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Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice

Published online by Cambridge University Press:  06 January 2021

Michael A. McCann
Michael A. McCann*
Affiliation:
Mississippi College School of Law; Harvard Law School; University of Virginia School of Law; Georgetown University
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Extract

There exists increasing concern that the Dietary Supplements Health and Education Act (“DSHEA”) has proven ineffective and perhaps counterproductive. Most illustratively, consider a recent and remarkably candid remark from Tommy Thompson, then Secretary of Health and Human Services: “I really think Congress should take a look at the food supplement law again. It doesn't make any sense to me.”

A health law that makes no sense to the Secretary of Health of Health and Human Services should certainly draw the attention of academics and policy-makers alike. Much of the debate concerning DSHEA regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Specifically, while pharmaceutical drugs must undergo years of costly pre-market testing, most dietary supplements—like most foods—can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (“FDA”) remove them.

Type
Article
Information
American Journal of Law & Medicine , Volume 31 , Issue 2-3 , June 2005 , pp. 215 - 268
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2005

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References

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4 Other instruments include powders, teas, loose plant parts, and lozenges. Id.

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6 Consumers can easily confuse black or green tea with “dieter's teas” advertised for weight loss. Dieter's teas are considered potentially harmful by the FDA. See Capriotti, Teri, Any science Behind the Hype of Natural’ Dietary Supplements?, 5 Med/Surg Nursing 339 (2004)Google Scholar.

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14 Leis, supra note 14.

15 Robin Davis, Deli Day, COLUMBUS DISPATCH, Sept. 29, 2004, at 01B.

16 Julie Deardorff, Sitting Pretty, CHI. TRIB., Jan. 25, 2004, at 1 (citing PAUL ZANE PILZER, THE WELLNESS REVOLUTION (2004)); see also StockSplits.com Announces 12 to 20 Plus Has Received Approval From Its Shareholders for a 1 for 57 Reverse Split, MARKET WIRE, Nov. 4, 2004, available at LEXIS News Database (projecting that retail sales in the dietary supplement market are expected to reach $21 billion by year 2007, according to Frost & Sullivan reports). But see Amy Klien, Diet Additive Seller Must Repay Millions, RECORD, July 13, 2004, at A1 (noting that recent litigation against dietary supplement manufacturers has damaged the industry's reputation).

17 See, e.g., id.

18 FDA Holds Public Meeting About Safety of Dietary Supplements (National Public Radio broadcast, Nov. 15, 2004), available at LEXIS, News Library, NPR file. But see Darshak Sanghavi, A Mainstream Doctor Finds a Place for Alternative Medicine, BOSTON GLOBE, June 22, 2004, at C1 (citing a study conducted by JAMA, which concluded that 42 percent of Americans use dietary supplements).

19 The market for children's supplements has also been growing. Industry analysts estimate annual sales of children's supplements reached $510 million as of July 2002 and represented one of the top niche markets in the supplement industry. Statement of Howard Beales, supra note 8.

20 For example, Zantrex-3, which includes caffeine, ginseng, and cocoa nut, has become especially popular as a supplement which helps people lose weight and regain energy. Moreover, its popularity has only increased since the FDA banned ephedra. See Hamilton, Carey, Ephedra Ban Tilts Diet Pill Market, SALT LAKE TRIB., Apr. 26, 2004Google Scholar, at A1.

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24 Paige Hewitt, Focus: Vaccinations, HOUS. CHRON., July 30, 2003, at A22.

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27 For extensive analysis of DSHEA, see infra Part III.F.

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29 Drugs are statutorily defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” 21 U.S.C. § 321(g)(1)(B) (2000).

30 21 U.S.C. § 355 (2000) (also known as the “Drug Efficacy Amendment”).

31 For a more detailed discussion regarding the Kefauver-Harris Amendment, see Merrill, Richard A., The Architecture of Government Regulation of Medical Products, 82 Va. L. Rev. 1753, 1764-69 (1996)CrossRefGoogle Scholar.

32 See 21 C.F.R. § 312.23(a)(6)(iii)(b) (2004); see also Merrill, supra note 32, at 1782 (detailing clinical guidelines).

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34 21 U.S.C. § 355.

35 See Michaels, Mara A., FDA Regulation of Health Claims under the Nutrition Labeling and Education Act of 1990: A Proposal for a Less Restrictive Scientific Standard, 44 Emory L.J. 319, 328 (1995)Google Scholar.

36 Pub. L. No. 75-717, 52 Stat. 1040 (1938) (current version at 21 U.S.C. §§ 301- 397 (2000).

37 See, e.g., 21 C.F.R. §§ 201.56(a)-(b) (2004). Prior to enactment of the FDCA, a drug manufacturer could set its own development and marketing schedule. If FDA disputed a drug's safety or effectiveness, the agency bore the burden of initiating the legal process and proving that it was dangerous or mislabeled. See Merrill, supra note 32, at 1797.

38 See id. at 1853 (exemplifying that if a manufacturer wished, implausibly, to market a drug for the treatment of both high blood pressure and diabetes, it would need to submit to FDA sufficient evidence that the drug was safe and effective for each “indication”).

39 See id. at 1768.

40 See 21 U.S.C. §§ 331(a)-(b), 352 (2000).

41 See New Legislation Introduced to Allow Health Plan Coverage of Dietary Supplements, PR NEWSWIRE, Sept. 4, 2001, available at LEXIS, News Library.

42 Id.

43 See, e.g., Arthur P. Grollman, professor of pharmacological sciences and medicine at the State University of New York, Regulation of Dietary Drugs is Long Overdue, N.Y. TIMES, Feb. 23, 2003Google Scholar, at 10 (stating “[h]erbal products are primarily used as medicines”); see also Friede, Arnold I, Dietary Supplements: Background for Dialogue Between the Industry and Medical Profession, 53 Food Drug L.J. 413, 419 (1998)Google ScholarPubMed (finding that consumers tend to choose self-medication through dietary supplements whenever exposed to new health claims among dietary supplement products).

44 See Li, Weishi, Botanical Drugs: A Future for Herbal Medicines, 19 J. Contemp. Health L. & Pol’Y 117, 119 (2002)Google ScholarPubMed; see also MICHAEL H. COHEN, BEYOND COMPLIMENTARY MEDICINE: LEGAL AND ETHICAL PERSPECTIVES ON HEALTH CARE AND HUMAN EVOLUTION (2000) (offering a historical account of supplement usage, including usage as medicines); see also Regulation of Dietary Supplements, 58 Fed. Reg. 33,690, 33,697-98 (proposed June 18, 1993) (finding that herbs have traditionally been used as medicines).

45 Aside from popular recognition of their functional similarity, dietary supplements and medicines have also been regarded as alike by members of Congress. For instance, in 2001, Senators Tom Harkin and Orrin Hatch proposed the Dietary Supplement Tax Fairness Act, legislation that would have amended Section 213(d) of the Internal Revenue Code of 1986, which limits the medical expense deduction to prescribed drugs, to include spending on dietary supplements within the definition of a medical expense. In introducing this legislation, Senator Harkin noted the need for parity, arguing, “Our current policy is unfair and is failing to take full advantage of the potential to improve health and hold down health care costs through preventive health care practices available to consumers. Bringing the code up to date to recognize and allow for this important need for wellness and health promotion is an important step forward to overall sound healthcare policy.” See Statements on Introduced Bills and Joint Resolutions, 147 Cong. Rec. S. 8709, Aug. 2, 2001. Also consider similar remarks by Rep. Dan Burton: “Many consumers often ask why there are no insurance benefits for dietary supplements, which are used primarily to maintain good health and wellness. Some dietary supplements, like Folic Acid, can help prevent disease or disease risks like birth defects. Many insurance companies would like to offer coverage to their beneficiaries who continually demand this type of coverage. Unfortunately, the tax code does not allow an insurer to offer this coverage without incurring tax liabilities to consumers and higher administration costs. This powerful disincentive needs to be removed so health insurers can begin developing meaningful and cost effective benefits for their beneficiaries and assist them in maintaining good health longer.” See Extension of Remarks by Rep. Burton, 147 Cong. Rec. E. 2288, Dec. 13, 2001.

46 See Kessler Criticizes Dietary Supplements, OMAHA WORLD-HERALD, Mar. 4, 1998, available at LEXIS, News Library (citing remarks by former FDA Commissioner David Kessler, who argued that dietary supplements are often marketed to confuse consumers into believing those products possess medicinal qualities).

47 See Eli Lilly & Co. v. Natural Answers, Inc., 233 F.3d 456, (7th Cir. 2000) (affirming enjoining use of defendant's mark under the Lanham Trademark Act, the Federal Trademark Dilution Act and state unfair competition law); see also Thanh Do, Liem, Dilution Standard Number: A Quantitative Approach in Proving Actual Dilution under the Federal Trademark Dilution Act, 11 Tex. Wesleyan L. Rev. 107, 128 (2004)Google Scholar (discussing the implications of the Eli Lilly holding).

48 See Marian Segal, FDA Warns Against Drug Promotion of “Herbal Fen-Phen”, FDA TALK PAPER, Nov. 6, 1997, available at http://www.fda.gov/bbs/topics/ANSWERS/ANS00832.html.

49 Regulation of Dietary Supplements, 58 Fed. Reg. 33,690, 33,692 (June 18, 1993); see also, e.g., Schwetz, Bernard A., Safety of Aristolochic Acid, 285 JAMA 2705 (2001)CrossRefGoogle Scholar (describing deleterious consequences of aristolochic acid when dispensed in high concentrations).

50 58 Fed. Reg. at 33,692; see also Jonas, Wayne B., Alternative Medicine: Learning From the Past, Examining the Present, Advancing to the Future, 280 JAMA 1616, 1618 (1999)Google Scholar (identifying historical trends of dietary supplement labeling that have proved deleterious for consumers). Notably, these phenomena appear exacerbated on the Internet with on-line vendors. See Morris, Charles A. & Avorn, Jerry, Internet Marketing of Herbal Products, 290 JAMA 1505, 1509 (2003)CrossRefGoogle ScholarPubMed.

51 McGuire, Elizabeth R., The Entitlement of Veterans Affairs Medical Patients to Vulnerable Population Status for Human Medical Research, 2 Health Matrix 259, 279-80 (1992)Google ScholarPubMed.

52 See Doug Cutter, The 7 Myths of Dietary Supplements, RICH. TIMES DISPATCH, Jan. 21, 2004, at D-8.

53 See Combs, supra note 9.

54 See Woolf, Alan D., Herbal Remedies and Children: Do They Work? Are They Harmful?, 112 Pediatrics 240, 240-46 (2003)Google ScholarPubMed; see also Bucher, H. C., Effects of dietary calcium supplementation on blood pressure: A meta-analysis of randomized controlled trials, 275 JAMA 1016, 1022 (1996)Google ScholarPubMed (concluding that contrary to popular belief, calcium supplementation appears to promote no appreciable reduction in blood pressure); Macknin, Michael L. et. al, Zinc Gluconate Lozenges for Treating the Common Cold in Children: A Randomized Controlled Trial, 279 JAMA 1962, 1967 (1998)CrossRefGoogle ScholarPubMed (finding that zinc offers no clinical value in treating the common cold).

55 See Hanson, Jon D. & Kysar, Douglas A., Taking Behavioralism Seriously: Some Evidence of Market Manipulation, 112 Harv. L. Rev. 1420, 1511 (1999)CrossRefGoogle ScholarPubMed.

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58 See Hanson & Kysar, supra note 55, at 1512; see also Segerstrom, Suzanne C. et al., Optimistic Bias Among Cigarette Smokers, 23 J. Applied Soc. Psychol. 1606, 1614-17 (1993)CrossRefGoogle Scholar; Strecher, Victor J. et al., Do Cigarette Smokers Have Unrealistic Perceptions of Their Heart Attack, Cancer, and Stroke Risks?, 18 J. Behav. Med. 45, 49 (1995)CrossRefGoogle ScholarPubMed.

