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\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\fs40 DIETARY SUPPLEMENTS: A REVIEW OF UNITED STATES REGULATION WITH EMPHASIS ON THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 AND SUBSEQUENT ACTIVITY
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\par Brian Scarbrough
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\par Class of 2004
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\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {April 2004
\par 
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\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {This paper is submitted in satisfaction of both the course requirement and the third year written work requirement
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\par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b ABSTRACT
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {This paper undertakes a review of notable dietary supplement regulation in the United States.  First, this paper discusses dietary supplements generally 
and their uses and economic characteristics.  Second, this paper discusses a brief general history of dietary supplement regulation in the United States including the Dietary Supplement Health and Education Act of 1994 (\'93DSHEA\'94).  
Emphasis is placed on the DSHEA and notable post-DSHEA governance in the form of Food and Drug Administration regulations, congressional activity, and other administrative and industry action.  Finally, this paper proposes how the United S
tates, both through government regulation and industry self-regulation, should proceed to handle dietary supplements in 2004 and beyond.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
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\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
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\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b I. INTRODUCTION}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Food and drugs \endash  at first glance they seem worlds apart but upon closer inspection their boundaries start to merge.  For decades, Congress and the 
Food and Drug Administration (\'93FDA\'94) struggled to define such boundaries until they finally created an intermediate product group called dietary supplements.  The Dietary Supplement Health and Education Act of 1994 (\'93DSHEA\'94) established the 
statutory category of dietary supplements and subjected them to various food standards as well as a host of new standards.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified as amended in scattered sections of 21 U. S. C.).}}}{  The DSHEA attempted to strike a
 balance between foods that are functional in that they have some health benefits and drugs that have clear
ly defined and approved health benefits.  Since passage of the DSHEA, Congress, the FDA, and the dietary supplement industry have strove, with varying degrees of success, to
 implement the DSHEA and give definition to the ever expanding and extremely popular dietary supplement market.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b II. GENERAL BACKGROUND REGARDING DIETARY SUPPLEMENTS
\par }{\b\i A. Types of Dietary Supplements
\par }{\tab Dietary supplements are defined in the DSHEA (now codified in scattered sections of Title 21 of the United States Code) as a product other than tobacco which includes one or more of the following dietary ingredients
: a vitamin, a mineral, an herb or other botanical, an amino acid, any other substance used to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 3 (codified at 21 U. S. C. \'a7
 321(ff)(1)(A-F)).  A dietary supplement also must be intended for ingestion in tablet, capsule, powder, soft gel, or liquid form.  }{\i Id.}{ (codified at 21 U. S. C. \'a7\'a7 321(ff)(2)(A)(i), 350(c)(1)
(B)(i)).  Further, if the dietary supplement is not intended for ingestion in such form, it must not be represented as conventional food and not represented as meal replacement.  }{\i Id.}{ (codified at 21 U. S. C. \'a7\'a7
321(ff)(2)(A)(ii), 350(c)(1)(B)(ii)).  Further, the dietary supplement, no matter the form, must not be represented for use as conventional food or meal replacement.  }{\i Id.}{ (codified at 21 U. S. C. \'a7
 321(ff)(2)(B).  Further, the dietary supplement must be labeled as a dietary supplement.  }{\i Id.}{ (codified at 21 U. S. C. \'a7 321(ff)(2)(C).  Finally, the dietary supplement definition includes and excludes certain drugs.  }{\i Id.}{
 (codified at 21 U. S. C. \'a7 321(ff)(3).}}}{  Whatever the form, dietary supplements are considered a special category of food and are not considered drugs.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 321(ff)); }{\i but see}{ 21 U. S. C. \'a7
 321(ff)(3) (in certain limited cases a dietary supplement can be a drug). I. S}{\scaps cott}{ B}{\scaps ass}{ & A}{\scaps nthony}{ L. Y}{\scaps oung}{, D}{\scaps ietary}{ S}{\scaps upplement}{ H}{\scaps ealth}{ }{\scaps and}{ E}{\scaps ducation}{ A}{
\scaps ct}{: A L}{\scaps egislative}{ H}{\scaps istory}{ }{\scaps and}{ A}{\scaps nalysis 1 (1996)}{; }}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The main categories of dietary supplements in the United States are as follows: vitamins,}{\cs18\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\fs20 Vitamins are defined as \'93[p]roducts that are organic (carbon-containing) nutrients that a
re essential in small quantities for normal metabolism, growth, and well-being. They must be obtained through the diet because they either are not synthesized in the body or are not synthesized in adequate amounts.\'94  C}{\scaps\fs20 enter}{\fs20  }{
\scaps\fs20 for}{\fs20  E}{\scaps\fs20 conomics}{\fs20  R}{\scaps\fs20 esearch}{\fs20 , R}{\scaps\fs20 esearch}{\fs20  T}{\scaps\fs20 riangle}{\fs20  I}{\scaps\fs20 nstitute, Economic Characterization of the Dietary Supplement Industry}{\fs20 
 1-1 (Final Report 1999) [Hereinafter }{\scaps\fs20 Economic Characterization}{\fs20 ].  There are thirteen vitamins necessary for human consumption: A, D, E, K (all fat-soluble) and B}{\fs20\sub 1}{\fs20 , }{\fs20\sub  }{\fs20 B}{\fs20\sub 2}{\fs20 , }{
\fs20\sub  }{\fs20 B}{\fs20\sub 3 }{\fs20 , B}{\fs20\sub 6}{\fs20 , }{\fs20\sub  }{\fs20 B}{\fs20\sub 12}{\fs20 , C, biotin, folic acid, and pantothenic acid (all water-soluble).  }{\i\fs20 Id.}{\fs20  at 2-1.}}}{ minerals,}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Minerals are defined as \'93
[p]roducts that are chemical elements in their inorganic form.  \lquote Minerals\rquote  are those that are required in amounts greater than 100mg/day, and \lquote trace minerals\rquote  are those required in lesser amounts.\'94  }{\i Id.}{
 at 1-1.  There are seventeen minerals commonly used in dietary supplements.  }{\i Id.}{ at 2-4.  }{\i See}{ }{\i id.}{ at 2-5 for a table of these seventeen commonly used minerals, their occurrence in foods, and the forms they take in supplements.}}}{
 herbals and botanicals (including extracts),}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Herbal refers to leaves and stems of a plant while botanical refers to roots, seeds, fruits, and any other part of a plant in addition to leaves and stems of a plant.  }{\i Id.}{ at 1-1, 4-14.  Herbal or botanical extracts are 
made from any part of a plant.  }{\i Id.}}}{ animal extracts,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ Animal extracts are \'93[p]roducts that are extracts of made from animal parts.\'94  }{\i Id.}{ at 1-1.  These extracts are from particular animal tissues or glands.  }{\i Id.}{ at 4-23.}}}{ amino acids,}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Amino acids are \'93[p]roducts that contain an amino group and an acidic function.\'94
  }{\i Id.}{ at 1-1.  They are the main constituent of proteins and are classified as either essential (not synthesized in the human body) or non-essential (synthesized in the human body).  }{\i Id.}{ at 4-14.}}}{ proteins,}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Proteins are \'93[p]roducts with the complete set of amino acids to make up proteins.
\'94  }{\i Id.}{ at 1-1.  They are \'93antibodies as part of the immune system\'94 and are key in regulating many body functions.  }{\i Id.}{ at 4-14.}}}{ concentrates, metabolites, and constituents,}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Concentrates, metabolites, and constituents refer to any products falli
ng within the other definitions of dietary supplement and broken into individual parts or components.  }{\i See}{ }{\i id.}{ at 1-1.}}}{ teas,}{\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\fs20 Teas refer to \'93[p]roducts infused in water that contain herbals, botanicals, or other . . . [dietary supplement] products.  Basic tea p
roducts have a standard of identity as a food product; however, many
\par }\pard \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 {\fs20 products are a combination of tea and dietary supplements.\'94  }{\i\fs20 Id.}{\fs20  at 1-1.}}}{ and miscellaneous products.}{\cs18\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\fs20 Miscellaneous products refers to \'93[a]ll other products meeting the criteria of dietary supplements that cannot be 
classified into the categories above. They include, for example, bee pollen,
\par }\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {propolis, and royal jelly; coenzyme Q; spirulina and other algaes; and nucleic acids.\'94  }{\i Id. }{
at 1-1.}}}{  Currently in the United States, dietary supplements play a key role alongside nutraceuticals}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ One definition of nutraceutical \'93is a product isolated or purified from foo
ds that is generally sold in medicinal form not usually associated with food.  A nutraceutical is demonstrated to have physiological benefit or provide protection against chronic disease.\'94  Steven Dentali, }{\i 
Regulation of Functional Foods and Dietary Supplements}{, F}{\scaps ood }{T}{\scaps echnology}{, June 2002, at 90.  Another definition for nutraceutical is \'93
a food, dietary supplement, or medical food that has a medical or health benefit, including the prevention and treatment of disease.\'94  }{\i Functional Foods Market Growing}{, F}{\scaps ood }{T}{\scaps echnology}{, Dec. 2003, at 90.}}}{
 and functional foods}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 One definition of functional food is a product \'93similar in appearance to, or may be, a conventional food, [which] is consumed as part of a usual diet and is demonstrated to have physiological benefits and/or reduce the risk 
of chronic disease beyond basic nutritional functions.\'94  Dentali, }{\i supra}{ note 13, at 90.  Neither this definition nor the definition of nutraceutical has any current legal status in the United States.  Dentali, }{\i supra}{
 note 13, at 90.  Often the term nutraceutical and the term functional food are used interchangeably.  }{\i Functional Foods Market Growing}{, }{\i supra}{ note 13.}}}{ in the ever expanding consumer health market.
\par \tab Dietary supplements commonly take several distinct forms.  The DSHEA delineates what forms a dietary supplement may take and thus plays a role in funneling dietary supplements into these certain forms.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i supra}{ note 2.}}}{  
The predominate forms of dietary supplements for purchase by consumers are capsules (both hard-shell and soft-gel), tablets, liquids (including solutions, elixirs, and syrups), powders and granules, and lozenges
 (substances produced to dissolve over time in the mouth).}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i See}{ }{\scaps Economic Characterization}{, }{\i supra}{ note 4, at 2-14 to 2-17.  Liquids should be intended for consumption in small amounts.  Dentali, }{\i supra}{ note 13, at 90.}}}{  Additionally, \'93
dietary supplements are allowed to be sold in conventional food form so long as the product \lquote is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.\rquote \'94}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Dentali, }{\i supra}{ note 13, at 90 (quoting 21 U. S. C. \'a7 350(c)(1)(B)(ii)).}}}{

\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {An illustrative part of the vast dietary supplement market is the sports supplement market.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Sports supplements are also referred to as performance-enhancing products or ergogenic aids.  Linda Milo Ohr, }{\i More for the Sport}{, F}{\scaps ood }{T}{\scaps echnology}{, Feb. 2003, at 63.}}}{  Currently, sports s
upplements enjoy enormous popularity within the broader sports nutrition market.  The sports nutrition market includes products that \'93focus on boosting energy [and recovery], increasing muscle mass, or improving muscle restoration.\'94}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
  Both dietary supplements and functional foods compose the sports nutrition market and are mostly sold in the forms of \'93[n]utrition bars, energy drinks, sports beverages, and protein mixes.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  Current examples of nutrition bars are PowerBar and Clif Bar and 
current examples of energy drinks are Invigor8, E}{\sub 2}{0, and SoBe No Fear.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Linda Milo Ohr, }{\i In Search of More Energy}{, F}{\scaps ood }{T}{\scaps echnology}{, March 2004, at 55, 56 [hereinafter }{\i Energy}{
].  While these products are marketed as conventional food and not dietary supplements, they contain ingredients such as taur
ine, ginseng, or guarana, which otherwise lie within the definition of dietary supplement.  Were such beverages marketed as dietary supplements they would fall within the DSHEA definition.  For the interaction between conventional foods (particularly func
tional foods and nutraceuticals) and dietary supplements }{\i see}{ Dentali, }{\i supra}{ note 13, at 89-94.}}}{  B vitamins often appear in energy drinks and sports beverages because of their role in energy production and tissue repair and maintenance.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Ohr, }{\i supra}{ note 18, at 63, 65.}}}{  Taurine
, an amino acid, is a popular sports supplement for its fat absorbing antioxidant and membrane-stabilizing properties.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i Energy}{, }{\i supra}{ note 21, at 56, 66.}}}{  Vitamin E, also a popular sports supplement, is used for its 
role in reducing damaging free radical activity in the body after exercise.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ Ohr, }{\i supra}{ note 18, at 65.}}}{  Protein is used as a sports supplement to maintain muscle tissue and is found in both soy varieties (in nutrition bars) and whey varieties.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  Other sports supplements include creatine,
 which is thought to increase muscle mass and augment intense exercise capability,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 66.}}}{ and carnitine, a metabolite amino acid derivative used to benefit sport performance and recovery.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i id.}{ at 68.}}}{  Some final examples of sports supplements used for th
eir energy boosting properties include: guarna (botanical), ginseng (an herb), and D-ribose (an amino acid).}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Energy}{, }{\i supra}{ note 21, at 56, 66.}}}{
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i B.  The Dietary Supplement Industry: Economics and Sales 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab There are five main dietary supplement industry groups in the United States: the Council for Responsible Nutrition, the American Herbal Productions Association,
 the Nonprescription Drug Manufacturers Association (focusing on vitamin and mineral supplements), the Utah Natural Products Alliance, and the National Nutritional Foods Association (the largest such industry group).}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Economic Characterization}{, }{\i supra}{ note 4, at 3-1.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {In general, the dietary supplement industry is characterized by high material costs (source costs) with much lower labor costs.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i id.}{ at 2-18 to 2-19.}}}{
  Thus the raw materials that compose dietary supplements are the most important part of the dietary supplement industry.  
