DSHEA'S failure: Why a proactive approach to dietary supplement regulation is needed to effectively protect consumers

University of Illinois Law Review

Volumn 2010, Issue 3, 2010, Pages 1045-1082

  Nowak, Richard E ^a  

^a UNIVERSITY OF ILLINOIS AT URBANA CHAMPAIGN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78650846006     PISSN: 02769948     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (335)

1. Walmart, Health & Beauty: Vitamins, http://www.walmart.com/catalog/ catalog.gsp?cat= 1005863 (follow "Supplements" hyperlink) (last visited Mar. 14,2010).
2. GNC, http://www.gnc.com (last visited Mar. 14, 2010). For example, GNC currently sells 480 different protein products and over 100 different diet and energy products. GNC, Sports Nutrition: Shop for All Categories, http://www.gnc.com (follow "Protein" or "Diet" hyperlinks) (last visited Mar. 14,2010).
3. 2O, Maximum, Essential, Teen Advantage, and Vitacraves Gummies.
4. Id.
5. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417,108 Stat. 4325 (codified as amended in scattered sections of 21 and 42 U.S.C).
6. HEATHER HEDRICK FINK ET AL., PRACTICAL APPLICATIONS IN SPORTS NUTRITION 259 (2006).
7. §3, 108 Stat, at 4327 (codified as amended at 21 U.S.C. §321(ff)(1) (2006)). The adopted definition is very similar to Merriam-Webster's definition of dietary supplement as being "a product taken orally that contains one or more ingredients (as vitamins or amino acids) that are intended to supplement one's diet and are not considered food." MERRIAM-WEBSTER'S COLLEGIATE DICTIONARY 348 (11th ed. 2006).
8. §3,108 Stat, at 4327 (codified as amended at 21 U.S.C. §321(ff)(1)).
9. See generally Nutrition Guide, Common Vitamins and Minerals, http://www.dcdoctor. com/pages/rightpages-wellnesscenter/dietandnutrition/ nutritionguide/nutriguide-vitamins.html (last visited Mar. 14,2010) (listing common vitamins and minerals).
10. See Lewis A. Grossman, Food, Drugs, and Droods: A Historical Consideration of Definitions and Categories in American Food and Drug Law, 93 CORNELL L. REV. 1091,1119 (2008). During the early 1900s there was a struggle over whether vitamins should be considered foods or drugs. Congress failed to address this question specifically, but vitamins nonetheless typically were considered to be food.
11. Id. at 1119-23.
12. Not surprisingly, Congress delegated the authority to regulate dietary supplements to the FDA, as it had previously done for food and drugs. See generally U.S. Food & Drug Administration, Overview of Dietary Supplements, http://www.cfsan.fda.gov/~dms/ds-oview.html#regulate (last visited Mar. 14,2010).
13. Bodybuilding.com, http://www.bodybuilding.com/fun/bbmainsupp.htm (enter "supplement" in the search box at top of the page) (last visited Mar. 14,2010).
14. Id. (enter "dietary supplement" in the search box at top of the page). The common use of the word "supplement" in the context of weightlifting and exercise would likely explain the difference in the overall number of results for searches for "supplement" and "dietary supplement," along with the other possible uses of the word supplement, beyond referencing dietary supplements.
15. Google, http://www.google.com (enter "dietary supplements" in the search box) (last visited Mar. 14,2010).
16. FINK ET AL., supra note 5, at 259
17. (citing Sports Nutrition and Weight Loss Market III, 1 NUTRITION Bus. J. 1,1-8 (2002)).
18. For example, the FDA estimated that Sports Nutrition Products accounted for only $927 million in sales in the year 1996. MARY K. MUTH ET AL., ECONOMIC CHARACTERIZATION OF THE DIETARY SUPPLEMENT INDUSTRY 5-2 (1999). This growth has not been limited to consumer spending as it has been estimated that one thousand new dietary supplements are marketed each year, raising the total number to over twenty-nine thousand.
19. NWEZE EUNICE NNAKWE, COMMUNITY NUTRITION: PLANNING HEALTH PROMOTION AND DISEASE PREVENTION 328 (2009).
20. See Saundra Young, Stop Using Hydroxycut Products, FDA Says, CNN, May 1, 2009, http://www.cnn.com/2009/HEALTH/05/01/hydroxycut.fda.recall/index.html.
21. See U.S. Food & Drug Administration, Warning on Hydroxycut Products, http://www.fda. gov/ForConsumers/ConsumerUpdates/ucml52152.htm (last visited Mar. 14, 2010).
22. In fact, the FDA did not even learn about the death until 2009 even though it occurred in 2007. Kathleen Doheny, Hydroxycut Recall Due to Liver Injuries, EMEDICINEHEALTH, May 1, 2009, http://www.emedicinehealth.com/script/ main/art.asp?articlekey=99885.
23. Council Directive 2002/46, On the Approximation of the Laws of the Member States Relating to Food Supplements, 2002 OJ. (L 183) 51 (EC) [hereinafter Food Supplements Directive].
24. The majority of DSHEA's requirements apply to both manufacturers and distributors. See, e.g., Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §8,108 Stat. 4325, 4331 (codified as amended at 21 U.S.C. §350b (2006)). For the purposes of this Note, I refer to them collectively as the manufacturer. This is to prevent confusion and unnecessary verbiage.
25. U.S. Food & Drug Administration, Centers & Offices, http://www.fda.gov/opacom/7org.html (last visited Mar. 14,2010).
26. U.S. Food & Drug Administration, What Do We Do, http://www.fda.gov/ AboutFDA/ WhatWeDo/default.htm (last visited Mar. 14,2010).
27. U.S. Food & Drug Administration, What FDA Regulates, http://www.fda.gov/comments/ regs.html (last visited Mar. 14,2010).
28. See U.S. Food & Drug Administration, Foods, http://www.fda.gov/Food/ default.htm (last visited Mar. 14,2010).
29. These products include-but are not limited to-food, drugs, cosmetics, animal products, and dietary supplements. See generally U.S. Food & Drug Administration, supra note 23.