59 See Reppucci, Jonathan D. et al., Unrealistic Optimism Among Adolescent Smokers and Nonsmokers, 11 J. Primary Prevention 227, 235 (1991)CrossRefGoogle ScholarPubMed. But see Kip Viscusi, W., Constructive Cigarette Regulation, 47 Duke L.J. 1095, 1113-14 (1998)Google ScholarPubMed (presenting evidence that optimism bias is unsupported in the context of cigarette smoking).

60 See Hanson & Kysar, supra note 55, at 1514.

61 See id.

62 Id. at 1515.

63 On May 18, 2005, a Google search of “ephedra free” yielded 421,000 results, and most of those results directed to websites that promoted the sale of “ephedra free” diet pills.

64 See Hanson & Kysar, supra note 55, at 1440 (noting this effect with the sale of used cars).

65 A similar concept would be how the presence of a delicious and fattening dessert option may encourage “would-be abstainers to order ice cream with fruit.” Id. at 1515; see also Richard Saltus, Tobacco Critics Say “Lite” Label Misleads, BOSTON GLOBE, Jan. 31, 1997, at B2 (noting research that longtime smokers lose motivation to quit when they switch to lighter brands).

66 See HA T. TU & J. LEE HARGRAVES, CTR. FOR STUDYING HEALTH SYS. CHANGE, DATA BULLETIN NO. 28: HIGH COST OF MEDICAL CARE PROMPTS CONSUMERS TO SEEK ALTERNATIVES (2004), available at http://www.hschange.org/CONTENT/722/.

67 Id.

68 See Dwyer, Johanna T. et al., Assessing Nutritional Status in Elderly Patients, 47 Am. Fam. Physician 63 (1993)Google ScholarPubMed; see also Earl Lane, As More Seniors Turn to Supplements, More Data Needed, MILWAUKEE J. SENTINEL, Feb. 3, 2004, at 01G (noting increasing trend of seniors to rely on dietary supplements for medicinal needs).

69 See Rebecca H. Madley, Reviving the Antioxidant Market, Nutraceuticals World, at http://www.nutraceuticalsworld.com/mar011.htm (last visited May 10, 2005).

70 See Lane, supra note 68 (citing comments by Susan Mayne, a Yale University epidemiologist). On the other hand, preliminary, if inconclusive data suggests that Vitamin E can improve the immune response to respiratory tract infections among the elderly. See Nikbin Meydani, Simin et al., Vitamin E and Respiratory Tract Infections in Elderly Nursing Home Residents, 292 JAMA 828, 836 (2004)Google Scholar. Similarly promising, if premature, findings have identified a positive correlation between Vitamin D consumption and reduced frequency of falling. See Bischoff-Ferrari, Heike A. et al., Effect of Vitamin D on Falls, 291 JAMA 1999, 2006 (2004)CrossRefGoogle ScholarPubMed.

71 See Grisso, Thomas, The Competence of Adolescents as Trial Defendants, 3 Psych. Pub. Pol. & L. 3, 14Google Scholar; see also Atwood, Barbara A., The Child's Voice in Custody Litigation: An Empirical Survey and Suggestions for Reform, 45 Ariz. L. Rev. 629, 657 (2003)Google Scholar; Arredondo, David E., Child Development, Children's Mental Health and the Juvenile Justice System: Principles for Effective Decision-Making, 14 Stan. L. & Pol’Y Rev. 13, 15 (2003)Google Scholar (describing impulsive behavior of adolescents).

72 See Feld, Barry C., Competence, Culpability, and Punishment: Implications of Atkins for Executing and Sentencing Adolescents, 32 Hofstra L. Rev. 463, 511 (2003)Google Scholar; see also ERIK H. ERIKSON, IDENTITY YOUTH AND CRISIS 156 (1968) (describing the appeal of risk to adolescents, since it helps them find a role in society). Indeed, these phenomena help explain why “tobacco, alcohol, and illicit drug use begin most often between the ages of sixteen and eighteen.” Cauffman, Elizabeth & Steinberg, Laurence, The Cognitive and Affective Influences on Adolescent Decision-Making, 68 Temp. L. Rev. 1763, 1767 (1995)Google Scholar.

73 See Campbell, Angela J., Ads2Kids.com: Should Government Regulate Advertising to Children on the World Wide Web?, 33 Gonz. L. Rev. 311, 320 (1997–1998)Google Scholar.

74 See Atwood, supra note 71, at 657.

75 See JAMES U. MCNEAL, KIDS AS CUSTOMERS: A HANDBOOK OF MARKETING TO CHILDREN 1-20 (1992).

76 See Karen E. Rondon, Innovations and Trends in the Electronic Toy Market, at 10 (SRI Consulting, Bus. Intelligence Program, No. D96-2028, 1996), available at http://www.sric-bi.com/; see also Barboza, David, If You Pitch It, They Will Eat It, N.Y. TIMES, Aug. 3, 2003Google Scholar, § 3, at 1 (reporting that between their own spending and their influence on parental spending, children four- to twelve-years-old are responsible for approximately $600 billion a year in expenditures).

77 See Money, supra note 10 (citing a study conducted by the NCAA).

78 See Steroids: Play Safe, Play Fair, American Academy of Pediatrics, at http://www.aap.org/family/steroids.htm (last visited May 10, 2005).

79 See Ebbeling, Cara B. et al., Childhood Obesity: Public-Health Crisis, Common Sense Cure, 360 Lancet 473, 476 (2002)CrossRefGoogle ScholarPubMed.

80 See generally Ann Kaczka, Kelly, From Herbal Prozac to Mark McGuire's Tonic: How the Dietary Supplement Health and Education Act Changed the Regulatory Landscape for Health Products, 16 J. Contemp. Health L. & Pol’Y 463 (2000)Google Scholar.

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82 See Metzl, Jordan D. et al., Creatine Use Among Young Athletes, 108 Pediatrics 421, 421-22 (2001)CrossRefGoogle ScholarPubMed.

83 Id.

84 See Sameh Fahmy, Muscle Madness, THE TENNESSEAN, May 11, 2004, at 1D (citing study conducted by Dr. Nick Evans of the UCLA Medical Center and Los Angeles Orthopedic Hospital).

85 See Metzl et al., supra note 82; see also Plax, Kati, Performance Enhances Pose Numerous Risks, ST. LOUIS POST-DISPATCH, Oct. 4, 2004Google Scholar, at 8 (reporting side effects); Salzman, Avi, Playing Fields and the Threat of Steroid Use, N.Y. TIMES, Dec. 19, 2004Google Scholar, § 14CN, at 1 (providing additional background information on appeal of creatine to children and adolescents).

86 See Jeremy Fowler, Clouds of Suspicion, ALBUQUERQUE TRIB., Nov. 27, 2004, at B1 (citing remarks by Professor Robert Robergs of the University of New Mexico, an expert on exercise physiology).

87 See Metzl et al., supra note 82; see also Salzman, Avi, Playing Fields and the Threat of Steroid Use, N.Y. TIMES, Dec. 19, 2004Google Scholar, at 1 (providing additional background information on appeal of creatine to children and adolescents). Not all studies identify health impairment with use of creatine. See e.g., Poortmans, J.R. & Franceux, M., Renal Dysfunction Accompanying Oral Creatine Supplements, 352 Lancet 234 (1998)CrossRefGoogle ScholarPubMed (concluding that “medium-term oral creatine supplements do not affect kidney function in healthy individuals”).

88 See supra note 65 and accompanying text.

89 See McBride, Brian F., Electrocardiographic and Hemodynamic Effects of a Multicomponent Dietary Supplement Containing Ephedra and Caffeine: A Randomized Controlled Trial, 291 JAMA 216, 221 (2004)CrossRefGoogle ScholarPubMed (concluding that “consumers are drawn to herbal preparations because of their nonprescription status, direct-to-consumer advertising, and the perception that natural products are innately safe. Unfortunately, the perception of safety may be the result of a lack of data”); see also Okie, Susan, Dietary Supplements Gaining Public Approval, If Not Government’s, WASH. POST, Nov. 25, 1997Google Scholar, at A1 (citing research conducted by Esther Sternberg, a rheumatologist with the National Institute of Mental Health, suggesting that consumers overestimate the degree of proven safety associated with dietary supplements).

90 See Revving Up’ on Hooey, WASH. POST, Aug. 26, 2003, at F3 (quoting David Nieman, director of the Human Performance Laboratory at Appalachian State University).

91 See Deardorff, supra note 16.

92 See id.

93 See Lifestyles of the Sick and Famous, ALAMEDA TIMES-STAR, Nov. 17, 2002, at Opinions/Editorials. Brolin played Dr. Steven Kiley in the short-lived television series Marcus Welby, M.D. See INTERNET MOVIE DATABASE, PROFILE: JAMES BROLIN, available at http://www.imdb.com/name/nm0000981/ (last visited Jan. 1, 2005).

94 See Michael Specter, Miracle in a Bottle, THE NEW YORKER, Feb. 2, 2004, at 64.

95 See Deardorff, supra note 16. Also consider that consumers may be confused by advice from physicians concerning dietary supplements, as physicians tend to embrace widely varied views of supplement efficacy. See Davis, Kenneth M. et al., Physician Marketing of Nutritional Supplements, 280 JAMA 967, 968 (1998)CrossRefGoogle ScholarPubMed. Accordingly, it would appear that “celebrity” endorsements might achieve greater salience among consumers.

96 See Spencer, Amber K., Comment, The FDA Knows Best … Or Does It? First Amendment Protection of Health Claims on Dietary Supplements: Pearson v. Shalala, 15 Byu J. Pub. L. 87 (2000)Google Scholar; see also Brand, Rachel, Hauser Tumbles into Chapter 11, ROCKY MOUNTAIN NEWS, Apr. 3, 2003Google Scholar, at 1B (detailing how Hauser, a dietary supplement manufacturer, blamed “intense competition in the dietary supplement industry” for its recent decision to declare bankruptcy).

97 See Shipley, Amy, New Steroids Sold Over Counter, WASH. POST, Dec. 6, 2002Google Scholar, at A1 (describing incentive for copy-cat practices among dietary supplement manufacturers given fierce market competition); see also Brand, supra note 96, at 1B.

98 See Allen, Jane E., A First Step Toward Standardizing Supplements, L.A. TIMES, Mar. 17, 2003Google Scholar, at 3; see also infra Part V.B.

99 See Page, Joseph A., The Passage of Time: The Implications for Product Liability, 58 N.Y.U.L. Rev. 853, 869 (1983)Google Scholar; see also Weingarten, S., Practice Guidelines and Prediction Rules Should be Subject to Careful Clinical Testing, 277 JAMA 1977, 1978 (1997)CrossRefGoogle ScholarPubMed (describing significance of clinical testing guidelines in the medical review process). Note that, in light of international competition among drug manufacturers, the FDA has become arguably less demanding of American manufacturers in regards to clinical testing and clinical trials. See Dawson, Nigel S. B., Pharmacopolitics: Drug Regulation in the United States and Germany, 292 JAMA 742, 743 (2004)Google Scholar.

100 See Angell, Marcia & Kassirer, Jerome P., Alternative Medicine: The Risks of Untested and Unregulated Remedies, 339 New Eng. J. Med. 839 (1998)CrossRefGoogle ScholarPubMed; see also Hurst, Jerry et. al, Are Physicians’ Office Laboratory Results of Comparable Quality to Those Produced in Other Laboratory Settings?, 279 JAMA 468, 471 (1998)CrossRefGoogle ScholarPubMed (distinguishing between varying clinical tests, including waived tests, provider-performed microscopy, and moderate-complexity and high-complexity tests).

101 See Bodekar, Gerard, A Regional Task Force on Traditional Medicine and AIDS, 355 Lancet 1284 (2000)CrossRefGoogle Scholar; see also Sanghavi, supra note 18 (illustrating lack of effectiveness among herbal remedies for AIDS); Kaluba, Austin, More Research Needed in Zambian Herbal Medicines, TIMES ZAMBIA, Jan. 24, 2005Google Scholar, at 1 (describing use of herbs by Zambian medical healers).

