the intended distinctions can be made clear and meaningful to consumers, or failing this, to identify other changes needed to improve consumers\rquote understanding of health-related claims.} {\cs16\super\insrsid14946713 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 GAO Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 35, at 26.}}}{\insrsid14946713 \par }\pard\plain \ql \li1080\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1080\itap0\pararsid14946713 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14946713 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4396919 {\insrsid14946713 Next, }{\insrsid13721124 the }{\insrsid14946713 GAO }{\insrsid4396919 recommended }{\insrsid14946713 that the FDA establish firm time frames in its 10-year plan to implement the DSHEA and take other necessary steps to (in relevant part)}{\insrsid4396919 : \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard\plain \s32\qj \fi-360\li1440\ri720\sa120\widctlpar\jclisttab\tx1440\aspalpha\aspnum\faauto\ls13\adjustright\rin720\lin1440\itap0\pararsid6367462 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14946713 clarify the boundary between conventional foods, including functional foods, and dietary supplement s, particularly the circumstances under which dietary supplements may be marketed in food form; \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab}develop and promulgate regulations or other guidance for industry on the safety-related information required on labels for dietary supplements and functional foods; \par {\listtext\pard\plain\s32 \f3\insrsid13525464 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}{\insrsid13525464 develop an}{\insrsid14946713 enhanced system to record and analyze reports of health problems associated with functional foods and dietary supplements; \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab}develop and promulgate regulations or other guidance for industry on the evidence needed to support structure/function claims; and \par {\listtext\pard\plain\s32 \f3\insrsid14946713 \loch\af3\dbch\af0\hich\f3 \'b7\tab} develop and implement a strategy for identifying and taking appropriate enforcement actions against companies marketing products with unsupported structure/function claims on their labels}{\insrsid4396919 .}{\cs16\super\insrsid4396919 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 Id.}{\insrsid16143335 at 27.}}} {\insrsid16534034 \par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid16534034 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid16534034 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4396919 {\insrsid16581649 \tab }{\insrsid15826799 The ADA}{\insrsid16534034 , a nutrition group, also had a lot to say about the current state of affairs and what the future should hold. The ADA}{\insrsid15826799 believes that the \'93 proliferation of claims on a variety of food products and dietary supplements has created an environment of confusion and distrust among health professionals and consumers.\'94}{\cs16\super\insrsid15826799 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 ADA Report, }{\i\insrsid16143335 supra}{\insrsid16143335 note 25, at 819.}}}{\insrsid15826799 Moreover, the ADA believes there should be consistency in food labeling and recommends an evaluation of the body of available scientific evidence prior to the development of consumer diet-health messages. In order to meet such a goal and t o ensure accurate and effective communication of health benefits and potential risks of consuming specific functional foods, the ADA suggests that collaboration among the food industry, health professionals, and government agencies will be required.}{ \cs16\super\insrsid15826799 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid15826799 The ADA recommends that all foods and dietary supplements, including functional foods, be regulated to ensure that they are safe and that they have been manufactured using recognized good manufacturing processes. Further, the ADA recommends a unitary applica ble standard for labeling claims, requiring that they be truthful and not misleading, as well as based on significant scientific agreement. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15826799 {\insrsid13721124 Another group, CSPI}{\insrsid16534034 (representing consumers)}{\insrsid13721124 , i}{\insrsid1769691 n a letter to FDA}{\insrsid13721124 , }{\insrsid1769691 urged that \'93functional foods hold much promise, but, without effective regulation, may merely become the snake oil of the next century.