To handle these important raw materials, there are estimated to be over 1,100 dietary supplement raw materials and manufacturing firms.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  at 3-1.  Another study in 2000 estimated there to be 1,973 such establishments.  C}{
\scaps enter}{ }{\scaps for}{ E}{\scaps conomics}{ R}{\scaps esearch}{, R}{\scaps esearch}{ T}{\scaps riangle}{ I}{\scaps nstitute, Survey of Manufacturing Practices in the Dietary Supplement Industry}{ 2-1 (Final Report 2000).}}}{
  The vast majority (over 78%) of these firms either solely manufactures dietary supplements or manufactures dietary supplements in combination with other functions such as importing or exporting.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See }{\scaps Economic Characterization}{, }{\i supra}{
 note 4, at 3-1.  Aside from manufacturing or importing and exporting, dietary supplement firms may also perform input supply, repacking, relabeling, encapsulating, and distribution.  }{\i Id.}}}{  Over 54%
 of dietary supplement firms produce or handle vitamins and minerals.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i {\*\bkmkstart OLE_LINK1}Id.}{ at 3-2{\*\bkmkend OLE_LINK1}.}}}{  Herbals and botanicals are produced or handled in 43% of dietary supplement firms.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  Herbal and botanical extracts followed at 14%, teas at 10%, amino acids at 4%, and animal extracts at 2% (percentages add to more than 100 due to overlap in production or handling by firms).  }{\i Id.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 { \tab The dietary supplement market is composed of many heterogeneous products.  A brief look at the definition of dietary supplement under the DSHEA confirms
 this.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See supra}{ notes 4-12.}}}{
  This causes the cross-price elasticity of demand for dietary supplement to be small which in turn means there is little economic substitution effect among dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Economic Characterization}{, }{\i supra}{ note 4, at 4-29.}}}{
  The substation effects between dietary supplements and non-dietary supplement products are also limited.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i id.}{
 at 4-30 to 4-31.  Dietary supplements are imperfect substitutes for conventional or fortified foods because consumers cannot receive all daily needed nutrients solely from dietary supplements.  }{\i Id.}{
 at 4-30.  Further, dietary supplements are imperfect substitutes for conventional medical care because only a tiny percentage of consumers rely completely on dietary supplements for medical care.  }{\i Id. }{at 4-31.}}}{
\par \tab Dietary supplement sales have been growing rapidly.  In 2002 (the most recent year for which figures are available), retail sales of dietary supplements were $18 billion, up 4% from 2001}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ National Nutritional Foods Association, }{\i Industry Facts}{ (2002) (}{\i citing}{ N}{\scaps 
utritional}{ B}{\scaps usiness}{ J}{\scaps ournal}{), }{\i available at}{ http://www.nnfa.org/news/industry/index.htm.}}}{ and up 310% from a 1997 estimate of $5.8 billion.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\scaps Economic Characterization}{, }{\i supra}{ note 4, at 5-1.}}}{
  This comprised 32% of the nutrition industry.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i 
See }{National Nutritional Foods Association, }{\i supra}{ note 38.  The nutrition industry is comprised of functional foods, supplements, natural and organic foods, and natural personal care products.  }{\i Id.}}}{  When dietary supplements are 
combined with functional foods, the total sales for 2002 were $29.8 billon comprising 67% of the nutrition industry.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  Among dietary supplements, vitamins led the way in 2002 with $6.2 billion in sales}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  Herbals were second with $4.3 billion; sports nutrition took in $1.8 billion and minerals took in $1.5 billion.  }{\i Id.}{ }}}{, an increase of 3% over 2001.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  According to a 1999 study, the average product price for a dietary supplement 
in the United States was $17.15.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ C}{\scaps enter}{ }{
\scaps for}{ E}{\scaps conomics}{ R}{\scaps esearch}{, R}{\scaps esearch}{ T}{\scaps riangle}{ I}{\scaps nstitute, Dietary Supplement Sales Information }{5-11 (Final Report 1999) [Hereinafter }{\scaps Dietary Supplement Sales Information].}}}{
\par \tab The dietary supplement industry has a market structure that encourages rapid growth.  This is because the dietary supplement market, at least in terms of manufacturing, is not highly concentrated.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Economic Characterization}{, }{\i supra}{ note 4, at 5-14.}}}{
  However, some submarkets, such as the vitamin market, are more concentrated.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i id.}{ at 5-15.}}}{  There are few dominant brands in the dietary supplement industry and barriers to entry are not high.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 5-16.}}}{  This structure is changing though as the dietary supplement 
market consolidates and as new federal and industry regulations are issued.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}}}{  This may lead to the rise of more identifiable dietary supplement brand names.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See id.}{ at 6-17.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Along with rapid growth in dietary supplement sales, the distribution channels for dietary supplements have been changing.  A 1999
 report found that the market share of natural and health food stores was growing at a rate of 55% while the market share of multilevel marketing firms was falling.}{\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\fs20\super \chftn }{\fs20  }{\i\fs20 Id.}{\fs20  at 5-11.  Multilevel marketing firms consist of \'93direct selling, party plans, relationship selling, person-to-person selli
ng, and network marketing.\'94  }{\i\fs20 Id.}}}{  Other distribution channels for dietary supplements include drugstores, mass merchandise outlets, mail order, the Internet, healthcare practioners, and specialty shops.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 5-9 to 5-13.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i C.  Dietary Supplement Use in the United States
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The uses for dietary supplements are just as varied as the types of dietary supplements available.  Some representative uses given by consumers are \'93
to improve nutrition, to make up for uses missing in the food supply, to decrease susceptibility to or severity of disease, or to increase energy or improve performance.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps U.S. Depar
tment of Health and Human Services, Use of Dietary Supplements in the United States, 1988-94}{ 1 (1999) [Hereinafter DHHS Dietary Supplement Use].}}}{   Some supplements, frequently herbals and botanicals, are also 
taken as an alternative to conventional medicine.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i 
Id.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The sports nutrition industry is an illustrative example of consumer dietary supplement use.  In 2001, the sports supplement market a
ccounted for $1.74 billion in sales.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Ohr, }{\i supra}{
 note 18, at 63 (citing N}{\scaps utritional}{ B}{\scaps usiness}{ J}{\scaps ournal)}{.  The sports supplement market includes hardcore sports beverages, sports powders, and sports pills.  }{\i Id.}{ at 63.}}}{
  More broadly, the sports nutritional functional foods market (including nutrition bars and sports and energy drinks like Gatorade) accounted for $4.3 billion in sales in 2001.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 63.}}}{  And in particular, the energy drink mar
ket (including both conventional foods and dietary supplements in liquid forms) increased 465% from 1998 to 2003, and it is predicted to grow by 210% from 2003 to 2008.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Energy}{, }{\i supra}{ note 21, at 56 (citing
 Mintel International Group, Ltd.).  Energy drinks can contain a wide array of dietary supplements or ingredients that would otherw
ise be considered dietary supplements if the product was marketed as a dietary supplement.  Examples include taruine, ginseng, carnitine, guarana, vitamins, minerals, herbs, protein and amino acids, creatine, and even hornet\rquote s saliva.  }{\i See}{
 Leslie Bonci, }{\i \'93Energy\'94 Drinks: Help, Harm or Hype?}{, }{\scaps Gatorade Sports Science Institute, 15 Sports Science Exchange 1, 2-3 (2002).}}}{
\par \tab As to the prevalence of use of dietary supplements, according to a 1999 report, \'93two out of every five people in the U.S. were taking dietary supplements between 1988 and 1994.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ DHHS Dietary Supplement Use, }{\i supra}{
 note 52, at 6.  The study targeted the U.S. population of at least two months of age.  }{\i Id.}{ at 1.}}}{  Among these users, females were more likely to use dietary supplement than males (44% compared to 35%),}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 3.}}}{ and children age one to five were among the largest user
s of dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ }{\i id.}{
 at 3-4.  Use ranged from 42% to 51%.  }{\i Id.}{ at 3.}}}{  Further, among adults age twenty and older, dietary supplement use tended to increase with age.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
 at 3-4.  Females age fifty and older had the highest percentage of dietary supplement use at over 55%.  }{\i See id.}{ at 4.}}}{  Educational level and total family income were both positively related to dietary supplement use,}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 4.}}}{ and among regions of the countr
y, people in the West were more likely (by at 10% margin) to take dietary supplements than people in any other region of the country.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  As to the amount of dietary supplements taken, just over two-thirds of dietary supplements users took only one supplement and of those single users, 46% took a
 vitamin or mineral combination product.}{\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\fs20\super \chftn }{\fs20  }{\i\fs20 Id.}{\fs20 
 at 5.  Generally, 47% of all dietary supplement users took a vitamin or mineral combination product.  }{\i\fs20 Id.}{\fs20   Other heavily used supplements included \'93
lecithin, garlic, ginseng, fiber, amino acids, protein drinks, and other performance-enhancing or body-building formulas.\'94  }{\i\fs20 Id.}{\fs20  at 7.}}}{  Overall what can be said of this and other similar studies is that \'93
dietary supplement use is more common among older adults, women, white people, people living in the West, and those with higher incomes and levels of education.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 6.  It shoul
d be noted that this study ended just as the federal government enacted the DSHEA. The study noted that the prevalence of dietary supplement use could change with passage of the DSHEA, as more scientific evidence accumulates supporting dietary supplement 
use, and as attitudes towards alternative medicine shift.  }{\i Id.}{
 at 7.  The ability of dietary supplement labels to now carry a variety of health claims (unqualified or qualified) certainly has had an impact on the prevalence of use.  For more about dietary supplement health claims, }{\i see}{ discussion }{\i infra}{
 Part III.C.5.}}}{
\par }{\b III. UNITED STATES REGULATION OF DIETARY SUPPLEMENTS
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab With this general background on dietary supplements in mind, this section now turns to a brief review of the history of notable dietary supplemen
t regulation in the United States with a focus on the DSHEA and post-DSHEA regulation and other activity.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 This review is not meant to be comprehensive.  It focuses on notable dietary supplement statutory, regulatory, and industry activity in order to convey an accurate record of dietary supplement regulation in the United States.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i A. Pre-DSHEA Regulation
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Regulation of dietary supplements is not a new phenomenon, and the DSHEA, while the most comprehensive legislation addressin
g dietary supplements, was not the first such legislation on the subject.  The major pieces of legislation addressing dietary supplements prior to the DSHEA were the Food, Drug, and Cosmetic Act of 1938 (\'93FDCA\'94),}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U. S. C. \'a7
 301 et seq.).}}}{ the 1976 addition of section 411 to the FDCA known as the Proxmire Amendment,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 94-278, 90 Stat. 401 (1976) (codified at 21 U. S. C. \'a7 350).}}}{ and the Dietary Supplement Act of 1992 (\'93DSA\'94).}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 102-571, 106 Stat. 4491 (1992).}}}{
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 1. The FDCA}{
\par \tab The FDCA made the first legislative reference to dietary supplements.  Specifically, section 403 of the FDCA (now codified at 21 U. S. C. \'a7 343(j)) referenced food for special dietary use.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ This p
rovision provided that a food for special dietary use would be considered misbranded unless its \'93}{\cf1 
label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.\'94  }{
21 U. S. C. \'a7 343(j).  \'93Secretary,\'94 here and in all other references in the paper, refers to the Secretary of Health and Human Services.  }{\i See}{ 21 U. S. C. \'a7 321(d).}}}{  Further, dietary supplements were included in the category of food 
in section 201(f) of the FDCA (now codified at 21 U. S. C. \'a7 321(f).}{\cs18\super \chftn {\footnote \pard\plain \s21\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ This section defined food as \'93(1) articles used for food or drink for man or other animals, (2) chewing gum, and{\*\bkmkstart 321.f_3} }{\cs22\cf1 (3)}{\cs22\b\cf1  }{\cf1 {\*\bkmkend 321.f_3}
articles used for components of any such article.\'94  Dietary supplements thus would have fallen under }{21 U. S. C. \'a7 321(f)(3); however, under the FDCA
 a dietary supplement would also have been considered a food additive unless it was a substance that was Generally Recognized as Safe (\'93GRAS\'94), or it had prior sanctioned status.  }{\scaps James L. Vetter, Ph.D, Food Laws and Regulations 153 (1996).
}{  Thus, if the dietary supplement was not GRAS or did not have prior sanctioned status, it would have had to comply with the food additive provisions of the FDCA.  }{\i See}{ discussion }{\i infra}{
 Part III.B.2 on dietary supplements, GRAS, and food additive provisions under the DSHEA.}}}{
\par \tab The FDCA also included new provisions regarding drugs, and the FDA quickly utilized these provisions to sweep certain food products, including certain dietary supplements, under these more stringent drug provisions.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ I. S}{\scaps cott}{ B}{\scaps ass}{ & A}{\scaps nthony}{ L. Y}{\scaps oung}{, D}{
\scaps ietary}{ S}{\scaps upplement}{ H}{\scaps ealth}{ }{\scaps and}{ E}{\scaps ducation}{ A}{\scaps ct}{: A L}{\scaps egislative}{ H}{\scaps istory}{ }{\scaps and}{ A}{\scaps nalysis 9 (1996)}{.}}}{
  Several cases during this time hinged on the claims made on the label of such dietary supplements or the literature accompanying them.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ See }{\i id. }{at 9-11 (contains a discussion of these cases).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {In the decades following enactment of the FDCA, the FDA passed several regulations pertaining to dietary supplements.  In 1941 the FDA promulgated the fi
rst recommended daily allowance (\'93RDA\'94) regulations for vitamin and mineral supplements and other foods for special dietary use containing added vitamins or minerals.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 6 Fed. Reg. 5921-5926 (1941).  }{\i See }{\scaps Commission on Dietary Supplement Labels, 
Report of the Commission on Dietary Supplement Labels}{ (Final Report 1997) 11 [hereinafter CDSL Report].  The regulations placed no limit on the amount or type of nutrients that could be included in such supplements.  CDSL Report}{\i  supra}{.}}}{
  In 1962 the FDA published a proposed notice that \'93only those nutrients recognized by \lquote competent authorities\rquote  as essential and of significant human value could be offered for sale.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ B}{\scaps ass}{, }{\i supra}{ note 71, at 11 (citing 27 Fed. Reg. 5815, 5817 (June 20, 1962)).}}}{
  Due to heavy pressure by the dietary supplement industry, this proposal never went into effect.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 11.}}}{  New regulations concerning labeling and content of special dietary food products were proposed in 1966}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 31 Fed. Reg. 8521, 8526 (June 18, 1966).}}}{ and were promulgated in final form in 1973.}{
\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\fs20\super \chftn }{ }{\fs20 38 Fed. Reg. 20,730, 20,732 (Aug. 2, 1973).  The FDA
 proposed that all vitamin and mineral supplements bear the following disclaimer: \'93
[v]itamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements.\'94  31 Fed. Reg. 15,730-15,736 (1966); 
}{\i\fs20 see}{\fs20  CDSL Report, }{\i\fs20 supra}{\fs20  note 73, at 11.  This proposed rule
 was not included in the final rulemaking.  In addition, the final rulemaking was subject to much FDA and court revision and was finally revoked in its entirety.  }{\i\fs20 See}{\fs20  CDSL Report, }{\i\fs20 supra}{\fs20  note 73, at 12.}}}{ 
 These regulations classified most vitamins and minerals as drugs if they exceeded certain levels of potency (based on RDAs) and also limited the sale of vitamin and mineral combination products.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 38 Fed. Reg. 20,730, 20,732 (Aug. 2, 1973).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 2. The Proxmire Amendment}{
\par \tab Stemming from FDA action in the 1960s and early 1970s concerning dietary supplement vitamin and mineral potency, Congress took action in 1976.  Unsatisfied with FDA regulations regarding vitamin and mineral potency, Congress responded with the 
Proxmire Amendment.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Pub. L. No. 94-278, 90 Stat. 401 (1976) (codified at 21 U. S. C. \'a7 350).  In an eight month span in 1973 approximately seventy bills were introduced in Congress seeking to limit the FDA\rquote s regulation of vitamin and mineral potency.  B}{\scaps 
ass}{, }{\i supra}{ note 71, at 12.  The Proxmire Amendment was the final result.}}}{  The Proxmire Amendment added section 411 to the FDCA (now codified at 21 U. S. C. \'a7 350) and negated the FDA\rquote 
s 1973 regulations concerning vitamin and mineral potency.  The Proxmire Amendment prohibited the FDA from placing maximum limits of potency on vitamins or minerals within a food,}{\cs18\super \chftn {\footnote \pard\plain 
\s21\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 94-278, 90 Stat. 401 (1976) (codified at 21 U. S. C. \'a7
 350(a)(1)(A)).  For purposes of 21 U. S. C. \'a7 350, the term food means \'93}{\cf1 food for humans which is a food for special dietary use }{which is or contains any natural or synthetic vitamin or mineral, and }{\cf1 which }{
is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or }{\cf1 if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.
\'94  }{21 U. S. C. \'a7 350(c)(1) (as amended by the DSHEA).}}}{ invalidated the FDA\rquote s authority to classify a vitamin or mineral as a drug based on potency,}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 94-278, 90 Stat. 401 (1976) (codified at 21 U. S. C. \'a7 350(a)(1)(B)).}}}{ and 
permitted vitamins and minerals to be sold in many forms, including combinations, within a food.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 350(a)(1)(C)).}}}{  The effect of the Proxmire Amendment was to limit the FDA's
 authority to regulate dietary supplements, at least when they contained vitamins or minerals.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ After the Proxmire Amendment, no formal dietary supplement labeling provisions were in effect until 1994.  CDSL Report, }{\i supra}{
 note 73 at 12.  However, most dietary supplement manufactures informally followed the FDA\rquote s 1973 regulations.  }{\i Id.}{ }}}{
\par \tab After the Proxmire Amendment, the FDA mostly abandoned its efforts to regulate dietary supplements under FDCA drug provisions and instead turned to FDCA food additive provisions.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The statutory provision regarding food additives is 21 U. S. C. \'a7
 348.  Basically, the FDCA requires premarket approval for food additives that are not prior sanctioned, GRAS, or the subject of a food additive regulation.}}}{  The FDA\rquote s theory was that dietary supplements could be attacked as 
unsafe food additives.  By 1992, U.S. courts of appeal rejected this theory at least regarding non-combination dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ United States v. Two Plastic Drums
, 985 F.2d 814 (7th Cir. 1993); United States v. 29 Cartons, 987 F.2d 33 (1st Cir. 1993).  Such non-combination dietary supplements thus were considered conventional food not subject to the food additives provision.  How
ever, the FDA and some courts then took the position that dietary supplements, except vitamins and minerals with a recognized nutritional value, were not considered conventional food.  }{\i See}{
 Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983); American Health Prod. Co. v. Hayes, 744, F.2d 912 (2d Cir. 1984); B}{\scaps ass}{, }{\i supra}{ note 71, at 15.}}}{
\par }{\ul 3. The DSA
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The next major governmental action regarding dietary supplements came when Congress passed the Nutrition Labeling and Education Act of 1990 (\'93NLEA\'94
).}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Pub. L. No. 101-535, 104 Stat. 2352 (1990) (codified in scattered section of 21 U. S. C.).}}}{  The NLEA provided foods, including dietary supplements, to bear nutritional labeling.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343).}}}{  Further, the NLEA created a health claim
 approval system for the FDA including the availability of separate procedures for dietary supplement health claims.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(r); B}{\scaps ass}{, }{\i supra}{ note 71, at 15.}}}{  However, the FDA failed to implement any separate NLEA 
health claim procedures for dietary supplements except to a very limited extent.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ B}{\scaps ass}{, }{\i supra}{ note 71, at 15.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The dietary supplement provisions of the NLEA were to be implemented by the FDA through publication of proposed and final rules, but a
s the FDA carried out this implementation,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 For example, the FDA published proposed health claim regulations for dietary supplements in 1991.  56 Fed. Reg. 60,537 (Nov. 27, 1991).}}}{ Congress passed the DSA.  The DSA instituted a one-year moratorium on implementation of 
dietary supplement labeling under the NLEA with certain exceptions for health claims.}{\cs18\super  \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 102-571, \'a7 202, 106 Stat. 4491 (1992).}}}{  New proposed regulations covering dietary supplement labeling were to be issued
 by June 15, 1993 with final regulations due by the end of that year.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}}}{  While the FDA worked to comply with these dates,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The FDA issued an advance notice of proposed rulemaking concerning dietary supplement in June 1993.  58 Fed. Reg. 33,690 (June 18, 1993).}}}{
 Congress passed the DSHEA, drastically reshaping dietary supplement regulation.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i B. The Dietary Supplement Health and Education Act of 1994
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Due in part to \'93the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention\'94
 and the increasing reliance of consumers on dietary supplements,}{\cs18\super  \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 2, 108 Stat. 4325 (1994).}}}{ Congress passed the DSHEA in 1994.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified as amended in scattered sections of 21 U. S. C.).}}}{  The 
DSHEA created a new structure for regulation of dietary supplements by making dietary supplements a new category of regulation within the framework of food and apart from drugs.  This was a drastic departure from previous decades of regu
lation.  The DSHEA enacted the following main provisions: (1) definitions of dietary supplements and dietary ingredients;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 3 (codified at 21 U. S. C. \'a7\'a7 321(ff), 321(s)(6), 350(c)(1)(B)).  The DSHEA also amended the definition of drug.  }{\i Id.}{ at \'a7
 10 (codified at 21 U. S. C. \'a7 321(g)(1)).}}}{ (2) dietary supplement safety provisions;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 4 (codified at 21 U. S. C \'a7 342(f)).}}}{ (3) certain dietary supplement labeling exemptions;}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{\i  Id.}{ \'a7 5 (codified at 21 U. S. C. \'a7 343-2).}}}{ (4) statement
s of nutritional support for dietary supplements;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i 
Id.}{ \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)).}}}{ (5) dietary supplement labeling requirements;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 7 (codified at 21 U. S. C. \'a7\'a7 343(s), 343(q)(5)(F), 343(r)(2)(F), 350(b)(2)); }{\i see also}{ }{\i id.}{ at \'a7 10 (codified at 21 U. S. C. \'a7 343(s)).