102 Id.

103 See H.J. Kaltsas, Patent Poisons, ALTERN MED., Nov. 1999, at 24-28; see also Ko, Richard J., Causes, Epidemiology, and Clinical Evaluation of Suspected Herbal Poisoning, 6 J. Toxicology 697 (1999)Google Scholar (explaining inconsistent quality controls of Chinese manufacturers, and how the central government has limited authority and resources to regulate the dietary supplement industry).

104 See generally A Herb a Day Keeps Doctors Away, CHINA DAILY, Oct. 27, 2003, available at LEXIS News Database. Recent data, however, suggests that ginseng may impair the absorption of anticlotting drugs. See Mitka, Mike, Study Reveals Ginseng Supplements May Hamper Effects of Anticlotting Drug, 292 JAMA 674 (2004)Google Scholar. It may also interfere with certain perioperative care procedures. See Ang-Lee, Michael K. et al., Herbal Medicines and Perioperative Care, 286 JAMA 208, 216 (2001)CrossRefGoogle ScholarPubMed.

105 See Lisa Liddane, No Flu Shot?, KNIGHT RIDDER/TRIBUNE NEWS SERVICE, Nov. 12, 2004, available at LEXIS News Database. Historically, elderberry has not always been associated with positive medicinal effect. For instance, in 1984, eight Californians who consumed elderberry juice suffered acute gastrointestinal and neurologic symptoms, resulting in one hospitalization. However, such problems typically do not emerge when preparers of the juice remove the bits of leaves and stems from the berries. See Elderberry Poisoning, 29 Am. Fam. Physician 346 (1984)Google Scholar.

106 See Diet, Physical Activity, and Dietary Supplements – the Scientific Basis For Improving Health, Saving Money, and Preserving Personal Choice: Hearing Before the House Comm. on Gov't Reform, 107th Cong. (July 25, 2002) (statement of Dr. David Heber, Director Division of Clinical Nutrition, University of California). Recent data also suggests that Vitamin A supplements can lessen the severity of hip fractures among older women. See Feskanich, Diane, Vitamin A Intake and Hip Fractures Among Postmenopausal Women, 287 JAMA 47, 54 (2002)CrossRefGoogle ScholarPubMed.

107 See McNeil, Donald G. Jr.,, Herbal Drug Widely Embraced In Treating Resistant Malaria, N.Y. TIMES, May 10, 2004Google Scholar, at 1 (noting that, in one outbreak in Vietnam, artemisinin allegedly cut the death rate by 97 percent).

108 See id.

109 See id.

110 See White, N.J. et al., Comparison of Artemether and Chloroquine for Severe Malaria in Gambian Children, 339 Lancet 317-21 (1992)CrossRefGoogle ScholarPubMed; see also Rediscovering Wormwood: Qinghaosu for Malaria, 339 Lancet 649-51 (1992)CrossRefGoogle Scholar (highlighting unexpectedness effectiveness of artemisinin); McNeil, supra note 107 (detailing how artemisinin has contained small outbreaks in mosquito-infested areas and prevented them from becoming epidemics). In fact, the resounding success of artemisin has encouraged the development of pharmaceutical derivatives of it and pyronaridin. See Pcoul, Bernard et. al, Access to Essential Drugs in Poor Countries: A Lost Battle?, 281 JAMA 361, 367 (1999)Google Scholar.

111 See Kemper, Kathy J. et al., Holistic Pediatrics: A Research Agenda, 103 Pediatrics 902-09 (1999)Google ScholarPubMed.

112 See Kerry Hughes, Functional Foods: Back to the Future, PREPARED FOODS, Mar. 1, 2001, at 35.

113 See id. Despite these anthropological findings, many western scientists remain skeptical. According to one study, the mere presence of “shamans” in Laos and throughout Southeast Asia may partly explain such skepticism, in that western scientists tend to dimly regard those who practice medicine without formal education or training. See Uba, Laura, Cultural Barriers to Health Care for Southeast Asian Refugees, 107 Pub. Health Rep. 544, 548 (1992)Google ScholarPubMed.

114 See Sanghavi, supra note 18. For instance, mental hospitalization is often regarded as highly stigmatizing, and certain supplements may diminish the need for such hospitalization. See Luchins, Daniel, Refusing Care: Forced Treatment and the Rights of the Mentally Ill, 290 JAMA 674, 675 (2003)CrossRefGoogle Scholar. Physicians can also be stigmatized by contemporary modes and norms of medical delivery. See e.g., Hampton, Tracy, Physicians Advised on How to Offer Pain Relief While Preventing Opioid Abuse, 292 JAMA 1164, 1162 (2004)Google ScholarPubMed (finding that physicians who prescribe pain medications often feel stigmatized within the health care community).

115 See Larkin, Marilynn, DHEA: Will Science Confirm the Headlines?, 352 Lancet 208 (1998)CrossRefGoogle ScholarPubMed; see also Kaplan, Arline, DHEA Lessens Depressive Symptoms, NIMH Study Shows, GERIATRIC TIMES, Nov. 1, 2004Google Scholar, at 4 (describing soon-to-be released study finding that that DHEA may prove more efficacious in treating mild-to-moderate midlife crisis than traditional antidepressant treatments).

116 Id. See also Luchins, supra note 114, at 675 (describing stigma of pursuing mental health medicines).

117 See Kemper et al., supra note 111; see also Yahn, G., The Impact of Holistic Medicine, Medical Groups, and Health Concepts, 242 JAMA 2202, 2205 (1979)CrossRefGoogle ScholarPubMed (offering historical survey of holistic medicine and its systemic interaction with modern clinical expectations).

118 See Leeches, Delbanco T., Spiders and Astrology: Predilections and Predictions, 280 JAMA 1560-62 (1998)Google Scholar.

119 See Boozang, Kathleen M., The Therapeutic Placebo: The Case for Patient Deception, 54 Fla. L. Rev. 687, 698-99 (2002)Google ScholarPubMed; see also Krakow, Barry et al., Placebo Effect in Posttraumatic Stress Disorders, 284 JAMA 563 (2000)CrossRefGoogle ScholarPubMed (identifying short-term value of placebos in treating posttraumatic stress disorders).

120 See HOWARD BRODY, PLACEBOS AND THE PHILOSOPHY OF MEDICINE 16 (1980). Intriguingly, these and similar phenomena have been evident since the practice of ancient priests thousands of years ago. See ARTHUR K. SHAPIRO & ELAINE SHAPIRO, THE POWERFUL PLACEBO: FROM ANCIENT PRIEST TO MODERN PHYSICIAN (1997)..

121 Id. at 9.

122 See Boozang, supra note 119, at 743.

123 See 109 CONG. REC. E316 (daily ed. Mar. 1, 2005) (statement of Rep. Moran); H.R. Res. 135, 109th Cong. (2005).

124 See generally 109 CONG. REC. H2534 (daily ed. Apr. 26, 2005) (statement of Rep. Emanuel).

125 For an extensive historical review of food and drug law, see generally Hutt, Peter B. & Hutt, Peter B. II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 Food Drug Cosm. L.J. 2 (1984)Google Scholar. See also PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES & MATERIALS 6-10 (1991).

126 See Denemark, Howard A., Improving Litigation Against Drug Manufacturers for Failure to Warn Against Possible Side Effects: Keeping Dubious Lawsuits from Driving Good Drugs Off the Market, 40 Case W. Res. L. Rev. 413, 415-16 (1990)Google Scholar; see generally STEWART H. HOLBROOK, THE GOLDEN AGE OF QUACKERY 14-28 (1959) (providing extensive information on some of the most outrageous products, many of which were heavily marketed).

127 Id. at 416.

128 Id. (discussing how “quacks” were undeterred by legal institutions and the law).

129 See, e.g., In re Eisner, 1893 U.S. App. LEXIS 2502 (C.C.S.D.N.Y. 1893) (noting that “[t]he Johann Hoff Malt Extract is a compound of many ingredients, made by a secret formula, consisting of herbs, roots, leaves, dextrine, water, hop extract and malt extract”).

130 1847 N.Y. LEXIS 54 (N.Y. 1847).

131 Id. at 3; see also In re Hunter, 60 N.C. 447 (1864) (court distinguishing “physical herb” from “medical herb”).

132 See STEPHEN B. THACKER, HISTORICAL DEVELOPMENT IN PRINCIPLES AND PRACTICE OF PUBLIC HEALTH SURVEILLANCE 3, 4 (Steven M. Teutsch & R. Elliot Churchill eds., 1994).

133 For instance, Dr. E.R. Squib, a merchant, spoke publicly about rampant fraud in the food and drug industry, and the need to separate legitimate merchants from illegitimate ones. Other reform parties included the American Medical Association, the American Public Health Association, labor unions, and consumer groups. See Merrill, Richard A. & Francer, Jeffrey K., Organizing Federal Food Safety Regulation, 31 Seton Hall L. Rev. 61, 79 (2000)Google Scholar.

134 See Peter Barton Hutt, Lecture at Harvard Law School, Jan. 4, 2005 (comments on file with author).

135 See HUTT & MERRILL, supra note 125, at 7-9.

136 Dr. Washington waged an uphill battle against fraudulent drugs and adulterated foods. To prove his beliefs, he even assembled a “poison squad,” a group of assistants who would test contaminated food and drug products and then publicize the conclusions. See HARRY E. NEAL, THE PROTECTOR'S: THE STORY OF THE FOOD AND DRUG ADMINISTRATION 12 (1970).

137 See Epstein, Richard A., Our New Federalism? National Authority and Local Autonomy in the War on Terror, 69 Brooklyn L. Rev. 1421 (2004)Google Scholar.

138 See id.

139 See, e.g., American School of Magnetic Healing v. McAnnulty, 187 U.S. 94, 109-10 (1902) (finding that even when determining the fraudulence of a product, the Postmaster General lacked the ability to make conclusions of law); Barton Hutt, Peter, A History of Government Regulation of Adulteration and Misbranding of Medical Devices, 44 Food Drug Cosm. L.J. 99, 101-02 (1989)Google Scholar (noting how the FDA regularly collaborated with the Post Office in policing fraudulent food and drug practices).

140 See Bass, Scott & Raul, Alan, The Single Food Safety Agency: A Modest Dialectic Dialogue, 59 Food Drug L.J. 453, 455 (2004)Google ScholarPubMed.

141 UPTON SINCLAIR, THE JUNGLE (1906).

142 See Merrill & Francer, supra note 133, at 79.

143 Pub. L. No. 59-384, § 2, 34 Stat. 768 (1906).

144 See Hipolite Egg Co. v. United States, 220 U.S. 45, 54 (1911) (holding that the purpose of the 1906 Act was to keep misbranded and adulterated products “out of the channels of interstate commerce, or, if they enter such commerce, to condemn them while being transported or when they have reached their destinations, provided they remain unloaded, unsold or in original unbroken packages”).

145 See HUTT & MERRILL, supra note 125, at 8-9.

146 Pure Food and Drugs Act of 1906 § 2.

147 Id.; see generally MARION NESTLE, FOOD POLITICS: HOW THE FOOD INDUSTRY INFLUENCES NUTRITION AND HEALTH (2002) (noting historical lack of resources for FDA). For an expanded discussion of the Pure Food and Drugs Act, see Noah, Lars & Merrill, Richard A., Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. Rev. 329, 331 (1998)Google Scholar.

148 See United States v. Johnson, 221 U.S. 488, 497-98 (1911) (Justice Holmes holding that a false claim to cure cancer did not satisfy the requirement that the claim be dangerous). But see Hayes, Laufer T. & Ruff, Frank J., The Administration of the Federal Food and Drugs Act, 1 Law & Contemp. Probs. 16 (1933)CrossRefGoogle Scholar (noting that the 1906 Act prohibited false claims).

