{\rtf1\ansi\ansicpg1252\uc1 \deff0\deflang1033\deflangfe1033{\fonttbl{\f0\froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman;}{\f1\fswiss\fcharset0\fprq2{\*\panose 020b0604020202020204}Arial;} {\f3\froman\fcharset2\fprq2{\*\panose 05050102010706020507}Symbol;}{\f6\fmodern\fcharset0\fprq1{\*\panose 00000000000000000000}Courier{\*\falt Courier New};}{\f27\fswiss\fcharset0\fprq2{\*\panose 020b0506020202030204}Arial Narrow;} {\f116\froman\fcharset238\fprq2 Times New Roman CE;}{\f117\froman\fcharset204\fprq2 Times New Roman Cyr;}{\f119\froman\fcharset161\fprq2 Times New Roman Greek;}{\f120\froman\fcharset162\fprq2 Times New Roman Tur;} {\f121\froman\fcharset186\fprq2 Times New Roman Baltic;}{\f122\fswiss\fcharset238\fprq2 Arial CE;}{\f123\fswiss\fcharset204\fprq2 Arial Cyr;}{\f125\fswiss\fcharset161\fprq2 Arial Greek;}{\f126\fswiss\fcharset162\fprq2 Arial Tur;} {\f127\fswiss\fcharset186\fprq2 Arial Baltic;}{\f278\fswiss\fcharset238\fprq2 Arial Narrow CE;}{\f279\fswiss\fcharset204\fprq2 Arial Narrow Cyr;}{\f281\fswiss\fcharset161\fprq2 Arial Narrow Greek;}{\f282\fswiss\fcharset162\fprq2 Arial Narrow Tur;} {\f283\fswiss\fcharset186\fprq2 Arial Narrow Baltic;}}{\colortbl;\red0\green0\blue0;\red0\green0\blue255;\red0\green255\blue255;\red0\green255\blue0;\red255\green0\blue255;\red255\green0\blue0;\red255\green255\blue0;\red255\green255\blue255; \red0\green0\blue128;\red0\green128\blue128;\red0\green128\blue0;\red128\green0\blue128;\red128\green0\blue0;\red128\green128\blue0;\red128\green128\blue128;\red192\green192\blue192;}{\stylesheet{\nowidctlpar\adjustright \snext0 Normal;}{\*\cs10 \additive Default Paragraph Font;}{\s15\qj\sl240\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext15 p0;}{\s16\fi-1967\li8441\sl481\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext16 p1;}{\s17\qc\sl240\slmult0\nowidctlpar\adjustright \sbasedon0 \snext17 c2;}{\s18\fi726\li731\sl243\slmult0\nowidctlpar\tx731\tx1457\adjustright \sbasedon0 \snext18 p3;}{\s19\fi731\sl481\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext19 p4;}{\s20\li708\sl240\slmult0\nowidctlpar\tx725\adjustright \sbasedon0 \snext20 p5;}{\s21\fi998\sl243\slmult0\nowidctlpar\tx997\adjustright \sbasedon0 \snext21 p6;}{\s22\sl328\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext22 p7;}{\s23\fi731\sl328\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext23 p8;}{\s24\fi-1967\li8441\sl481\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext24 p9;}{\s25\fi-1967\li8441\sl328\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext25 p10;}{\s26\qc\sl240\slmult0\nowidctlpar\adjustright \sbasedon0 \snext26 c11;}{\s27\li885\sl240\slmult0\nowidctlpar\tx2318\adjustright \sbasedon0 \snext27 p12;}{\s28\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext28 p13;}{\s29\fi539\li731\sl481\slmult0\nowidctlpar \tx731\tx1269\tx1672\adjustright \sbasedon0 \snext29 p14;}{\s30\li584\sl240\slmult0\nowidctlpar\tx2018\adjustright \sbasedon0 \snext30 p15;}{\s31\fi-1967\li8441\sl328\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext31 p16;}{ \s32\fi-1967\li8441\sl243\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext32 p17;}{\s33\li3895\sl240\slmult0\nowidctlpar\tx5329\adjustright \sbasedon0 \snext33 p18;}{\s34\fi731\sl481\slmult0\nowidctlpar\tx731\tx1269\adjustright \sbasedon0 \snext34 p19;}{\s35\sl328\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext35 p20;}{\s36\sl240\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext36 p21;}{\s37\li703\sl243\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext37 p22;}{\s38\fi731\sl255\slmult0\nowidctlpar\adjustright \sbasedon0 \snext38 p23;}{\s39\qc\sl240\slmult0\nowidctlpar\adjustright \sbasedon0 \snext39 c25;}{\s40\fi-732\li998\sl240\slmult0\nowidctlpar\tx266\tx997\adjustright \sbasedon0 \snext40 p26;}{ \s41\qc\sl240\slmult0\nowidctlpar\adjustright \sbasedon0 \snext41 c27;}{\s42\li1026\sl240\slmult0\nowidctlpar\tx2460\adjustright \sbasedon0 \snext42 p28;}{\s43\fi-465\li731\sl240\slmult0\nowidctlpar\tx266\tx731\adjustright \sbasedon0 \snext43 p29;}{ \s44\fi-731\li703\sl481\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext44 p30;}{\s45\sl255\slmult0\nowidctlpar\adjustright \sbasedon0 \snext45 p31;}{\s46\li318\sl240\slmult0\nowidctlpar\tx1751\adjustright \sbasedon0 \snext46 p32;}{ \s47\sl243\slmult0\nowidctlpar\tx1672\adjustright \sbasedon0 \snext47 p33;}{\s48\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext48 p34;}{\s49\li6049\sl240\slmult0\nowidctlpar\tx7483\adjustright \sbasedon0 \snext49 p35;}{\s50\sl481\slmult0 \nowidctlpar\tx204\adjustright \sbasedon0 \snext50 p36;}{\s51\li1174\sl240\slmult0\nowidctlpar\tx2607\adjustright \sbasedon0 \snext51 p37;}{\s52\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext52 p38;}{\s53\li1452\sl240\slmult0\nowidctlpar \tx2885\adjustright \sbasedon0 \snext53 p39;}{\s54\fi731\sl294\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext54 p40;}{\s55\sl243\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext55 p41;}{\s56\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext56 p42;}{\s57\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext57 p43;}{\s58\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext58 p44;}{\s59\li6917\sl240\slmult0\nowidctlpar\tx8350\adjustright \sbasedon0 \snext59 p46;}{\s60\li5034\sl240\slmult0\nowidctlpar\tx6468\adjustright \sbasedon0 \snext60 p47;}{\s61\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext61 p48;}{\s62\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext62 p49;}{ \s63\li130\sl240\slmult0\nowidctlpar\tx1303\adjustright \sbasedon0 \snext63 p50;}{\s64\fi1196\sl294\slmult0\nowidctlpar\tx1196\adjustright \sbasedon0 \snext64 p51;}{\s65\fi-1967\li8441\sl221\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext65 p52;}{\s66\sl481\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext66 p53;}{\s67\fi731\sl481\slmult0\nowidctlpar\tx731\adjustright \sbasedon0 \snext67 p54;}{\s68\fi1270\sl243\slmult0\nowidctlpar\tx1269\adjustright \sbasedon0 \snext68 p55;}{\s69\li12\sl240\slmult0\nowidctlpar\tx1445\adjustright \sbasedon0 \snext69 p56;}{\s70\fi731\sl221\slmult0\nowidctlpar\tx731\tx997\adjustright \sbasedon0 \snext70 p57;}{\s71\fi-731\li703\sl328\slmult0\nowidctlpar \tx731\adjustright \sbasedon0 \snext71 p58;}{\s72\qc\sl240\slmult0\nowidctlpar\adjustright \sbasedon0 \snext72 c59;}{\s73\fi-884\li550\sl240\slmult0\nowidctlpar\tx884\adjustright \sbasedon0 \snext73 p60;}{\s74\fi731\sl221\slmult0\nowidctlpar\adjustright \sbasedon0 \snext74 p61;}{\s75\fi-1967\li8441\sl113\slmult0\nowidctlpar\tx6474\tx7795\adjustright \sbasedon0 \snext75 p62;}{\s76\fi-1883\li8351\sl226\slmult0\nowidctlpar\tx6468\tx7789\adjustright \sbasedon0 \snext76 p63;}{\s77\qc\sl240\slmult0 \nowidctlpar\adjustright \sbasedon0 \snext77 c64;}{\s78\sl362\slmult0\nowidctlpar\tx204\adjustright \sbasedon0 \snext78 p65;}}{\info{\title Author:}{\author Faculty Library}{\operator Faculty Library}{\creatim\yr2001\mo2\dy23\hr16\min18} {\revtim\yr2001\mo2\dy23\hr16\min18}{\version2}{\edmins0}{\nofpages1}{\nofwords4695}{\nofchars26767}{\*\company Harvard Law School Library}{\nofcharsws32871}{\vern113}}\margl1434\margr1446\margt1258\margb1264 \widowctrl\ftnbj\aenddoc\hyphcaps0\viewkind4\viewscale100 \fet0\sectd \sbknone\linex0\headery1200\sectdefaultcl {\*\pnseclvl1\pnucrm\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl3 \pndec\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang{\pntxta )}}{\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}} {\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl8\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl9\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}\pard\plain \s24\fi-1967\li8441\sl-481\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 1 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 DISEASE-PREVENTION CLAIMS AND THE FIRST AMENDMENT: \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 "WHO WILL PROTECT US FROM OUR PROTECTORS?"