30. Carol Rados, FDA Law Enforcement: Critical to Product Safety, FDA CONSUMER, Jan.-Feb. 2006, http://www.fda.gov/AboutFDA/WhatWeDo/History/ FOrgsHistory/ORA/ucm084102.htm.
31. MARY FRANCES PICCIANO, OFFICE OF DIETARY SUPPLEMENTS, WHO Is USING DIETARY SUPPLEMENTS AND WHAT ARE THEY USING? 5 (2005), http://ods.od.nih.gov/ pubs/fnce2005/M%20F% 20Picciano- Who%20Is%20Using%20Dietary%20Supplements%20and%20What%20are%20They% 20Using.pdf.
32. See MUSCLE & FITNESS, Dec. 2008, at 50. The current estimate is twenty-two billion dollars each year.
33. Id.
34. PICCIANO, supra note 27, at 12. Another study conducted by Harris Interactive in 2001, showed that nearly sixty percent of the 1027 American adults surveyed reported regularly taking dietary supplements.
35. See Michael Devitt, Supplement Use Continues to Rtee in the U.S., ACUPUNCTURE TODAY, Oct. 2001, http://www.acupuncturetoday.com/mpacms/at/article. php?id=27871.
36. See S. REP. No. 109-324, at 2 (2006) (noting that critics of DSHEA have urged requirements of premarket approval for at least some dietary supplements).
37. For example, the 2006 U.S. census report found the population of the United States to be 300 million with 72.5 percent of the population being twenty years of age or older. United States Census Bureau, Age and Sex, http://factfinder.census.gov/servlet/STTable?-bm=y&-geo-id=01000US&-qr- name=ACS-2006-EST-G00-S0101&-ds-name=ACS-2006-EST-G00- (last visited Mar. 14, 2010). Applying these figures results in a finding that 217.5 million Americans are in that age group, and if fifty-two percent of Americans in this age range are taking dietary supplements, then over 113 million Americans consume dietary supplements. Though the 150 million estimate may seem high, the 113 million estimate does not include anyone under the age of nineteen, and there are numerous vitamin supplements available for children as well as adults.
38. PICCIANO, supra note 27, at 18. In athletes, the usage rate of dietary supplements is even greater, with twenty-three percent of National Collegiate Athletic Association (NCAA) athletes reporting taking dietary supplements at least five times per week. FINK ET AL.,
39. supra note 5, at 259. Considering the NCAA places restrictions on the types of dietary supplements and performanceenhancing substances that may be used, this figure is likely an underestimate of the actual usage among NCAA athletes.
40. See National Collegiate Athletic Association, Nutritional Supplements, http://www.ncaa.org/wps/ncaa?ContentID-8787 (last visited Mar. 14,2010).
41. For example, in the ten year span from 1991 to 2001, dietary supplement sales tripled from five billion to fifteen billion dollars. Scott Eric Barrett, Supplementing Your Profits: Health Supplement Sales Continue to Rise, LOOKING FIT, Feb. 1, 2003, http://www.lookingfit.com/articles/321feat2. html.
42. Iona N. Kaiser, Comment, Dietary Supplements: Can the Law Control the Hype?, 37 HOUS. L. REV. 1249,1262 (2000).
43. U.S Food & Drug Administration, History, http://www.fda.gov/AboutFDA/ WhatWeDo/ History/Default.htm (last visited Mar. 14, 2010). Prior to the passing of the Pure Food and Drugs Act, the FDA began as the Division of Chemistry, which was modified in 1901 to be the Bureau of Chemistry.
44. John P. Swann, FDA's Origins, http://www.fda.gov/AboutFDA/WhatWeDo/ History/Origin/ ucml24403.htm (last visited Mar. 14, 2010). The 1906 Act began the modern era of the FDA as it added regulatory functions to the agency's mission.
45. Id.
46. Pure Food and Drugs Act, ch. 3915, 34 Stat. 768, 768-72 (1906), repealed by Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717,52 Stat. 1040,1040.
47. Pure Food and Drugs Act §§3-4.
48. In fact, it was not until 1911 that scientists isolated and identified the substances now known as vitamins. HARVEY A. LEVENSTEIN, REVOLUTION AT THE TABLE: THE TRANSFORMATION OF THE AMERICAN DIET 148 (1988).
49. Grossman, supra note 9, at 1119 ("[I]n 1911, scientists isolated and identified a series of substances they called 'vitamins'...").
50. Pure Food and Drugs Act §6.
51. Id.
52. See Grossman, supra note 9, at 1119. In addition to being advertised as preventing ailments, vitamins were also at the time marketed in both "drug-like dosage forms and in drug-like packaging."
53. Id. at 1120. It would not be surprising then that the general public likely misconceived the properties of vitamins and their actual functionality.
54. See id. at 1115-16.
55. U.S. FOOD & DRUG ADMIN., FDA CONSUMER HEALTH INFORMATION, FORTIFY YOUR KNOWLEDGE ABOUT VITAMINS 1 (2009), http://www.fda.gov/downloads/ ForConsumers/ ConsumerUpdates/ucml42298.pdf.
56. 21 U.S.C. §321(f) (2006).
57. The lack of clarity is primarily caused by the fact that both definitions of food are circular and use the word "food" in the definition.
58. 21 U.S.C. §321(g)(1)(B).
59. Pure Food and Drugs Act, ch. 3915, §7, 34 Stat. 768, 769-70 (1906), repealed by Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040,1040. Drugs were deemed adulterated if when "sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differed] from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation..."
60. Id. §7. Meanwhile, foods were deemed adulterated only if they contained specific deleterious ingredients or failed to satisfy other mixture and appearance requirements.
61. Id.
62. The heading for section 3 is "Definition of Certain Foods as Dietary Supplements." Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §3,108 Stat. 4325, 4327 (codified as amended at 21 U.S.C. §321(ff)(1)); U.S. Food & Drug Administration, Dietary Supplements, http://www.fda.gov/Food/DietarySupplements/default.htm (last visited Mar. 14,2010).
63. See 21 U.S.C. §321(ff).
64. Matthew Herper & Peter Kang, The World's Ten Best-Selling Drugs, FORBES, Mar. 22, 2006, http://www.forbes.com/home/sciencesandmedicine/2006/03/ 21/pfizer-merck-amgen-cx-mh-pk- 0321topdrugs.html.