149 Pub. L. No. 62-301, 37 Stat. 416 (1912).

150 See Merrill, supra note 31, at 1760-61.

151 See generally Hayes & Ruff, supra note 148.

152 225 U.S. 501 (1912).

153 Id. at 531 (holding that “Congress has thus limited the scope of its prohibitions. It has not included that at which the Indiana statute aims”).

154 198 U.S. 45 (1905).

155 See Levin, Nickolai G., Constitutional Statutory Synthesis, 54 Ala. L. Rev. 1281, 1328-29 (2003)Google Scholar.

156 See Cavers, David F., The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Probs. 2, 20 (1939)CrossRefGoogle Scholar. Also significant was the 1917 Report of the USDA Bureau of Chemistry, which advocated greater FDA enforcement powers. See HUTT & MERRILL, supra note 125, at 10-11.

157 Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 321-393 (2000))

158 See HUTT & MERRILL, supra note 125, at 187.

159 Gardner v. Toilet Goods Ass’n, 387 U.S. 167, 180 (1967) (citing 21 U.S.C. § 343(j)).

160 21 U.S.C. § 403(j) (2000).

161 See id. (including under the definition of misbranded food any item which “purports to be or is represented for special dietary uses, unless its 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 to fully inform purchasers as to its value for such uses”).

162 For a discussion, see Noah & Merrill, supra note 147, at 331-34.

163 See Colloton, Meghan, Dietary Supplements: A Challenging Facing the FDA in Mad Cow Disease Prevention, 51 Am. U. L. Rev. 495, 512 (2003)Google Scholar.

164 21 C.F.R. § 125 (1941).

165 21 C.F.R. § 125.

166 6 Fed. Reg. 5921 (1941).

167 See Kaczka, supra note 80, at 468; see also Markel, Michael F., Foods for Special Dietary Uses—An Historical Outline of Regulatory Aspects, 22 Food Drug Cosm. L.J. 110, 114 (1967)Google Scholar.

168 See, e.g., 6 Fed. Reg. 5921, 5925 (Nov. 22, 1941); 6 Fed. Reg. 3304, 3310 (July 8, 1941); 5 Fed. Reg. 3565 (Sept. 5, 1940); see also Gilhooley, Margaret, Herbal Remedies and Dietary Supplements: The Boundaries of Drug Claims and Freedom of Choice, 49 Fla. L. Rev. 665, 672 (1997)Google Scholar (describing the limitations of such regulatory language).

169 See I. SCOTT BASS & ANTHONY L. YOUNG, DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: A LEGISLATIVE HISTORY AND ANALYSIS 9 (1996).

170 See Noah & Merrill, supra note 147, at 336 (citing Food Additives: Hearings Before a Subcomm. of the House Comm. on Interstate and Foreign Commerce, 85th Cong. 421-22 (1957) (statement of Elliot L. Richardson, Asst. Secretary, Health, Education & Welfare (HEW) (“The commendable actions of the great majority [of companies], however, cannot provide protection against the minority. We have had some narrow escapes in the food field.”))).

171 See Brown, Robert C., The Liability of Retail Dealers for Defective Food Products, 23 Minn. L. Rev. 585, 596-610 (1939)Google Scholar.

172 See Noah & Merrill, supra note 147, at 336.

173 See Barton Hutt, Peter, Government Regulation of Health Claims in Food Labeling and Advertising, 41 Food Drug Cosm. L.J. 3 (1986)Google Scholar.

174 United States v. Mytinger and Casselberry, Inc. FDA Not. of Jud. No. 3383 (S.D. Cal. 1951), reprinted in FEDERAL FOOD DRUG AND COSMETIC ACT 1951-1952, at 204 (FDLI 1953).

175 See Hutt, supra note 173, at 52; see also Lev, Lester L., The Nutrilite Consent Decree, 7 Food Drug Cosm. L.J. 56, 56 (1952)Google Scholar; Kaczka, supra note 80, at 471 (contending that the FDA successfully pursued implementing the Nutrilite Consent Decree); Kassel, Mark A., From A History of Near Misses: The Future of Dietary Supplement Regulation, 49 Food & Drug L.J. 237 (1994)Google Scholar (finding that while the FDA generally failed to use litigation to ensure safety of food products, the agency perceived greater success with dietary supplements, particularly through the NCD).

176 335 U.S. 345 (1948)

177 Id. at 349-50.

178 Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified as amended in scattered sections of 21 U.S.C. (2000)).

179 See Noah & Merrill, supra note 147, at 336-40.

180 Id.

181 See McNamara, Stephen H., Dietary Supplements of Botanicals and Other Substances: A New Era of Regulation, 50 Food & Drug L.J. 341 (1995)Google Scholar.

182 See generally HUTT & MERRILL, supra note 125.

183 See id. at 207 n.2; see also Gilhooley, supra note 168, at 673 (describing the ineffectiveness of the case-by-case approach).

184 See Kaczka, supra note 80, at 471-72; see also Pendergast, William R., Dietary Supplements, in 1 Fundamentals Of Law And Regulation 266 (FDLI 1997)Google Scholar.

185 See Kassel, supra note 175, at 262.

186 Sean Harmon, , Melatonin Mania: Can the FDA Regulate Hormonal Dietary Supplements to Protect Consumer Interests in Light of the Dietary Supplement Health and Education Act of 1994?, 22 Dayton L. Rev. 77, n. 2 (1996)Google Scholar (citing Ralph L. Smith, The Vitamin Healers, THE REPORTER, Dec. 16, 1965, at 18-25).

187 See Dietary Foods, 31 Fed. Reg. 8521, 8522 (June 18, 1966).

188 27 Fed. Reg. 5815 (June 20, 1962).

189 See Gilhooley, supra note 168, at 673; see also Goodrich, William W., The Coming Struggle over Vitamin-Mineral Pills, 20 Bus. Law. 145 (1964)Google Scholar (describing how dietary supplement manufacturers often asserted that daily food consumption failed to provide sufficient nutrients).

190 Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified at 21 U.S.C. § 355 (2000)) (the amendment is also commonly known as the “Drug Efficacy Amendment”).

191 The requisite political support for the Kefauver-Harris Amendment was derived largely from the thalidomide tragedy. The pre-market approval process of claims required controlled studies, unless the product was generally recognized by experts as effective based on similar studies. See generally Gilhooley, supra note 168, at 672.

192 Id. at 673.

193 See generally id.

194 See 27 Fed. Reg. 5815, 5815 (1962); Kaczka, supra note 80, at 472.

195 See Goodrich, supra note 189.

196 Dietary Foods, 31 Fed. Reg. 8521, 8525 (proposed June 18, 1966).

197 See Definition, Identity, and Label Statements; Proposed Findings of Fact, Conclusions, and Tentative Order Following a Public Hearing, 38 Fed. Reg. 2152, 2153 (proposed Jan. 19, 1973) (outlining hearings that led to 1973 proposed rule making). For an excellent review of the hearings, see Colloton, supra note 163, at 515-16.

198 See Barton Hutt, Peter, Regulating the Misbranding of Food, 43 Food Tech. 288 (1989)Google Scholar; see also Hutt, supra note 167 (describing significance of contemporaneous staff changes at the FDA).

199 Id.

200 See Dietary Supplements of Vitamins and Minerals, 38 Fed. Reg. 20730, 20731 (Aug. 2, 1973) (codified at 21 C.F.R. §§ 105.3, 105.60, 105.77, 105.85 (2005).

201 Id.

202 See 38 Fed. Reg. 20716 (1973).

203 See 38 Fed. Reg. 20708, 20730 (1973).

204 In fact, there were nearly 22,000 responses to the proposed regulations. See Colloton, supra note 163, at n.140 (citing 38 Fed. Reg. 20730). It is arguable that RDAs had originally been devised as a measurement standard for scientific and governmental research purposes, not as an enforceable standard for the general population. See MONICA MILLER, FOUNDATION FOR THE ADVANCEMENT OF INNOVATIVE MEDICINE, The History of Dietary Supplement Regulation, available at http://www.faim.org/supplements.htm (last accessed May 31, 2005).

205 See HUTT & MERRILL, supra note 125, at 215.

206 504 F.2d 761 (2d Cir. 1974).

207 Id. at 767.

208 Note that, even with potency limits, consumers could still digest the same level of supplements by consuming a greater number of reduced-sized tablets. See National Nutritional Foods, 504 F.2d at 792 (Judge Friendly suggesting that consumers could “take as many more tablets” as needed to procure the desired effect).

209 Id. at 783-84.

210 Id. at 789; see Gilhooley, supra note 168, at 674 (explaining how “intent” was proscribed).

211 See BASS & YOUNG, supra note 169, at 12; see also Kassel, supra note 175, at 257 (detailing lobbying efforts).

212 Pub. L. No. 94-278, 90 Stat. 410 (1976) (codified as amended at 21 U.S.C. § 350 (2000)).

213 See 21 U.S.C. § 350(a)(1)(A) (2000).

214 See 21 U.S.C. § 350(a)(1)(C) (2000).

215 See 21 U.S.C. § 350(a)(1)(B) (2000).

216 See Gilhooley, supra note 168, at 676; see also General Accounting Office, Report to Senator Kennedy, at 4 (B252966, July 2, 1993), reprinted in BASS & YOUNG, supra note 169, at 300 (noting that the agency was “dissuaded” by the Proxmire Amendment) [hereinafter GAO Report].

217 See GAO Report, supra note 216, at 6.

218 Regulation of Dietary Supplements, 58 Fed. Reg. at 33,698-99 (June 18, 1993) (discussing the market prevalence of dietary supplements).

219 See Rubin, Howard M., Courts, Congress Re-examine Nondrug Products, 21 Nat’L L.J., July 5, 1999Google Scholar, at B8.

220 See Nutritional Health Alliance v. Shalala, 953 F. Supp. 526, 526 (Dist. Ct. S.D.N.Y. 1997).

221 See Christopher Smith, Supplements and the Feds, SALT LAKE TRIB., May 21, 2001, at A8.

222 See Vladeck, David C., Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements, 19 J. Pub. Pol’Y & Marketing 132 (2000)CrossRefGoogle Scholar. For instance, dietary supplement companies marketed claims ranging from “Stone Free Kidney and Gall Formula” to “Fat Burners,” which erroneously suggested effective treatments for serious afflictions. Id.

223 Id.

224 Pub. L. No. 101-535, 104 Stat. 2353 (1990) (codified as amended at 21 U.S.C. §§ 301– 397).

225 For an expanded discussion of the NLEA, see McCann, Michael A., Economic Efficiency and Consumer Choice Theory in Nutritional Labeling, 2004 Wis. L. Rev. 1161, 1187-91 (2004)Google Scholar.

226 § 2, 104 Stat. at 2353–57 (codified as amended at 21 U.S.C. § 343).

227 See McCann, supra note 225, at 1187 (discussing § 2, 104 Stat. at 2353–59).

228 See § 3, 104 Stat. at 2358.

229 Id; 21 U.S.C. § 343(r)(3)(B)(i).

230 21 C.F.R. § 101.9(a)(1) (2004).

231 Until 1997, health claims required FDA premarket approval, which was based on “the totality of publicly available scientific evidence … [that the claim is supported by] significant scientific agreement, among experts qualified by scientific training and experience.” 21 U.S.C. § 343(r)(3)(B)(i). In 1997, the Food and Drug Administration Act was passed, which largely removed the requirement of FDA approval, but still mandated that claims for non-restauarant food be derived from “authoritative statements” of a scientific body. See McCann, supra note 225, at 1189.

232 See Gilhooley, supra note 168, at 679.

233 See 21 U.S.C. § 343(r)(5)(D) (2000) (“A subparagraph (1)(B) claim made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances shall not be subject to subparagraph (3) but shall be subject to a procedure and standard, respecting the validity of such claim, established by regulation of the Secretary”).