}}}{ (6) regulations pertaining to new dietary ingredients;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i Id.}{ \'a7 8 (codified at 21 U. S. C. \'a7 350b).}}}{ (7) dietary supplement good manufacturing practices;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 9 (codified at 21 U. S. C. \'a7 342(g)).}}}{ (8) revocation of the FDA\rquote s advance notice of proposed rulemaking under the DSA;}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 11.}}}{ (9) establishment of a 
Commission on Dietary Supplement Labels;}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ 
\'a7 12.}}}{ and (10) establishment of the Office of Dietary Supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}{ \'a7 13 (codified at 42 U. S. C. \'a7 287c-11).}}}{
\par }{\ul 1. Dietary Supplement Definitions
\par }\pard\plain \s17\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab }{\fs24 The DSHEA defined dietary supplements as food,}{\cs18\fs24\super  \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 3 (codified at 21 U. S. C. \'a7
 321(ff)).  This definition does not apply for purposes of 21 U. S. C. \'a7321(g) (the FDCA definition of drug).  This preserved the FDA\rquote 
s ability to deem a dietary supplement a drug if the dietary supplement makes certain claims.  Certain dietary supplements can also be considered drugs under 21 U. S. C. \'a7 321(ff)(3).  Dietary suppleme
nts are excluded from the definition of drugs based on certain health or structure/function claims made on the label in compliance with other sections of the FDCA.  21 U. S. C. \'a7321(g)(1)(D).}}}{\fs24  
thus ending previous decades of controversy over whether dietary supplements should be fit into the existing food or drug frameworks.  Specifically, the DSHEA created a new category of food and then defined this category by the inclusion of the 
specific dietary ingredients of vitamins, minerals, herbs or botanicals, amino acids, any substances consumed to supplement the diet, or concentrates, metabolites, constituents, extracts, or combinations thereof.}{\cs18\fs24\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 3 (codified at 21 U. S. C. \'a7 321(ff)); }{\i see supra}{
 Part II.A for a discussion of types of dietary supplements.}}}{  }{\fs24 The DSHEA also stated that dietary supplements must be intended for ingestion in tablet, capsule, powder, soft gel, or liquid form.}{\cs18\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7\'a7 321(ff)(2)(A)(i), 350(c)(1)(B)(i)).}}}{\fs24   
Further, if the dietary supplement is not intended for ingestion in such form, it must not be represented as conventional food and must not be represented as meal replacement.}{\cs18\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7\'a7 321(ff)(2)(A)(ii), 350(c)(1)(B)(ii)).}}}{\fs24   
Further, the dietary supplement, no matter the form, must not be represented for use as conventional food and must not be represented as meal replacement.}{\cs18\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 321(ff)(2)(B)).}}}{\fs24   Additionally all 
dietary supplements must be labeled as a dietary supplement.}{\cs18\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 321(ff)(2)(C)).}}}{\fs24   
\par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab 
The significance of the new definitions for dietary supplements cannot be understated.  These provisions mean that dietary supplements, like all o
ther foods, are classified based on the intended use of such products as demonstrated by label claims, advertising, or product statements.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ D}{\scaps entali}{, }{\i supra note}{ 13, at 89.}}}{
  Even though the DSHEA specifies certain types of dietary supplements and the forms such supplements must take, the DSHEA allows dietary supplements to be sold in conventional food form so long as they are not represented as conventional food or
 as meal replacement and so long as they are labeled as dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ 21 U. S. C. \'a7\'a7 321(ff)(2)(B)-(C), 350(c)(1)(B)(ii).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {The DSHEA also took the monumental step of excluding dietary supplements and dietary ingredients intended for use in dietary supplements from the definition of food additives,}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 321(s)(6)).}}}{
 thus clearing up decades of controversy on that subject.
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The exclusion of dietary supplements from the FDCA food additive provisions also 
cannot be understated.  Because dietary supplements are now excluded from the FDCA food additive provisions, dietary supplements cannot be deemed adulterated under food additive provisions of the FDCA.  All dietary supplements thus bypass the nee
d to receive specific approval from the FDA for use as food additives.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ Food additive provisions of the FDCA are codified at 21 U. S. C. \'a7 342.  New dietary ingredients, however, must be approved by the FDA otherwise the dietary supplement will be considered adulterated.  }{\i See}{ discussion }{\i 
infra}{ Part III.B.6.  As to the food additive provisions, the process avoided is an onerous one.  A brief
 account of the food additive process is as follows: the dietary supplement manufacturer must (1) file a food additive petition, (2) conduct scientific data review regarding the food additive, and (3) fulfill criteria of the FDA.  }{\scaps G
eorge A. Burdock, }{\i The GRAS Process}{,}{\scaps  Food Technology}{
, May 2003, at 17.  The FDA must then (1) issue a proposed rule regarding the food additive petition for notice and comment and (2) issue a final rule regarding the food additive petition in the Federal Register.  }{\scaps Burdock}{, }{\i supra}{.}}}{
  Dietary supplements also bypass the need to be Generally Recognized as Safe (\'93GRAS\'94) by the FDA or the food industry.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Food additives must either be GRAS or have prior sanctioned status by the FDA from before 1958, otherwise such ingredients are considered food additives and subject to food additive provisions.  }{\i See}{
 Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (1958) (codified at 21 U. S. C. \'a7\'a7
 342(a)(2)(C), 348, 321(s)).  To have prior sanctioned status, the food ingredient could not have been a drug or herbal remedy and must have been used by a significant number of people before 1958.  }{\scaps Burdock, }{\i supra }{
note 115.  If a food ingredient is GRAS for its intended use, then it may be used without seeking specific approval from the FDA.  However, for an ingredient to be GRAS, it must have been found safe through a series of scientific tests and informatio
n.  Specifically, for a substance to be GRAS
\par }\pard \s17\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\'93
there must be reasonable certainty in the minds of scientist that is it not harmful under its conditions of intended use; the data and information to establish this conclusion must be publicly available; and th
ere must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use.\'94
\par }\pard \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\scaps Anthony A. Anscombe, }{\i Regulating Botanicals in Food}{,}{\scaps  Food Technology}{, Jan. 2003, at 18.  This procedure is, like the foo
d additive procedures, an onerous one.  The basic framework is as follows: the dietary supplement manufacturer must (1) have a well prepared and researched substance, (2) have a technical use and purpose for the substance, (3) have documentation regarding
 
to what the substance is to be added and at what levels, (4) review the published literature and data concerning the substance, (5) develop any needed data, (6) compile all of this information and data into a GRAS monograph, (7) have the GRAS monograph re
viewed by an independent expert panel which must produce a consensus statement regarding the GRAS status of the substance, and (8) optionally notify the FDA.  }{\scaps James T. Heimbach, }{\i GRAS Determination: A Short Guide}{,}{\scaps  Prepared Foods}{
, Jan. 2003, 123, 123-129.}}}{  And notably, by virtue of being excluded from the definition of food additives, dietary supplements do not have to comply with the DeLaney Clause prohibiting the FDA from approving food additives that have been \'93}{\cf1 
found to induce cancer when ingested by man or animal.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ 21 U. S. C. \'a7 348(c)(3)(A).  Dietary supplements containing color additives must still comply with the DeLaney Clause.  21 U. S. C. \'a7 379e(b)(5)(B)(i).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The new dietary supplement definition and the exclusion of dietary supplements from food additive provisions mean that the manner in which a product
\rquote s intended use (conventional food versus dietary supplement) has an enormous impact on the regulatory process.  For example, the DSHEA, under the new dietary
 supplement provisions, grandfathered in many botanicals that do not have to undergo a new dietary ingredient procedure.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 8 (codified at 21 U. S. C. \'a7 350b); D}{\scaps entali}{, }{\i supra note}{ 13, at 92.}}}{
  These botanicals thus may be used in dietary supplements without regulatory hassle; however, many of these same botanicals were not grandfathered in by the Food Additives Amendment of 1958 and thus would either have to be GRAS or undergo the onerous 
food additive approval process.  Thus, a company wishing to introduce such a botanical could save significant time and money by introducing the botanical as a dietary supplement rather than a conventional food or ingredient in a conventional food.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ This is par
ticularly true because botanicals have not generally undergone large scale safety studies or accumulated other relevant scientific data which would be useful fro GRAS determination of the food additive approval process.  }{\scaps Anscombe}{, }{\i supra}{
 note 116, at 17.}}}{  However, dietary supplement procedures are not always the easier approach.  For example, McNeil Consumer Healthcare sought to introduce Benecol, 
a canola oil margarine substance that contains cholesterol-lowering herbals or botanicals (specifically sitostanol esters), into the U.S. market as a dietary supplement.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ D}{\scaps entali}{, }{\i supra note}{ 13, at 92.}}}{
  McNeil figured this would present the lowest regulatory hurdles; however, the FDA rejected Benecol as a dietary supplement.}{\cs18\super  \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  The chief reason for rejection was that Benecol was represented as a conventional food.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 The statement of identity listed Benecol as a butter or margarine replacement that would help manage cholesterol levels naturally through food consumption.  }{\i Id.}}}{
  The FDA further held that the sitostanol esters were unapproved food additives and not GRAS, though McNeil was able to later demonstrate GRAS status and Benecol was approved as a conventional food.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  As an additional example, The Hain Foods Group, I
nc., tried to introduce a line of soups containing Echinacea and St. John\rquote s Wart as dietary supplements.  }{\i Id.  }{The FDA rejected this use stating that labeling which contained the word \'93soup,\'94
 pictures of soup, and references to conventional foods found in soup served to represent the product as conventional food.  }{\i Id.}{  Further, the FDA stated that both Echinacea and St. John\rquote 
s Wart were unapproved food additives that had yet to be demonstrated GRAS.  }{\i Id.}}}{
\par An additional example demonstrates the malleability of the dietary supplement/conventional food distinction.  The FDA and the Herbal Products Association have recently been in disagreement over whether juice beverages
 including herbal ingredients may be represented as dietary supplements.  In 2000 and 2001 the FDA sent warning letters to several juice manufactures alleging that the presence of certain herbal ingredients in their jui
ce beverages constituted adulteration.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
 at 94.}}}{  These juice beverages were marketed as conventional foods and thus the FDA treated the herbal ingredients in the beverages as unapproved food additives.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  The FDA did acknowledge, however, that dietary supplements could be marketed
 in beverage form similar to conventional food so long as the labeling was accurate and the dietary supplement was not represented for use as conventional food.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  Thus, the FDA has allowed c
alcium based dietary supplements to be sold as confectionary \'93chews.\'94  }{\i Id.}{  In general though, the FDA is of the opinion that standardized food beverage names and terms like \'93spring water,\'94 \'93orange juice,\'94 \'93drink\'94 or \'93
beverage\'94 cannot appear on the label of a dietary supplement.  }{\i Id.}{ }}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 2. Dietary Supplement Safety
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Because under the DSHEA dietary supplements are considered food not subject to food additive provisions, dietary supplements
 are generally considered safe under the FDCA unless proven otherwise by the FDA.  To prove that a conventional food is unsafe, the FDA must follow the statutory adulteration provisions.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342.}}}{  However, t
he DSHEA created new standards by which to judge dietary supplement safety.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7 342(f)).}}}{  Under the DSHEA, a dietary supplement (or any food containing a dietary ingredient) is deemed adulterated if any one of four conditions is met.  First, a dieta
ry supplement is deemed adulterated if it \'93presents a significant or unreasonable ri{\*\bkmkstart 342.f_1_A_i}sk of illness or injury under \endash  (i) {\*\bkmkend 342.f_1_A_i}conditions of use recommended or suggested in labeling, or 
{\*\bkmkstart 342.f_1_A_ii}(ii) {\*\bkmkend 342.f_1_A_ii}if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(f)(1)(A).}}}{  Second, a dietary supplement is deemed adulterated if it \'93}
{\cf1 is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(f)(1)(B).}}}{\cf1   Third, a dietary supplement is deemed adulterated if it 
\'93pose[s] an imminent hazard to public health or safety.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ 21 U. S. C. \'a7 342(f)(1)(C).}}}{\cf1   Finally, a dietary supplement is deemed adulterated if it meets a conventional food adulteration standard in the FDCA \'93
under the conditions of use recommended or suggested in the labeling of such dietary supplement.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(f)(1)(D).  Specifically, the dietary supplement must meet the adulteration standard under 21 U. S. C. \'a7
 342(a)(1).  Section 342(a)(1) states that a food is deemed adulterated \'93[}{\cf1 i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in
 case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.\'94}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\cf1 \tab The DSHEA exemption of dietary supplements from all but one conventional food adulteration standard in the FDCA was a monumental change.  Bef
ore the DSHEA, dietary supplements and dietary ingredients were held to all the conventional food adulteration standards under 21 U. S. C. \'a7 342.  This meant that before the DSHEA, a dietary supplement was deemed adulterated if
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 (1) it bore or contained \'93any poisonous or deleterious substance which . . . [could have] render[ed] it injurious to health,\'94}{\cs18\cf1\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(a)(1).  For a more detailed
 discussion of previous adulteration standards for dietary supplements }{\i see}{ B}{\scaps ass}{, }{\i supra}{ note 71, at 43.}}}{\cf1  
\par (2) in the case of a dietary supplement that contained no added substances (that is, it was not considered a combination product or it contained only naturally occurring ingredients), if the amount of such substance was considered unsafe
 within the meaning of other statutory language,}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 21 U. S. C. \'a7\'a7 342(a)(2)(A), 346.}}}{\cf1  
\par (3) it bore or contained a \'93pesticide chemical residue that [wa]s unsafe\'94 within the meaning of other statutory language}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7\'a7 342(a)(2)(B), 346a(a).}}}{\cf1  
\par (4) it bore or contained a food additive that was unsafe within the meaning of the Food Additive Amendment of 1958,}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7\'a7 342(a)(2)(C), 348.}}}{\cf1  
\par (5) its composition or packaging met certain filth standards,}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ 21 U. S. C. \'a7 342(a)(3)-(a)(4).}}}{\cf1  
\par (6) it was the product of a diseased animal or of an animal that had died other than by slaughter,}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(a)(5).}}}{\cf1  
\par (7) its container included \'93any poisonous or deleterious substance which . . . [could have] render[ed] the contents injurious to health,\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(a)(6).}}}{\cf1 
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 (8) it had been intentionally exposed to radiation not approved by other statutory language,}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7\'a7 342(a)(7), 348.}}}{\cf1  
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 (9) it had been adulterated in an economic sense,}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(b).}}}{\cf1 
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 (10) it bore or contained a color additive deemed unsafe under other statutory language,}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7\'a7 342(c), 379e(a).}}}{\cf1  or
\par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 (11) it met certain special confectionary or oleomargarine adulteration provisions.}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 342(d)-(e).}}}{\cf1 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\cf1 But after the DSHEA, all of these provisions (save for those listed in (1) and (2) above) were wiped clean and replaced with more limited provisions.}{
\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Even though the adulteration provisions under 21 U. S. C. \'a7 342(a)(1) are applied to dietary supplements, they have been narrowed for dietary supplements by 21 U. S. C. \'a7 342(f)(1)(D) too look only at recommended or suggested conditions of use.}}}{
\cf1   Combined with the exclusion of dietary supplements from food additive provisions, the dietary supplement industry faced vastly fewer regulatory hurdles than faced with conventional food.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\cf1 \tab The DSHEA went even further in its revisions of dietary supplement safety by placing the burden
 of proof on the government to demonstrate that a dietary supplement is adulterated.}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7 342(f)(1)).}}}{\cf1   No longer did
 dietary supplement manufactures have to prove that a supplement was safe, rather the FDA had to prove the dietary supplement unsafe.  This brought dietary supplement safety enforcement in line with the conventional food
s, which are presumed to be safe unless the FDA proves otherwise, rather than drugs, which must be proven by manufacturers to be safe and efficacious
.  Further, the DSHEA laid out certain legal procedures that were to be followed concerning dietary supplement safety enforcement, in effect removing some FDA power over administrative review of dietary supplements.}{\cs18\cf1\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Specifically, when in court on any issue under 21 U. S. C. \'a7
 342(f)(1), such issue is to be decided de novo by the court rather than by deferring to FDA interpretation.  }{\i Id.}{  Additionally, before the government takes  action in the form of a civil proceeding concerning dietary supplements under 21 U. S. C. 