\'94}{\cs16\super\insrsid1769691 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI Newsroom, }{\i\insrsid16143335 FDA Urged to Improve Regulation of \'93Functional Foods}{\insrsid16143335 ,\'94 (Mar. 25, 1999), }{\i\insrsid16143335\charrsid12798205 available at}{\insrsid16143335 http://www.cspinet.org/new/functional_foods.html. }}}{\insrsid1769691 }{ \insrsid16581649 In CSPI\rquote s Report on Functional Foods}{\insrsid1769691 accompanying this letter}{\insrsid16581649 (more specifically, in the section entitled \'93United State}{\insrsid1769691 s \endash A Good System Gone Bad\'94), CSPI}{ \insrsid16581649 states that th e central issue for the FDA and society at large is to figure out whether, and if so, where, the line between foods and drugs should be drawn, being that there are so many functional foods being developed with additives that have drug-like effects. In ad dition, the FDA and FTC should act to ensure that functional foods are regulated so as to maximize health benefits and minimize health risks.}{\cs16\super\insrsid16581649 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 CSPI Report, }{ \i\insrsid16143335 supra}{\insrsid16143335 note 25.}}}{\insrsid16581649 }{\insrsid4396919 \tab }{\insrsid16581649 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16581649 {\insrsid16581649 Regarding medical foods}{\insrsid7822488 and the regulatory loophole the current regime creates}{\insrsid16581649 , }{ \insrsid4396919 CSPI believes that FDA should reconsider its}{\insrsid4937721 decision to withdraw}{\insrsid16581649 the ANPR}{\insrsid4937721 due to the serious risks posed by unregulated medical foods, especially when many of these medical foods are marketed directly to consumers. CSPI claims}{\insrsid7822488 disapprovingly}{\insrsid4937721 that \'93[a]t some food industry conferences, manufacturers are actually advised to market their products as medical foods to escape FDA scrutiny.}{\cs16\super\insrsid4937721 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 CSPI, }{\i\insrsid16143335 Starvation Diet, supra}{\insrsid16143335 note 146, at 37, citing, Pharmaceutical Division of the Institute for International Research, }{\i\insrsid16143335 Promoting Functional Foods, Medical Foods and Nutritionals}{\insrsid16143335 , Nutrimarket \rquote 97 at 5, (Mar. 24 & 25, 1997) (Conference Notice).}}}{\insrsid4937721 }{\insrsid4396919 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7418655 {\insrsid16581649 CSPI}{\insrsid7822488 made}{\insrsid7418655 a series of }{\insrsid16581649 specific recommendations regarding the regulation of functional foods and medical f}{\insrsid7418655 oods, as follows. }{\insrsid7822488 First,}{\insrsid16581649 FDA should prohibit c ompanies from marketing functional foods as dietary supplements, and the FDA should comprehensively evaluate a food at the outset to determine which regulatory category it belongs in when companies attempt to label it as a dietary supplement}{ \insrsid7822488 . Second,}{\insrsid7418655 }{\insrsid16581649 FDA should close the loophole allowing unapproved health claims on the labels of medical foods and instead require that health claims for medical foods be approved prior to marketing, as is required for conventional foods. Companies should be prohibited from calling functional foods sold in grocery stores and health food stores \'93medical foods\'94 unless they are actually designed to be used under the supervision of a physician.}{\insrsid7822488 Third,}{\insrsid7418655 }{\insrsid7822488 f}{ \insrsid16581649 unctional ingredients in food should be GRAS or regulated as food additives, and in certain cases, a post-marketing surveillance system should be established to monitor adverse effects from functional ingredients in foods.}{ \insrsid7822488 Fourth,}{\insrsid7418655 FDA should consider requiring that labels of functional foods indicate recommended dosages and provide related instructions for use, like Japan\rquote s FOSHU system. As it stands, there are no guidelines on the labels of functional foods telling consumers who should actually consume the product, how much should be contained in a serving, how much should be cons umed per day, whether side effects are possible, and if the product can safely be consumed in combination }{\insrsid7822488 with other foods and drugs. Fifth, h}{\insrsid7418655 ealth claims for functional foods should be approved pursuant to the NLEA, such that companies should be required to demonstrate that their claims are supported by significant scientific agreement based on the totality of the publicly av}{\insrsid7822488 ailable scientific evidence. Sixth,}{\insrsid7418655 FDA should issue regulations controlling structure/function claims for foods, requiring that st ructure/function claims be based on universally recognized factual statements concerning known and substantively significant relationships regarding the effect of a substance on the structure or functioning of the body. FDA should also require that foods making structure/function claims meet specified nutrient levels (akin}{\insrsid7822488 to the \'93jellybean rule\'94). }{\insrsid7418655 Finally, the FTC should update its Enforcement Policy Statement to clarify that health claims for functional foods will be considered non-deceptive only if the y meet requirements set forth by FDA, since advertisements that hype functional ingredients, make unapproved health claims, or make misleading or inadequately substantiated structure/function claims undermine FDA\rquote s efforts to protect consumers.