65. See supra notes 27-28 and accompanying text.
66. NAT'L CTR. FOR HEALTH STAT., HEALTH, UNITED STATES, 2004: WITH CHARTBOOK ON TRENDS IN THE HEALTH OF AMERICANS 91 (2004), http://www.cdc.gov/nchs/data/ hus/hus04.pdf. Although these numbers seem equivalent to the number of Americans reporting using dietary supplements, these figures include the entire population, including those persons under eighteen years old. The statistics on dietary supplement statistics are only based on adult usage.
67. See supra note 31 and accompanying text.
68. PRISCILLA EBERSOLE ET AL., TOWARD HEALTHY AGING: HUMAN NEEDS AND NURSING RESPONSE 320-21 (6th ed. 2004).
69. U.S. Food & Drug Administration, Use Caution with Pain Relievers, http://www.fda. gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ ucml33425.htm (last visited Mar. 14, 2010).
70. Additionally, Lipitor, a common prescription drug used to fight high cholesterol, has side effects ranging from headache and stomach pain to serious muscle and liver problems. Lipitor, Lipitor Side Effects, http://www.lipitor. com/about-lipitor/side-effects.aspx (last visited Mar. 14,2010).
71. See 21 U.S.C. §321(f)-(g)(1) (2006). In fact, "drugs are required to undergo a series of preclinical and clinical studies to determine effectiveness, safety, possible interactions with other substances, and appropriate dosages." SHAWN M. TALBOTT, A GUIDE TO UNDERSTANDING DIETARY SUPPLEMENTS 1 (2003). The FDA does not authorize or test dietary supplements before marketing.
72. Id. at 1-2.
73. Remember that Congress did not actually define dietary supplements until DSHEA's enactment in 1994. Therefore, any use of the term dietary supplement before then is merely to reference those products which are now officially considered dietary supplements.
74. Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040. Note that FDCA remains good law and subsequent legislation, including DSHEA, are simply amendments or additions to FDCA.
75. See generally 21 U.S.C. §301.
76. See Federal Food, Drug, and Cosmetic Act §§201, 402-403;
77. see aim W. STEVEN PRAY, A HISTORY OF NONPRESCRIPTION PRODUCT REGULATION 205 (2003).
78. Food Additives Amendment of 1958, Pub. L. No. 85-929,72 Stat. 1784.
79. See Kaiser, supra note 34, at 1252.
80. Food Additives Amendment §2.
81. An in-depth discussion of the scientific differences and chemical reactions within the body is outside the scope of this Note, but it is important to note that vitamins which naturally exist in foods react differently in the body than do over-the-counter vitamin pills. For this reason, the FDA and the 2005 Dietary Guidelines for Americans advise that nutrient needs be met through food consumption and only suggest vitamin supplementation for certain sensitive population groups.
82. See U.S. FOOD & DRUG ADMIN., supra note 44.
83. HARVEY A. LEVENSTEIN, PARADOX OF PLENTY: A SOCIAL HISTORY OF EATING IN MODERN AMERICA 20 (1993).
84. Peter Barton Hutt, FDA Statutory Authority to Regulate the Safety of Dietary Supplemente, 31 AM. J.L. & MED. 155,158 (2005).
85. See Grossman, supra note 9, at 1119.
86. The rise in vitamin popularity has often been linked with the changing perceptions of body image and the incredible claims scientists were making about vitamins throughout the early twentieth century and the Depression Era.
87. See, e.g., LEVENSTEIN, supra note 64, at 11-14.
88. Food Additives Amendment of 1958, Pub. L. No. 85-929, §4(c)(3)(A), 72 Stat. 1784, 1786 (codified as amended at 21 U.S.C. §348(c)(3)(A) (2006)).
89. For example, Congress primarily focused on regulating herbal supplements using tactics aimed at irrational combinations or potency levels.
90. See Reilley Michelle Dunne, Note, How Much Regulation Can We Swallow? The Ban on Ephedra and How It May Affect Your Access to Dietary Supplements, 31 J. LEGIS. 351, 353-54 (2005).
91. See id. at 353
92. (citing Kaiser, supra note 34, at 1252) ("As a result of the [Food Additives Amendment], the FDA devoted considerable resources to protecting the public from potential dangers presented by dietary supplements... [and] in the 1960s, the FDA... spent more money trying to regulate dietary supplements than in any other area.").
93. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §4, 108 Stat. 4325,4328 (codified as amended at 21 U.S.C. §342(f)).
94. Dunne, supra note 69, at 354. Furthermore, the costs associated with a food additive petition to the FDA are immense. The Committee on Labor and Human Resources estimated that such a petition can cost two million dollars and that it typically takes between two and six years to receive FDA approval.
95. See S. REP. No. 103-410, at 21 (1994).
96. Health Research and Health Services Amendments, Pub. L. No. 94-278, 90 Stat. 401, 410 (1976) (codified at 21 U.S.C. §§350, 321, 341, 343). The section of this Act that amends the FDCA is commonly referred to as the Proxmire Amendments.
97. See, e.g., PRAY, supra note 59, at 205;
98. Dunne, supra note 69, at 353-54.
99. FDA 's Regulation of the Dietary Supplement L-tryptophan: Hearing Before the Human Resources and Intergovernmental Relations Subcomm. of the Comm on Government Operations H.R., 102d Cong. 98 (1991) (statement of Douglas L. Archer, Deputy Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration). Prior to the amendment, the FDA had the authority to "limit[] the potency of a vitamin or mineral supplement based on either food misbranding charges or on the grounds that the supplement would be a drug if it exceeded the level of potency that FDA considered to be rational or useful."
100. Id. at 105.
101. Dunne, supra note 69, at 354. The result of this scaled-back effort was that herbal supplements became more popular and the industry grew considerably.
102. Grossman, supra note 9, at 1139. This growth allowed the industry to put considerable pressure on Congress as well as mount an organized and well-funded defense if the FDA sought to increase its regulations on dietary supplements.
103. See Dunne, supra note 69, at 355.
104. Kaiser, supra note 34, at 1255.
105. Id. These deaths were primarily caused by increased incidents of eosinophilia-myolagia syndrome (EMS), which was linked to L-tryptophan usage.