\'a7 342(f)(1)(A), the adverse party must receive proper notice and an opportunity to be heard.  21 U. S. C. \'a7 342(f)(2).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 3. Dietary Supplement Labeling Exemptions
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The DSHEA made clear what did and did not constitute labeling for a dietary supplement.  Under the DSHEA,
\par }\pard \ql \li0\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab [a] publication, including an article, a chapter in a book, or an official abstract of a
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin720\itap0 {peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, 
which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary
\par }\pard \ql \fi720\li0\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin0\itap0 {supplement to consumers when it--
\par }\pard \ql \fi720\li0\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin0\itap0 {(1) is not false or misleading;
\par (2) does not promote a particular manufacturer or brand of a dietary supplement;
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin720\itap0 {(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a 
balanced view of the available scientific information on a dietary supplement;
\par (4) if displayed in an establishment, is physically separate from the dietary supplements; and
\par (5) does not have appended to it any information by sticker or any other method.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 5 (codified at 21 U. S. C. \'a7 343-2(a)).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {This section cleared up years of prior FDA regulations regarding which types of publications carried in stores selling dietary supplements could be considered labeling under the FDCA an
d thus subject to labeling regulation.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Specifically, 21 U. S. C. \'a7 321(m) states that \'93[t]he term \lquote labeling\rquote  means all labels and other written, printed, or graphic matter{\*\bkmkstart 321.m_1} }{\cs22\cf1 (1)}{\cs22\b\cf1  }{\cf1 {\*\bkmkend 321.m_1}
upon any article or any of its containers or wrappers, or{\*\bkmkstart 321.m_2} }{\cs22\cf1 (2)}{\cs22\b\cf1  }{\cf1 {\*\bkmkend 321.m_2}accompanying such article.\'94  If the term \'93labeling\'94 applies than the labeling sections of the FDA apply.  }{
\i\cf1 See, e.g.,}{\cf1  21 U. S. C. \'a7\'a7 343, 350.  The FDA had used 21 U. S. C.}{ \'a7 321(m) }{\cf1 
and accompanying labeling provisions of the FDCA to restrict books and other publications sold in stores also selling dietary supplements.  For a discussion of this prior FDA activity, }{\i\cf1 see}{\cf1  }{B}{\scaps ass}{, }{\i supra}{
 note 71, at 49-50.  Briefly, in the decades before the DSHEA, courts, including the U.S. Supreme Court, had upheld the FDA\rquote s broad reading of what constituted labeling under 21 U. S. C. \'a7 321(m).  B}{\scaps ass}{, }{\i supra}{ note 71, at 49.}}
}{  Specifically, this section limited the FDA\rquote s ability to regulate books and other publications as dietary supplement labeling by defining the exact conditions needed to avoid being considered labeling.  In addition, 
the DSHEA made clear the right of a retailer or wholesaler of dietary supplements to sell books or other publications as part of their business regardless of the new DSHEA labeling exemptions.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 5 (codified at 21 U. S. C. \'a7 343-2(b)).}}}{  Finally, the DSHEA p
ut the burden of proof on the government concerning any proceeding brought under the new DSHEA labeling exemptions.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343-2(c)).}}}{  Thus, 
as with the exclusion of dietary supplements from food additive provisions, definition as drugs, and many of the conventional food adulteration provisions, the trend of relaxed dietary supplement regulation continued in this section.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 4. Statements of Nutritional Support
\par }{\tab The DSHEA took the significant step of allowing dietary supplement labeling and packaging to contain certain statements of nutritional support unavailable to conventional foods by expanding the realm of such statements.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 This modifies the NLEA amendments, Pub. L. No. 101-535, 104, Stat. 2352 (1990) (codified as amended at 21 U. S. C. \'a7 343(r)), to the FDCA for dietary supplements.}}}{  Specifically, the DSHEA allowed a statement of nutritional support on the label of 
dietary supplements without the dietary supplement being deemed misbranded if
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\faauto\rin0\lin720\itap0 {the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such 
disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the document
ed mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)(A)).}}}{
\par }\pard \ql \li720\ri0\widctlpar\faauto\rin0\lin720\itap0 {
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {Thus dietary supplements could make classical nutrient deficiency disease statements, claims about structure or function, and general well-being statements (together referred to as 
statements of nutritional support or structure/function claims).  Even before the DSHEA, structure/function claims for nutrients in conventional foods were excluded from the definition of a drug.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7 321(g)(1)(C).}}}{  Such claims could be made without notifying the FDA
 and without being deemed drug claims if they \'93concerned a non-disease-related effect on the structure or function of the body and the claimed effect derived from a food attribute, such as nutritive value.\'94}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 65 Fed. Reg. 999, 1001 (Jan. 6, 2000).  The FDA allowed, and still allows, traditional structure/function claims (such as \'93calcium builds strong bones\'94) to be made for conventional foods.  B}{\scaps ass}{, }{\i supra}{ note 71, at 56.}}}{
  If the claims linked a nutrient to a disease or a health-related condition (so called \'93health claims\'94 rather than structure/function claims), these were also allowed before the DSHEA but required authorization by specific FDA regulation.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 U. S. C. \'a7
 343(r)(1)(B), (r)(3), (r)(5)(D).  For a more detailed discussion of pre-DSHEA regulation of structure/function claims and other health related claims, }{\i see}{ B}{\scaps ass}{, }{\i supra}{ note
 71, at 56-58.  After passage of the Food and Drug Administration Modernization Act of 1997 (\'93FDAMA\'94), Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified at 21 U. S. C. \'a7
 343(r)), such health claims, if based on an authoritative statement, could also be made without pre-authorization by the FDA .}}}{\b  }{ What the DSHEA accomplished was to provide expanded safe harbor from drug provision for 
statements of nutritional support made on dietary supplements concerning nutrients and}{\i  }{dietary ingredients.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Premarket approval is not permitted nor can it be required for such claims.  The Statement of Agreement to the DSHEA specifically confirms this.  140 }{\scaps Cong. Rec. }{
H11179 (daily ed. Oct. 6, 1999).   However, while
 the DSHEA provision do not require premarket approval nutrient content claims, the FDA must be notified within thirty days of marketing a dietary supplement making a claim under this provision.  21 U. S. C. \'a7
 343(r)(6)(C).  This is a significant departure from traditional claims for drugs, all of which must receive prior approval from the FDA.  }{\i See}{ 21 U. S. C. \'a7 355.}}}{  The DSHEA also ensured that complying with 
these statements of nutritional support provisions would not lead to a dietary supplement being deemed a drug.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 10 (codified at 21 U. S. C. \'a7 321(g)(1)(D)).  This amended the definition of drug under the FDCA.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {The DSHEA also required that a manufacturer of a dietary supplement containing a statement of nutritional support on its label must have \'93}{\cf1 
substantiation that such statement is truthful and not misleading.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}{ \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)(B)).}}}{\cf1   And the DSHEA further required that the label contain the following disclaimer: 
''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.''}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(r)(6)(C)).}}}{\cf1   Finally, the DSHEA made
 clear that a dietary supplement shall not \'93claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  This serves as a line of demarcation between dietary supplements and drugs and their respective claims.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 5. Dietary Supplement Labeling
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The DSHEA enacted significant changes to dietary supplement labeling.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ All dietary supplement labels were required to meet these spe
cifications after December 31, 1996.  }{\i Id.}{ \'a7 7.}}}{  First, the label of a dietary supplement must list the name of each ingredient and the quantity of such ingredient.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{(codified at 21 U. S. C. \'a7
 343(s)(2)).  If the dietary supplement contains a proprietary blend of ingredients, then the label need only list the total quantity of all ingredients in the blend.  }{\i Id. }{(codified at 21 U. S. C. \'a7
 343(s)(2)(A)(ii)(II)).  If the dietary supplement contains an herbal or botanical, then the label must identity \'93}{\cf1 any part of the plant from which the ingredient is derived.\'94  }{\i\cf1 Id.}{\cf1  (codified at 21 U. S. C. }{\'a7 343(s)(2)(C)).
}}}{  Second, the label must bear the term \'93dietary supplement.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(s)(2)(B)).  The term \'93dietary supplement\'94 may be modified by the name of an included ingredient.  }{\i Id.}}}{  Finally, if the dietary supplement is \'93
covered by the specifications of an official compendium,\'94 it must meet these specifications if the dietary supplement represents that it conforms to such specifications.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7
 343(s)(2)(D)).  The U.S. Pharmacopoeia is an example of an official compendium.}}}{  If the dietary supplement is not covered by an official compendium, it must contain the identity and strength that it is represented to have,}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(s)(2)(E)(ii)(I)).  }}}{
 and it must contain the quality, purity, and compositional specifications that it is represented to have.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(s)(2)(E)(ii)(II)).  }}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The DSHEA also amended the FDCA (as amended by the NLEA) nutritional labeling and content claims for dietary supplements.  Dietary supplements must 
include nutrition information \'93in a manner which is appropriate for the product.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(q)(5)(F)).}}}{  Specifically, ingredients present in a dietary supplement in a s
ignificant amount and for which there is a recommendation for daily consumption (a recommended daily intake (\'93RDI\'94) or daily reference value (\'93DRV\'94)) must be listed first on the nutrition label.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7
 343(q)(5)(F)(i)).  If such an ingredient is not present in a significant amount, it need not be listed.  }{\i Id.}{
  This is also a change from FDA regulations for conventional food which require foods to list certain nutrition information ingredients regardless of their presence in the food.  21 U. S. C. \'a7 343(q)(1)(D); 21 C. F. R. \'a7 101
.9.  As to what constitutes a \'93significant amount\'94 for dietary supplement nutritional label listing, }{\i see}{ 58 Fed. Reg. 361 (Jan. 4, 1994) (implementing NLEA dietary supplement labeling).}}}{  More importantly, the DSHEA then required
 all other dietary ingredients present to be listed in the nutrition label even if they had no RDI or DRV.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 7 (codified at 21 U. S. C. \'a7 343(q)(5)(F)(i)).}}}{  Before the DSHEA, the FDA did not allow such a listing.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Specifically, such substances could not be included in the Nutrition Facts Box of the label.  21 C. F. R. \'a7 101.9(c) (1995).  Conventional foods still must adhere to this rule.}}}{
  Further, the nutritional label must include the quantity of each listed ingredient per serving.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 7 (codified at 21 U. S. C. \'a7 343(q)(5)(F)(ii)).  This section also applied to propriety blends of ingredients.  }{\i Id.}}}{  Finally, 
the nutrition label may include the source of a dietary ingredient, nutrition information must precede ingredient statements on the label, and if a dietary ingredient is listed 
with the nutrition information it need not also be listed with the statement of ingredients.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(q)(5)(F)(iii)-(iv)).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The DSHEA also made several other 
changes for dietary supplement nutrition labeling.  First, a dietary supplement label may contain percentage-level claims for which there is no RDI or DRV without being deemed misbranded.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(r)(2)(F)).}}}{  Second, the DSHEA placed
 all dietary supplements within the Proxmire Amendment\rquote 
s provision that listing dietary ingredients on the label with other conventional food ingredients will not cause a dietary supplement to be deemed misbranded so long as all ingredients are listed and proper regulations are followed.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{(codified at 21 U. S. C. \'a7 350(b)).}}}{  Finally, the DSHEA 
made clear that }{\cf1 a \'93dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{\i  Id. }{\'a710 (codified at 21 U. S. C. \'a7 343(s)).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 6. New Dietary Ingredients
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab As a tradeoff for excluding dietary supplements from the onerous food additive provisions and
 GRAS provisions of the FDCA, the DSHEA enacted specific safety provisions for substances considered new dietary ingredients.  Under the DSHEA, a new dietary ingredient is \'93}{\cf1 
a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 8 (codified at 21 U. S. C. \'a7 350b(c)).}}}{  
Thus, all dietary supplements in use before October 15, 1994 are grandfathered in and need only meet the new, limited adulteration standards for all dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 4 (codified at 21 U. S. C. \'a7 342(f)).}}}{  However, a
 dietary supplement containing a new dietary ingredient shall be deemed adulterated under these new adulteration standards for all dietary supplements unless \'93[t]
he dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food h{\*\bkmkstart 350b.a_2}as not been chemically altered.\'94}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 8 (codified at 21 U. S. C. \'a7
 350b(a)(1)).  A new use of an existing dietary supplement or an increase in the recommended dose does not make the dietary supplement new. CDSL Report, }{\i supra}{ note 73, at 20.}}}{  Thus, dietary supplements containing only 
chemically unaltered ingredients from conventional foods are excluded from the definition of new dietary ingredient.  If the above condition is not met, a dietary supplement containing a new dietary ingredient can still avoid being deemed adulterated if

\par }\pard\plain \s21\ql \li720\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 {\*\bkmkend 350b.a_2}[t]
here is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at le
ast 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articl
es, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.}{\cs18\fs24\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 8 (codified at 21 U. S. C. \'a7 350b(a)(2)).  \'93}{\cf1 T
he Secretary shall keep confidential any information provided under \'85 [this subsection] for 90 days following its receipt. After the e
xpiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.\'94  }{\i\cf1 Id.}{\cf1   For the definition of \'93
Secretary\'94 }{\i\cf1 see}{\cf1  discussion }{\i\cf1 supra}{\cf1  note 69.}}}{\fs24 
\par }\pard \s21\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\fs24 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {With this subsection, the DSHEA enacted a notification provision which manuf
actures of new dietary ingredients must follow.  This is a notifications provision only, and it does not require, as with drugs, premarket approval from the FDA.  
Further, if a dietary supplement manufacturer does not want to follow this notification provision for new dietary ingredients, the DSHEA allows such manufacturer to, in the alternative, petition the FDA for \'93}{\cf1 
issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 8 (codified at 21 U. S. C. \'a7 350b(b)).}}}{\cf1   
The Secretary must then rule on the petition within 180 days of filing.}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id.}{  Additionally, the ruling of the Secretary on the petition is considered final agency action.  }{\i Id.}}}{\cf1 
  This enables a manufacture of a supplement containing a new dietary ingredient to skip the notification provision and instead seek, as one scholar terms it, \'93an optional approval scheme.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ B}{\scaps ass}{, }{\i supra}{ note 71, at 41.  Such a provision was added to appease secto
rs of the dietary supplement industry craving \'93greater certainty regarding new dietary ingredients.\'94  }{\i Id.}}}{\cf1   Seeking (and receiving) this optional approval rather than issuing a notification would likely eliminate the possibility of 
FDA action against the new dietary ingredient once marketing began.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\cf1 \tab  As a note, the DSHEA provisions regarding
 the safety of new dietary ingredients are linked to the DSHEA provisions of safety for all dietary supplements.  Thus, like with dietary supplements in general,}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7
 342(f)(1)).  For a more detailed discussion on the interaction of the general DSHEA safety provisions for dietary supplements and those for new dietary ingredients, }{\i see }{B}{\scaps ass}{, }{\i supra}{ note 71, at 41-42.}}}{\cf1 
 with new dietary ingredients, the FDA bears the burden in proving adulteration.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\cf1 \tab Additionally, the DSHEA made it a prohibited act to introduce or deliver for introduction into interstate commerce a dietary supplement that
 is unsafe under the new dietary ingredient provisions of the DSHEA.}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 10 (codified at 21 U. S. C. \'a7 331(v)).}}}{\cf1   The enforcement of this new provision could be
 problematic because the DSHEA provisions on new dietary ingredients do not refer to unsafe dietary supplements.}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ B}{\scaps ass}{, }{\i supra}{ note 71, at 42.}}}{\cf1 
\par }{\ul 7. Dietary Supplement Good Manufacturing Practices}{
\par \tab The DSHEA granted the Secretary the ability to issue regulations covering good manufacturing practices (\'93GMPs\'94) for dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 9 (codified at 21 U. S. C. \'a7 342(g)).}}}{  
Such regulations may cover preparation, packaging and handling of dietary supplements and may include expiration date labeling.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 342(g)(1)).}}}{  Such regulations must \'93}{\cf1 be modeled after current good manufacturing practice r
egulations for food and may not impose standards for which there is no current and generally available}{\f56\cf1  }{\cf1 analytical methodology.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7
 342(g)(2)).  Further, the Secretary must follow notice and comment rulemaking for such regulations.  }{\i Id.}}}{
\par }{\ul 8.  Miscellaneous Provisions}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab Finally, the DSHEA enacted several other provisions.  First, the DSHEA rescinded the advance noti
ce of proposed rulemaking concerning dietary supplements issued by the FDA in June of 1993 to comply with the DSA.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ \'a7 11.  The specific rulemaking rescinded appeared in 58 Fed. R
eg. 33,690 (June 18, 1993).  The FDA rescinded this rulemaking in 59 Fed. Reg. 62,644 (Dec. 6, 1994).}}}{  This avoided overlap problems between the DSA and DSHEA.  Second, the DSHEA created the Commission on Dietary Supplement Labels (\'93CDSL\'94).}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 12.}}}{  The CDSL was to be 
an independent executive branch agency with seven members appointed by the President.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  The purpose of the CDSL was to issue recommendations regarding \'93the regulation of label claims and statements for dietary supplements, including the
 use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  Such recommendations were to be made in final report from within two years from enactment of the DSHEA.  }{\i Id.}{  Fu
rther, the FDA was to act on such recommendations within ninety days of issuance of the final report and complete rulemaking within two years of issuance of the final report.  }{\i Id.}}}{  Finally, the DSHEA created the Office of Dietary Supplements (
\'93ODS\'94) to be placed within the National Institutes of Health.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\i Id. }{\'a7 13.}}}{  The purpose of the ODS was to conduct, coordinate, and assemble research regarding dietary supplements and to serve as the principal dietary supplement advisor to the Secretary.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i C. FDA Activity Regarding Dietary Supplements Post-DSHEA}{
\par \tab While the DSHEA enacted a significant and detailed new framework for dietary supplements, the DSHEA left it to the Secretary, through the FDA, to implement and flesh out this new framework.}{\cs18\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\fs20 This was made all the more important by the fact that little
 legislative history was adopted as part of the DSHEA.  Specifically, the Statement of Agreement passed by the House and the Senate read: \'93This statement comprises the entire legislative history for the Dietary Supplement Health and Education Act of 19
94, S.784.  It is the intent of the chief sponsors of the bill \'85 that no other reports or statements be considered as legislative history for the bill.\'94  140 }{\scaps\fs20 Cong. Rec. }{\fs20 
H11179 (daily ed. Oct. 6, 1999).  The Statement of Agreement went on to list only five short, limited points to include in the legislative history.  }{\i\fs20 Id.}}}{  The sections below explore notable details, successes, and failures of the FDA\rquote 
s implementation of the DSHEA.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 1. Dietary Supplement Labeling and Labeling Exemptions
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab The DSHEA enacted several new provisions concerning dietary supplement labeling,}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7\'a7 3 (codified at 21 U. S. C. \'a7 343-2), 7 (codified at 21 U. S. C. 
\'a7\'a7 343(s), 343(q)(5)(F), 343(r)(2)(F), 350(b)(2)); 10 (codified at 21 U. S. C. \'a7 343(s)), 12.  }{\i See}{ discussion }{\i supra}{ Part.III.B.}}}{ but it left most of the work to be done by FDA implementation.  Specifically, the CDSL was to firs
t issue a final report on dietary supplement labeling on which the FDA was then to act.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 12.}}}{  The CDSL issued its final report on November 27, 1997.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ CDSL Report, }{\i supra}{ note 73.}}}{  The CDSL final report 
covered recommendations on safety, label statements, health claims, substantiation of claims, and botanical supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  As to the labeling exemptions under the DSHEA, the CDSL final report offered guidance that the FDA undertake \'93proactive monitoring of practice in this
 area . . . as resources permit and that regulatory guidance be developed if necessary.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at xi.}}}{  The CDSL final r
eport specified that providing balanced, truthful information to consumers was the primary goal and as such the exemption should be used with care and its requirement be strictly observed.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
 at 47.  For recent FDA activity regarding such third party labeling and food products including dietary supplements, }{\i see}{ Letter from Margaret M.
 Dotzel, Associate Commission for Policy, Center for Food Safety and Applied Nutrition, Food and Drug Administration, to Daniel J. Popeo\line  & Paul D. Kamenar, Washington Legal Foundation (Nov. 1, 2001), }{\i available at}{ 
http://www.cfsan.fda.gov/~dms/labwww.html.}}}{  As to specific labeling, the CDSL simply stated that \'93[t]he Commission supports the informative label format mandated by DSHEA and urges orderly implementation of appropriate regulations.\'94}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ CDSL Report, }{\i supra}{
 note 73, at 29.  This response was partly shaped by the fact that at the time of issuance of the CDSL final report the FDA had already issued proposed and then final regulations for dietary supplement labeling regarding identity, nutr
ition, and ingredient labeling.  }{\i See }{60 Fed. Reg. 67,194-67,224 (Dec. 28, 1995); 62 Fed. Reg. 49,859-49,868 (Sep. 23, 1997).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab The FDA did not wait for the CDSL final report before issuing detailed dietary supplement labeling regulations under the DSHEA.  In 1995, the FDA issued
 proposed rules regarding the statement of identity on dietary supplement labels, specific nutrition and ingredient labeling for dietary supplements, and type-size requirements for such labels. }{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 60 Fed. Reg. 67,194 (Dec. 28, 1995).}}}{  These regulations were issued in final form in 1997,}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 62 Fed. Reg. 49,826 (Sep. 23, 1997) (codified in scattered sections of 21 C. F. R.).}}}{ and they became effective March 23, 1999.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  The regulations require that the statement of identity on a dietary supplement product label must contain the term dietary supplement.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,847 (codified at 21 C. F. R. \'a7 101.3(g)).}}}{
  This could be modified by dropping the term \'93dietary\'94 and substituting the name of the dietary supplement ingredient (such as \'93Vitamin C Supplement\'94) or including other descriptive terms (such as \'93Herbal Supplement\'94).}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,827 (codified at 21 C. F. R. \'a7 101.3(g)).}}}{
  However, generic terms (such as \'93Food Supplement\'94) are not allowed because such terms failed to identify or describe the dietary ingredient or ingredients present in the supplement.}{\cs18\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i\fs20 Id.}{  }{\fs20 The regulations also stipulated that type-
size requirements in effect for conventional foods would not be altered for dietary supplements. }{\i\fs20  Id.  }{\fs20 Thus the statement of identity for dietary supplements was required to \'93
be in a size reasonably related to the most prominent printed matter\'94 on the label.  }{\i\fs20 Id.}{\fs20  (codified at 21 C. F. R. \'a7 101.3(d)).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {The labeling regulations for dietary supplement go into much more detail (greater than can be presented here), but a cursory glance at some of the more prominent provisions
 is warranted.  The regulations require that dietary supplements list the serving size, particularly by actually using the term \'93serving size\'94 instead of an alternative term like \'93recommended use\'94 or \'93dose.\'94}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,849. (codified at 21 C. F. R. \'a7 101.36).}}}{  Also
 required is that all dietary supplement labels list the fourteen nutrients mandatory for conventional food labels unless such nutrients are absent or present in an insignificant amount.}{\cs18\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i\fs20 See id.}{\fs20  (codified at  21 C. F. R. \'a7 101.36).  The fourteen nutrients mandatory for conventional food 
labels are calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.  21 C. F. R. \'a7 101.9(c)
.  The regulations also refuse to exempt herbal and botanical dietary supplements from listing these fourteen nutrients if present in a significant amount.  62 Fed. Reg. 49,828 (Sep. 23, 1997).}}}{
  Further, for dietary supplements containing dietary ingredients that do not have an RDI or DRV, dietary supplement labels must bear a footnote stating as such,}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,826, 49,832, 49,850 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7 101.36(b)
(2)(iii)(F)).}}}{ and the label must list all such dietary ingredients under a heavy bar and after all listed dietary ingredient with an RDI or DRV.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,838, 49,851-852 (codified at 21 C. F. R. \'a7 101.36(e)(6)(ii)).}}}{  
The regulations also took the important step of requiring dietary supplement labels to include nutrition informational in a box entitled \'93Supplement Facts\'94 rather than the title \'93Nutrition Facts\'94 used on conventional foods.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{at 49,851 (codified at 21 C. F. R. \'a7
 101.36(e)(1)).  Some comments to this proposed rule argued that the title \'93Nutrition Facts\'94
 should be allowed for dietary supplement because the DSHEA used the term nutritional information for dietary supplement labels, that the information provided on the dietary supplement label was at least in par
t nutritional information, and that dietary supplements were marketed for their nutritional value.  }{\i Id.}{ at 49,837.  The FDA rejected these arguments in favor of facilitating consumer identification of dietary supplements versus conventional food.  