}{\f6\super 1}{\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s18\fi726\li731\sl-243\slmult0\nowidctlpar\tx731\tx1457\adjustright {\f6 As to the particular consumer's interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day's most urgent political debate.}{\f6\super 2}{\f6 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\tx1457\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx731\tx1457\adjustright {\f6 I. Introduction \par }\pard\plain \nowidctlpar\tx731\tx1457\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 The area of disease-prevention claims ("health claims") for food poses a broad spectrum of d-ilemmas that often arise in the food and drug law area and in other regulatory situations. These recurring questions include: How does an agency balance the public's right to information with the agency's desire to prevent consumer deception? Given an agency's broad mandate to protect public health, what type of consumer should it aim to protect with its limited resources? What should an agency do in the face of uncertainty? To what extent, and under what conditions, is informed choice desirable? How much of an agency's role is or should be educational? How should an agency balance consumers' need for information with the problem of information overload? \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 This paper will attempt to address these and other issues in the context of the arguments over the First Amendment constitutionaljty of FDA's recently revised treatment of health \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par \par \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 1 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul Who Will Protect Us From Our Protectors?}{\f6 , }{\b\f6\fs22 Obi. News., May \par }\pard\plain \s22\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 1962, at 20. \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s23\fi731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 2 }{\f6 Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s31\fi-1967\li8441\sl-328\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 2 \par }\pard\plain \s26\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s27\li2319\nowidctlpar\tx2318\adjustright {\b\f6\fs16 3 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 claims for food. Ultimately, this paper concludes that the \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 FDA's approach is not only open to attack on First Amendment grounds, but also misconceived from an overarching policy perspective. This paper will ultimately advance an alternative approach which, although not without its ow n problems, would likely survive scrutiny on First Amendment grounds and also address the major policy questions set forth above. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx204\adjustright {\f6 II. Statutory and Regulatory Background \par }\pard\plain \nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s29\fi539\li731\sl-481\slmult0\nowidctlpar\tx731\tx1269\tx1672\adjustright {\f6\ul A.\tab The 1990 Nutrition LabelinQ and Education Act}{\f6 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\tx1269\tx1672\adjustright {\f6 \par }\pard\plain \s23\fi731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\f6 In 1990, Congress enacted the Nutrition Labeling and \par }\pard\plain \s30\li2018\nowidctlpar\tx2018\adjustright {\b\f6\fs16 4 \par }\pard\plain \nowidctlpar\tx2018\adjustright {\b\f6\fs16 \par }\pard\plain \s22\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 Education Act, in order to "help U.S. consumers maintain healthy dietary practices and to protect these consumers from unfounded \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 health claims."}{\f6\super 5 }{\f6 Congress characterized the need for regulation as "co mpelling" in a House Report of June, 13, 1990. Some proponents of the statute emphasized that it was intended to alleviate the problems of classifying foods as drugs whenever health claims are made about them and that it was intended to be a more flexible standard than the standards for new drugs.}{\f6\super 6 }{\f6 One proponent of the statute admitted that it was intended to remedy \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 3 \par }\pard\plain \nowidctlpar\tx725\adjustright {\b\f6\fs16 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 The highly contentious debate over dietary supplements is beyond the scope of this paper, as is an in\emdash depth analysis of the FTC's approach to these issues in the advertising context. Rather, the scope of this paper is limited to the FDA's regulation of conventional food labels. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 104 Stat. 2353 (Nov. 8, 1990). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 58 Fed. Reg. 2478\emdash 01. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See}{\f6 Cong. Rec. H5844 (statement of Congressman Waxman); 58 Fed. Reg. 2478-01. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 3 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 the fact that "[n]either Federal regulation nor industry efforts have kept pace with scientific knowledge about diet and nutrition. }{\f27\fs12 "' \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f27\fs12 \par }\pard\plain \s23\fi731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\f6 The Act adds a new section governing health claims to the \par }\pard\plain \s33\li5329\nowidctlpar\tx5329\adjustright {\b\f6\fs16 8 \par }\pard\plain \nowidctlpar\tx5329\adjustright {\b\f6\fs16 \par }\pard\plain \s22\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 federal Food, Drug, and Cosmetic Act. A food bearing a health claim must meet the requirements of this new section (403(r)) and \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 the regulatory requirements of the FDA in order to be excluded from the statutory definition of a drug and all of the regulatory requirements accompanying new drug approval. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 It is important to note at the outset that much of the contention in this area surrounds the proper scope of \'a7 403, which states that "[a] food s hall be deemed to be misbranded (a) If (1) its labeling is false or misleading in any particular }{\f1\fs8 .... }{\f6 The underlying question in much of the debate is the proper scope of the term "misleading," since this definition will determine the permissible scope of the FDA's regulations. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx731\adjustright {\f6\ul B. FDA Regulations}{\f6 \par }\pard\plain \nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6\ul 1. Pre-1990 Treatment of Health Claims}{\f6 . }{\f1\fs8 -- }{\f6 The FDA's regulation of health claims for food has proceeded in stages.