106. Id.
107. Id. In fact, the FDA argued that amino acids were not actually dietary supplements, but were "unapproved food additives that did not have 'adequate scientific evidence to ensure their safe use.'"
108. Id. at 1256
109. (quoting Regulation of Dietary Supplements, 58 Fed. Reg. 33,690, 33,697 (proposed June 18,1993)).
110. See Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, §3,104 Stat. 2353, 2360 (codified as amended at 21 U.S.C. §343 (2006)).
111. Labeling; General Requirements for Health Claims for Food, 56 Fed. Reg. 60,537, 60,539 (proposed Nov. 27,1991) (to be codified at 21 C.F.R. pts. 20,101).
112. Dunne, supra note 69, at 354.
113. For example, dietary supplement manufacturers organized a "National Blackout Day" where retailers covered the bottles of potentially affected dietary supplements with black cloths to emphasize to consumers that Congress was seeking to limit access to them.
114. Id. at 354-55;
115. see also Kaiser, supra note 34, at 1258.
116. Clearly, Congress had difficulty making up its mind and withstanding pressure from the public and manufacturers because the L-tryptophan scare was likely still fresh in the minds of legislators when the initial bill seeking to amend the FDCA came before the Senate in March of 2002, less than three years later.
117. See S. 2835,102d Cong. (1992).
118. Grossman, supra note 9, at 1144.
119. 21 U.S.C. §321(ff) (2006). There are two primary exceptions to this rule.
120. Id. The first is under subsection (g), which defines the term "drug" and establishes that dietary supplements meeting the definition of drug shall be considered drugs.
121. Id. §321(g). The second falls under §350f, which requires a report to the FDA when the food will cause serious health consequences or death.
122. Id. § 350f.
123. Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, §403(j), 52 Stat. 1040, 1048 (codified as amended at 21 U.S.C. §343(j)). This information must include the different vitamin, mineral, and other dietary properties in order to fully inform purchasers as to its value as determined by the Secretary and prescribed by the regulations as necessary for such special dietary use. 21 U.S.C. § 343G).
124. 21 U.S.C. §201(g).
125. Hutt, supra note 65, at 156.
126. These premarket requirements remain in effect today.
127. See 21 U.S.C. §360e.
128. See S. REP. No. 103-410, at 1 (1994).
129. Dietary Supplement Health and Education Act, Pub. L. No. 103-417, §3,108 Stat. 4325,4327 (codified as amended at 21 U.S.C. §321(ff)).
130. See id.
131. TALBOTT, supra note 56, at 4-5;
132. Dunne, supra note 69, at 355.
133. §§2(2), (15)(A), 108 Stat, at 4325, 4326 (codified as amended at 21 U.S.C. §321). This legislation may also account for the growing impact and size of the dietary supplement industry as Congress also noted that in 1994, the six hundred United States-based dietary supplement manufacturers produced around 4000 products with annual sales from those products totaling more than four billion dollars.
134. Id. §2(12)(C), 108 Stat, at 4326.
135. S. REP. No. 103-410, at 6.
136. See supra notes 76-78 and accompanying text.
137. S. REP. No. 103-410. The only mention of tryptophan is that it is an essential amino acid because it is not synthesized by the human body.
138. Id. at 12.
139. §2(13), 108 Stat, at 4326 (codified as amended at 21 U.S.C. §321). Obviously no one would argue that Congress should not limit the flow of "safe products and accurate information."
140. Id. (emphasis added). The main purpose of this Note, however, is that DSHEA generally fails to limit the flow of any dietary supplement or information about them. Id.
141. Id.
142. See Grossman, supra note 9, at 1141;
143. see also Food Additives Amendment of 1958, Pub. L. No. 85-929, §409, 72 Stat. 1784,1785 (codified as amended at 21 U.S.C. §341). This Act defined the requirements for food ingredients by taking a German Rule approach, deeming such ingredients unsafe unless satisfying the requirements set forth in the act.
144. Hutt, supra note 65, at 156. This change is important because food additives still require premarket approval from the FDA whereas dietary supplement manufacturers no longer must meet such a burden.
145. See Dunne, supra note 69, at 355.
146. Grossman, supra note 9, at 1147 n.405
147. (citing Federal Food, Drug, and Cosmetic Act §413(a) (1938) (codified as amended at 21 U.S.C. §350b(a))).
148. §8,108 Stat, at 4331 (codified as amended at 21 U.S.C. §350b(c)).
149. FINK ET AL., supra note 5, at 263.
150. §4,108 Stat, at 4328 (codified as amended at 21 U.S.C. §342(f)(1)). The information must be submitted to the Office of Nutritional Products, Labeling, and Dietary Supplements. 21 CF.R. § 190.6(a) (2009). This regulatory subsection also outlines in detail what information must be submitted as well as the duties of the FDA to acknowledge the receipt of such information.
151. Id. §190.6(b)(c).
152. 21 C.F.R. §190.6(a).
153. Id.
154. TALBOTT, supra note 56, at 10. Talbott also notes that "[a]lthough one would hope that all supplement manufacturers would exercise the highest ethical and scientific standards to develop strong safety evidence before introducing a new product, such is not always the case."
155. Id.
156. FINK ET AL., supra note 5, at 263.
157. 21 U.S.C. §342(f)(1)(B). Section (f)(1) explicitly specifies that the FDA bears the burden of proof because it states "the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated."
158. Id. §342(f)(1).
159. See id. §343(r).
160. Id. §343(r)(6).
161. See id. §321(g)(1)(B).
162. Id. §343(r)(6).
163. Id. §343(r)(6)(A).
164. Id.
165. The Federal Trade Commission has defined "advertising substantiation" as a reasonable basis for believing that each claim in the advertisement is true. BLACK'S LAW DICTIONARY 63 (9th ed. 2009). Again, because the burden is placed on the FDA under DSHEA, although the manufacturer under §343(r)(6)(B) must have substantiation, in reality the standard is that the FDA must show they did not have substantiation.
166. 21 U.S.C. §343(r)(6)(C).