}{\i Id.}}}{  This serves to easily distinguish dietary supplements from conventional foods, especially when dietary supplements are sold in conventional food form.
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The FDA also promulgated an additional set of final rules in 1997 that addressed certain labeling issues.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,859 (Sep. 23, 1997) (codified in scattered sections of 21 C. F. R.).}}}{
  This regulation allows a dietary supplement containing a dietary ingredient for which there is no RDI or DRV to state the percentage level of such dietary ingredient without the need for approval from the FDA.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,867 (codified at 21 C. F. R. \'a7
 101.13(q)(3)(ii)).  The label must also list the actual amount of the dietary supplement per serving next to the percentage level claim.  }{\i Id.}{ (codified at 21. U. S. C. \'a7 101.13(q)(3)(ii)(A)).}}}{
  This is something that is not allowed on conventional food because conventional food is forbidden to list non-RDI or DRV nutrients on the nutrition label.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab While the above 1997 final rules took care of much of the details of the design and content of dietary supplement labels, the FDA proposed additional
 labeling rules in 1999.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 64 Fed. Reg. 1765 (Jan. 12, 1999).}}}{  These proposed rules stated that dietary supplements could, in addition to listing nutritional information on a per serving basis, also list such nutritional information on a per day basis.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
  Further, if the dietary supplement is recommended to be taken more than once a day, the total qualitative amount and the percent of daily value of each dietary ingredient recommended to be taken per day must appear on the label.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
  As of April 2004 the FDA has not issued a final rule on this point.
\par }{\ul 2. New Dietary Ingredients
\par }{\tab As a tradeoff for relaxing the adulteration regulations for dietary supplements and removing dietary supplements from food additive and GRAS procedures, the DSHEA enacted special safety provisions for new dietary ingredients.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 8 (codified at 21 U. S. C. \'a7 350b).  }{\i See}
{ discussion }{\i supra}{ Part III.B.6.  }}}{  Included within these new safety procedures was a provision requiring the Secretary to be notified prior to the introduction of a dietary supplement containing a new dietary ingredient.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  Specifically, a dietary supplement can 
avoid being deemed adulterated if 
\par }\pard \s17\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 [t]
here is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expecte
d to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citat
ion to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
\par }\pard \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Pub. L. No. 103-417, \'a7 8 (codified at 21 U. S. C. \'a7 350b(a)(2)).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab In 1996, the FDA issued proposed rules establishing a premarket notification procedure for new dietary ingredients.}{\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 61 Fed. Reg. 50,774 (Sep. 27, 1996).}}}{
  And in 1997 the FDA issued final rules regarding new dietary ingredient premarket notification.}{\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,886 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7 190.6).}} }{ These regulations apply only to a new dietary ingredient \'93
that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{at 49,892 (codified at 21 C. F. R. \'a7
 190.6(a)).  Premarket notification of new dietary ingredients thus applies only to new dietary ingredients described in section 413(a)(2) of the DSHEA.  }{\i See }{Pub. L. No. 103-417, \'a7 8 (codified at 350b(a)(1)).}}}{  The notification 
is to include: (1) the complete address of the manufacturer or distributor, (2) the name of the dietary supplement, (3) a description of the dietary supplement including the level at which the new 
dietary ingredient is present in the new dietary supplement, and (4) the conditions of recommend or suggested use.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,886, 49,892 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7 190.6(b)).  If there is no recommend or suggested conditions of us
e, the notification must include the ordinary conditions of use for the dietary supplement.  }{\i Id.}}}{  Further, the notification must include the history of use or other evidence demonstrating that the dietary supplement will reasonably be ex
pected to be safe for its intended use.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  Further the notification must include a signature.  }{\i Id.}}}{  The regulations also prohibit introduction of a new dietary ingredient within seventy-five days of filing of the premarket notification.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  (codified at 21 C. F. R. \'a7
 190.6(c)).  The regulations also provide for supplemental information concerning history of use and safety to be submitted after the initial notification and that the FDA will not disclose the notification submission for ninety days.  }{\i Id.}{
 (codified at 21 C. F. R. \'a7 190.6(d)-(e)).}}}{  Finally, the regulations provide that a failure of the FDA to respond to the notification, while not baring introduction of the dietary supplement, does not constitute approval by the FDA.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  (codified at 21 C. F. R. \'a7 190
.6(f)).  As of September 10, 2001 the FDA had received and acted on over ninety-six notifications.  }{\scaps Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 
New Dietary Ingredients in Dietary Supplements}{ (Sep. 10, 2001), }{\i at}{ http://www.cfsan.fda.gov/~dms/ds-ingrd.html. Most notifications were filed without comment by the FDA.  }{\i Id.}}}{  This reinforces the point that the DSHEA merely created a 
premarket notification procedure for new dietary supplements and not a premarket approval procedure as with drugs.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 3. Nutrient Content Claims
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab }{\f0\fs24 A nutrient content claim is one that describes the level of a nutrient in a conventional food or dietary supplement by using certain terms
 or compares the level of nutrients in such product to another product.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and
 Applied Nutrition, Food and Drug Administration, Claims That Can Be Made for Conventional Foods and Dietary Supplements (}{Sep. 2003), }{\i available at}{ http://www.cfsan.fda.gov/~dms/hclaims.html [hereinafter C}{\scaps laims}{].}}}{\f0\fs24   The NLEA 
allowed nutrient content claims to be made for both conventional food and dietary supplements if the FDA first promulgated a regulation regarding such a claim.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 101-535, 104, Stat. 2352 (1990) (codified as amended at 21 U. S. C. \'a7
 343(r)).  Generally the NLEA regulation process beings with a petition from a manufacturer.  21 C. F. R. \'a7 101.69.}}}{\f0\fs24   The DSHEA did not change this regulatory framework.  The first FDA action post-DSHEA concer
ning nutrient content claims for dietary supplements came in 1995.  In that year, the FDA published proposed rules for certain nutrient content claims for both conventional food and dietary supplements.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 60 Fed. Reg. 67,176 (Dec. 28, 1995).}}}{\f0\fs24   Then in 1997, the FDA promulgated final 
version of these rules.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 62 Fed. Reg. 49,859 (Sep. 23, 1997) (codified in scattered sections of 21 C. F. R.); 62 Fed. Reg. 49,868 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7\'a7 101.54, 101.50).}}}{\f0\fs24   These final rules specify several terms that can be used
 to describe the nutrient content in dietary supplements.  First, while dietary supplements can list nutrition information for nutrients that have no RDI and DRV, the regulations make clear \'93that the use of defined nutrient content claims, such as 
\lquote more\rquote  and \lquote high,\rquote  remains limited, for both conventional foods and dietary supplements, to those dietary ingredients that have RDI's or DRV's.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 62 Fed. Reg. 49,859, 49,861 (Sep. 23, 1997).  However, percentage nutrient content claims for dietary ingredients with no RDI or DRV are allowed.  }{\i See }{discussion }{\i supra}{ Part III.C.1.}}}{\f0\fs24   Second, the regulations allow
 the following nutrient content terms to be used on dietary supplement labels: (1) \'93high,\'94 \'93rich in,\'94 or \'93excellent source,\'94}{\cs18\f0\fs24\super \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 \f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\f0\super \chftn }{
\f0  62 Fed. Reg. 49,859, 49,867 (codified at 21 C. F. R. \'a7 101.54(b)).  To use these terms, the dietary supplement must have \'9320 percent or more of the RDI or the DRV per reference amount customarily consumed.\'94  }{\i\f0 Id.}}}{\f0\fs24  (2) \'93
good source,\'94 \'93contains,\'94 or \'93provides,\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i Id. }{(codified at 21 C. F. R. \'a7 101.54(c)).  To use these terms, the dietary supplement must have \'9310 to 19 percent of the RDI or the DRV per reference amount customarily consumed.\'94  }{\i Id.}}}{\f0\fs24  (3) \'93more,\'94 \'93
fortified,\'94 \'93enriched,\'94 or \'93added.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i Id. }{(codified at 21 C. F. R. \'a7 101.54).}}}{\f0\fs24   Third, a separate set of regulations issued the same day allow dietary supplements to use the terms \'93high potency,\'94 and \'93antioxidant.\'94}{\cs18\f0\fs24\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,868, 49,880 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7
 101.54(e)).  For a list of more approved nutrient content terms, }{\i see}{ 21 C. F. R. \'a7\'a7 101.13, 101.54, 101.56, 101.60-101.62;}{\i  }{\scaps Center for Food Safety and Applied Nutrition, Food and Drug Administration, A Food Labeling Guide}{, 
Appendix A (June 1999), }{\i available at}{ http://www.cfsan.fda.gov/~dms/flg-6a.html; }{\scaps Center for Food Safety and Applied Nutrition, Food and Drug Administration, A Food Labeling Guide, }{Appendix B (June 1999), }{\i available at}{ 
http://www.cfsan.fda.gov/~dms/flg-6b.html.  }}}{\f0\fs24   Finally, the FDA currently has issued proposed rules to amend sodium level regulations in conventional foods and dietary supplements that use the term \'93healthy.\'94}{\cs18\f0\fs24\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 68 Fed. Reg. 8163 (Feb. 20, 2003).}}}{\f0\fs24 
\par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {When the FDCA was amended by the Food and Drug Administration Modernization Act of 1997 (
\'93FDAMA\'94), it allowed nutrient content claims for conventional food and dietary supplements to be made by an additional route.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified in scattered sections of 21 U. S. C.); }{\i see}{ }{\scaps Office of Labeling, Food and Drug Administration,
 Guidance for Industry: }{\scaps Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body}{ (June 11, 1998), }{\i available at}{  http://www.cfsan.fda.gov/~dms/hclmguid.html 
[hereinafter Guidance Doc.].}}}{ Specifically, the FDAMA allowed nutrient content claims to be made without the need for an FDA regulation if based upon current, published authoritative statements from certain scientific bodies.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified at 21 U. S. C. \'a7
 343(r)).}}}{   The FDAMA specified premarket notification procedures that must be met in such a case.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ (codified at 21 U. S. C. \'a7 343(r)(2)(G)).  Specifically, a nutrient content claim may be made without an FDA regulation covering such claim if
\par }\pard\plain \s26\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cf1 (i) 
a scientific body of the United States Government with official responsibility for public health p
rotection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statemen
t, which is currently in effect, which identifies the nutrient level to which the claim refers; 
\par }\pard\plain \s25\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs28\cf1 {\*\bkmkstart 343.r_2_G_ii}(ii) }{{\*\bkmkend 343.r_2_G_ii}a person has submitted to the Se
cretary, at least 120 days . . . before the first introduction into interstate commerce of the food with a label containing the claim,}{\cf1 
\par }\pard\plain \s31\ql \li2160\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin2160\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs33\cf1 {\*\bkmkstart 343.r_2_G_ii_I}(I) }{{\*\bkmkend 343.r_2_G_ii_I}
a notice of the claim, which shall include the exact words used in the claim and shall include a concise description of the basis upon which such person relied for determining that the requirements of subclause (i) have been satisfied,}{\cf1 
\par }{\cs33\cf1 {\*\bkmkstart 343.r_2_G_ii_II}(II) }{{\*\bkmkend 343.r_2_G_ii_II}a copy of the statement referred to in subclause (i) upon which such person relied in making the claim, and}{\cf1 {\*\bkmkstart 343.r_2_G_ii_III}
\par }{\cs33\cf1 (III) }{{\*\bkmkend 343.r_2_G_ii_III}a balanced representation of the scientific literature relating to the nutrient level to which the claim refers; }{\cf1 
\par }\pard\plain \s25\ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs28\cf1 {\*\bkmkstart 343.r_2_G_iii}(iii) }{{\*\bkmkend 343.r_2_G_iii}the claim and the foo
d for which the claim is made are in compliance with [existing regulations and statutory sections concerning labeling terms, nutrient content claims, and false and misleading claims ] . . . and }{\cf1 
\par }{\cs28\cf1 {\*\bkmkstart 343.r_2_G_iv}(iv) }{{\*\bkmkend 343.r_2_G_iv}the claim is stated in a manner so that the claim is an 
accurate representation of the authoritative statement referred to in subclause (i) and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context
 of a total daily diet{\*\bkmkstart 343.0}{\*\bkmkend 343.0}.}{\cf1 
\par }\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {21 U. S. C. \'a7 343(r)(2)(G).  }}}{  
If these notification procedures are met and the FDA does not act within the specified statutory time frame, the nutrient content claim may be made.  The FDA lists only one dietary supplement nutrient content claim made under this provision \endash  a 
2001 petition concerning dietary supplements containing chlorine.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\scaps Center for Food Safety and Applied Nutrition, Food and Drug Administration. Nutrient Content Claims Notification for Chlorine Containing Foods}{ (Aug. 20, 3001), }{\i available at}{ http://www.cfsan.fda.gov/~dm
s/flcholin.html.  The FDA did not choose to act within the 120 day statutory period and thus the claim was allowed to be used.  }{\i Id.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 4. Structure/Function Claims
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Under the DSHEA, a claim is a structure/function claim if
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {the statement claims a benefit related to a classical nutrient deficiency disease and discloses the p
revalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain
 such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)(A)); }{\i see }{discussion }{\i supra}{ Part III.B.4.}}}{
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f0\fs24 The FDA allows structure/function claims to be made for conventional foods without notification so long as such statements are truthful, not misleading, and 
derive from the nutritive value of the food.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 21 U. S. C. \'a7\'a7 321(n), 343(a)(1); 62 Fed. Reg. 49,859, 49,860 (Sep. 23, 1997); C}{\scaps laims}{, }{\i supra}{ note 228.}}}{\f0\fs24   Further such structure/function claims for conventional foods must concern \'93
a non-disease-related effect on the structure or function of the body and the claimed effect derived from a food attribute.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 65 Fed. Reg. 999, 1001 (Jan. 6, 2000).}}}{\f0\fs24   The DSHEA preserved this framework but 
enlarged the scope of structure/function claims that could be made for dietary supplements without being considered drug claims.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)); }{\i see }{discussion }{\i 
supra}{ Part III.B.4.  To make such claims, the man
ufacturer of the dietary supplement must have substantiation of the claims, must include a disclaimer on the label that such claims have not been evaluated by the FDA and are not intended to treat a disease, and must notify the FDA of the claim within thi
rty days of introducing the product. Pub. L. No. 103-417, \'a7 6 (codified at 21 U. S. C. \'a7 343(r)(6)).}}}{\f0\fs24   In 1995, the FDA issued proposed regulations concerning structure/function claims for dietary supplements.}{\cs18\f0\fs24\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 60 Fed. Reg. 67,176 (Dec. 28, 1995).}}}{\f0\fs24   The 
FDA issued these regulations in final from in 1997.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ 62 Fed. Reg. 49,859 (Sep. 23, 1997) (codified in scattered sections of 21 C. F. R.).  The regulations make clear th
at a dietary supplement may follow the previous structure/function framework for conventional foods if it qualifies for the food exemption under 21 U. S. C. \'a7
 321(g)(1)(C) unless the dietary supplement contains no nutritive value (in which case it must  comply with the DSHEA procedures).  }{\i Id. }{at 49,863-864.}}}{\f0\fs24   Specifically, these regulations spell
 out the exact language of the disclaimer or disclaimers that must appear on the dietary supplement label if a structure/function claim is made and the placement and size of the disclaimer on the label.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at  49,867-868 (codified at 21 C. F. R. \'a7101.93).}}}{\f0\fs24 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab In 1996, the FDA issued proposed rules for the notification and substantiation
 procedure under the DSHEA for dietary supplements making structure/function claims.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 61 Fed. Reg. 50,771 (Sep. 27, 1996).}}}{  The FDA issued its final rule pertaining to notification and substantiation in 1997.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 49,883 (Sep. 23, 1997) (codified at 21 C. F. R. \'a7 101.93).}}}{
  This rule provides that notification must be made within thirty days of introducing the dietary supplement with the structure/function claim.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 49,886.}}}{  Further, the notification must includ
e: (1) the name and address of the manufacturer or distributor, (2) the text of the claim made, (3) the name of the dietary ingredient that is the subject of the claim, 
(4) the name of the dietary supplement, including the brand name, on which the claim appears, and (5) a signature certifying that the manufacturer or distributor has substantiation that the claims is truthful and not misleading. }{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
\par \tab In 1998, the FDA undertook the more monumental tasks of (1) defining the general types of structure/function claims that could be made on dietary supplement labels and (2) attempting to distinguish such claims from disease or health-related condition
 claims \endash  claims \'93that describe the relationship between a nutrient and a disease or health related condition.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 63 Fed. Reg. 23,624 (April 29, 1998).}}}{  The FDA issued final rules on this topic in 2000 after receiving over 235,000 comments and holding a public meeting.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 65 Fed. Reg. 1000 (Jan. 6, 2000) (codified at 21 U. S. C. \'a7
 101.93)}}}{  The final rule distinguishes general structure/function claims (which need no FDA prior approval) from disease or health-related condition claims (which need FDA authorization, or premarket notification under the FDAMA
, or else are handled as new drug claims).}{\cs18\super \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 \f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\f0\super \chftn }{
\f0  }{\i\f0 Id.}{\f0  at 1001, 1050.  The FDA noted that while it \'93believes that dietary supplements have potential benefits for consumers, dietary supplements labeled with unproven disease claims, i.e., those that have not met the requirements of
 health claim authorization or new drug approval, can pose serious risks.\'94  }{\i\f0 Id.}{\f0   For more on health claims, }{\i\f0 see}{\f0  discussion }{\i\f0 infra}{\f0  Part III.C.5.}}}{  The final rule promulgated three main provisions.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 65 Fed. Reg. 1000, 1050 (Jan. 6, 2000
) (codified at 21 C. F. R. \'a7 101.93).}}}{  First, the FDA preserved the definition of \'93disease or health-related condition\'94 in conjunction with claims made by dietary supplements.}{\cs18\super \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 \f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\f0\super \chftn }{ }{\i\f0 Id.}{\f0  at 1000.  The definition states 
\par }\pard \s30\ql \li916\ri0\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin916\itap0 {\f0 [d]isease or health-related condition means 
damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a
 state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.