234 See Smith, supra note 186.

235 Senator Hatch would later say that his former aide, Dr. Kessler “had been captured” by the FDA. Id.

236 See Hearing Before the Subcomm. On Health and Environment of the House Comm. on Energy and Commerce, 108th Cong. (2003) (remarks of David Kessler).

237 See NPR: Dietary Supplements and Regulations Pertaining to Them, (NPR radio broadcast, Apr. 19, 1999) (noting remarks from Dr. David Kessler, former head of the FDA) [hereinafter NPR Transcript].

238 See Gilhooley, supra note 168, at 679.

239 See National Association of Attorneys General Summer Meeting, Resolution on Deceptive Claims in Dietary Supplement Labeling and Advertising, 49 Food & Drug Report 474 (1993)Google Scholar.

240 See MILLER, supra note 204.

241 See NPR Transcript, supra note 237.

242 See Kolasky, William J. Jr.,, The Impact of the Food and Drug Administration's Reproposal on Vitamins, Minerals, and other Nutritional Supplements, 45 Food Drug Cosm. L.J. 639, 644-45 (1990)Google Scholar.

243 Dietary Supplement Act of 1992, Pub. L. No. 102-571, 106 Stat. 4491 (1992).

244 Id. at § 202(a)(1).

245 Id. at § 202(a)(2)(A).

246 See Regulation of Dietary Supplements, 58 Fed. Reg. 33,690 (June 18, 1993).

247 Id. at 33,697.

248 Id. at 33,698 (for example, the FDA noted that toxic hepatitis has been associated with the consumption of chaparral, a popular herbal supplement).

249 Id.

250 Food Labeling: General Requirements for Health Claims in Dietary Supplements, 58 Fed. Reg. 33,700, 33,700 (June 18, 1993).

251 See Wallace, Phil, Senate Increases Funding for Labeling Enforcement, FOOD CHEMICAL NEWS, Nov. 12, 2001Google Scholar, at 21. Senator Tom Harkin (D-IA) said of the FDA, “We admonish the agency not to wield the heavy hand it did for over three decades, the over-bearing attitude which led Congress to pass [DSHEA] so overwhelmingly in the first place.” Id.

252 See United States v. An Article of Food, 678 F.2d 735, 739 (7th Cir. 1982).

253 See Regulation of Dietary Supplements, 58 Fed. Reg. at 33,692 n.2.

254 See FDA Safeguards Against Improper Disclosure of Financially Sensitive Information: The Product Approval Centers, Final Report 162 (Nov. 14, 1991) reprinted in 33 FOOD CHEM. NEWS, Nov. 4, 1991, at 67.

255 See McNamara, supra note 181, at 343.

256 See United States v. Two Plastic Drums, 984 F.2d 814 (7th Cir. 1993).

257 See id. at 816. The FDA's reasoning behind this structural argument rested in 21 U.S.C. § 321(s), with the agency surmising that the BCO became a literal “component” of food when combined with two other “components.” Id.

258 See McNamara, Stephen H. & Wes Siegner, A., FDA has Substantial and Sufficient Authority to Regulate Dietary Supplements, 57 Food Drug L.J. 15, 16 (2002)Google ScholarPubMed; see also S. REP. NO. 103-410, at 16 (Oct. 8, 1994) (“The cost to a manufacturer to prepare a food additive petition can run to $2 million. FDA approval of a food additive petition typically takes from 2 to 6 years.”).

259 S. REP. NO. 103-410, at 16 (OCT. 8, 1994)

260 See United States v. 29 Cartons, 987 F.2d 33, 37-39 (1st Cir. 1993); Two Plastic Drums, 984 F.2d at 820; see also Noah & Merrill, supra note 147, at 346-47.

261 29 Cartons, 987 F.2d at 39.

262 See Noah & Merrill, supra note 147, at 347.

263 Id. at 349.

264 See, e.g., Price, Elizabeth C., Teaching the Elephant to Dance: Privatizing the FDA Review Process, 51 Food & Drug L.J. 651, 654-59 (1996)Google ScholarPubMed (arguing that FDA suffers from “an institutional culture that breeds risk avoidance and an autocratic style of regulation”).

265 See Shalala, 953 F. Supp. at 528.

266 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (codified as amended in scattered sections of 21 U.S.C.) [hereinafter DSHEA].

267 See Hanson, Gayle, FDA and Vitamins: Bitter Pill or good Rx?, WASH. TIMES, Nov. 18, 2003Google Scholar, at A12 (detailing efforts of opposition on Capital Hill).

268 See Vignulo, Peter A., The Herbal Street Drug Crisis: An Examination of the Dietary Supplement Health and Education Act, 21 Seton Hall Legis. J. 200, 216-17 (1997)Google Scholar. For instance, the Nutrition Health Alliance hired Anthony T. Podesta, former aide to Edward M. Kennedy (D-MA), the Chairman of the Senate Labor and Human Resources Committee, to spearhead the group's lobbying efforts. See Ramos, Dante E.A., Vitamin Makers Try a Dose of Lobbying, 25 Nat'L Health J. 1879 (1993)Google Scholar.

269 The process began in the Senate Labor and Human Resources Committee, where DSHEA passed 12-5, over the objection of Chairman Edward M. Kennedy. See Smith, supra note 186.

270 140 CONG. REC. S14,798-800 (daily ed. Oct. 7, 1994).

271 Congressional Findings of Fact, reprinted in Pub. L. No. 103-417 § 2 (1994), 108 Stat. 4325 (2004).

272 Although there is no general requirement for manufacturers of dietary supplements to submit evidence of product safety to the FDA before marketing a product, there exists “a 75-day premarket notification requirement for manufacturers or distributors of dietary supplements that contain new dietary ingredients’ that were not marketed in the U.S. before October 15, 1994, unless the supplement contains only ingredients that have been present without chemical alteration in the food supply as an article used for food.” Center for Food Safety and Applied Nutrition Director Comments on Status of Dietary Supplements in U.S., State News Service: Hearing on Ten Years After the Implementation of DSHEA: The Status of Dietary Supplements in the United States, Before the House Comm. on Government Reform, Subcomm. On Human Rights and Wellness, 108th Cong., Mar. 23, 2004, available at LEXIS News Wire (statement of Robert E. Brackett, Ph.D., Director Center for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services) [hereinafter Statement of Robert E. Bracket].

273 DSHEA § 11 (voiding 58 Fed. Reg. 33,690 (June 19, 1993)).

274 Id. at § 3(b) (codified as amended at 21 U.S.C. § 321(s)(6) (2000)).

275 Id. at § 3(b)(3) (codified as amended at 21 U.S.C. §§ 321(s)(6), 321(ff)(3)(A)); see also Beisler, Joshua A., Dietary Supplements and Their Discontents: FDA Regulation and the Dietary Supplement Health and Education Act of 1994, 31 Rutgers L.J. 511, 515 (2000)Google Scholar.

276 See Gilhooley, supra note 168, at 682.

277 DSHEA § 3.

278 See Gilhooley, supra note 168, at 682.

279 See Statement by Robert E. Brackett, supra note 272.

280 Pub. L. No. 107-188, 116 Stat. 694 (2002) (codified in scattered sections of 42 U.S.C.).

281 21 U.S.C. § 350d(a)(1) (Supp. 2002).

282 21 U.S.C. §§ 342(a), (f) (Supp. 2002).

283 As noted by Professor Hutt, although DSHEA did clarify the “poisonous or deleterious” substance standard by providing that any food or supplement is only deemed to be adulterated if it may be injurious to health under the conditions of use recommended or suggested on the labeling, “this difference is of no practical importance because the Supreme Court had adopted a similar interpretation of the provision as early as 1914 and that decision has remained unchanged ever since.” See Peter Barton Hutt, FDA Statutory Authority to Regulate The Safety of Dietary Supplements (draft of forthcoming article, Oct. 3, 2004, on file with author) (21 U.S.C. § 342(f) and United States v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914), respectively).

284 Labels on conventional food can make structure/function claims without any disclaimer.

285 21 U.S.C. § 343(r)(6)(C) (stipulating that the product labels must include the following language: “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”).

286 21 U.S.C. § 343(r)(6). A structure/function claim is permitted so long as the FDA is notified, the manufacturer has substantiation that the claim is truthful and not misleading, and the product contains a disclaimer. The following disclaimer must accompany structure/function claims: “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.” Shalala, 953 F. Supp. at n.11 (citing 21 U.S.C. § 343(r)(6)(C) (1994)).

287 21 U.S.C. § 343(r)(6).

288 21 U.S.C. § 342(r)(6).

289 The product claims refer to products “CardiAll,” “Liverite,” and “Resist,” respectively. See Specter, supra note 94.

290 See Pinco, Robert G. & Rubin, Paul D., Ambiguities of the Dietary Supplement Health and Education Act of 1994, 51 Food Drug L.J. 383, 385 (1996)Google ScholarPubMed.

291 See Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements, 60 Fed. Reg. 67,194, at 67,205 (Dec. 28, 1995) (codified at 21 C.F.R. pt. 101); see also 62 Fed. Reg. 49,826 (Sept. 23, 1997) (codified at 21 C.F.R. pt. 101) (explaining that “supplement facts” was chosen instead of “nutrition facts” because with “nutrition facts … the information presented, at least in part, is about nutrition, or because these products are marketed for their nutritional value. The nutritional value of a particular product does not determine whether it is a dietary supplement or a conventional food. Many dietary supplements contain many DV-nutrients; many contain none.”).

292 See Overview of Dietary Supplements, FDA, Jan. 3, 2001, at http://vm.cfsan.fda.gov/∼dms/ds-oview.html; 62 Fed. Reg. 49,825, at 49,849 (Sept. 23, 1997) (codified at 21 C.F.R. pt. 101).

293 See DSHEA § 12(e)(3); see also Gilhooley, supra note 168, at n. 87 (explaining the significance of the Commission on FDA rulemaking).

294 See REPORT OF THE COMM’N ON DIETARY SUPPLEMENT Labels at 30 (Nov. 1997), available at http://www.health.gov/dietsupp/.

295 Id. at 34.

296 Id. at 35; see also FDLI meeting reviews US dietary supplements legislation, 2 NUTRACEUTICALS INT’L (1997) (noting how the DSHEA Commission recommended that the FDA improve the process by encouraging external input from scientists and governmental experts).

297 140 Cong. Rec. S14780 (daily ed. Oct. 7, 1994).

298 DSHEA: Statement by President Clinton Upon Signing S. 784, 1995 U.S.C.C.A.N. 3523-1 (Oct. 25, 1994). President Clinton also heralded how “manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.” Id.

299 See Smith, supra note 186.

300 See Gilhooley, supra note 168, at 666 (noting that “the term being DSHEAed’ has become a popular byword for deregulation”); see also Nestle, supra note 147, at 233 (describing concerns of potential quackery generated by DSHEA).

301 See NPR Transcript, supra note 237 (quoting Annette Dickinson, head of the Supplement Trade Association, the Council for Responsible Nutrition.); see also Pinco, Robert G. & Halpern, Todd H., Guidelines for the Promotion of Dietary Supplements: Examining Government Regulation Five Years After Enactment of the Dietary Supplement Health and Education Act of 1994, 54 Food Drug L.J. 567, 579 (1999)Google ScholarPubMed (noting that DSHEA surprised the FDA).

302 See Schulman, Sara, Addressing The Potential Risks Associated with Ephedra Use, 118 Pub. Health Rep. 487, 492 (2003)Google ScholarPubMed.

303 See NPR Transcript, supra note 237 (quoting Annette Dickinson, head of the Supplement Trade Association, the Council for Responsible Nutrition.).

304 See Goldman, Arthur P., Unregulated Herbal Remedies—an Accident Waiting to Happen, CHI. TRIB., Dec. 24, 2002Google Scholar, at C19 (Professor Goldman noting that most Americans are unaware that dietary supplements do not receive premarket testing).

305 See supra at Part III.C.

306 See Pat Kendall, Benecol: Cholesterol-Fighting Margarine, COLO. ST. U. COOPERATIVE EXTENSION, Mar. 24, 1999, at http://www.ext.colostate.edu/pubs/columnnn/nn990324.html.