167. Id. §342(g)(1). Congress thereafter granted the FDA the authority to "prescribe good manufacturing practices for dietary supplements" by regulation.
168. See id. §342(g)(2).
169. Id. §342(g)(1). The typical good manufacturing practices in place for food generally require that "personnel follow sanitary procedures and have suitable training; processing facilities be clean; processing equipment be designed to permit thorough cleaning and be properly maintained; and... finished products be appropriately packaged, labeled, stored, and shipped."
170. See Council for Responsible Nutrition, Before and After DSHEA, http://www.crnusa.org/about-pubs-DSHEA-facts.html (last visited Mar. 14,2010).
171. See Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 72 Fed. Reg. 34,752 (June 25,2007) (codified at 21 C.F.R. pt. 111).
172. See, e.g., 21 C.F.R. pt. 110 (2009).
173. RICHARD R. ABOOD, PHARMACY PRACTICE AND THE LAW 48 (4th ed. 2005).
174. See id.
175. Dietary Supplement and Nonprescription Drug Consumer Protection Act, Pub. L. No. 109-462,120 Stat. 3469 (2006) (codified as amended at 21 U.S.C. §371).
176. S. REP. No. 109-324, at 2-3 (2006).
177. §761,120 Stat, at 3472 (codified as amended at 21 U.S.C. §379aa-l).
178. Id.§ 761(b)(1).
179. An adverse event is "any health-related event associated with the use of a dietary supplement that is adverse." Id. §761(a)(1). Note that although this definition is circular, it is pretty clear that Congress meant adverse to mean "causing harm."
180. See MERRIAM-WEBSTER'S COLLEGIATE DICTIONARY 19 (11th ed. 2006).
181. §761(a)(2)(A)-(B), 120 Stat, at 3472 (codified as amended at 21 U.S.C. §379aa-l).
182. Draft Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability, 72 Fed. Reg. 58,313,58,314 (Oct. 15,2007).
183. See Dunne, supra note 69, at 359-60.
184. I refer to ephedrine as ephedrine alkaloids because this is how it is referred to by the FDA in its final register ruling. See infra note 140;
185. see aim FINK ET AL., supra note 5, at 260.
186. NCAAM, FDA Has Banned Ephedra: Consumer Advisory, http://nccam.nih.gov/ news/ alerts/ephedra/consumeradvisory.htm (last visited Mar. 14,2010).
187. Id.
188. Dunne, supra note 69, at 358.
189. Press Release, U.S. Food & Drug Admin., FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice that Consumers Stop Using These Products (Feb. 6,2004), http://www.thenhf.com/FDAPressRelease-02062004.pdf.
190. Dunne, supra note 69, at 358.
191. Jaime Holguin, Pressure on to Ban Ephedra, CBS EVENING NEWS, Aug. 13, 2002, http://www.cbsnews.com/stories/2002/08/13/eveningnews/main518563.shtml.
192. Dunne, supra note 69, at 351-52. Furthermore, the FDA received over 16,000 adverse event reports related to the use of ephedra before enacting the ban. Id. at 352. Though some have disagreed with the FDA's conclusion that ephedra caused a significant number of deaths, critics like Mike Fillon, the author of Ephedra: Fact or Fiction, have not stated that ephedra products were safe, but that they were not convinced ephedra was unsafe.
193. Larry M. Edwards, Metabolife: Morally Corrupt or Misunderstood Victim?, SAN DIEGO MAG., Mar. 2004, at 52 (citing MIKE FILLON, EPHEDRA: FACT OR FICTION (2004)).
194. See Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788, 6853 (Feb. 11, 2004) (codified at 21 C.F.R. pt. 119) (promulgating that all dietary supplements containing ephedrine alkaloids are considered to be adulterated under FDCA).
195. Press Release, Nat'l Health Fed'n, Dietary Supplements Containing Ephedrine Alkaloids Final Rule Summary (2004), http://www.thenhf.com/ EphedrineBanSummary.pdf.
196. Press Release, U.S. Food & Drug Admin., FDA Acts to Remove Ephedra-Containing Dietary Supplements from Market (Nov. 23, 2004), available at http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/2004/ucml 08379.htm.
197. Id.
198. WILLIAM B. SCHULTZ & LISA BARCLAY, A HARD PILL TO SWALLOW: BARRIERS TO EFFECTIVE FDA REGULATION OF NANOTECHNOLOGY-BASED DIETARY SUPPLEMENTS 18 (2009).
199. U.S. Food & Drug Administration, Adverse Events with Ephedra and Other Botanical Dietary Supplements (Sept. 1994), http://www.fda.gov/Food/ DietarySupplements/Alerts/ucmlll208.htm.
200. See id.
201. Id.
202. Id.
203. See supra notes 124-27 and accompanying text.
204. Press Release, U.S. Food & Drug Admin., supra note 136. The statement explicitly refers to section 4 of DSHEA, which states that the "United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated." Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §4, 108 Stat. 4325, 4328 (codified as amended at 21 U.S.C. § 342(f)(1) (2006)).
205. See Dietary Supplements Containing Ephedrine Alkaloids, 62 Fed. Reg. 30,678 (proposed June 4,1997) (to be codified at 21 C.F.R. pt. 111).
206. See U.S. Government Accountability Office, http://www.gao.gov/ (last visited Mar. 14, 2010). The GAO is a nonpartisan agency that seeks to "provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced."
207. Id. (follow "About GAO" hyperlink) (last visited Mar. 14,2010).
208. Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1036 (10th Cir. 2006)
209. (citing GOVERNMENT ACCOUNTING OFFICE, DIETARY SUPPLEMENTS: UNCERTAINTIES IN ANALYSES UNDERLYING FDA's PROPOSED RULE ON EPHEDRINE ALKALOIDS 11 (1999), http://www.gao.gov/ archive/1999/h299090.pdf.).
210. See Dietary Supplements Containing Ephedrine Alkaloids; Withdrawal in Part, 65 Fed. Reg. 17,474 (proposed Apr. 3,2000) (to be codified at 21 C.F.R. pt. 111).
211. Dunne, supra note 69, at 363.
212. See 720 III. COMP. STAT. ANN. 602/10 (West 2004);
213. see ateo N.Y. GEN. Bus. LAW §391-0 (McKinney 2009).