\par }\pard \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 {\f0 21 C. F. R. \'a7
 101.14(a)(5).  The regulations codified this definition for dietary supplement purposes at 21 C. F. R. \'a7 101.93(g).}}}{  Second, the regulations narrowed what is considered a disease of health-related condition for dietary supplement purposes:
\par }\pard\plain \s30\ql \li922\ri0\sl360\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin922\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f0\fs24 menopause, aging, and pregnancy are not themselves diseases but . . . certain conditions associated with them are diseases if they are recognizable to consumers or health p
rofessionals as abnormal [and] . . . [c]ommon conditions associated with natural states or processes that do not cause significant or permanent harm will not be treated as diseases.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 65 Fed. Reg. 1000 (Jan. 6, 2000).  A version of the language was codified at 21 C. F. R. \'a7
 101.93(g).}}}{\f0\fs24 
\par }\pard \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 {\f0\fs24 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {Thus conditions like hot flashes, hair loss due to aging, and certain types of acne are
 not considered diseases and thus are eligible for dietary supplement structure/function claims.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 1000, 1050 (codified at 21 C. F. R. \'a7 101.93(g)).}}}{  Finally, the final rule allows dietary supplement manufacturers
 to substantiate label claims by citing (on the label) to the title of publication referring to a disease so long as, in the context of the whole label, such citation does not imply \'93that the product may be used to diagnose, treat, mitiga
te, cure, or prevent disease.\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  For a summary of structure/function regulations }{\i see}{ }{\scaps Center for Food Science and Applied Nutrition, Small Entity Compliance Guide: Structure/Function Claims}{, (Jan. 9, 2002), available at http://www.cfsan.fda.gov/~dms/sclmguid.html.}}}{

\par }{\ul 5. Health Claims}{
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f0\fs24 \tab While the DSHEA did expand the types of statements of nutritional support that could be made on dietary supplement labels without prior approval by the FDA,}{\cs18\f0\fs24\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See }{discussion }{\i supra}{ Parts III.B.4, III.C.4. }}}{
\f0\fs24  it did not include any provisions for health-related condition or disease claims (\'93health claims\'94) for dietary supplements.  This was left to other statutes and regulations.  Health claims are claims that \'93describe
 a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{.C}{\scaps laims}{, }{\i supra}{ note 228; }{\i see also}{ 21 C. F. R. \'a7 101.14.}}}{\f0\fs24 

\par 
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f0\fs24 
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f0\fs24 
\par 
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\f0\fs24 (i) The NLEA
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f0\fs24 \tab 
One way that a health claim may appear on a dietary supplement is by following provisions under the NLEA allowing for health claims upon approval by the FDA after careful review of scientific evidence.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 101-535, 104, Stat. 2352 (1990) (codified as amended at 21 U. S. C. \'a7 343(r)).}}}{
\f0\fs24  
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f0\fs24 \tab 
The DSHEA did not alter the NLEA framework regarding health claims for dietary supplements.  In 1994, before passage of the DSHEA, the FDA had issued final rules on health claims for dietary supplements.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 59 Fed. Reg. 395 (Jan. 4, 1994).}}}{\f0\fs24   These regulations stated that
 dietary supplements would be held to the same health claim standards as conventional foods.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  The NLEA had specifically exempted dietary supplement
s from these new health claim provisions for conventional foods, instead leaving it to the Secretary to promulgate regulations.  Pub. L. No. 101-535, 104 Stat. 2352 (1990) (codified at 21 U. S. C. \'a7 343(r)(5)(D)).}}}{\f0\fs24 
  Rather than enact new health claim provisions for dietary supplements, the DSHEA appointed the CDSL to issue recommendations on such health claims.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a712, 108 Stat. 4332 (1994).}}}{\f0\fs24   The FDA was
 then to timely complete final rulemaking on the CDSL recommendations or else the 1994 FDA final regulations on dietary supplement health claims would be rescinded.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{\f0\fs24   The CDSL issued its final report in 1999, specifically recommending that 
\'93[t]he process for approval of health claims as defined by the NLEA should remain the same for dietary supplements and conventional food.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ CDSL Report, }{\i supra}{ note 73, at 35.}}}{\f0\fs24   This effectively preserved the FDA\rquote 
s 1994 final regulations on health claims and dietary supplements.  Thus a dietary supplement may make a health claim by complying with the NLEA provisions regarding health claims for conventional foods.
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab 
Under the NLEA, a health claim may be made if the FDA has issued a regulation permitting such a health claim.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 101-535, 104, Stat. 2352 (1990) (codified as amended at 21 U. S. C. \'a7 343(r)(3)(A)(i)).  The Secretary may issue such a regulation 
\par }\pard \s17\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 if the food for which the claim is made does not contain, 
as determined by the Secretary by regulation, 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 t
otal daily diet.
\par }\pard \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\cf1 Id.}{\cf1  (codified as amended at }{21 U. S. C. \'a7 343(r)(3)(A)(ii)).  Generally the regulation process begins with a petition by a manufacturer.  21 C. F. R. 
\'a7\'a7 101.70.}}}{  Such regulation shall issue 
\par }\pard \ql \li720\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\cf1 only if the Secretary 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 significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 101-535, 104, Stat. 2352 (1990) (}{\cf1 codified as amended at }{21 U. S. C. \'a7
 343(r)(3)(B)).}}}{\cf1 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The key phrase in this statutory language is \'93significant scientific agreement.\'94  To help manufacturers of dietary supplements
 (as well as conventional foods) determine what the FDA considers to be \'93significant scientific agreement,\'94 in 1999 the FDA issued a guidance document.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Center for Food Safety and Applied Nutrition,
 Food and Drug Administration, Guidance for Industry \endash  Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements}{ (Dec. 22, 1999), available at http://www.cfsan.fda.gov/~dms/ssaguide.html.}}}{
  The guidance documents states that the \'93FDA's determination 
on significant scientific agreement represents the agency's best judgment as to whether qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim.\'94}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
\par This is as strict yet objective standard designed to make \'93the key determination of whether a change in the dietary intake of the substance will result in a change in a disease endpoint.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Under the NLEA and accompanying regulations, several health claims have bee
n approved for use on dietary supplement (as well as conventional food) labels.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 C. F. R. \'a7\'a7 101.72-101.83; }{\scaps Center for Food Safety and Applied Nutrition, Food and Drug Administration, A Food Labeling Guide, }{Appendix C (Nov. 2000), }{\i 
available at}{ http://www.cfsan.fda.gov/~dms/flg-6c.html [hereinafter Food Label Appendix C]; }{\i see Approved Health Claims}{, F}{\scaps ood }{T}{\scaps echnology}{, Dec. 2003, at 88-89.}}}{  These range from calcium-osteoporosi
s claims to folate-neural tube defects claims to plant stanols-coronary heart disease claims.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 21 C. F. R. \'a7\'a7 101.72-101.83;}{\scaps  }{Food Label Appendix C, }{\i supra}{ note 274; }{\i see Approved Health Claims}{, }{\i supra}{ note 274.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i (ii) The FDAMA and Health Claims Based on Authoritative Statements
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The FDAMA provided an additional means for listing health claims on the labels of conventional foods: use of a premarket
 notification system for health claims based on an authoritative statement from certain scientific bodies.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified at 21 U. S. C. \'a7 343(r)(3))
.  The FDAMA enacted the same premarket notification scheme for nutrient content claims based on authoritative statements.  For a listing of these pre-notification procedures }{\i see}{ discussion }{\i supra}{ Part III.C.3, especially note 240.}}}{  Th
us health claims may be made under the FDAMA without the need for premarket approval by the FDA.  However, the FDAMA did not enact this premarket notification system for health claims on dietary supplement labels.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See }{Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified at 21 U. S. C. \'a7
 343(r)(3)).  The FDAMA is limited to conventional foods only here.}}}{
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab }{\f0\fs24 Noting that the FDAMA had created an add
itional health claim procedure for conventional foods but not for dietary supplement, the FDA issued proposed rules in 1999 to equalize the health claim treatment of dietary supplements and conventional foods.}{\cs18\f0\fs24\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 64 Fed. Reg. 3250 (Jan. 21, 1999).}}}{\f0\fs24   The FDA stated that it \'93
believes that, for health claims, conventional foods and dietary supplements should be subject to the same standards and procedures, including the notification procedure provided by FDAMA.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 3251.}}}{\f0\fs24 
  As of April 2004, the FDA has yet to issue final rules on this subject.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The proposed rules do, however, point to a guidance document.  }{\i Id.}{ at 3252; }{\i see}{ Guidance Doc., }{\i supra}{
 note 238.  Additionally, currently three health claims based on authoritative statements are in use for conventional foods (but not dietary supplements).  }{\i See }{Food Label Appendix C, }{\i supra}{ note 274; }{\scaps 
Center for Food Safety and Applied Nutrition, Food and Drug Administration, Health Claim Notification for Whole Grain Foods with Moderate Fat Content}{ (Dec. 9, 2000), }{\i available at}{ http://www.cfsan.fda.gov/~dms/flgrain2.html; }{\i see also}{ }{\i 
Approved Health Claims}{, }{\i supra}{ note 274.}}}{\f0\fs24 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\i (iii) Qualified Health Claims
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab In 1999, a U.S. Court of A
ppeals ruled that under the commercial speech doctrine of the First Amendment, the FDA could not reject health claims for dietary supplements based on their potential to mislead unless the FDA found that no dis
claimer would eliminate such potential deception.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).  The court went on to invalidate the FDA\rquote s decision not to authorize, under the NLEA, health claims for }{\cs34\cf1 dietary fiber and cancer, antioxidant vitamins and cancer, om
ega-3 fatty acids and coronary heart disease, and folate neural tube defects.  }{\cs34\i\cf1 Id.}{\cs34\cf1 
  The FDA subsequently revoked its decision not to authorize such health claims.  65 Fed. Reg. 58,917 (Oct. 3, 2000).  In 2000 and 2001, the FDA announced its decision on these health claims in several letters and Talk Papers.  }{\cs34\i\cf1 See}{
\cs34\cf1  http://www.cfsan.fda.gov/~dms/ds-labl.html#qualified for a specific list of letters and Talk Papers (last visited April 26, 2004).}}}{
  Thus, the opinion meant that the FDA could not insist on the significant scientific standard under the NLEA as the sole means for approving health claims in dietary supplement.  Such health claims that do not meet the NLEA significant scient
ific standard are referred to by the FDA as qualified health claims.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ 68 Fed. Reg. 66,040, 66,041 (Nov. 25, 2003).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab In response to the court decision, the FDA issued a notice in 2000 delineating circumstances in which the agency might exercise enforcement discreti
on for a qualified health claim in dietary supplement labeling.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ 65 Fed. Reg. 59,855 (Oct. 6, 2000).}}}{  This notice was followed by a FDA notice in 2002 of forthcoming interim industry guidance for making qualified health claims for dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 67 Fed. Reg. 78,002 (Dec. 20, 2002).}}}{  This notice further specified that the
se interim procedures would also be applied to qualified health claims for conventional foods.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{at 78,003.}}}{  In December of 2002, the FDA also instituted \'93
the Consumer Health Information for Better Nutrition Initiative, to make available more and better information about conventional human food and human dietary supplements.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 68 Fed. Reg. 41,387 (July 11, 2003).}}}{  This initiative resulted in the issuance in 2003 of 
the promised interim procedures for health claims in dietary supplements and conventional foods.}{\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\fs20\super \chftn }{\fs20  }{\i\fs20 Id.}{\fs20   }{\scaps\fs20 Center for Food Safety and Applied Nutrition, Food and Drug Administration,
 Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements Guidance}{\fs20  (July, 2003), }{\i\fs20 available at}{\fs20  http://www.cfsan.fda.gov/~dms/hclmgui3.html [hereinafter }{\scaps\fs20 
Interim Procedures]}{\fs20 ; }{\scaps\fs20 Center for Food Safety and Applied Nutrition}{\fs20 , }{\scaps\fs20 Food and Drug Administration,}{\fs20  }{\scaps\fs20 Interim Evidence-based Ranking System for Scientific Data Guidance }{\fs20 (July 2003), }{
\i\fs20 available at}{\fs20  http://www.cfsan.fda.gov/~dms/hclmgui4.html [hereinafter }{\scaps\fs20 Interim Evidence}{\fs20 ].  Both of these guidance documents apply to qualified health claims for dietary supplements or conventional foods. }}}{  
As of April 2004, these procedures are currently in effect on an interim basis.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab The interim procedures provide that the FDA will regulate qualified health claims for dietary supplements and conventional foods \'93}{\cf1 
based on the extent to which the totality of the publicly available evidence supports the claim [and] . . . [d]ifferent levels of evidence will result in different qualifying language.\'94}{\cs18\cf1\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Interim Procedures}{, }{\i supra}{ note 287.}}}{\cf1   The interim procedures 
outline the general process for petitioning the FDA for a qualified health claim,}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
  The general petition procedure is as follows: (1) filing of the petition for review with a response from the FDA on completeness of the petition within 45 days; (2) prioritization by the FD
A concerning review of the petition; (3) a sixty day public comment period; (4) scientific review by the FDA after the close of the comment period; (5) notification of a regulatory decision by the FDA within 270 days of receipt of the petition; (6) availa
bility of reconsideration of the FDA\rquote s decision.  }{\i Id.}{
  Additionally, the substance of the petition is to comply with regulations for health claims under the significant scientific agreement standard of the NLEA; however, the petition need only demonstrate credible evidence supporting the claim.  }{\i Id.}{
  For the NLEA regulations for health claims, }{\i see }{\cf1 21 C. F. R. \'a7 101.70.}}}{\cf1  and they create an evidence-based ranking system to \'93rate the strength of the evidence behind a proposed substance/disease relationship.\'94}{
\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Interim Evidence}{, }{\i supra}{
 note 287.  A simplified version of the evidence-based system is as follows: (1) define the relationship between the
 dietary supplement or conventional food at issue and the disease at issue; (2) collect and submit all relevant studies concerning the substance/disease relationship to be tested; (3) rate each study based on its experimental design; (4) rate each study f
or overall quality; (5) rate the strength of the total body of evidence based on quantity, consistency, and relevance to disease reduction; (6) rank the strength of the evidence for a health claim; (7) report the rank.  }{\i Id.}}}{\cf1 
  The result of the evidence-based ranking system is placement of the qualified health claim in one of three categories: (1) a moderate or good level of comfort that the claimed relationship is scientifically valid,}{\cs18\cf1\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  An example of a label statement in this category is \'93}{\cf1 
although there is scientific evidence supporting the claim, the evidence is not conclusive.\'94  }{\scaps Interim Procedures}{, }{\i supra}{ note 287.}}}{\cf1  (2) a low level of comfort that the claimed relationship is scientifically valid,}{
\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Interim Evidence}{, }{\i supra}{
 note 287.  An example of a label statement in this category is \'93[}{\cf1 s]ome scientific evidence suggests . . . however, FDA has determined that this evidence is limited and not conclusive.\'94  }{\scaps Interim Procedures}{, }{\i supra}{ note 287.}}
}{\cf1  or (3) an extremely low level of comfort that the claimed relationship is scientifically valid.}{\cs18\cf1\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Interim Evidence}{, }{\i supra}{ note 287.  An example of a label statement in this category is \'93[}{\cf1 v]ery limited an
d preliminary scientific research suggests . . . FDA concludes that there is little scientific evidence supporting this claim.\'94  }{\scaps Interim Procedures}{, }{\i supra}{ note 287.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Under the current interim procedures, the FDA issues letters in response to petitions for qualified health claims.}{\cs18\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Interim Procedures}{, }{\i supra}{ note 287.}}}{  
As of April 2004, the FDA has received numerous petitions and has approved seven qualified health claims for dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Center for Food Safety and Applied Nutrition, Food and Drug Administration, Summary of Qualified Health Claims Permitted}{ (Sep. 2003), }{\i available at}{ 
http://www.cfsan.fda.gov/~dms/qhc-sum.html; }{\i Qualified Health Claims}{, F}{\scaps ood }{T}{\scaps echnology}{, Dec. 2003, at 90.  Additionally, as of April 2004, eight petitions for qualified health claims are open for comment.}}}{
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f0\fs24 \tab The FDA has issued an advance notice of proposed rulemaking (\'93ANPRM\'94) soliciting comments
 on permanent, long-term procedures for qualified health claims for dietary supplements and conventional foods.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 68 Fed. Reg. 66,040 (Nov. 25, 2003).}}}{\f0\fs24    The ANPRM listed three options under consideration: (1) incorporate, through notice a
nd comment rulemaking, the current interim standards and procedures, including the evidence-based ranking system, (2) change, through notice and comment rulemaking, the current significant scientific agreement standard for health claims under the NLEA to 
look at \'93the accuracy of the characterization of the evidence supporting the claim, instead of the underlying substance-disease relationship,\'94 
or (3) examine qualified health claims on a post-market basis wholly outside the NLEA health claims provisions.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 66,042.}}}{\f0\fs24   After an extension, the comment period for this ANPRM ended February 25, 2004.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 69 Fed. Reg. 3868 (Jan. 27, 2004).}}}{\f0\fs24 
  As of April 2004, a proposed rule had not yet issued.