307 See Ringel Heller, Illene, Functional Foods: Regulatory and Marketing Developments, 56 Food Drug L.J. 197, 210-11(2001)Google Scholar.

308 Id.

309 See 21 C.F.R. § 101.14(a)(1) (2005); Deborah Pines, Time Limit on FDA Vitamin Review, N.Y.L.J., Feb. 6, 1997, at 1. Such review could last an indeterminable period, particularly since the FDA offered no fixed deadline to promulgate final regulations for a health claim. 21 C.F.R. § 101.14(a)(1).

310 21 C.F.R. § 101.14(a)(1).

311 See Gilhooley, supra note 168 (mentioning this language as a useful illustration of DSHEA's definitional murkiness).

312 See Massey, Patrick B., Be Wary of Supplements Labeled Proprietary Blend’, CHI. DAILY HERALD, Feb 16, 2004Google Scholar, at 5 (Dr. Massey is medical director for alternative and complementary medicine for Alexian Brothers Hospital Network).

313 See Walsh, Charles J. & Klein, Marc S., From Dog Food to Prescription Drug Advertising: Litigating False Scientific Establishment Claims Under the Lanham Act, 22 Seton Hall L. Rev. 389, 392 (1992)Google Scholar.

314 See United States v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547 (D.N.J. 2004).

315 See Squires, Sally, High Irony: New Supplement Labels are Short on Facts, WASH. POST, Mar. 7, 2000Google Scholar, at Z14.

316 See Valluck, Tom, Keeping Dietary Supplement Regulations Slim and Fit: Finding a Healthy Balance between Paternalism and Consumer Choice, 2 Geo. J.L. & Pub. Pol'Y 285, 300 (2004)Google Scholar (citing Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976); Pearson v. Shalala, 164 f.3d 650, 658 (D.C. Cir. 1999)).

317 14 F. Supp. 2d 10, (D.D.C., 1998), rev’d 164 F.3d 650 (D.C. Cir. 1999).

318 14 F. Supp. 2d at 10.

319 Pearson, 164 F.3d at 656.

320 Id. at 657.

321 Id. at 658.

322 See supra pp. 248-49.

323 See generally 21 U.S.C. §§ 321-393 (2000); see also 21 U.S.C. § 321(m) (defining the term “labeling”); Pinco & Halpern, supra note 301, at 579 (distinguishing labeling from advertising).

324 See Federal Trade Commission Act, 15 U.S.C. §§ 45(a), 52, 55 (1972 & West Supp. 2004) (prohibiting unfair or deceptive acts or practices in or affecting commerce, and false advertisements for food, drugs, devices, services, or cosmetics in or affecting commerce); see also 59 Fed. Reg. 395, 409 (Jan. 4, 2004); FTC DIETARY SUPPLEMENTS ADVERTISING GUIDE FOR INDUSTRY (1998) (defining advertising).

325 See Substantiation Policy Statement, appended to Thompson Medical Co., 104 F.T.C. 648, 839 (FTC, 1984); Deception Policy Statement, Letter Dated Oct. 14, 1983 from Commission to Chairman John D. Dingell, appended to Cliffdale Associates, Inc., 103 F.T.C. 110, 174 (1984); 15 U.S.C. §§ 52, 55 (2000) (instructing advertisers to provide substantiated and accurate product information).

326 This deduction appears consonant with research conducted by Dr. Kenneth Walker of Toronto General Hospital, as he found that dietary supplement users tend to be most attracted to certain cue words on labels, such as “natural” and “organic.” See Walker, Kenneth, Understand the Facts about Ginkgo Biloba, CHI. SUN-TIMES, Apr. 2, 2000Google Scholar, at 8.

327 See generally, Hanson & Kysar, supra note 55, at 1427.

328 See supra p. 228.

329 See FTC-FDA Liaison Agreement, 4 Trade Reg. Rep. (CCH) PP9851-52 (1971); see also In the Matter of Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Proposed Rule, Comments of the Staff of the Bureau of Consumer Protection of the Federal Trade Commission, Docket No. 98N-0044, Aug. 27, 1998 (“Their shared jurisdiction means that the two agencies coordinate closely to ensure that their actions are consistent to the fullest extent feasible given the statutory authority of each”); see also Taylor, Sarah E. & Feld, Harold J., Promoting Functional Foods and Nutraceuticals on the Internet, 54 Food Drug L.J. 423, 440-41 (1999)Google ScholarPubMed (explaining cooperation between the FDA and FTC in regulating dietary supplement claims on the Internet).

330 See FTC Enforcement Policy Statement on Food Advertising, § III(A)(1) (May, 1994), available at http://www.ftc.gov/bcp/policystmt/ad-food.htm.

331 See Pinco & Halpern, supra note 301, at 581.

332 See The Food and Drug Law Institute's 45th Annual Educational Conference Keynote Addresses, 57 Food Drug L.J. 227, 239 (2002)Google Scholar (noting comments by Shelia F. Anthony, Commissioner of the U.S. Trade Commission).

333 See FDA Backgrounder, How FDA Handles Problem Reports (Aug. 2003), available at http://www.fda.gov/opacom/backgrounders/report.html.

334 See Panel Offers Recommendations for Monitoring Adverse Events from Dietary Supplements, Life Sciences Research Office (Nov. 15, 2004), available at http://www.innovationsreport.de/html/reports/medicine_health/report-36264.html.

335 See Department of Health and Human Services, Office of the Inspector General, Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, OEI-01-00-00180, at 16 (Apr. 2001) (quoting Annual Industry Overview 2000, NUTRITION BUS. J., at 4).

336 See McDonald, John A., Dietary Aids Facing Scrutiny, HARTFORD COURANT, May 5, 2003Google Scholar, at A1.

337 See Department of Health and Human Services, Office of the Inspector General, supra note 335, at 16.

338 This viewpoint is often expressed by FDA administrators. For instance, Christine Taylor, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements, finds “the government does bear a considerable burden in post-marketing world.” McDonald, supra note 336.

339 See FDA Hires Contractor to Handle Information Requests in its Adverse Events Reports AER System, FOOD CHEMICAL NEWS, June 7, 1999 (citing remarks by Daniel Mowrey of the American Phytotherapy Research Laboratory).

340 See Jun P. Tagalog, P3.6B Worth of Illegal Drugs Seized in Cebu, BUSINESSWORLD , Mar. 18, 2004, at 12.

341 Id.

342 Interview with Dr. Andrew Weil, CNN TRANSCRIPTS, Mar. 20, 2004, available at LEXIS News Library, CNNTRN file (citing comments by Dr. Weil, director of the Integrated Medicine Program at the University of Arizona).

343 ANDREW CHEVALLIER, THE ENCYCLOPEDIA OF MEDICINAL PLANTS (1996) (noting that in the 1800s, ephedra was thought to cure gonorrhea and syphilis).

344 See Schulman, supra note 302.

345 U.S. General Accounting Office, Dietary Supplements Containing Ephedra: Health Risks and FDA's Oversight, Testimony before the House Subcommittee on Oversight of and Investigations (July 23, 2003), available at http://www.gao.gov/new.items/d031042t.pdf.

346 See Schulman, supra note 302.

347 Id.

348 Brody Mullins, Ephedra Battle Heats Up, ROLL CALL, Mar. 12, 2003, at 1. available at LEXIS, News Library, ROLLCL file.

349 U.S. Department of Health and Human Services, Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period, Docket no. 95N-0304, Feb. 28, 2003, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-npr0003.pdf (including the following: “WARNING: Contains ephedrine alkaloids. Heart attack, stroke, seizure, and death have been reported after consumption of ephedrine alkaloids. Not for pregnant or breast-feeding women or persons under 18. Risk of injury can increase with dose or if used during strenuous exercise or with other products containing stimulants (including caffeine). Do not use with certain medications or if you have certain health conditions. Stop use and contact a doctor if side effects occur.”).

350 Crawford, Lester M., Remarks of the Acting FDA Commissioner: FDLI's 47th Annual Conference, 59 Food Drug L.J. 201, 206 (2004)Google ScholarPubMed. After a three-month grace period, ephedra became an adulterated food as well as an unapproved and misbranded drug in February 2004. Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk, 69 Fed. Reg. 6788 (Feb. 11, 2004) (to be codified at 21 C.F.R. pt. 119) (declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk of illness or injury).

351 Virginia Anderson, Risky Ephedra Banned, ATLANTA J. CONST., Dec. 31, 2004, at 1A.

352 Phil Wallace, Court Challenge Seeks to Overturn FDA's Ban Reasoning, FOOD CHEMICAL NEWS, Dec. 13, 2004, at 12.

353 Id.

354 Most recently, in November 2004, the United States Attorney for the Southern District of Texas in U.S. District Court in Houston filed a complaint charging that VITERA-XT, an ephedracontaining dietary supplement marketed by Houston-based Asia MedLabs, Inc., represents an adulterated food as well as an unapproved and misbranded drug which presents an unreasonable risk of illness or injury. FDA Acts to Remove Ephedra-Containing Dietary Supplements From Market, FDA Press Releases, Nov. 23, 2004, available at LEXIS News Library, ALLNEWS file.

355 See, e.g., Jennifer Heldt Powell, Feds Circle Date for Ephedra Ban, BOSTON HERALD, Feb. 7, 2004, at 30.

356 See, e.g., Haller, Christine A. & Benowitz, Neal L., Adverse Cardiovascular and Central Nervous System Events Associated with Dietary Supplements Containing Ephedra Alkaloids, 343 N. Engl. J. Med. 1833-38 (2000)CrossRefGoogle ScholarPubMed; Samenuk, D. et al., Adverse Cardiovascular Events Temporally Associated with Ma Huang, an Herbal Source of Ephedrine, 77 Mayo Clin Proc 12–16 (2002)CrossRefGoogle ScholarPubMed.

357 See, e.g., Boozer, C.N. et al., Herbal Ephedra/Caffeine for Weight Loss: A 6-Month Randomized Safety and Efficacy Trial, 26 Int’L J. Obesity 610 (2002)Google ScholarPubMed.

358 Health Highlights, CONN. POST, Apr. 12, 2004.

359 No. 2:04CV409 TC, 2005 WL 852157 (D. Utah Apr. 13, 205).

360 Id.

361 See Crabtree, Penni, Experts Debating Scope of Decision, SAN DIEGO TRIB., Apr. 16, 2005Google Scholar, at C1 (citing remarks by Kimberly Rawlings, an FDA spokeswoman). At the time of this writing, the Acting U.S. Solicitor General, Paul D. Clement, is considering whether to appeal.

362 See Bent, Stephen et al., The Relative Safety of Ephedra Compared with Other Herbal Products, 138 Annals Am. Med. 1006 (2003)Google ScholarPubMed.

363 See Dietary Supplement Safety: Hearing Before the Senate Governmental Affairs Subcommittee on Oversight of Government Management, FED. DOC. CLEARING HOUSE CONG. TESTIMONY, June 8, 2004 (testimony of Mr. Charles Bell Program Director, Executive Office, Consumer Reports (available at LEXIS, Nexis Library, CNGTST file.

364 See Hanson & Kysar, supra note 55.

365 See Sarasohn, Judy, A Departure from the Proscribed Path, WASH. POST, Jan. 22, 2004Google Scholar, at A23.

366 COMMISSION OF THE EUROPEAN COMMUNITY, Proposal for a Directive of the European Parliament and of the Council Amending the Directive 2001/83/EC As Regards Traditional Herbal Medicinal Products (2002), available at http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2002/janv/com2002_1_en.pdf.

367 Long Wait Ahead For EU Supplements Industry on Maximum Doses, NUTRACEUTICALS INT’L, July 1, 2004 (noting that the European Union is now negotiating tolerable upper intake levels for the substances, and that process will continue until April 2005), available at LEXIS, News Library, NUTINT file. However, the European Court of Justice recently ruled that classifying dietary supplements as medicines if they contained more than one or three times the Recommended Daily Allowance for the relevant vitamins or minerals constituted a barrier to the free movement of goods across the EU. Id.