214. This litigation culminated in the Tenth Circuit case of Nutraceutical Corp. v. Von Eschenbach, which is discussed at length infra Part III.A.4.
215. The actual ban was first promulgated in 2004, but it was not until the Court of Appeals in Nutraceutical reversed the lower court's overturning of the ephedra ban that it was fully implemented.
216. See infra notes 216-22 and accompanying text.
217. Food Supplements Directive, supra note 19, at 51.
218. Nicole Coutrelis, The Legal Statui and Regulatory Context of "Health Foods" in the European Union, 58 FOOD & DRUG LJ. 35,36 (2003).
219. See Health Supreme News Blog, EU Food Supplements Directive: Scientists Challenge Philosophy of Precaution, Apr. 4, 2007, http://www.newmediaexplorer. org/sepp/2007/04/04/eu-food- supplements-directive-scientists-challenge- philosophy-of-precaution.htm.
220. See Food Supplements Directive, supra note 19, art. 4.
221. This includes states such as the United Kingdom, as European legislation overrides domestic legislation within the individual member states. See Fiona LeCong, Food Supplemente Directive: An Attempt to Restore the Public Confidence in Food Law, 29 LOY. L.A. INT'L & COMP. L. REV. 105,108 (2007).
222. Food Supplements Directive, supra note 19, Annex II.
223. Id.
224. The reason for the regulatory differences is that eight different compounds may comprise vitamin E tablets, but only alpha-tocopherol is on the positive list and permitted to be sold in the European Union, while the other seven are permitted in the United States. See id. Compare European Union Directive on Dietary Supplements, http://www.thefactsaboutfitness.com/news/eu.
225. Additionally, other dietary supplements such as selenium yeast, tin, manganese, and vitamin K2 were not on the "positive list" as of summer 2004 and were the subject of over 500 separate appeals. See Sam Lister, Health Groups Lose Appeal on EU Food Supplement Ban, TIMES (London), July 13,2005, http://www.timesonline.co.uk/tol/news/uk/article543347.ece.
226. Kathrin Jungbeck, Food Supplements Directive Set to Overhaul Europe, EUROMONITOR INT'L, June 15, 2004, http://www.euromonitor.com/Food-supplements- directive-set-to-overhauL Europe;
227. see ateo LeCong, supra note 163, at 109 (estimating the costs at £80,000 to £250,000).
228. Based on the exchange rate as of February 2, 2009, a single euro traded for $1.29050, meaning that getting a dietary ingredient added to the positive list would cost between $129,050 and $516,200. See U.S. Dollar Exchange Rate Graph-Euro, http://www.exchange-rates.Org/history/USD/EUR/T (last visited Mar. 14,2010).
229. See LeCong, supra note 163, at 109.
230. Id.
231. Lister, supra note 166.
232. Joined Cases C-154/04 & C-155/04, The Queen, In re Alliance for Natural Health v. Sec'y of State for Health, 2005 E.C.K. 1-6451,1-6524. Jim Murray, the Director of the European Consumers' Organisation, even opined that the decision was "a clear victory for consumers and for the EU's right to regulate on the safety of food products." Lister, supra note 166.
233. In fact, even celebrities spoke out against the Food Supplements Directive, including Paul McCartney and Elton John. LeCong, supra note 163, at 109.
234. S. REP. No. 103-410, at 2 (1994).
235. See Eric S. Nguyen, Weight Loss Testimoniale: A Critique of Potential FTC Restrictions on Diet Advertising, 63 FOOD & DRUG LJ. 493,495 (2008).
236. §4,108 Stat, at 4328 (codified as amended at 21 U.S.C. §342(f)).
237. See id. §2; see also S. REP. No. 103-410, at 2.
238. 21 U.S.C. §342(f); Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1038, 1040 n.6 (10th Cir. 2006). This standard requires the FDA to support its position with the greater weight of the evidence.
239. See Metropolitan Stevedore Co. v. Rambo, 521 U.S. 121,137-38 n.9 (1997).
240. As discussed throughout Part II, Congress intended to limit the FDA's ability to proactively regulate dietary supplements in order to increase consumer access and in response to public outcry to heightened restrictions. See supra Part II.A-B.
241. S. REP. No. 103-410, at 21 (1994).
242. §4,108 Stat, at 4328 (codified as amended at 21 U.S.C. §342(f)). While DSHEA provides that the U.S. Secretary of Health and Human Services may also declare that the dietary supplement at issue poses an imminent hazard to public health and safety, I disregard this because as of 2004, it has never happened.
243. See 150 CONG. REC. S86, 7081 (daily ed. June 21, 2004) (statement of Sen. Hatch). Furthermore, if a dietary supplement label does not contain suggested or recommended conditions of use, the FDA must show that it presents a significant or unreasonable risk of illness or injury under "ordinary conditions of use." §4,108 Stat, at 4328 (codified as amended at 21 U.S.C. §342(f)). Congress chose not to define "ordinary conditions of use" in DSHEA, yet the burden remains on the FDA to meet this standard.
244. See id.
245. Ephedra is a perfect example of this phenomenon. See supra Part U.C.
246. §2(14), 108 Stat, at 4326 (codified as amended at 21 U.S.C. §321).
247. National Consumers League, Health: Answers to Your Questions About OTC Painkillers, http://www.nclnet.org/health/100-over-the-counter-medicines/272- answers-to-your-questions-aboutotc-painkillers (last visited Mar. 14,2010).
248. Michael A. McCann, Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, 31 AM. J.L. & MED. 215, 258 (2005). For clarity, I am using the word overdose to mean taking more than the recommended dosage and not as a cause of death.
249. Over-the-counter medications are considered to be drugs because they satisfy the Code definition of drug. See 21 U.S.C. §321(g)(1).
250. See JULIE GARDEN-ROBINSON, N.D. STATE UNIV. EXTENSION SER., Q & A ABOUT DIETARY SUPPLEMENTS 1 (1997), http://www.ag.ndsu.edu/pubs/yf/foods/fn574. pdf.