}{\f6\super 9}{\f6 Since 1938, seeing numerous products marketed with unfounded \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par \par \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f1\fs26 14\'b1.. }{\f6 (statement of Congressman Madigan). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See}{\f6 FD&C Act \'a7 403(r). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See}{\f6 }{\f6\ul generally}{\f6 Peter Barton Hutt, }{\f6\ul Government Regulation of Health Claims in Food Labeling and Advertising}{\f6 , 41 }{\b\f6\fs22 Food Drug Cosm. L.J. 3 (1986) \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 4 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 claims that they would cure various diseases, }{\b\f6\fs16 10 }{\f6 the FDA has made it an enforcement priority to prevent false or misleading nutrition claims in food labeling. A main aspect of this strategy has been to classify products for which health claims are made as new drugs that be approved and meet the other statutory requirements for drugs. This approach, however, was not entirely effective, because it only worked if the manufacturer made explicit health claims. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Although the food-drug (and also the food-dietary food) distinction was all-important until very recently, there has been an attempt with the recent statutory amendments to make this distinction less determinative of the level of regulation of a given pro duct. In the face of constantly increasing evidence of the link between proper diet and decreased risk of disease, the FDA must now reconsider its traditional skepticism of all health claims for food. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6\ul 2. Post-1990 FDA Policy: The Distinction Between "Dietary Guidelines" and "Health Claims." }{\f1\fs8\ul -- }{\b\f6\fs22\ul (a) Introduction}{\b\f6\fs22 . }{\f1\fs8 -- }{\f6 In an attempt to balance its educative with its protective function, and in order to comply with the 1990 Act, the FDA has set forth a distinction between "dietary guidelines," which are to be \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s23\fi731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 10 }{\f6 For a particularly amusing example, see the advertisement for "Grant's Hygienic Crackers" in Hutt, }{\f6\ul supra}{\f6 note 9, at 6. \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See, e.g.}{\f6 , Surgeon General' s Report on Nutrition and \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 Health, DHHS (PHS) Pub. No. 88-50210 (1988) (discussing the \par relationship of diet to health and disease); National Academy of \par }\pard\plain \s36\nowidctlpar\tx204\adjustright {\b\f6\fs22 Sciences, Diet and Health: Implications for Reducing Chronic \par Disease Risk (1989) (same). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 5 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 encouraged, and "health claims," which are still forbidden except \par }\pard\plain \s33\li5329\nowidctlpar\tx5329\adjustright {\b\f6\fs16 12 \par }\pard\plain \nowidctlpar\tx5329\adjustright {\b\f6\fs16 \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 when expressly authorized by the FDA. This Part will examine the FDA's attempt to distinguish the two concepts, and whether \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 this attempt has been successful. \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 The regulations implementing the 1990 Act define a "health claim" on a label to include any claim that \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 expressly or by implication, including "third party" references, written statem~nts (e.g., a brand name including a term such as "heart"), symbols (e.g. , a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health related condition. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 An example of a health claim is "X helps reduce the risk of heart disease." Implied health claims are subject to the same rules as e xplicit health claims, in order to alleviate the prior problem of what to do when the manufacturer does not make explicit health claims. FDA defines implied health claims as: \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 those statements, symbols, vignettes, or other forms of communication that a man ufacturer intends, or that would be reasonably understood in the context in which they are presented, to assert a relationship between the presence or level of a substance in the food and a disease or health-related condition.}{\f6\super 14}{\f6 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 Whether implicit or explic it, FDA identifies two elements of a health claim: first, there must be reference to a "substance," defined as a "specific food or component of food;" and second, there must be reference to a "disease or health\emdash related \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par \par \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 12 }{\f6 \'a7 101.14(e) (1), (e)(2). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 13 }{\f6 21 C.F.R. \'a7 101.14(a) (1). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 14 }{\f6 58 Fed. Reg. 2478\emdash 01. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 6 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 condition," defined as "damage to an organ, part, structure, or system of the body such that it does not function properly }{\f1\fs8 ... }{\f6 or a state of health leading to such dysfunctioning }{\f1\fs8 .... }{\b\f6\fs16 ,,15 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\b\f6\fs16 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 FDA identifies certain claims as exempt from the definition of health claim. One gro up of claims that is allowed is identified as "dietary guidance," defined as "claims that do not contain both basic elements of a health claim and are therefore not 'health claims.'"}{\f6\super 16 }{\f6 An example would be a claim that "provide[s] guidance about a general f ood choice or about how to achieve a healthy lifestyle." FDA elaborates in another regulation that claims about the "nutritive value" of food, defined as those claims relating to a "value in sustaining human existence by such processes as promoting growth , replacing loss of essential nutrients, or providing energy," are not considered health claims.}{\f6\super 17}{\f6 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 (}{\f6\ul b~ The Fuzziness of the Distinction}{\f6 . }{\f1\fs8 -- }{\f6 For the most part, the era of the food/drug or food/dietary food distinction as the key to determining a product's l evel of regulation is behind us, given the 1990 amendments. Yet FDA makes fine distinctions between health claims, both explicit and implicit, which are still forbidden for the most part, and nutritional guidelines, \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 15 }{\f6 21 C.F.R. \'a7\'a7 l0l.14(a)(2), (6). \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 16 }{\f6 58 Fed. Req. 2478\emdash 01. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s38\fi731\sl-255\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 17 }{\f6 21 C.F.R. \'a7 l0l.14(a)(3). Claims relating to diseases that are related to deficiencies in essential nutrients are also exempted from the definition of health claim. }{\f6\ul See}{\f6 21 C.F.R. \'a7101.14 (a) (6). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 7 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 which are appropriate and even encouraged. But what assumptions are reflected in the health claim/health guidance distinction, and is it an improvement? The attempt to distinguish the two is inevitably confusing }{\f1\fs8 \emdash \emdash }{\f6 perhaps even more than the food/drug or food/dietary food distinctions. The FDA has conceded as much: \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 [Ulse of the term "dietary guidance" to describe claims that do not constitute "health claims" is }{\f1\fs8 ... }{\f6 confusing because "health claims" themselves provide a form of dietary guidance. In addition to "health claims" and "dietary guidance," there is a broader class of claims that encompasses all other truthful information about diet and health as well as dru g claims.}{\f6\super 18}{\f6 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 An example may serve to illustrate the dilemma faced by manufacturers in making the distinction. Suppose that a manufacturer wishes to include on his label certain information contained in an AMA report that is favorable toward the main ingredi ent of its product. The FDA has stated that: \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 [P]ublicly available dietary information provided to consumers by Federal or private programs and used in food labeling by manufacturers may be either dietary guidance or a health claim depending upon the conte nt of the information and the context in which it is presented in the labeling. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 Faced with such nebulous distinctions, it is virtually impossible for a manufacturer to tell whether its particular claim will be approved. Yet although these distinctions are tenuous, they are outcome-determinative under the new regulations, and at stake is whether or not a manufacturer can make the statement at all. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par \par \par \par \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 58 Fed. Reg. 2478\emdash 01. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 8 \par }\pard\plain \s39\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s39\qc\nowidctlpar\tx6474\tx7795\adjustright {\b\f6\fs22 III. First Amendment Complications \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\b\f6\fs22 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 The FDA's policies toward health claims are especially troublesome when First Amendment considerations are added to the analysis. The FDA's approach is vulnerable to First Amendment attacks on many differ ent fronts. After a brief explanation of commercial speech doctrine, this Part will canvass the various free speech implications of FDA's policies in this area. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s40\fi-732\li998\nowidctlpar\tx266\tx997\adjustright {\f6\ul A.\tab Virginia Pharmacy and the Emergence of Commercial Speech}{\f6 \par }\pard\plain \nowidctlpar\tx266\tx997\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 Until 1976, commercial speech was an unprotected speech \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s41\qc\nowidctlpar\tx731\adjustright {\b\f6\fs16 19 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 category, like libel and obscenity. However, the Supreme Court \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 abandoned this approach in }{\f6\ul Virginia Pharmacy Bd. v. Virginia}{\f6 \par }\pard\plain \s42\li2460\nowidctlpar\tx2460\adjustright {\b\f6\fs16 20 \par }\pard\plain \nowidctlpar\tx2460\adjustright {\b\f6\fs16 \par }\pard\plain \s35\sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6\ul Consumer Council}{\f6 , when it held that commercial speech that is not misleading (or proposing an illegal transaction) is entitled \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 to First Amendment protection, though not as extensive as speech nearer the "core of First Amendment values."}{\f6\super 21}{\f6 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 The }{\f6\ul Virginia Pharmacy}{\f6 Court had two primary rationa les for protecting commercial speech. First, society has a strong interest in the "free flow of commercial information;" and second, the First Amendment prohibits a state from deciding that consumers would be best protected by ignorance (in that case, \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 19 }{\f6\ul See}{\f6 Valentine v. Chrestensen, 316 U.S. 52 (1942). \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 20 }{\f6 425 U.S. 748 (1976). \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 21 }{\f6\ul Id}{\f6 . \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 9 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s45\sl-255\slmult0\nowidctlpar\tx204\adjustright {\f6 ignorance of prescription drug prices) }{\b\f6\fs16 {\field{\*\fldinst SYMBOL 183 \\f "Symbol" \\s 8}{\fldrslt\f3\fs16}}}{\b\f6\fs16 22 }{\f6 Thus, }{\f6\ul Virginia}{\f6 \par }\pard\plain \sl-255\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6\ul Pharmacy}{\f6 seems to represent a shift in First Amendment emphasis from the traditional right to }{\f6\ul disseminate}{\f6 information to the right to }{\f6\ul receive}{\f6 information, though this contention is still controversial. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Qualifications present in the }{\f6\ul Virginia Pharmacy}{\f6 opinion itself will prove to be pivotal in the health claim area. First, the Court acknowledged that false or misleading advertising can be prohibited; second, the Court hinted that broader regulation of the time, place, and manner of commercial sp eech might be possible; and third, the Court stated that a strong presumption against prior restraints might not apply to commercial speech. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s43\fi-465\li731\nowidctlpar\tx266\tx731\adjustright {\f6\ul B.\tab The Status of Health Claims }{\f1\fs8\ul -- }{\f6\ul Commercial or Noncommercial}{\f6 ? \par }\pard\plain \nowidctlpar\tx266\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Although labeling has been characterized as commercial speech by some courts, no court has directly addressed the speech implications of the regulation of scientific claims on labels. Thus, one of the questions that must be resolved in order to evaluate t he First Amendment soundness of the FDA's approach is: \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s44\fi-731\li731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 where does scientific speech end and commercial speech begin? Some commentators argue that health claims fall outside of \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s44\fi-731\li731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 the commercial speech realm because they convey scientific \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 22 }{\f6\ul See}{\f6 }{\f6\ul also}{\f6 Linmark Assocs., Inc., v. Willingboro, 431 U.S. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s45\sl-255\slmult0\nowidctlpar\tx204\adjustright {\f6 85 (1977) (holding that a town's prohibition of "For Sale" and "Sold" signs violated the First Amendment because it was an attempt to prevent white flight by keeping the public in ignorance). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 10 \par }\pard\plain \s26\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s46\li1752\nowidctlpar\tx1751\adjustright {\b\f6\fs16 23 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 information. Under this reasoning, health claims should \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 receive full First Amendment protection. Thus, the traditional First Amendment analysis would be used: FDA's regulations would be constitutional only if they furthered an important governmental interest unrelated to the suppression of free expression and i f the regulations were no more restrictive than necessary. Under such an analysis, even though the prevention of consumer fraud is certainly an important governmental interest, FDA's polices would likely fail as insufficiently narrow to accomplish that ob jective.}{\f6\super 24}{\f6 \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Another aspect of health claims that lends strength to argument that they are noncommercial in nature is the express Congressional and administrative policy of educating the public in order to promote healthier lifestyle choices. The most common ly used definition of commercial speech is speech that does "no more than propose a commercial transaction."}{\f6\super 25 }{\f6 Yet given the educative purposes of such claims, they appear to do much more than that. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Finally, the Court has said that it is inappropriate to lower the level of First Amendment protection based solely on the \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 23 }{\f6\ul See}{\f6 Martin H. Redish, }{\f6\ul Product Health Claims and the First}{\f6 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s47\sl-243\slmult0\nowidctlpar\tx1672\adjustright {\f6\ul Amendment:\tab Scientific Expression and the Twilight Zone of Commercial Speech}{\f6 , 43 Vand. L. Rev. 1433 (1990). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx1672\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 24 }{\f6\ul See}{\f6 }{\f6\ul id}{\f6 . \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s37\li731\sl-243\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 25 }{\f6\ul See}{\f6 }{\f6\ul Central Hudson}{\f6 , 447 U.S. at 562. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 11 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s56\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 presence of a profit motive.}{\f6\super 26 }{\f6 The argument would be that punishing a manufacturer for saying something that could be said in }{\f6\ul JANA}{\f6 is improper because it "effectively exclude[s] one sector \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s49\li7483\nowidctlpar\tx7483\adjustright {\b\f6\fs16 27 \par }\pard\plain \s56\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 of society from participating in the public debate." To \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s57\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 overcome these arguments, the FDA would have to argue that speech "linking a product to a current public debate" can still be \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s51\li2608\nowidctlpar\tx2607\adjustright {\b\f6\fs16 28 \par }\pard\plain \s57\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 commercial speech. Nevertheless, if we say that commercial \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s58\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 speech is anything that is intended to enrich the company, then we are perched precariously on an intent standard, which the \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s53\li2886\nowidctlpar\tx2885\adjustright {\b\f6\fs16 29 \par }\pard\plain \s58\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 Court has forbidden. Profit motive has never been a useful way \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 to classify speech }{\f1\fs8 -- }{\f6 one need only think of recording stars and film producers to see the pitfalls of this approach. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 There are also those who argue that the commercial/non\-commercial speech distinction itself makes little sense. These theorists argue that s uch a distinction is not in the Constitution, and that the "common sense differences" identified in }{\f6\ul Virginia Pharmacy}{\f6 }{\f1\fs8 -- }{\f6 that commercial speech is more easily verifiable than noncommercial speech, and that commercial speech is more durable than noncommercial speech simply because it is \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s54\fi731\sl-294\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 26 }{\f6\ul See. e.g.}{\f6 , New York Times Co. v. Sullivan, 376 U.S. 254 (1964) \par }\pard\plain \s23\fi731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 27 }{\f6 Alex Kozinski & Stuart Banner, }{\f6\ul Who's Afraid of Commercial Speech?}{\f6 , 76 Va. L. Rev. 627, 642 (1990). \par }{\b\f6\fs16 28 }{\f6\ul See}{\f6 Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 (1983) (holding that drug company mailings containing discussions of important public issues (e.g. venereal diseases and family planning) were nevertheless commercial speech). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s54\fi731\sl-294\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 29 }{\f6\ul See}{\f6 }{\f6\ul Virginia Pharmacy}{\f6 , 425 U.S. at 761 }{\f1\fs8 \emdash }{\f6 65. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s65\fi-1967\li8441\sl-221\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 12 \par }\pard\plain \sl-221\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par \par \par \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 engaged in for profit }{\f1\fs8 \emdash \emdash }{\f6 are not necessarily accurate and in any \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 case might not lead to the conclusion that commercial speech \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s60\li6468\nowidctlpar\tx6468\adjustright {\b\f6\fs16 30 \par }\pard\plain \s61\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 should get less protection than other speech. Professor Tribe \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s66\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 notes that, when the government tries to suppress information based on the possibility that the communicative impact of the message will cause harm, the regulation must survive strict \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s63\li1304\nowidctlpar\tx1303\adjustright {\b\f6\fs16 31 \par }\pard\plain \s66\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 scrutiny; on this view, as discussed above, the FDA regulations \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s66\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 would almost invariably be struck down. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Even then-Justice Rehnquist's hostility toward commercial speech, as demonstrated in his dissent in }{\f6\ul Virginia Pharmacy}{\f6 , is helpful in attempting to classify health claims as noncommercial as opposed to commercial speech. Justice Rehnquist argued that the Fi rst Amendment was designed to protect discussion of "political, social and other public issues, rather than the decision of a particular individual as to whether to purchase one or another kind of shampoo." Nutrition and health are certainly "social" and "public" issues, and they are much less "trivial" than a choice of shampoos. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s17\qc\nowidctlpar\tx731\adjustright {\f6\ul C. Health Claims as Commercial Speech}{\f6 \par }\pard\plain \nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx731\adjustright {\f6 Because the Court stated in }{\f6\ul Virginia Pharmacy}{\f6 that time, \par }\pard\plain \nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 place, and manner restrictions ("TPM restrictions") can be somewhat freer when necessary to prevent commercial speech from \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 30 }{\f6\ul See}{\f6 Kozinski, }{\f6\ul supra}{\f6 note 27. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s64\fi1196\sl-294\slmult0\nowidctlpar\tx1196\adjustright {\f6\ul See}{\f6 Laurence Tribe, American Constitutional Law (2d ed. 1988) (labeling such cases "track 1" cases). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s65\fi-1967\li8441\sl-221\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 13 \par }\pard\plain \sl-221\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 being misleading, FDA has a strong argument that, if health claims are commercial speech, its regulations are proper. Nevertheless, the FDA's treatment of health claims is problematic even under a liberal interpretation of the commercial speech doctrine. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 The }{\f6\ul Virginia Pharmacy}{\f6 Court stated that TPM restrictions are permissible only if "they are justified without reference to the content of the regulated speech, }{ \f1\fs8 ... }{\f6 they serve a significant governmental interest, and }{\f1\fs8 ... }{\f6 in so doing they leave open ample alternative channels for communication of information."}{\f6\super 32 }{\f6 In that case, because advertisements of prescription drug prices were prohibited, the Court held that the proper bounds of TPM restrictions were "plainly exceeded," because the statute "single[d] out s peech of a particular content and [sought] to prevent its dissemination."}{\f6\super 33 }{\f6 Along those lines, FDA's regulations are vulnerable, because they attempt to single out only specific kinds of claims about products. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s67\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 FDA's policies are also open to criticism as invalid TPM restrictions when one focuses on the actual purposes of the regulations, which is one factor of the analysis. Even without these regulations, FDA had the authority to forbid false or misleading claims on labels, and it also has the duty to pre vent harmful products. A problem arises, however, when the goal of \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 32 }{\f6\ul See}{\f6 }{\f6\ul Virginia Pharmacy}{\f6 , 425 U.S. 748. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par }\pard\plain \s68\fi1270\sl-243\slmult0\nowidctlpar\tx1269\adjustright {\f6\ul Id}{\f6 . \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 14 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s61\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 preventing deception leads FDA to forbid truthful, accurate information. It is an open questio n whether the harms the FDA is trying to prevent, primarily misinformation about nutrition and waste of money, are sufficient to justify such broad regulations. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 FDA's approach is even vulnerable under the four\emdash part }{\f6\ul Central Hudson}{\f6 test,}{\f6\super 34 }{\f6 which seems to se ems to suggest a type of intermediate scrutiny for commercial speech. Under the }{\f6\ul Central Hudson}{\f6 test, a regulation of commercial speech is allowed if: (1) the speech is not protected at all (i.e. it's misleading or concerning an unlawful activity); (2) the governmental interest is "substantial;" (3) the regulation "directly advances" the governmental interest; and (4) the regulation is "not more extensive than is necessary" to accomplish the governmental interest; in other words, there is not a less restric t ive alternative ("LRA"). Even if FDA can persuasively argue that all or a majority of health claims are inherently misleading, and even though the government interest in prevention of consumer fraud is substantial, it is still possible to argue persuasive ly that the regulation is more extensive than necessary and does not directly advance the interest in prevention of consumer fraud. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 Although speech that has only the potential to mislead can be \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s69\li1446\nowidctlpar\tx1445\adjustright {\b\f6\fs22 35 \par }\pard\plain \nowidctlpar\tx1445\adjustright {\b\f6\fs22 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 regulated, when information can be presented either in a \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 Central Hudson Gas v. Public Serv. Comm'n, 447 U.S. 557 (1980) (involving a ban on promotional advertising by utilities). \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 \par }\pard\plain \s70\fi731\sl-221\slmult0\nowidctlpar\tx731\tx997\adjustright {\b\f6\fs22 ~\tab $~\'b1..g\'b1. }{\f6 Friedman v. Rogers, 440 U.S. 1 (1979) (upholding a Texas ban on the use of trade names by optometrists, on the ground tha t there was a "significant possibility that \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 15 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 misleading or a nonmisleading way a statute must attempt to regulate only the misleading format.}{\f6\super 36 }{\f6 Thus, it is likely that FDA could be required to use the methods it uses in other situations to prevent consumer misconceptions }{\f1\fs8 \emdash \emdash }{\f6 for example, regulation of the type size or location of health claims on the package. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Some might argue for an even higher level of scrutiny than that of the }{\f6\ul Central Hudson}{\f6 majority, especially in the case of health claims. For example, in his }{\f6\ul Central Hudson}{\f6 concurrence, Justice Blackm un argued that, although intermediate scrutiny is fine when speech is potentially misleading or coercive, it gives too little protection against content-based regulation. Justice Blackmun defined a regulation as content\emdash based if it is a "covert attempt by the state to manipulate the choices of its citizens \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 by depriving the public of the information needed to make a free choice." Furthermore, some Justices have expressed the view that strict scrutiny should apply whenever the government suppresses commercia l speech and its purpose is to "deprive consumers of accurate information concerning lawful activity."