}{ \cs16\super\insrsid7418655 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 CSPI Report, }{\i\insrsid16143335\charrsid12798205 supra}{\insrsid16143335 note 25.}}}{\insrsid7418655 \par }{\insrsid5179166 Two years later, CSPI issued a statement concerning the Council of Better Business Bureau\rquote s request that the FDA halt false and misleading labels for more than 100 functional foods, including Arizona Rx Memory Mind Elixir tea beverage containing ginko biloba. CSPI\rquote s closing statement sums up its general stance towards functional foods \endash \'93[f]unctional foods may represent a major public health advance or amount to little more than 21}{\super\insrsid5179166\charrsid5179166 st}{\insrsid5179166 century quackery \endash it all depends on whether the FDA ensures that ingredients are safe and that claims are valid.\'94}{\cs16\super\insrsid5179166 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\i\insrsid16143335 }{\insrsid16143335 CSPI, }{\i\insrsid16143335 Statement of director of legal affairs Bruce Silverglade}{\insrsid16143335 (April 4, 2001), }{ \i\insrsid16143335\charrsid12798205 available at}{\insrsid16143335 http://www.cspinet.org/new/bbbltr_fda.html. }}}{\insrsid5179166 \par }{\insrsid7168289 A little less than a year later, CSPI submitted to the FDA a Petition for Rulemaking on Functional Foods and Request to Establish an Advisory Committee, urging FDA to act on the GAO\rquote s recommendations (both to Congress and t o the Agency) from its July 2000 report, and arguing that the FDA already has statutory authority to take each of the steps suggested by the GAO in its recommendations to Congress.}{\cs16\super\insrsid7168289 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 CSPI }{ \i\insrsid16143335\charrsid7168289 Petition for Rulemaking on Functional Foods and Request to Establish an Advisory Committee}{\insrsid16143335 (submitted March 21, 2002), }{\i\insrsid16143335 available at}{\insrsid16143335 }{ \insrsid16143335\charrsid2822225 http://www.cspinet.org/reports/funcgaopt_032102.pdf}{\insrsid16143335 .}}}{\insrsid7168289 \par }{\insrsid16534034 Yet another}{\insrsid7168289 group was quite explicit about its recommendations as well. }{\insrsid16534034 The IFT (which is an international not-for-profit scientific society with members working in food science, technology and related professions in the food industry, academia and government)}{\insrsid11879210 in its 2005 Expert Report, stated its belief that consumers should not be blocked off from access to knowledge about the benefits of incorporating functional foods into their diets, simply because of traditional definitions and arbitrary distinctions between food and medicine.}{\insrsid16088985 Existing terminology and regulatory frameworks should be modified where they are inadequate to address the full scope of benefits for functional foods. }{\insrsid15432159 For example, currently, structure/function claims must be phrased so as to avoid implying that a food prevents a certain disease, but this often results in convoluted claims that contradict the supporting science. The IFT}{\insrsid15285943 Expert Panel} {\insrsid15432159 recommends that product labeling be allowed to accurately reflect the scientific evidence so that }{\insrsid14310024 health and }{\insrsid15432159 structure/function claims would actually be allowed to im ply reduction of disease risk as long as they have adequate scientific basis}{\insrsid14310024 , without triggering drug status}{\insrsid15432159 .}{\cs16\super\insrsid5470235 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See }{\insrsid16143335 IFT Expert Report, }{ \i\insrsid16143335 supra }{\insrsid16143335 note 16, at 27, 51.}}}{\insrsid6827046 }{\insrsid14310024 The latter part of this recommendation is crucial, since attempts to avoid classification as a drug have resulted in misleading and sometimes ou tright false statements of the underlying science. }{\insrsid6827046 In addition}{\insrsid11746599 , the IFT}{\insrsid15285943 Expert Panel}{\insrsid11746599 recommends that the wording of qualified health claims clearly indicate the degree of scientific support or certainty associated with a biological effect or modification of disease risk, so as to promote consumer understanding.