251. Id.
252. See 21 U.S.C. §360e.
253. See S. REP. No. 103-410, at 20 (1994).
254. Press Release, U.S. Food & Drug Admin., FDA Announces Major Initiatives for Dietary Supplements (Nov. 4, 2004), available at http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2004/ucml08369.htm [hereinafter FDA Initiative].
255. See Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033,1039 n.35 (10th Cir. 2006).
256. See id.
257. Ephedrine and ephedrine alkaloids were first isolated in 1887 and were introduced to the United States in 1924 as decongestants and bronchodilators for asthma. See UNIV. OF WASH., EPHEDRA 17 (n.d.), www.fammed.washington.edu/ predoctoral/CAM/images/ephedra.pdf. As a result, neither fell within the definition of new dietary ingredient, or one that was "not marketed in the United States before [DSHEA]."
258. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103417, §8,108 Stat. 4325,4331 (codified as amended at 21 U.S.C. §350b).
259. §8,108 Stat, at 4331 (codified as amended at 21 U.S.C. §350b); 21 CF.R. §190.6(a) (2009); see ateo FDA Initiative, supra note 190.
260. U.S. Food & Drug Administration, New Dietary Ingredients in Dietary SupplementsBackground for Industry, http://www.cfsan.fda.gov/~DMS/ds-ingrd.html (last visited Mar. 14, 2010) [hereinafter DSHEA New Dietary Ingredients].
261. Id.
262. Id.
263. §4,108 Stat, at 4328 (codified as amended at 21 U.S.C. §342(f)).
264. See Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1040 n.6 (10th Cir. 2006). The FDA would have to demonstrate that the evidence does not establish that the dietary supplement would not reasonably be expected to be safe under the conditions recommended or suggested in the dietary supplement label. §8,108 Stat, at 4331 (codified as amended at 21 U.S.C. §350b(a)(2)).
265. DSHEA New Dietary Ingredients, supra note 195.
266. Id. For example, the FDA provided such a response to the manufacturer of a dietary supplement containing manganese glucosamine gluconate in 2005.
267. See Letter from Dr. Susan J. Walker, Dir., Div. of Dietary Supplement Programs, U.S. Food & Drug Admin., to Brent M. Burningham, Gen. Counsel, Albion Laboratories, Inc. (Nov. 10, 2005), http://www.fda.gov/ohrms/dockets/ DOCKETS/95s0316/95s-0316-rpt0298-02-vol233.pdf.
268. See Letter, supra note 201.
269. See Dietary Supplement and Nonprescription Drug Consumer Protection Act, Pub. L. No. 109-462, 120 Stat. 3469 (2006) (codified as amended at 21 U.S.C. §371).
270. In fact, the Senate Committee on Health, Education, Labor, and Pensions affirmed this fact by stating: Critics of the regulatory scheme laid out by DSHEA argue that all, or at least some, dietary supplement products or ingredients (such as stimulants) should be subject to premarketing approapval by the government. When approving DSHEA, this committee and later the Congress rejected such a regulatory system given the history of safe use of the majority of supplement products and the inherent cost of any preapproval marketing requirement. The committee is not reconsidering that decision with this legislation. S. REP. No. 109-324, at 2 (2006).
271. §760, 120 Stat, at 3469 (codified as amended at 21 U.S.C. §379aa).
272. Id. §760 (codified at 21 U.S.C. §379aa(a)(3)(A)).
273. See id. §760 (codified at 21 U.S.C. §379aa). An adverse event, for purposes of dietary supplements, is simply defined as an event "that is adverse." Id. §760 (codified at 21 U.S.C. § 379aa(a)(l)). As discussed in Part II.B.2, this definition is circular but its interpretation as meaning to cause harm is pretty clear.
274. The 2006 Act requires a "responsible person" to submit the information. Id. §760 (codified at §379aa(b)(l)). The responsible person includes the manufacturer, packer, or distributor whose name appears on the dietary supplement label. Id. For the purposes of this Note and for simplicity's sake, I refer to the responsible person collectively as the manufacturer.
275. Id.
276. The Senate Committee's explanation of the 2006 Act affirms this interpretation as it specifispecifically states in the Senate Report that "[t]he manufacturer... of the supplement... must submit through the MedWatch form any serious adverse event report it receives and a copy of the labeling for the product to the [FDA] within 15 business days after the report is received." S. REP. No. 109-324, at 5 (2006) (emphasis added).
277. See id;
278. see also §760, 120 Stat, at 3469 (codified as amended at 21 U.S.C. §379aa). The limited reporting requirement also suggests that adverse events are underreported to the FDA. For example, Metabolife, the manufacturer of an ephedra-containing weight loss product, in a letter to the FDA explained it had never received consumer notice of a serious adverse health event when it had received over fifteen thousand reports of adverse events from consumers.
279. Edwards, supra note 139, at 54.
280. See supra note 204 and footnote text.
281. Dunne, supra note 69, at 351-52.
282. Id. at 352.
283. In fact, the FDA wanted to implement the ban much sooner. See Dietary Supplements Containing Ephedrine Alkaloids, 62 Fed. Reg. 30,678 (proposed June 4,1997) (to be codified at 21 C.F.R. pt. 111).
284. 459 F.3d 1033 (10th Cir. 2006), rev'g sub nom Nutraceutical Corp. v. Crawford, 364 F. Supp. 2d 1310 (D. Utah 2005), cert, denied, 550 U.S. 933 (2007). What makes this case noteworthy is that such a challenge is incredibly rare because dietary supplements containing ephedrine alkaloids are the only dietary supplements banned for presenting a significant or unreasonable risk.
285. See 21 C.F.R. § 119.1 (2009) (listing only supplements containing ephedrine alkaloids among "Dietary Supplements that Present a Significant or Unreasonable Risk").
286. Several other cases did arise out of the ephedra ban following Nutraceutical, but these were often dismissed at the summary judgment stage. See, e.g., Hi-Tech Pharm., Inc. v. Crawford, 505 F. Supp. 2d 1341,1358 (N.D. Ga. 2007).