368 Sidley Austin Brown & Wood LLP, International National Products Regulation Q&A: What Effect do They Really Have on the U.S.?, available at http://www.nnfa.org/services/government/pdf/Codex_EUdir.pdf (last visited Jan. 8, 2005).

369 Kathrin Jungbeck, Food Supplements Directive Set to Overhaul Europe, EUROMONITOR INT’L, June 15, 2004, available at http://www.euromonitor.com/article.asp?id=3258 (last visited Jan. 8, 2004).

370 Communication from the Commission on the Precautionary Principle, Commission of the European Communities, COM (2000), Feb. 2, 2000, at 7; see also York, George E.C., Global Foods, Local Tastes & Biotechnology: The New Legal Architecture of International Agriculture Trade, 7 Colum. J. Eur. L. 423, 443-46 (2001)Google Scholar (explaining usage of the precautionary principle in Europe).

371 Huhn, Wilson, Three Legal Frameworks for Regulating Genetic Technology, 19 J. Contemp. Health L. & Pol'Y 1, 33 (2002)Google ScholarPubMed.

372 See, e.g., U.N. Conf. on Env't and Dev., Rio Declaration on Env't and Dev., Principle 15, U.N. Doc. A/Conf.151/5 (1992), reprinted in 31 I.L.M. 874 (1992) (finding that lack of absolute scientific certainty should not impair “cost effective measures” when those measures do not appear harmful); see also Lively, Sarah, The ABCs and NTBs of GMOs: The Great European Union-United States Trade Debate-Do European Restrictions on the Trade of Genetically Modified Organisms Violate International Trade Law?, 23 N.W. J. Int’L L. & Bus. 239, 246–248Google Scholar (explaining limits of the Precautionary Principle in the EU).

373 Dethlefsen, Volkert et al., The Precautionary Principle: Towards Anticipatory Environmental Management, in Clean Production Strategies 41, 41–62 (Tim Jackson ed., 1993)Google Scholar.

374 Fitzgerald Bone, Paula & Russo France, Karen, International Harmonization of Food and Nutrition Regulation: The Good and the Bad, 22 J. Public Pol’Y & Mktg. 102 (2003)Google Scholar.

375 See generally Howells, Geraint G. & Mildred, Mark, Is European Products Liability More Protective than the Restatement (Third) of Torts: Products Liability?, 65 Tenn. L. Rev. 985 (1998)Google Scholar; see also Kysar, Douglas A., The Expectations of Consumers, 103 Colum. L. Rev. 1700 (2003)CrossRefGoogle Scholar (explaining the role of the consumer expectations test in American jurisprudence).

376 Allen, Jane E., No Minor Mix-up, L.A. TIMES, Jan. 10, 2000Google Scholar, at 1.

377 See generally U.S. Pharmacopoeia, http://www.usp.org/ (last visited Jan. 10, 2005).

378 U.S. Pharmacopoeial Convention, Dietary Supplements, available at http://www.usp.org/dietarySupplements/ (last visited Jan. 8, 2005).

379 Packer-Tursman, Judy, Certified, to a Point, WASH. POST, Nov. 19, 2002Google Scholar, at F01 (citing industry research finding that when a consumer is given the choice between two products, all other things being equal, the consumer will select the product that has a credible third-party certification).

380 See Allen, supra note 98.

381 See Woolf, supra note 54.

382 Id.

383 See Streisand, Betsy, The Guru of Product Potential, N.Y. TIMES, Aug. 31, 2003Google Scholar, § 3, at 1 (citing comments by Patrick D. Rea of the Nutrition Business Journal concerning the impact of negative publicity on the entire dietary supplement market).

384 Id. (citing study by Nutrition Business Journal which found slowing industry growth and citing comments by Patrick D. Rea of the Nutrition Business Journal concerning the impact of negative publicity).

385 This phenomenon appeared in the tobacco litigations, as the industry's reputation plummeted with a flurry of lawsuits, which only beget another series of litigations. See Mather, Lynn, Theorizing about Trial Courts: Lawyers, Policymaking, and Tobacco Litigation, 23 Law & Soc. Inquiry 897, 935 (1998)CrossRefGoogle Scholar.

386 See Saslow, Linda, Nassau Restricts Herbal Aids with Stimulant, N.Y. TIMES, Aug. 18, 1996Google Scholar, § 13LI, at 1 (citing comments by Gerard McIntee, director of marketing for Nature's Plus, a manufacturer of vitamins and herbs).

387 See Japsen, Bruce, FDA Could Supplement Vitamin Regulation, CHI. TRIB., Sept. 6, 1998Google Scholar, at 1C.

388 This phenomenon has been evidenced among those industries where actors exploit cheap, foreign labor. See Sorbella, William B., Less Developed Country as Start-up Corporation: Adopting the Venture Capital Model for Development in Light of Global Capital Market Realities, 31 L. & Pol’Y Int’L Bus. 517, 542 (2000)Google Scholar.

389 See Allen, supra note 98, (citing comments by Annette Dickinson, the president of the Council for Responsible Nutrition).

390 See Packer-Tursman, supra note 379 (citing comments by David Schardt, senior nutritionist at the Center for Science in the Public Interest).

391 Similar false deductions often arise with “green” symbols indicating that a product is somehow environmentally-friendly. Many times, those products either offer no meaningful environmental benefit or are based deceptively on half-truths. See generally Wayne, Roger D., The Emperor's New Eco-Logos?: A Critical Review of the Scientific Environmental Report Card and the Green Seal Certification Mark Programs, 14 Va. Envtl. L.J. 51 (1994)Google Scholar.

392 See Kysar, Douglas A., Preferences for Processes: the Process/Product Distinction and the Regulation of Consumer Choice Preferences, 118 Harv. L. Rev. 525, 626-27 (2004)CrossRefGoogle Scholar.

393 See Schmetzer, Uli, Australia Recalls Diet Supplements, CHI. TRIB., May 2, 2003Google Scholar, at C4.

394 See Packer-Tursman, supra note 379.

395 See Roan, Shari, Recall of 2 Products Points Up Risk of Using Supplements, L.A. TIMES, Feb. 18, 2002Google Scholar, at S3.

396 For example, Chattem, the Chattanooga-based health and beauty aids company, produces Ban deodorant, Icy Hot topical pain reliever, Selsun Blue dandruff shampoo, and the Dexatrim nutrient and energy bar. See generally http://www.chattem.com/ (last visited Jan. 10, 2005); see also Japsen, supra note, 387 (explaining difficulties of negotiations between larger supplement manufacturers and those with short-term desire for significant revenue).

397 See Japsen, supra note 387.

398 Pub. L. No. 59-384, ch. 3915, § 2, 34 Stat. 768 (1906) (superseded by the FD&C Act in 1938).

399 Id.

400 See Shalala, 504 F.2d at 789.

401 See Kay McPherson, Rhonda, Pharmaceuticals: Politics, Policy & Availability, 8 Geo. Public Pol’Y Rev. 25, 31 (2003)Google Scholar; see also Mikva, Abner J., Deregulating Through the Back Door: The Hard Way to Fight a Revolution, 57 U. Chi. L. Rev. 521, 523Google Scholar (describing early legislative efforts to control pharmaceutical price gouging).

402 See supra Part II.D.

403 See generally RICHARD H. THALER, TOWARD A POSITIVE THEORY OF CONSUMER CHOICE, in CHOICES, VALUES, AND FRAMES 269 (Daniel Kahneman & Amos Tversky eds., 2000).

404 Indeed, even Dr. Kessler has noted that there are “certain problems you are not going to solve” and dietary supplements are “one of them.” See Gilhooley, supra note 168 (citing Burros, Marian, F.D.A. Commissioner Is Resigning After 6 Stormy Years in Office, N.Y. TIMES, Nov. 26, 1996Google Scholar, at A1).

405 See supra Part III.F.

406 See Breidenbach, T.H. et al., Drug Interaction of St. John's Wort with Ciclosporin, 355 Lancet 1912 (2000)CrossRefGoogle Scholar. Also consider that herbal products are often sold as mixtures of 10 or more different plants, vitamins, and minerals, and that such “stacking” of herbs increases the risk of toxicity from any one of them or from interactions with each other. See Woolf, supra note 54.

407 See Martin, Andrew, Panel Urges FDA Alter List of Daily Nutrients, CHI. TRIB., Dec. 12, 2003Google Scholar, at C1 (citing research by Dr. Irwin Rosenberg, dean of the Gerald J. and Dorothy R. Freidman School of Nutrition Science and Policy at Tufts University).

408 See Craig Andrews, J. et al., Consumer Generalization of Nutrient Content Claims in Advertising, 62 J. Marketing 62 (1998)CrossRefGoogle Scholar.

409 Id. at 63.

410 See Alan S. Levy et al., Consumer Impacts of Health Claims: An Experimental Study, Center for Food and Applied Nutrition, FDA, Jan. 10, 1997, available at http://vm.cfsan.fda.gov/dms/hclm-toc.html; see also Marilyn Chase, Lost in Fat City: Studies Stir Confusion Over Butter and Oils, WALL STREET J., July 10, 1995, at B1.

411 See Note, What you Need to Know about Calcium, 6 Harv. Health Letter 1 (Apr. 2003)Google Scholar.

412 Id.; see also Squires, supra note 315 (noting that the National Institutes of Health recommends 1,500 milligrams of calcium per day for older women).

413 See O’Donnell, Erin, How to Buy the Best Vitamin, 2 Nat’L Health 76 (2003)Google Scholar (citing research of Dr. Jeffrey Blumberg of Tufts University, who notes that seniors and women often benefit with higher doses of nutrients than recommended by daily values).

414 See Martin, supra note 407 (citing remarks by Dr. Irwin Rosenberg, dean of the Gerald J. and Dorothy R. Freidman School of Nutrition Science and Policy at Tufts University).

415 See supra Part III.C and accompanying notes.

416 See Andrews et al., supra note 408, at 72.

417 See Burros, Marian, Read Any Good Nutrition Labels Lately?, N.Y. TIMES, Dec. 1, 2004Google Scholar, at F1 (noting that while many Americans find food labels useful, many also struggle with utilizing all aspects of it; Professor Burros proposes that Americans receive better education on how to observe the facts panel).

418 See, e.g., Prepared Testimony of Al Clausi and the National Food Processors’ Association before the Senate Labor and Human Resources Committee, FEDERAL NEWS SERV., Apr. 11, 1997, available at LEXIS News Database (concluding that proposed FDA changes to food labels would “unnecessarily take up label space”).

419 See, e.g., FDA Folic Acid Health Claim Misses Mark, CRN Says, PR NEWSWIRE, Oct. 21, 1993, available at LEXIS Newswire (citing remarks by Paul Bolar, director of regulatory affairs for Pharmavite Corporation and chairman of Council for Responsible Nutrition's quality assurance committee).

420 See Variyam, Jayachandran N., New Health Information is Reshaping Food Choices, 1 Food Rev. 13 (2002)Google Scholar. This defect of product labeling is identified with pharmaceutical drug labels, which often contain myriad disclosures in tiny font type. See generally Geistfeld, Mark, Inadequate Product Warnings and Causation, 30 U. Mich. J.L. Ref. 309 (1997)Google Scholar; see also Romano, Roberta, A Comment on Information Overload, Cognitive Illusions, and Their Implications for Public Policy, 59 S. Cal. L. Rev. 313 (1986)Google Scholar (providing detailed analysis of information overload).

421 I measured the surface areas from labels of the following products: Advanced Whey Protein; Centrum Performance; BCAA Plus; Universal Nutrition Amino 1900; Carb Intercept; Centrum; Cher-Amino Protein; Cytovol; Glutamine Fuel; Glutamine Powder; Lean Max Matrix Protein; Leptropin-Anorex; Max-Amino; Mood Factors; Muscle Mix; Perfect L-Glutamine; Power Bar Harvest; Super Amino; Tazo Green Ginger Green Tea; and Vogi Herbal Tea.