}{ \cs16\super\insrsid11746599 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{ \i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 28}}}{\insrsid11746599 The IFT}{\insrsid15285943 Expert Panel}{\insrsid11746599 thus recommends that FDA prohibit claims that rely on very limited and preliminary studies and develop guidelines to protect consumers from limited scientific information.}{\cs16\super\insrsid11746599 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 29.}}}{\insrsid11746599 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7418655 {\insrsid11746599 Further, the IFT}{\insrsid15285943 Expert Panel}{\insrsid11746599 recommends that FDA not restrict the health effects of foods to the currently limited concept of }{\insrsid16278679 \'93}{\insrsid11746599 nutritive value,}{\insrsid16278679 \'94}{\insrsid11746599 but instead }{\insrsid16278679 \'93}{\insrsid11746599 nutritive value}{\insrsid16278679 \'94}{\insrsid11746599 should be re-defined so as to be more broad-based and to address the extensive lin ks between health and nutrition as well as other scientific disciplines such as physiology, endocrinology, biochemistry, neurology and genetics. This would add credibility to claims on food products.}{\cs16\super\insrsid11746599 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{ \i\insrsid16143335 id.}{\insrsid16143335 at 27, 51.}}}{\insrsid15432159 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7418655 {\insrsid16088985 Moreover, because developing functional foods is an expensive process, and because}{\insrsid13721124 (as urgently recognized by Dr. DeFelice and the FIM)}{\insrsid16088985 the returns from such development are not exclusive to the developing company }{\insrsid15285943 whose health claim is approved by the FDA }{\insrsid16088985 (but rather shared by any and all competing companies once a health claim is documented), the government needs to step in to provide the push that is needed for further development. Government should invest in basic and applied research in order to promote the development of functional foods, and private co mpanies should be given additional incentives, like a period of exclusivity or tax incentives}{\insrsid7740252 for health and nutrition research}{\insrsid16088985 , to encourage them to pursue functional food development.}{\cs16\super\insrsid16088985 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See id.}{ \insrsid16143335 at 10.}}}{\insrsid11879210 }{\insrsid7740252 The IFT Expert Panel believes that the lack of exclusivity of health claims encourages companies to limit their research efforts and to utilize structure/function claims rather than approved health claims, even though structure/function claims are more limited and cannot accurately convey the health effects to consumers.}{ \insrsid15285943 In order for the industry to expand and for accurate and helpful information about functional foods to be disseminated to the public, it is crucial that manufacturers view functional food development as a profitable venture.}{ \insrsid11879210 \par }{\insrsid4792365 Lastl}{\insrsid16278679 y, the IFT concluded that health claims on food labels should be used as the foundation for consumer education regarding dietary components for health.}{\cs16\super\insrsid16278679 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}{\insrsid16143335 at 51.}}}{\insrsid16278679 Consumer education, as seen over and over again, is viewed as one of the most important components of the success of functional f oods, and the IFT notes that all food communicators, including food scientists and health professionals, must work together to improve this valuable resource by accurately characterizing new scientific developments. \par }\pard\plain \s1\qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid7822488 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid4988548 {\*\bkmkstart _Toc132795407}X}{ \insrsid4468092 I}{\insrsid13920109 . Conclusion}{\insrsid7822488 {\*\bkmkend _Toc132795407} \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7822488 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid7822488 \tab }{\insrsid6827046 Regardless o}{\insrsid16278679 f the approach taken to update}{\insrsid6827046 the regulatory policies applicable to functional foods, it is apparent that something must be done. }{\insrsid6451016 The current regulatory framework applicable to functional foods in the United States is disorganized, has promoted consumer and manufacturer confusion, and has failed to adequately protect consumers fr}{\insrsid4990198 om claims that may be inappropriate} {\insrsid6451016 , unsubstantiated, or outright false. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6451016 {\insrsid7822488 On February 16-17, 2000, a group of interested parties, including FDA employees, professors, consultants, CSPI repre sentatives, and industry representatives, met to hold a preliminary discussion regarding a conceptual framework for structure/function claims for conventional foods. In the summary report of this meeting, it was noted that \'93 [c]ollectively, participants thought a conceptual framework for structure and function claims should be }{\i\insrsid7822488 effective, consistent, }{\insrsid7822488 and }{\i\insrsid7822488 dynamic}{\insrsid7822488 .}{\insrsid2822225 \'94}{ \cs16\super\insrsid7822488 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 FDA}{ \i\insrsid16143335 Structure/Function Claims, supra}{\insrsid16143335 note 124.}}}{\insrsid7822488 }{\insrsid2690736 Although}{\insrsid10710836 this meeting was particular to improving the approach for regulating structure/function claims, }{ \insrsid6827046 the three principles arrived at}{\insrsid2690736 }{\insrsid10710836 seem quite }{\insrsid2690736 applicable to the attempt to make}{\insrsid10710836 order out of the chaotic functional foods situation. }{\insrsid2690736 First, any conceptual framework for regulation of functional foods clearly must be effective, in order to (as noted by the meeting participants): mainta}{\insrsid6827046 in consumer confidence in foods;}{\insrsid2690736 ensure that food labels are effecti}{\insrsid6827046 ve tools for consumer education; stimulate research; }{\insrsid2690736 en}{\insrsid6827046 courage healthier eating trends;}{\insrsid2690736 provide a strong scientific foun}{\insrsid6827046 dation for claims that are made;}{\insrsid2690736 clarify the target audience for whom these claims may be beneficial and who, if anyone, should avoid part}{\insrsid6827046 icular foods or food components;}{\insrsid2690736 prohibit inappro}{ \insrsid6827046 priate foods from making claims;}{\insrsid2690736 improve substantiation of claims}{\insrsid6827046 ; }{\insrsid2690736 establish a minimum effective dose to b}{\insrsid6827046 ring about the specified effect;}{\insrsid2690736 and clarif y the maximum dose beyond which no further effect or a negative effect may occur.}{\cs16\super\insrsid2690736 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid2690736 Next, the framework should strive for consistency. One of the main problems with the way in which functional foods currently end up being regulated is that there is no one way. }{\insrsid12928928 Unlike in Japan, where there is a separate system for evaluating and approving functional foods, f}{\insrsid2690736 unctional foods}{\insrsid12928928 in the U.S.}{\insrsid2690736 end up regulated on a case-by-case basis}{\insrsid6827046 , in categories that also lack consistency with one another}{\insrsid2690736 , and this leads to much confusion on the part of consumers and manufacturers. A consistent framework would (as noted by the meeting participants)}{\insrsid6827046 :}{ \insrsid2690736 establish a clear, adequate and appropriate regulatory process; establish rational, understandable, enforceable regulations for cla ims that can be made on the labels of functional foods; clarify the guidelines for industry; and be simple to enforce.}{\cs16\super\insrsid2690736 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid16143335 \chftn }{\insrsid16143335 }{\i\insrsid16143335 See}{\insrsid16143335 }{\i\insrsid16143335 id.}}}{\insrsid2690736 Finally, whatever framework is adopted for functional foods, it should be dynamic, and able to adapt to (rather than shy away from) evolving science, such as biotechnology.}{\insrsid6827046 }{\insrsid7822488 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7822488 {\insrsid6827046 \tab The foods we choose to eat can have a profound impact on our health, for better or for worse. }{\insrsid6451016 Functional foods may very well hold the key to better well-being and a less expensive and administratively cumbersome approach to healthcare. }{\insrsid1447619 Moreover, biotechnology is increasingly influencing the potential for foods to provide even greater benefits for the public health. }{\insrsid6451016 There is mounting desire on the part of consumers for foods that provide short- and long-term health benefits, and, at the same time, manufacturers in the industry are getting more and more creative about how they market their food products to the public in order to avoid, to the greatest extent possible, the scrutiny of the Food and Drug Administration and its pre- and post-market regulatory requirements. However, i}{\insrsid6827046 n order to advance public awareness and knowledge of the true benefits or harms that functional foods can pose, and in order to ensure that functional foods do not slip through the regulatory cracks, FDA\rquote s cur}{\insrsid1447619 rent policies must be altered to create a framework that is more effective, more consistent, and more dynamic t}{\insrsid12928928 han what the public is experiencing today}{\insrsid1447619 .}{\insrsid6827046\charrsid7822488 \par }}