287. See Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788 (Feb. 11, 2004) (codified at 21 C.F.R. pt. 119).
288. Nutraceutical, 459 F.3d at 1035.
289. Crawford, 364 F. Supp. 2d. at 1319,1321.
290. Nutraceutical, 459 F.3d at 1044.
291. Nutraceutical Corp. v. Von Eschenbach, 550 U.S. 933 (2007).
292. Nutraceutical, 459 F.3d at 1038 (quoting Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. at 6823).
293. To meet its preponderance burden, the FDA had to support its position with the greater weight of the evidence. Nutraceutical, 459 F.3d at 1040.
294. See id. at 1041-42.
295. Id. at 1042-43.
296. Id. at 1043.
297. Id. at 1039.
298. LeCong, supra note 163, at 117.
299. Id. at 117 (quoting Gina Kolata, The Unwholesome Tale of the Herb Market, N.Y. TIMES, Apr. 21,1996, at E6).
300. Dunne, supra note 69, at 357. The effectiveness of these public warnings, however, is quesquestionable as these warnings by themselves do not result in the removal of the product from the market. Id.
301. See supra Part II.D.
302. See Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §2(9), 2(12), 2(14), 108 Stat. 4325,4325-26 (codified as amended at 21 U.S.C. §321 (2006)).
303. See, e.g., Grossman, supra note 9, at 1139 (discussing how the herbal supplement industry grew from a market of "small niche companies" to a corporation-dominated industry capable of de fending itself against the FDA).
304. §2(13), 108 Stat, at 4326.
305. Food Supplements Directive, supra note 19, art. 4.
306. §8,108 Stat, at 4331 (codified as amended at 21 U.S.C. §350b(a)(2)).
307. LeCong, supra note 163, at 115.
308. Food Supplements Directive, supra note 19, art. 4.
309. Id. art. 5. Once this maximum dosage is established, the manufacturer must include a warning not to exceed the state recommended daily dose on the label. Id. art. 6(l)-(3)(c).
310. See Coutrelis, supra note 160, at 36.
311. See supra note 167 and accompanying text.
312. Jungbeck, supra note 167.
313. See LeCong, supra note 163, at 117-18.
314. Id.
315. Natural Health Products Regulations (Food and Drugs Act) SOR/2003-196 (Can.);
316. see also Health Canada, Compliance Policies for Natural Health Products, http://www.hc-sc.gc.ca/dhp-mps/ prodnatur/legislation/pol/complian-conform-pol- eng.php#tocl (last visited Mar. 14,2010).
317. See supra Part III.B.
318. For the purposes of this Note, it is not necessary to fully lay out specific requirements the dietary supplement manufacturers must satisfy to have their supplements placed on the list of permitted supplements. Newer manufacturers of dietary supplements would also not be harmed under this standard because they would be allowed to use ingredients shown by other manufacturers to have marketed pre-DSHEA. For example, if Company A effectively demonstrates that a certain type of vitamin A was available prior to 1994, then Company B may market its vitamin A as well, so long as it does not contain any additional ingredients that do not satisfy the pre-1994 requirements.
319. A manufacturer would have a larger incentive to act quickly because it would likely still be manufacturing the dietary supplements at issue and failure could result in lost profits.
320. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §2(14), 108 Stat. 4325, 4326 (codified as amended at 21 U.S.C. §321 (2006)). Admittedly, both L-tryptophan and ephedra were dangerous dietary supplements marketed before DSHEA. Both are no longer allowed to be sold in the United States, however, alleviating the problems associated with them.
321. Throughout the 1990s, the dietary supplement industry experienced growth of over ten per cent each year. TALBOTT, supra note 56, at 2.
322. KAREN EICH DRUMMOND & LISA M. BREFERE, NUTRITION FOR FOODSERVICE AND CULINARY PROFESSIONALS 291 (6th ed. 2007).
323. Id. This is despite the fact that dietary supplement labels must contain disclaimers stating that any claims they make regarding their effect on the structure or function of the body have not been evaluated by the FDA.
324. See U.S. Food & Drug Administration, supra note 10.
325. See supra notes 194-200 and accompanying text.
326. See supra Part III.A.3.
327. This may seem like a harsh result as these dietary supplements will have already been marketed to consumers at the time this approach is enacted. The burden, however, is only heightened for manufacturers of dietary supplements that were first marketed only since the DSHEA's passage or those for whom serious adverse event reports or a significant number of adverse events have been reported. 257. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579,592-94 (1993).
328. Id. at 592-95.
329. The FDA could implement such interpretations by publishing Proposed and Final Rules in the Federal Regteter and ultimately codifying them in the Code of Federal Regulations. Because the FDA would implement these standards and utilize them in its Tier III evaluations, it would be in the best position to establish the most appropriate working standard.
330. Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, §2(15)(A), 108 Stat. 4325,4326 (codified at 21 U.S.C. §321 (2006)).
331. Products liability lawsuits also have the potential to deter dietary supplement manufacturers from marketing potentially unsafe products. Although the actual deterrent effect of such suits is beyond the scope of this Note, additional congressional action is needed to adequately protect consumers with one reason being the inherent difficulty for plaintiffs to establish a class action under Federal Rule of Civil Procedure 23(b)(3). This is emphasized by a New York district court's refusal to certify a settlement class against an ephedra manufacturer because the predominance requirements were not satisfied. See In re Ephedra Prods. Liab. Litig., 231 F.R.D. 167,171 (S.D.N.Y. 2005);
332. FED. R. CIV. P. 23(b)(3) (stating that the court must find that "the questions of law or fact common to class members predominate over any questions affecting only individual members"). "Innumerable questions affecting individual class members would arise," because the plaintiff class ranged from individuals with no actual injuries to the survivors of those who had died from the product.
333. In re Ephedra Prods. Liab. Litig., 231 F.R.D. at 168-70 (citing
334. Amchem Prods, v. Windsor, 521 U.S. 591, 622 (1997)) ("[The] common interest in a fair, reasonable and adequate settlement is not a question to be considered under the predominance test."). Furthermore, the purpose of the tier system is to prevent un safe dietary supplements from reaching the market in the first place, whereas a products liability suit is a reactive measure. Coupling lawsuits with a more proactive regulatory scheme would be the most effective way to protect consumers.
335. §2(6)(A), 108 Stat, at 4326 (codified at 21 U.S.C. §321).