}{\f6\super 37}{\f6 Under this reasoning, FDA's attempt to protect consumers from making mistakes in the face of health claims would be struck \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par }\pard\plain \s71\fi-731\li731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\f6 trade names will be used to mislead the public"). }{\b\f6\fs16 36 }{\f6\ul See}{\f6 }{\f6\ul In re}{\f6 R.M.J. \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See}{\f6 Posadas de Puerto Rico Associates v. Tourism Co. of Puerto Rico, 478 U.S. 328 (1986) (Brennan, J., joined by Marshall, J., and Blackmun, J., dissenting). \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 16 \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s71\fi-731\li731\sl-328\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 down. \par }\pard\plain \sl-328\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 In sum, because content\emdash based regulations are generally frowned upon, FDA's fine distinctions between claims and guidance are quite vulnerable. The FDA can certainly proscrib e false and misleading statements in labeling. But when it regulates products differently based on the content of the claims made about them, many would argue that it oversteps the bounds of its mandate of protecting health and safety and enters the realm of impermissible content\emdash based regulation. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s72\qc\nowidctlpar\tx731\adjustright {\f1\fs8 IV. A Less Restrictive Alternative: \par }\pard\plain \nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s72\qc\nowidctlpar\tx731\adjustright {\f1\fs8 FDA Non-Endorsement of Health Claims Pending Approval \par }\pard\plain \nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s72\qc\nowidctlpar\tx731\adjustright {\f1\fs8\ul A. Introduction}{\f1\fs8 \par }\pard\plain \nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s67\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 Because the underlying tenet of the First Amendment is to "counter speech with speech,"}{\f1\fs8\super 38 }{\f1\fs8 this Part analyzes ways that FDA could avoid the next-to-impossible attempt to distinguish between guidance and claims, and in the process decrease the possibility of consumer misconceptions while at the same time allowing truthful information to reach th e public. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s72\qc\nowidctlpar\tx731\adjustright {\f1\fs8\ul B. A Practical Alternative}{\f1\fs8 \par }\pard\plain \nowidctlpar\tx731\adjustright {\f1\fs8 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 There is a less restrictive alternative to a nearly complete ban on health claims: rather than broadening its own power and discretion at the expense of personal choice, FDA could require that health claims include a statement that they have not been endorsed by the FDA, and any other statement that it feels is \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 \par \par \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f1\fs8 38 }{\f1\fs8\ul See}{\f1\fs8 Kozinski, }{\f1\fs8\ul supra}{\f1\fs8 note 27, at 648. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 17 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s44\fi-731\li731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 necessary in order to prevent certain common misconceptions. The warning might be along the following lines: \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s73\fi-884\li884\nowidctlpar\tx884\adjustright {\b\f6\fs22 NOTE:\tab THE FDA DOES NOT ENDORSE THE HEALTH CLAIMS MADE BY THIS \par }\pard\plain \nowidctlpar\tx884\adjustright {\b\f6\fs22 \par }\pard\plain \s36\nowidctlpar\tx204\adjustright {\b\f6\fs22 PRODUCT. INDIVIDUAL HEALTH NEEDS VARY ACCORDING TO AGE, BODY \par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs22 \par }\pard\plain \s36\nowidctlpar\tx204\adjustright {\b\f6\fs22 SIZE, AND OTHER FACTORS. PLEASE SEE YOUR DOCTOR BEFORE RELYING \par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs22 \par }\pard\plain \s36\nowidctlpar\tx204\adjustright {\b\f6\fs22 ON HEALTH CLAIMS ABOUT ANY PARTICULAR PRODUCT. \par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs22 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Such a warning could be coupled with regulations that would provide only that the health claim must }{\f6\ul accurately express, in simple terms, the amo unt of medical data backing the particular claim}{\f6 . In other words, if a manufacturer wanted to make a claim based on only one study, it could do so if it stated that fact explicitly. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s72\qc\nowidctlpar\tx731\adjustright {\f6\ul C. The Advantages of This AP~roach}{\f6 \par }\pard\plain \nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 This approach recognizes the value of informed choice,}{\f6\super 39 }{\f6 the utility of warnings as demonstrated in areas in which there is even greater danger of harm to the consumer,}{\f6\super 40 }{\f6 and the desirability of individual medical judgment in the areas of \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par \par \par \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 As one journalist put it, "[t]rusting David Kes sler to decide what health claims you may hear is about as sensible as trusting Pat Robertson to decide what movies you may see." Stephen Chapman, }{\f6\ul FDA's War Against Health Claims Also Attacks Free Speech}{\f6 , Chicago Trib., Jan. 20, 1994, at 21. \par }\pard\plain \s74\fi731\sl-221\slmult0\nowidctlpar\tx731\adjustright {\f6 The FDA's grad ual inclusion of more nutritional information and more ingredients on labels as health awareness has increased also supports the possibility of informed choice in this area. \par }\pard\plain \sl-221\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s74\fi731\sl-221\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 40 }{\f6 The FDA's broad interpretation of "misleading" in this area is inconsistent wi th its reliance on warnings and informed choice in areas where there is a tangible risk of harm. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s32\fi-1967\li8441\sl-243\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 18 \par }\pard\plain \s17\qc\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \nowidctlpar\tx6474\tx7795\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 health and nutrition.}{\f6\super 41 }{\f6 This approach also is more in keeping with the spirit of the First Amendment.}{\f6\super 42 }{\f6 For all of these reasons, this approach is more likely than FDA's current practice to reach a favorable resolution to the policy questions posed at the beginning of this paper. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Of course, this proposal is not without disadvantages. First, the same complications would arise as always in terms of what to do about small packages, small manufacturers, and other special situations. Second, manufacturers might claim that such a warni ng unduly restricts their promotional activities, since consumers might well assume that a manufacturer making an unendorsed claim is untrustworthy. Third, the requirement of such a warning might intensify the pressure on FDA to loosen its standards of ap proval. Fourth, on the theory that too much information can be overwhelming and counterproductive, the barrage of claims accompanied by warnings may be too much for \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 41 \par }\pard\plain \nowidctlpar\tx725\adjustright {\b\f6\fs16 \par }\pard\plain \s68\fi1270\sl-243\slmult0\nowidctlpar\tx1269\adjustright {\f6 In similar situations, FDA has argued that consumers might forego medical treatment if they think that they are receiving all of the available information. The difficulty with this argument is that it does not support FDA's current approach. A complete nutritional picture will always be impossible on a label; thus, it is preferable to give c onsumers as much information as is feasible and then tell them to seek additional advice before relying exclusively on the given material. Some health and nutrition organizations have advocated that the FDA require language on food labels to the effect th at diet is only one factor in a person's total health profile, in order to ensure that people will not conclude that exercise, for example, is irrelevant. Such demands, of course, could go on ad infinitum. \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 42 \par }\pard\plain \nowidctlpar\tx725\adjustright {\b\f6\fs16 \par }\pard\plain \s68\fi1270\sl-243\slmult0\nowidctlpar\tx1269\adjustright {\f6 The proposal decreases the free speech concerns by fighting speech with speech rather than prohibiting it. The Supreme Court has in fact expressed a preference for explanations over prohibitions. \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s75\fi-1967\li8441\sl-113\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 19 \par }\pard\plain \sl-113\slmult0\nowidctlpar\tx6474\tx7795\adjustright {\f6 \par \par }\pard\plain \s44\fi-731\li731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 many consumers, who will simply "tune out" all of the messages.}{\f6\super 43}{\f6 Nevertheless, the advantages to an approach that would \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par }\pard\plain \s28\sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 increase consumer information and choice outweigh these disadvantages. It avoids undermining the public's confidence in the FDA. It allows positive uncertainty (e.g. the chance that a given hea lth claim will eventually be proven to the satisfaction of the FDA) to be on par with negative uncertainty (e.g. the risk of harm as expressed in package inserts and other warnings)." It is a more economically efficient way to distribute the information-g athering burden.}{\f6\super 45 }{\f6 It is more realistic than the \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx204\adjustright {\f6 \par \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6\ul See}{\f6 Jacob Jacoby et al., }{\f6\ul Corrective Advertising and Affirmative Disclosure Statements: Their Potential for Confusing and Misleading the Consumer}{\f6 , 46 J. Mktg. 61, 70 (1982). \par }\pard\plain \s20\li726\nowidctlpar\tx725\adjustright {\b\f6\fs16 44 \par }\pard\plain \nowidctlpar\tx725\adjustright {\b\f6\fs16 \par }\pard\plain \s68\fi1270\sl-243\slmult0\nowidctlpar\tx1269\adjustright {\f6 To date, FDA has authorized only two health claims: that folic acid can diminish birth defects and that calcium can prevent osteoporosis. So far, claims about the relationship between vitamin E and heart disease are not allowed. FDA's scientific standard is "significant scientific agreement," a standard under which many great breakthroughs will go unnoticed. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx1269\adjustright {\f6 \par }\pard\plain \s21\fi998\sl-243\slmult0\nowidctlpar\tx997\adjustright {\f6 Suppose the only alternative for a consumer who wants to be informed about promising medical information about nutrition, until the FDA is satisfied, is to inform herself via the scientific journals. Inevitably, she will have to subscribe to more than one journal. Invariably, she will have to read each journal with more than one product in mind }{\f1\fs8 \emdash \emdash }{\f6 in fact, with each potential element of her diet in mind . It would be much more efficient for a company with only one product or one line of products to canvass all of the literature and attempt to present the latest scientific data in a way that laymen will understand. This manufacturer will be punished if it makes fraudulent claims, and now more of FDA's resources will be available to police such claims. As Cass Sunstein has argued, because informational approaches to regulation "leave considerable room for freedom of choice, they avoid the inefficiencies of centralized dictation of outcomes." Cass R. Sunstein, }{\f6\ul Informing America: Risk. Disclosure, and the First Amendment}{\f6 , 20 Fla. St. U. L. Rev. 653, 660 (1993); }{\f6\ul see}{\f6 }{\f6\ul also}{\f6 Stephen Chapman, }{\f6\ul Scruelching of Facts may be Hazardous to your Health}{\f6 , Chicago Trib., July 11, 1993, at 3 \par }{\fs20 \page }{\f6 \sect }\sectd \sbknone\linex0\headery1200\sectdefaultcl \pard\plain \s76\fi-1883\li8351\sl-226\slmult0\nowidctlpar\tx6468\tx7789\adjustright {\f6 Author:\tab 403\emdash 8573\emdash 80 Page 20 \par }\pard\plain \sl-226\slmult0\nowidctlpar\tx6468\tx7789\adjustright {\f6 \par \par \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 FDA's goal to prevent all health claims that could potentially be \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 misleading, and thus it frees up FDA's resources for the policing \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s77\qc\nowidctlpar\tx204\adjustright {\b\f6\fs16 46 \par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs16 \par }\pard\plain \s55\sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 of more harmful areas, while at the same time allowing FDA to continue to make progress toward authorizing more health claims. \par }\pard\plain \sl-243\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s39\qc\nowidctlpar\tx204\adjustright {\b\f6\fs22 V. Conclusion \par }\pard\plain \nowidctlpar\tx204\adjustright {\b\f6\fs22 \par }\pard\plain \s19\fi731\sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 Although the 1990 Act represents an advance over the previous strict prohibition on health claims for food, it nevertheless only allows such claims as specifically authorized by FDA under narrow circumstances. FDA's interpretation of the statute has creat e d needless confusion over the difference between nutritional guidance and health claims. In this area, it is important to remember that we are talking about safe products and truthful claims as the starting point, since FDA can always prohibit unsafe prod ucts and false or misleading claims. Yet the FDA cannot prevent consumers from making mistakes any more than it can prevent all risks in food or drugs. A mistake-free society is no more possible than a risk\emdash free society, but an informed society is within our reach and should be our goal. Thus, although the governments objectives in this area are laudable, its approach can and should be criticized. \par }\pard\plain \sl-481\slmult0\nowidctlpar\tx731\adjustright {\f6 \par \par \par \par \par }\pard\plain \s78\sl-362\slmult0\nowidctlpar\tx204\adjustright {\f6 ("The best way to assure that information gets out quickly is to allow its transmission by the people who stand to profit."). \par }\pard\plain \sl-362\slmult0\nowidctlpar\tx204\adjustright {\f6 \par }\pard\plain \s74\fi731\sl-221\slmult0\nowidctlpar\tx731\adjustright {\b\f6\fs16 46 }{\f6 The cost of the new FDA rules has been estimated at between $1.7 billion over 20 years and $2 billion for the first year alone. }{\f6\ul See}{\f6 Sunstein, }{ \f6\ul supra}{\f6 note 45, at 665. \par }}