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\ul 6. Good Manufacturing Practices
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab }{\f0\fs24 The DSHEA did not enact good manufacturing practices (\'93GMPs\'94) for dietary supplement but rather subjected dietary supplements to GMPs
 for conventional food with the proviso that the Secretary could issue GMPs regulations specifically for dietary supplements.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 9 (codified at 342(g)).  GMPs for conventional foods are codified at 21 C. F. R. \'a7 110.}}}{\f0\fs24   The FDA issued an ANPRM in 1997 
inviting comments regarding the need for rulemaking for minimum GMPs for dietary supplements and dietary ingredients.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 5700 (Feb. 6, 1997).}}}{\f0\fs24   Prior to the ANPRM, the FDA had received a draft proposal on dietary supplement GMPs from the dietary supplement industry.}{
\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{
 at 5700.  In 1999, the CDSL had addressed dietary supplement GMPs in its final report.  CDSL Report, }{\i supra}{ note 73.  The CDSL supported the effort of the FDA and industry to develop GMPs for dietary supplements.  }{\i Id.}{ at 2
1.  The CDSL also stated the substantiation files for statements of nutritional support regarding dietary supplement should contain \'93[a]ssurance that GMPs were followed in the manufacture of product.\'94  }{\i Id.}{ at 44.}}}{\f0\fs24   In 2003, a
fter a six year delay, the FDA finally issued proposed rules for dietary supplement GMPs.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 68 Fed. Reg. 12,157 (March 13, 2003).}}}{\f0\fs24   The purpose of the proposed rules are \'93to the ensure that manufacturing practices will not r
esult in an adulterated dietary supplement and that supplements are properly labeled.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i\fs20 Id.}{\fs20  at 12,164 (March 13, 2003).  The rules state that a \'93manufacturer of . . . a dietary supplement cannot make claims that state or imply that the . . . 
dietary supplement is safe and/or effective simply because it has been manufactured in compliance with current good manufacturing practice.\'94  }{\i\fs20 Id}{\fs20 .  However, a compliance statement might be lawful in context and with disclaimers.  }{
\i\fs20 Id.}}}{\f0\fs24   The proposed rules focus on the personnel, equipment, production and process controls, holding and distributing, consumer GMPs complaints, and recordkeeping.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{at 12,164-12,165, 12,175-12,218.}}}{\f0\fs24   After an extension, the comment period 
for the proposed rules ended August 11, 2003.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 68 Fed. Reg. 27,008 (May 19, 2003).}}}{\f0\fs24   As of April 2204, the FDA has yet to take any further action.
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\ul 7. Specific Dietary Supplements
\par }\pard\plain \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \cbpat8 
\f2\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f0\fs24 \tab Since the DSHEA, the FDA has issued several regulations concerning specific groups of dietary supplements.  In 1997, the FDA issued a final rule
 requiring label warnings on certain iron containing dietary supplements.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 2217 (Jan. 15, 1997).  Parts of this final rule were revoked in 2003 to comply with a U.S. Court of Appeals ruling.  68 Fed. Reg. 59,714 (Oct. 17, 2003); }{\i see}
{ }{\scaps Center for Food Science and Applied Nutrition, Food and Drug Administration, Iron-Containing Supplements and Drugs: Label Warning Statements \endash  Small Entity Compliance Guide}{ (Oct. 17, 2003), }{\i available at}{ 
http://www.cfsan.fda.gov/~dms/secgiro2.html.}}}{\f0\fs24   The FDA issued this final rule to prevent accidental overdose of iron-containing dietary supplements leading to poising and death in children under six years of age.}{\cs18\f0\fs24\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{62 Fed. Reg. 2217 (Jan. 15, 1997).}}}{\f0\fs24 
\par }\pard \s30\ql \li0\ri0\sl480\slmult1\widctlpar\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \cbpat8 {\f0\fs24 \tab T
he FDA recently issued a final rule deeming dietary supplements containing Ephedrine Alkaloids (popularly know as Ephedra) to be adulterated \'93because }{\f0\fs24\cf1 they present an unreasonable risk 
of illness or injury under the conditions of use recommended or suggested in }{\f0\fs24 labeling, or . . . under ordinary conditions of use.\'94}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 69 Fed. Reg. 6787, 6788 (Feb. 11, 2004).}}}{\f0\fs24   This final rule utilized the DSHEA 
provisions for dietary supplement safety.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7 342(f)).  The final rule specifically utilizes the \'93unreasonable risk\'94 standard for dietary supplements in 21 U. S. C. \'a7 342(f)(1)(A).  The final rule does not utilize the \'93
significant risk\'94 standard under 21 U. S. C. \'a7 342(f)(1)(A), the \'93imminent hazard to public health or safety\'94 standard under 21 U. S. C. \'a7 342(f)(1)(C), or the adulteration standard for conventional foods under 21 U. S. C. \'a7
 342(a)(1) as applied to dietary supplements under 21 U. S. C. \'a7 342(f)(1)(D).  Further, because Ephedrine Alkaloids were not considered new dietary ingredients, the new dietary ingredient safety provisions under 21 U. S. C. \'a7
 342(f)(1)(B) and 21 U. S. C. \'a7 350b were not applicable.}}}{\f0\fs24   The FDA had moved as early as 1997 to ban Ephedrine Alkaloids under dietary supplement safety provisions by issuing proposed rules,}{\cs18\f0\fs24\super \chftn {\footnote 
\pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 30,677 (June 4, 1997).}}}{\f0\fs24  but the FDA 
faced several difficulties, not the least of which was that under the DSHEA, the FDA had the burden of proof in banning Ephedrine Alkaloids.}{\cs18\f0\fs24\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The FDA withdrew part of its proposed rule in 2000 due
 to receipt of new adverse event reports regarding Ephedrine Alkaloids
 and then twice reopened the comment period before issuing the final rule in 2004. 65 Fed. Reg. 17,474 (April 3, 2000); 65 Fed. Reg. 46,721 (July 31, 2000); 68 Fed. Reg. 10,417 (March 5, 2003).}}}{\f0\fs24\cf1 
\par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {Finally, the FDA has recently taken action regarding weight loss
 dietary supplements.  On April 1, 2004, the FDA announced that it had recently sent warning letters to sixteen weight loss dietary supplement manufacturers.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Press Release, Food and Drug Administration, FDA Warns Distributors of Dietary Supplements Promoted Online for Weight Loss (April 1, 2004), }{\i available at}{ http://www.fda.gov/bbs/topics/news/2004/NEW01045.html [hereinafter Weight Loss Press Release].
}}}{  Such warning letters stated that insufficient substantiation under the FDA notification and substantiation regulations for dietary supplement structure/function claims.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See id.}{ For the notification and substantiation regulations, }{\i see}{ discussion }{\i 
supra}{, Parts III.B.4, III.C.4.  These warning are especially important because there is mounting evidence that weight loss dietary supplements are not actually safe and effective.  }{\i See}{ Salynn Boyles, }{\i Do Weight Loss Supplements Work?}{, }{
\scaps WebMDHealth }{(April 2, 2004), }{\i available at}{ http://my.webmd.com/content/article/85/98401.htm (last visited April 26, 2004).  For more on the FDA\rquote s regulation of weight loss dietary supplements and the improvements needed, }{\i see}{ }
{\i When Diets Turn Deadly: Consumer Safety and Weight Loss Supplements, Hearing Before Senate Subcomm. on Oversight of Gov\rquote t Mgmt., Restructuring and the Dist. of Columbia, Comm. on Gov\rquote t Affairs, }{107th Cong. (2002) [Hereinafter Hous
e Weight Loss Hearing].}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 8. Dietary Supplement Safety
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab While the DSHEA did enact new safety standards for dietary supplements,}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7 342(f)).}}}{ the FDA has not passed 
general regulations concerning such safety standards.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 Instead the FDA has passed specific regulations that impact on dietary supplement safety (such as with GMPs, Ephedra, and new dietary ingredients).}}}{  Generally, the FDA must gather data on its own or through voluntary adverse event reporting f
rom industry and then issue warning letters to manufactures.  The FDA has issued many such letters as well as taken other actions since passage of the DSHEA.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ See }{\scaps Office of the
 Inspector General, Department of Health and Human Services, Adverse Event Report for Dietary Supplements \endash  An Inadequate Safety Valve}{ Appendix B (April 2001) [hereinafter }{\scaps OIG Adverse Event Report}{
].  Recently, the FDA has taken such action with certain weight loss dietary supplements and androstendione.  Weight Loss Press Release, }{\i supra}{
 note 312; Press Release, Department of Health and Humans Services, HHS Launches Crackdown on Products Containing Andro (March 11, 2004), }{\i available at}{ http://www.fda.gov/bbs/topics/news/2004/hhs_031104.html.}}}{
  When the FDA feels it has gathered enough evidence to deem a dietary supplement unsafe, it can remove the substance from the market as it did with Ephedrine Alkaloids.  The FDA\rquote s handling of Ephedrine Alkaloids
 seems to indicate that it is content to rely on the statutory language of the DESHA for guidance and passive post-marketing surveillance systems.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See }{discussion }{\i supra}{
, Part. III.C.7, particularity note 309.  As to passive post-marketing surveillance systems, }{\i see }{discussion }{\i infra}{ Part III.E.1.  In 1999, the CDSL endorsed such an approach to dietary supplement safety.  CDSL Report, }{\i supra}{
 note 73, at vi.}}}{  However, in 1997 the FDA did issue one regulation concerning dietary supplement safety.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 62 Fed. Reg. 39,439 (July 23, 1997).}}}{  This regulation preserved the definition of \'93imminent hazard,\'94 which is one method by which a dietary supplem
ent can be deemed adulterated under the DSHEA.}{\cs18\super \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i\fs20 
Id.}{\fs20 ; }{\i\fs20 see}{\fs20  21 C. F. R. \'a7 2.5.  The DSHEA references this term in section 4 (codified at 21 U. S. C. \'a7 342(f)(1)(C).  Dietary supplement safety may also be subject to the }{\fs20\cf1 Public H
ealth Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, 116 Stat. 594 (June 12, 2002).  The FDA issued interim final rules under this Act in 2003.  }{\i\fs20\cf1 See}{\fs20\cf1  68 Fed. Reg. 58,893 (Oct. 10, 2003).}}}{
  More recently, the FDA reaffirmed its commitment to dietary supplement safety.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Press Release, Food and Drug Administration, Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement (April 19, 2004), }{
\i available at}{ http://www.fda.gov/bbs/topics/news/2004/NEW01055.html.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i D. Congressional Activity Regarding Dietary Supplements Post-DSHEA
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab While Part III.C above detailed the FDA\rquote s response to the DSHEA, this section provides a cursory view of cong
ressional activity regarding dietary supplements post-DSHEA.  Aside from the FDAMA, which is dealt with separately above, little legislation affecting dietary supplements has been enacted since the DSHEA.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The FDAMA and how it affected dietary supplements is discussed }{\i supra}{
, Parts III.C.3, III.C.5.ii.  Also the }{\cf1 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and its effects on dietary supplements is discussed }{\i\cf1 supra}{\cf1  Part III.C.8, at note 319.}}}{
  One applicable piece of legislation is the Farm Security and Rural Investment Act of 2002.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Pub. L. No. 170-171, \'a7 10806, 116 Stat. 143 (2002).}}}{  This act deemed a dietary supplement to be misbranded 
"[i]f it purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax."}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at \'a7 10806(b)(2).  The Act also stated that \'93}{\cs34\cf1 the term \lquote ginseng
\rquote  may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant {\*\bkmkstart SDU_1095}{\*\bkmkend SDU_1095}classified within the genus Panax; and}{\cf1  . . . }{\cs34\cf1 
only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term \lquote ginseng\rquote .\'94  }{\cs34\i\cf1 Id.}{\cs34\cf1  at \'a7 10086(b)(1).}}}{  The FDA subsequently proposed to incorporate this
 statutory restriction into regulations.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 
68 Fed. Reg. 51,738 (Aug. 28, 2003).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 1. Past and Pending Proposed Bills Concerning Dietary Supplements
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab In 1995, shortly after the DSHEA, a bill entitled The Food and Dietary Supplement Consumer Informatio
n Act of 1995 was introduced in the U.S. House of Representatives.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ H.R. 1951, 104th Cong. (1995).}}}{  The bill would have removed dietary supplements from the definition of food while also prohibiting them from being deemed drugs, thus creating a truly independent category of substances.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  
The bill would also have repealed provisions of the DSHEA concerning nutrition content claims and health claims instead holding such claims to a new uniform standard.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  CDSL Report, }{\i supra}{
 note 73, at 13.  The proposed standard was that label claims must be truthful and not misleading.  H.R. 1951, 104th Cong. (1995).}}}{  No action was taken on this bill.
\par \tab In subsequent years from 1995 through the present, numerous bills have been introduced in Congress pertaining to dietary supplements, but none have become law.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See, e.g.,}{
 the Nutraceutical Research and Education Act, H.R. 3001, 106th Cong. (1999) (to establish a new legal classif
ication and regulatory scheme for dietary supplements and foods with health benefits); the Consumer Health Free Speech Act, H.R. 1077, 106th Cong. (1999) (specifically excluding dietary supplements from the definition of drugs for purposes of making struc
t
ure function claims and also increasing the burden of proof on the FDA to demonstrate a dietary supplement is adulterated); the Dietary Supplement Fairness in Labeling and Advertising Act, H.R. 3305 (1999), 106th Cong. (1999) (loosening both the restricti
o
ns on the regulation of scientific studies as labeling when used in conjunction with dietary supplements and the restrictions on dietary supplement advertising); the Consumer Freedom Protection Act, H.R. 4604, 106th Cong. (2000) (to allow for qualified he
alth claims for dietary supplements consistent with }{\ul Pearson v. Shalala}{
); the Dietary Supplement Information Act, H.R. 3065, 107th Cong. (2001) (to require dietary supplement manufacturers to register with the FDA and supply the FDA with adverse event report
s); the Health Information Independence Act of 2001, H.R. 3811, 107th Cong. (2002) (to establish a health claim review system for food and dietary supplement independent of the FDA).}}}{  There are also a number of bills
 concerning dietary supplements pending in the current Congress.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i See, e.g.,}{ the Dietary Supplement Information Act, H.R. 724, 108th Cong. (2003) (reintroduction of H.R. 3065, }{\i supra}{
 note 328); the Dietary Supplement Access and Awareness Act, H.R. 3377, 108th Cong. (2003) (to require manufacturers of dietary supplement to submit adverse event reports to the FDA and allowing for the Secretary
 to ban sales of dietary supplements to minors); the Health Information Independence Act, H.R. 4004, 108th Cong. (2004) (reintroduction of H.R. 3811, }{\i supra}{
 note 328); the DSHEA Full Implementation and Enforcement Act of 2003, S. 1538, 108th Cong. (2003) (t
o authorize appropriations and institute accountability to ensure that the goals of the DSHEA are met); the Dietary Supplement Tax Fairness Act of 2003, H.R. 2627, 108th Cong. (2003) (to treat amounts paid for dietary supplements as medical expenses for t
ax purposes).  Additionally, prior to the FDA\rquote s issuance of its final rule on Ephedrine Alkaloids, numerous bills on this subject were introduced in the 108th Congress.  }{\i See, e.g.,}{
 the Ephedrine Alkaloids Consumer Protection Act, H.R. 275, 108th Cong. (2003).}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 2. Congressional Hearings Concerning Dietary Supplements}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0 {\tab Since the DSHEA, there have also been a number of congressional hearings examining a variety of aspects of dietary supplements.  The number of hearings are too numerous to list here,
}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See, e.g.,}{ }{\i 
Dietary Supplement Health and Education Act: Is the FDA Trying to Change the Intent of Congress?, Hearing Before the House Comm. on Gov\rquote t Reform}{, 106th Cong. (1999); }{\i Six Years After of DSHEA: The Status of National and International Dietary
 Supplement Research and Regulation, Hearing Before the House Comm. on Gov\rquote t Reform,}{ 107th Cong. (2001); }{\i Hearing on Diet, Physical Activity and Dietary Supplements Before the House Comm. on Gov\rquote t Reform,}{ 107th Cong. (2002); 
House Weight Loss Hearing}{\i , supra }{note 313; }{\i Hearing on Dietary Supplements Containing Ephedra Before Senate Subcomm. on Oversight of Gov\rquote t Mgmt., Restructuring and the Dist. of Columbia, Comm. on Gov\rquote t Affairs, }{
107th Cong. (2002); }{\i Joint Hearing on Issues Relating to Ephedra Dietary Supplements Before House Subcomm. on Commerce, Trade, and Consumer Prot., Comm. on Energy and Commerce,}{ 108th Cong. (2003).}}}{
 but a most recent hearing in 2004 is instructive.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{
\i Hearing on Dietary Supplements Before the House Subcomm. on Human Rights and Wellness, Comm. on Gov\rquote t Reform,}{ 108th Cong. (2004) [hereinafter 2004 House Hearing].}}}{  This hearing was held on the 10th anniversary year of the DSHEA to ensure 
\'93federal health agencies and the }{dietary supplement }{industry have maintained the integrity of this act, so that}{ }{Congress might consider ways in which the act could be improved and}{ }{educate American consumers to the latest developments in }{
dietary supplement }{policy and nutritional labeling practices.}{\'94}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{\i  Id.}{ at 3 (statement of Rep. Dan Burton, Chairman, House Comm. on Gov\rquote t Reform).}}}{  One U.S. House Rep. noted that regarding
 dietary supplement safety, the DSHEA forces the FDA to act after the fact when substantial harm may have already occurred.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 6 (statement of Rep. Susan Davis).}}}{  In that regard, another congressman
 noted that he would like to see mandatory adverse event reporting for dietary supplement manufacturers.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 10 (statement of Sen. Richard Durbin).  One industry group supported this.  }{\i Id.}{ at 41 (stateme
nt of Annette Dickinson, President, Council for Responsible Nutrition).}}}{  However, the director of the FDA Center for Food Safety and Applied Nutrition (\'93CFSAN\'94) testified that the FDA is not seeking additional legisl
ation for dietary supplements because it believes the DSHEA provides an adequate framework.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 15-16 (statement of Dr. Robert Brackett, }{
Director, FDA Center for Food Safety and Applied Nutrition).  Dr. Brackett did concede that the voluntary adverse reporting system was
 not particularity robust, but he did point out that a new adverse event reporting system is now in place for dietary supplements.  }{\i See id.}{ at 18, 20.}}}{
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i E. Additional Post-DSHEA Industry Activity Regarding Dietary Supplements
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab This section presents a fraction of the notable industry activity that has taken place regarding dietary supplements post-DSHEA.