422 This arrangement could approximate that for pharmaceutical drugs. Indeed, for particular pharmaceutical drugs, the FDA requires that package inserts containing product information be provided and that such inserts inform product users of the risks and benefits associated with usage. See Joanne Rosok, Mae, Direct-to-Consumer Advertising of Prescription Drugs: After a Decade of Speculation, Courts Consider Another Exception to the Learned Intermediary Rule, 24 Seattle Univ. L. Rev. 629, 638 (2000)Google Scholar (citing See Patient Package Inserts for Oral Contraceptives, 21 C.F.R. § 310.501 (2000); Patient Package Inserts for Estrogens, 21 C.F.R. § 310.515 (2000).

423 See FDA's Implementation of “Qualified Health Claims”: Questions and Answers, Apr. 2004, available at http://www.cfsan.fda.gov/∼dms/labqhcqa.html.

424 164 F.3d 650 (D.C. Cir. 1999) (basing decision on the First Amendment and administrative record compiled in the challenged rulemakings).

425 See FDA, Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data & Guidance for Industry and FDA: Interim Procedures for Health Claims in the labeling of Human Dietary Supplements (July 10, 2003), available at http://vm.cfsan.fda.gov/∼dms/hclmgui3.html.

426 See Acting FDA Commission Speaks at Council for Responsible Nutrition Annual Conference, STATES NEWS SERVICE, Oct. 25, 2004, available at LEXIS News Wire.

427 Vendors of chopped walnuts may claim “supportive but not conclusive research shows that eating 1.5 oz. [a little more than a handful] of walnuts per day as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake, may reduce the risk of coronary heart disease.” See Squires, Sally, Omega-3 Foods Can Put Benefits on Label, FDA Says, WASH. POST, Sept. 9, 2004Google Scholar, at A04.

428 Products containing omega-3 fatty acids may state “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” Id.

429 See FDA, FDA Allows Qualified Health Claim to Decrease Risk of Coronary Heart Disease, (Nov. 1, 2004), available at http://www.fda.gov/bbs/topics/news/2004/NEW01129.html (noting that “There is limited but not conclusive evidence that suggests that consumers may reduce their risk of CHD if they consume monounsaturated fat from olive oil and olive oil-containing foods in place of foods high in saturated fat, while at the same time not increasing the total number of calories consumed daily).

430 Others are more skeptical, however. In Center for Science in the Public Interest v. FDA, 2004 U.S. Dist. LEXIS 20781 (U.S.D.C. Sept. 17, 2004), a consumer group sued the FDA, alleging that the Interim Guidance Procedures, in failing to comply with the procedural requirements and substantive standards of the NLEA, allows health claims without the requisite scientific support. Although the case was dismissed in September 2004 for lack of standing, the manner and willingness with which the FDA approves qualified health claims should be monitored closely to ensure sufficient consumer protection. Similar concerns have been raised of the lack of specificity of qualified health claims. See, e.g., Squires, supra note 427 (quoting Bruce Silverglade of the Center for Science in the Public Interest).

431 324 F. Supp. 2d 582 (D.N.J. 2004).

432 Because of such specific health claims, the court deemed the product's marketing as consistent with drug marketing. Thus, the product was considered an unapproved new drug with a misbranded label. Id. at 582-84.

433 The sanction included: all inventory of these products be destroyed under FDA supervision and Lane Labs make restitution on all sales of these products since 1999. Id.

434 See FDA Press Release, Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement, Apr. 19, 2004, available at LEXIS News Wire.

435 See Levitt, Joseph A., FDA's Plate Remains Full, LEGAL TIMES, Mar. 1, 2004Google Scholar, at 25. Dietary supplement GMPs were originally enacted by DSHEA. Specifically, DSHEA amended the FDC Act and added the dietary supplement CGMP, which deems a product “adulterated,” if “it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). 21 U.S.C. § 342(g)(1). Subparagraph (2) of § 342(g) provides that, “the Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology.” 21 U.S.C. § 342(g)(2).

436 See, e.g., Nutritional Health Alliance v. FDA, 318 F.3d 92 (6th Cir. 2003).

437 See FDA, Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement, (Apr. 19, 2004), available at http://www.fda.gov/bbs/topics/news/2004/NEW01055.html.

438 See Prepared Statement of the Federal Trade Commission, Before the Comm. on Energy and Commerce, Subcomm. on Oversight and Investigations, 108th Cong. (June 16, 2004), available at http://www.ftc.gov/os/2004/06/040616dietarysupptestimony.pdf.

439 See Federal Trade Commission v. National Urilogical Group et al., Civil No. 1:04-GV- 3294, (D.G.A. Nov. 30, 2004), available at http://www.ftc.gov/os/caselist/0223165/041130comp0223165.pdf. In August 2004, the FDA also negotiated a $1 million settlement with two dietary supplement marketers who had falsely advertised that certain dietary supplements caused substantial weight loss without diet or exercise. See FTC Press Release, Two Maine Dietary Supplement Marketers Pay Nearly $1 Million to Settle FTC Deceptive Advertising Complaints (Aug. 27, 2004), at http://www.ftc.gov/opa/2004/08/pvt.htm.

440 See FTC Press Release, FTC Charges Marketers with Making Deceptive Efficacy and Safety Claims about Ephedra and Yohimbine Dietary Supplements (Nov. 30, 2004), at http://www.ftc.gov/opa/2004/11/nationalurological.htm.

441 See generally JAMES R. BETTMAN, AN INFORMATION PROCESSING THEORY OF CONSUMER CHOICE 173–228 (Addison-Wesley Publishing Co. 1979) (explaining Theory of Consumer Choice); see also McCann, supra note 225, at 1177 (explaining consumer choice in the context of food consumption choices).

442 See, e.g., Fisher Kellner, Lauren, Trade Dress Protection for Computer User Interface “Look and Fee”, 61 U. Chi. L. Rev. 1011, 1023 (1994)Google Scholar (describing the increase of consumer confidence in microcomputer markets with predictable and standardized labeling mechanisms); Reith, Thomas T. III, Consumer Confidence: The Key to Successful E-Commerce in the Global Marketplace, 24 Suffolk Transnat'L L. Rev. 467, 484 (2001)Google Scholar (noting that the EU's Organisation For Economic Cooperation and Development finds that a combination of industry standards and governmental legislation may lead to enhanced consumer confidence).

443 See supra Part IV.B.

444 See Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods”, Gen. Acct. Off. Rep. No. RCED-00-156, at 12 (July 11, 2000), available at http://www.gao.gov/archive/2000/rc00156.pdf.

445 Aristolochia has been linked to kidney failure and cancer and has been banned in 10 countries. Germander has been linked to liver damage and has been banned in Germany and France. See Twelve Supplements You Should Avoid, CONSUMER REPORTS, May 2004, available at http://www.consumerreports.org (last visited, Feb. 15, 2005).

446 See Hwa Lee, Seon, et al., Vitamin C-Induced Decomposition of Lipid Hydroperoxides to Endogenous Genotoxins, 292 Science 2083 (2001)CrossRefGoogle Scholar.

447 See Deliganis, Chryssa V., Death by Apple Juice: The Problem of Foodborne Illness, the Regulatory Response, and Further Suggestions for Reform, 53 Food Drug L.J. 681, 725 (1998)Google ScholarPubMed.

448 See supra Part III.

449 21 U.S.C. § 350d(a)(1) (Supp. 2002); see also Hutt, supra note 283, at 17 (“All of the provisions in the Bioterrorism Act apply to dietary supplements and dietary ingredients as well as to conventional foods”).

450 In 2003, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) established the Center's Adverse Event Reporting System (CAERS) to monitor adverse event reports on CFSANregulated products, including dietary supplements. CAERS is a computerized system that records voluntarily received reports and separates them into product problems and adverse events. This system unifies CFSAN's adverse event reporting through one common portal. See Statement of Robert E. Bracket, supra note 272.

451 See FDA, supra note 436 (Dr. Crawford outlining plans for the FDA to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data) evidence-based reviews, and adverse event information). Id.

452 See Life Sciences Research Office, supra note 334.

453 See id. (noting how proposed changes in federal regulation of the dietary supplement industry have spurred some manufacturers to consider their monitoring systems).

454 Imposing a more taxing standard on dietary supplement manufacturers than on pharmaceutical drug manufacturers does not appear justified on any known evidentiary grounds. The standard's relative stringency could be revisited, however, if it were to prove insufficient in the dietary supplement setting.

455 21 C.F.R. 600.80(c)(1)(i) (stating that pharmaceutical manufacturers must reveal all “serious and unexpected” adverse reactions). This would entail that whenever a supplement manufacturers learns of a serious and unexpected reaction (e.g., death, a life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization) from product usage, it would immediately notify the FDA. See Baram, Michael, Making Clinical Trials Safer for Human Subjects, 27 Am. J. L. & Med. 253, 262-63 (2001)Google ScholarPubMed (illustrating the “serious and unexpected” standard).

456 See Colloton, supra note 163, at 549 (noting that some manufacturers complain that the FDA fails to keep them informed of adverse reactions to their products).

457 Id.

458 See, e.g., Dietary Supplement Safety Act of 2003, S. 722, 108th Cong. (2003).

459 See, e.g., Spokes, Jennifer J., Confusion in Dietary Supplement Regulation: The Sports Irony, 77 B.U. L. Rev. 181 (1997)Google Scholar; Diaz, Leticia M., First St. John's Wort, Now SAM-e: Is Society as a Whole at Risk Without FDA Regulation of Psychiatric Self-Medication?, 9 Kan. J.L. & Pub. Pol'Y 279 (1999)Google Scholar.

460 See Croley, Steven P., Theories of Regulation: Incorporating the Administrative Process, 98 Colum. L. Rev. 1, 32 (1998)CrossRefGoogle Scholar (explaining that compromises and trade-offs among competing groups can yield preferable political outcomes).

461 See S. 722, 108th Cong. (2003).

462 See Proposed Section 416(c)(2)(“PERIODIC ADVERSE DIETARY SUPPLEMENT EXPERIENCE REPORTING— A manufacturer of a dietary supplement shall annually (or at such shorter intervals as the Secretary may require), in accordance with such requirements as the Secretary may establish, submit to the Secretary a report that discloses all information received with respect to adverse dietary supplement experiences …”). Id. at § 416(c)(2).

463 Specifically, it would amend Chapter IV of the FDCA by adding several sections. Id.

464 Specifically, the DSSA would strike (other than tobacco)’ from the FDCA and insert (other than tobacco or a product that bears or contains an anabolic steroid (including a substance that is chemically and pharmacologically related to testosterone but not including an estrogen, progestin, or corticosteroid)).’ Id. at § 4.

465 The dietary supplement lobby, along with various holistic medicine groups, have deftly employed fear tactics to stymie legislative progression. Indeed, consider comments by the National Nutritional Foods Association: “[DSSA] would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary. Products that have been used safely for hundreds—and in some cases, thousands—of years would be subject to clinical evaluation using standards that are at the complete discretion of the FDA. Oppose this Legislation” See Healing Earth Resources, The Dietary Supplement Safety’ Act, at http://www.healingearthresources.com/site/epage/11711_163.htm (last visited, Jan. 1, 2005).

466 For an excellent discussion on paternalism and the drug approval process, see Greenberg, Michael D., Information, Paternalism, and Rational Decision-Making: The Balance of FDA New Drug Approval, 13 Alb. L.J. Sci. & Tech. 663, 674-77 (2003)Google Scholar.

467 See STEPHEN BREYER BREAKING THE VICIOUS CIRCLE: TOWARD EFFECTIVE RISK REGULATION 11 (1993) (noting that policies which encourage automatic removal of asbestos from buildings—regardless of the amount of asbestos—can cause more damage than asbestos itself).