\par }{\ul 1. Dietary Supplement Safety and Adverse Event Reporting
\par }{\tab Post-DSHEA, there has been considerable industry involvement regarding the safety of dietary supplements.  First, after passage of the DSHEA, the FDA was faced with a sizable challenge regarding dietary supplement safety.  Specifically, it was not
 enabled by the DSHEA to institute a premarket review system for dietary supplements marked for use in the United States prior to October 15, 1994.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ See Pub. L. No. 103-417, \'a7 4 (codified at 21 U. S. C. \'a7 342(f)), \'a7
 8 (codified at 21 U. S. C. \'a7 350b).}}}{  To decide then how to ensure the safety of such dietary supplements, the FDA turned to the National Academies, including the Institute of Medicine (\'93IOM\'94), to develop a 
framework for evaluating dietary supplement safety.  In 2002 the IOM issued a proposed framework,}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Institute of Medicine, Proposed Framework for Evaluating the Safety of Dietary Supplements}{ (2002).}}}{ and just recently the IOM released its final report.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Institute of Medicine, Dietary Supplements: A 
Framework for Evaluating the Safety of }{(2004) [hereinafter IOM Report].}}}{  The report contains a detailed framework for the FDA to follow in order to ensure the safety of dietary supplements}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{  In short, the FDA can either
 proactively initiate a review of a dietary supplement or can wait to receive a signal indicating the possibility of serious health problem regarding the dietary supplement.  }{\i Id.}{
 at 3-3 to 3-4.  The FDA would then make an initial review of the available information and determine the level of concern it has about the dietary supplement.  }{\i Id.}{
 at 3-5.  If the level of concern is low, the FDA could monitor and continue to collect data.  }{\i Id.}{  If the level of concern is high the FDA could take immediate action.  }{\i Id.}{
  If the level of concern is moderate or it is high but the FDA does not want to take immediate action, the FDA would engage in an integrative evaluation.  }{\i Id.}{ at 3-5 to 3-6.  The integrative evaluation contains four parts: \'93
in-depth literature search a
nd review, drafting of a safety monograph based on this information, integrating the available data into an analysis to complete the monograph, and possibly referring the draft monograph to an expert committee for additional input.\'94  }{\i Id.}{
 at 3-6.  The FDA is to enter at step three, examine the draft monograph, and then take regulatory action, take no action and continue to monitor, or proceed with step four by referring the monograph to an expert committee for review.  }{\i Id.}{
 at 3-9 to 3-10.  If the FDA proceeds with step four, the expert committee is to submit a report to FDA after which the FDA will decide whether to take action or to continue to monitor.  }{\i Id.}{
 at 3-11. As part of its report, the IOM prepared six prototype monographs for the dietary supplements chaparral, chromium picolinate , glucosamine, melatonin, saw palmetto, and shark cartilage.  }{\i Id.}{
 at appendices D to I.  The full monographs are available at http://www.iom.edu/subpage.asp?id=19554 (last visited April 22, 2004).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {As mentioned in Part III.C.8, the FDA must rely on post-market surveillance and voluntary adverse event reporting to review the safety of
 dietary supplements (at least for those dietary supplements not falling within the new dietary ingredient provision of the DSHEA).  Two major reports have a
ddressed the effectiveness of such a system for dietary supplement safety.  First, in 2000 the General Accounting Office (\'93GAO\'94) issued a report on the safety of dietary supplements and functional foods.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps United States General Accounting Office, Food Safety \endash 
 Improvements Needed in Overseeing the Safety of Dietary Supplement and Functional Foods}{ (July 2000) [hereinafter GAO Safety Report].}}}{  The report concludes that there is limited assurance of safety for dietary supplement and functional foods.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id. }{at 12.}}}{
  The report attributed this to the absence of guidance and regulations for dietary supplements in many areas including removal of unsafe products and the making of structure/function claims as well
 as a lack of a clearly defined boundary between dietary supplements and functional foods in conventional form.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 13-25.  Specifically, the report found that the FDA lacked guidance reg
arding the use and safety of new dietary ingredients and also lacked consistent standards on the removal of unsafe dietary supplements.  }{\i Id.}{
 at 15.  Further, the report found a lack of FDA guidance on requiring safety information on dietary supplement labe
ls, lack of an effective FDA system for adverse event reporting, and lack of consistent FDA guidance on the making of structure/function claims on dietary supplement labels. }{\i  Id}{
. at 15-21.  Finally, the report found that the difference between structure/function claims and health claims was not understood by consumers leading to consumer confusion over what such claims meant.  }{\i Id.}{
 at 23-25.  The report also made formal recommendations to the FDA for correcting these deficiencies.  }{\i Id.}{ at 27.  For the FDA\rquote s response to a draft of this report, }{\i see id.}{ at appendix II.}}}{  
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {A second major safety report was issued in 2001 by the Office of the Inspector General of the Department of Health and Human Services.  It concerned 
the FDA\rquote s adverse event reporting system for dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs18\super \chftn }{ }{\scaps OIG Adverse Event Report, }{\i supra}{ note 316.}}}{  \'93An adverse event is an incident of illness or injury that }{\i may }{be associated with a product or ingredient.\'94}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at i.}}}{  The FDA must rely on consumers, health professionals, and dietary supp
lement manufacturers for these reports as such reporting is entirely voluntary.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at i, 4.}}}{  The 2001 report concludes that the FDA\rquote s adverse event reporting detected only a small amount of such events for dietary supplements 
and as a result the FDA rarely took responsive safety actions.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i Id.}{ at ii-iii, 9-18.}}}{  Such problems were attributed to the limited information the FDA receives and the lack of a well developed system for analyzing such information.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}{ at 9-18.}}}{  The FDA responded to this report in announcing the creation of the CFSAN
 Adverse Event Reporting System (\'93CAERS\'94)}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{
\scaps Center for Food Safety and Applied Nutrition, Announcing CAERS \endash  the Adverse Event Reporting System}{ (Aug. 29, 2002), }{\i available at}{ http://www.cfsan.fda.gov/~dms/caersltr.html.}}}{.  CAERS is eventually 
to form a centralized reporting system for all CFSAN regulated products (including all dietary supplements) by replacing previous decentralized and uncoordinated FDA adverse event reporting systems.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i Id.}}}{  As of 2004, the effectiveness of CARES has yet to be proven.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ 2004 House Hearing, }{\i supra}{
 note 331, at 20 (statement of statement of Dr. Robert Brackett, }{Director, FDA Center for Food Safety and Applied Nutrition).}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Finally, there are also industry based safety measures in place.  The National Nutrition Foods Association (\'93NNFA\'94)
 conducts the TruLabel program which all of its members (manufacturing dietary supplements under their own label) must join.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps National Nutritional Foods Association, NNFA TruLabel Program}{, }{\i available at}{ http://www.nnfa.org/services/science/bg_TruLabel.htm#over
 (last visited April 22, 2004) [hereinafter }{\scaps TruLabel}{].  For empirical information about dietary supplement labeling and claims (at least as of 1999) }{\i see}{ }{\scaps Dietary Supplement Sales Information, }{\i supra}{ note 44, at 5-5 to 5-11.
}}}{  This program ensures that the dietary supplement labels of all participants comply with all FDA regulations.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps TruLabel}{, supra note 351.  The NNFA also conducts a GMPs program for dietary supplement manufacturer members. }{\i See }{\scaps 
National Nutritional Foods Association, NNFA GMP Certification Program Overview}{, }{\i available at}{ http://www.nnfa.org/services/science/gmp.htm (last visited April 22, 2004).}}}{  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul 2. Dietary Supplement Analysis
\par }{\tab A further area of industry action regarding dietary supplements concerns dietary supplement analysis performed by the Association of Analytical Communities International (\'93AOAC\'94
).  The AOAC is under contract with the FDA and the National Institutes of Health to develop \'93reliable analytical methods . . . to verify ingredient identity and measure the amounts of declared ingredients\'94 in dietary supplements.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ James Giese, }{\i Dietary Supplement Analysis}{, }{\scaps 
Food Technology}{, Aug. 2003, at 92; AOAC International, Call for Methods for Saw Palmetto, SAMe, Vitamin E, CoEnzyme Q}{\sub 10}{, }{\i Panaxquinquefolius, Panaz ginseng,}{ Eleuthero, Kava Kava, Yohimbe and Cranberry, }{\i available at }{
http://www.aoac.org/dietsupp/Call_11_05_2003.pdf (last visited April 23, 2004).}}}{  Such action will certainly aid the FDA in ensuring dietary supplement safety.
\par }{\b\i F. Dietary Supplement Advertising Regulation
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab As with any consumer product, advertising plays
 an important role for dietary supplements.  Not only do retail outlets engage in advertising for dietary supplements, but so too do dietary supplement manufactures through the use of medical journals, television, radio, magazines, retail trade publicat
ions, and public relations campaigns.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps 
Economic Characterization, }{\i supra}{ note 4, at 5-13.}}}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {The Federal Trade Commission (\'93FTC\'94) is responsible for regulating advertising claims for all foods, including dietary supplements.  
Specifically, the FTC may prohibit the dissemination of false or misleading dietary supplement advertising.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ 15 U. S. C. \'a7\'a7 52, 55.  Section 52 states that the dissemination of any false advertisement constitutes \'93an unfair or deceptive practice\'94 under 15 U. S. C. \'a7
 45 (granting general authority to the FTC to regulate unfair or deceptive practices).}}}{  The FTC requires that dietary supplement advertising be truthful and not misleading and have adequate substantiation for all claims.}{\cs18\super \chftn 
{\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\scaps Federal Trade Commission, FTC Policy Statement on Deception}{
 (Oct. 14, 1983), available at http://www.ftc.gov/bcp/policystmt/ad-decept.htm; }{\scaps Federal Trade Commission, FTC Policy Statement Regarding Advertising Substantiation }{(1983), available at http://www.ftc.gov/bcp/guides/ad3subst.htm; }{\scaps 
Federal Trade Commission, Dietary Supplements: An Advertising Guide for Industry }{3, }{\i available at}{ http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm [hereinafter }{\scaps Advertising Guide}{].  Specifically, the FTC will look to all
 express and implied claims made by the advertising, the types of disclosure made in the advertising, and whether the advertiser has a reasonable basis for all express and implied claims.  }{\scaps Advertising Guide,}{ }{\i supra}{, at 3-18.}}}{  The FTC 
tries to harmonize its enforcement of advertising claims with the FDA\rquote s enforcement of claims in food and dietary supplement labels.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ 59 Fed. Reg. 28,388 (June 1, 1994) (the FTC\rquote 
s Enforcement Policy Statement on Food Advertising); GAO Safety Report, }{\i supra}{ note 340, at 22; }{\scaps Advertising Guide, }{\i supra}{ note 356, at 24-25 (the FTC will generally follow the FDA\rquote 
s labeling approach under the DSHEA for third party advertising).}}}{  However, there are situations where these enforcement approaches do not meet up.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 For example, in some situations the FTC may allow a qualified health claim to be made in dietary supplement adverting while the FDA would not allow such a claim on the dietary supplement label.  GAO Safety Report, }{\i supra}{
 note 340, at 22.  As another example, use of the label disclaimer required under the DSHEA for statements of nutritional support in dietary supplements may not constitute adequate disclosure under FTC advertising regulations.  }{\scaps Advertising Guide
, }{\i supra}{ note 356, at 23.}}}{
\par Several bills were introduced in Congress in the late 1990s to remedy different standards of enforcement between the FDA and FTC.  In 1998 the Dietary Supplement Fairness in Advertising Act was introduced in the U.S. House of Representatives.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ H.R. 4581, 105th Cong. (1998).}}}{
  The bill would have ensured that dietary supplement advertising that met the provisions of the FDCA and DSHEA and made certain disclosures about studies used in making advertisement claims would not constitute unfair competition or
 deceptive trade practices under the FTC statutory provisions.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super 
\chftn }{ }{\i Id.}}}{  In 1999, the Dietary Supplement Fairness in Labeling and Advertising Act was introduced in Congress to exempt all dietary supplement publications considered labeling under the DSHEA (specifically 21 U. S. C. \'a7
 342-2) from regulation as advertising by the FTC.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 H.R. 3305, 106th Cong. (1999).  The same bill was introduced in the Senate.  }{\i See }{S. 1749, 106th Cong. (1999).}}}{  Neither of these bills became law and no bills on this topic are currently pending in Congress.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b IV. RECOMMENDATIONS REGARDING FUTURE REGULATION OF DIETARY SUPPLEMENTS
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab This section discusses some recommendations for both the FDA and Congress concerning dietary supplement regulation.  
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {It could not be expected that the massive changes the DSHEA enacted for dietary supplement could be swiftly and 
seamlessly detailed and implemented by the FDA.  Ten years later, the FDA has made a serious effort to implement most all of the provisions of the DSHEA with varying amount of success and failure.  However, the FDA still has plenty of work to do 
regarding dietary supplements.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab One area that needs further improvement is general dietary supplement safety.  By excluding most dietary supplements from drug 
regulations and excluding all dietary supplements from regulation as food additives, the DSHEA greatly freed up manufacturers of dietary supplements.  Dietary supplements are not subject to premarket approval like drugs,
 nor must they be shown to be GRAS or otherwise comply with the Food Additives Amendment of 1958 like all conventional food.  However, this places an enormous safety burden on the FDA, a burden which all too often the FDA has failed to carry.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ Some of this slack is picked up by the NNFA\rquote 
s TruLabel program.  }{\i See}{ discussion }{\i supra}{ Part III.E.1.  This program should certainly continue and expand in scope to reach industry wide.}}}{  The FDA\rquote 
s action regarding Ephedrine Alkaloids demonstrated the costs of having to meet such heavy burdens.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ discussion }{\i supra}{ Part III.C.7.}}}{  There are several ways to remedy this.  First, the FDA\rquote 
s creation of CARES, a unified adverse event reporting system, is a step in the right direction.  Second, adverse event reporting should be made mandatory.  All dietary supplement manufacturers
 should be required to submit adverse event reports to the FDA as they become available to such manufacturers.  Third, all manufacturers of dietary supplements should be required to register with the FDA.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 A bill currently pending in the House would require this as well as mandatory adverse event reporting.  }{\i See }{Dietary Supplement Information Act, H.R. 724, 108th Cong. (2003).  The }{\cf1 
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and its registration requirements for food manufacturers are steps in this direction.  }{\i\cf1 See }{\cf1 discussion }{\i\cf1 supra}{\cf1  notes 319, 321.}}}{
  This would greatly strengthen the FDA\rquote s ability to detect signals relating to dietary supplement safety.  Fourth, the FDA should also adopt the detailed framework for dietary supplement safety recently submitted to the FDA by the IOM
, which would create a detailed FDA post-market surveillance system for dietary supplements.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ IOM Report, }{\i supra}{ note 338.}}}{
  Finally, while the FDA has implemented notification procedures for new dietary ingredients, it has not implemented guidance on the amount and type of evidence needed in this notification to demonstrate the safety of new dietary ingredients.}{
\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ The FDA was alerted to this need in 2000.  }{\i See}{
 GAO Safety Report, }{\i supra }{note 340, at 27.}}}{  Such guidance is greatly needed in order to provide the dietary supplement industry with standards by which to test and produce new dietary supplements.
\par \tab And additional area that needs improvement is the making of claims of nutritional support on dietary supplement labels.  Claims of nutritional support, and particularly structure/function claims and health claims (both qualified and unqualified) ar
e currently subject to varied and numerous regulations.  However, there is still consumer confusion and inability to distinguish between such claims.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See }{GAO Safety Report, }{\i supra}{ note 340, at 23-25.}}}{
  One possible solution might be to create an agency independent of the FDA to handle and review statements of nutritional support for dietary supplements in a consistent manner while clearly defining the differences in each type of claim.}{\cs18\super 
\chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 A bill currently pending in the House would require this type of independent review system for health claims in dietary supplements and other nutritional foods.  }{\i See}{
 Health Information Independence Act, H.R. 4004, 108th Cong. (2004).  A less drastic but still satisfying solution would be the FDA\rquote s ANPRM proposal of subjecting all qualified health claims to a new post-market review system.  }{\i See}{
 68 Fed. Reg. 66,040 (Nov. 25, 2003); }{\i see also}{ discussion }{\i supra}{ Part III.C.5.iii.}}}{  Harmonizing FDA and FTC regulations in this area would also be helpful and would lessen consumer confusion.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ }{\i See}{ discussion }{\i supra}{ Part III.F for several bills that proposed a version of this.}}
}{
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Finally, the FDA should work to better distinguish dietary supplements from conventional foods.  As nutrition h
as become more important to society, the line between dietary supplements and functional yet conventional foods has blurred.  And while the DSHEA does require a dietary supplement to be labeled as such, its allowance for
 dietary supplements to be marketed in conventional food form in certain circumstances only adds to the confusion.  The FDA should seek to explain these boundaries both for manufacturers and for consumers through new regulations
 and public relations campaigns.}{\cs18\super \chftn {\footnote \pard\plain \s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{
 The FDA was alerted to this need in 2000.  }{\i See}{ GAO Safety Report, }{\i supra }{note 340, at 27.}}}{  Because of the similarity bet
ween functional foods and dietary supplements, perhaps a new category of regulation should be created combining these two product types.}{\cs18\super \chftn {\footnote \pard\plain 
\s17\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs18\super \chftn }{ In 1999, a bill proposing a version of this was introduced in the House. }{\i See }{
Nutraceutical Research and Education Act, H.R. 3001, 106th Cong. (1999).}}}{  This new category could take these more \'93drug like\'94 products for which structure/function and various health claims are made and subject them to 
uniform claim procedures separate from conventional foods.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b V. CONCLUSION
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Dietary supplements are interstitial \endash  spaced between conventional foods and drugs.  However, this status has not affected their popularity,
 which has been and continues to be unprecedented.  While Congress and the FDA wrestled for decades with how to treat dietary supplements, they took a strong stance with the DSHEA and subsequent regulations.  The DSHEA considered dietary supplements to be
 food but also subjected dietary supplements to some standards applied neither to food nor drugs.  This categorization has fit, but imperfectly.  The history of dietary supplement regulation since the DSHEA is
 one of trying to force a previously undefined product group into unsuitable clothing and of trying to ensure availability of a popular product group while also ensuring safety.  Real progress has been made, 
but the unsettling question still remains: where is the line between a food and a drug?  The DSHEA has given the FDA the tools to search for the line, but in this era of emphasis on nutrition and functional foods additional, or at least refurbished,
 tools may be required.
\par }}