Devaluing truth: Unverified health claims in the aftermath of Pearson v. Shalala

Food and Drug Law Journal

Volumn 54, Issue 4, 1999, Pages 535-553

  Vladeck, David C ^a,b  

^a GEORGETOWN UNIVERSITY LAW CENTER   (United States)

^b Public Citizen Litigation Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NON PRESCRIPTION DRUG;

CONSUMER; DIET SUPPLEMENTATION; DRUG EFFICACY; DRUG INFORMATION; DRUG LEGISLATION; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; LAW SUIT; REVIEW; UNITED STATES;

DIETARY SUPPLEMENTS; HEALTH PROMOTION; HUMANS; MARKETING OF HEALTH SERVICES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033399622     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (139)

1. As defined in the FDCA, a dietary supplement is a "product (other than tobacco) intended to supplement the diet that bears or contains . . . a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any [of the above ingredients]." 21 U.S.C. § 321 (ff)(1) (1994).
2. See, e.g., Mark A, Kassel, From A History of Near Misses: The Future of Dietary Supplement Regulation, 49 FOOD & DRUG L.J. 237,254-61 (1994) (chronicling the history of congressional and FDA efforts to regulate dietary supplements); see also Note, Where There's Smoke There's Fire: The Dangers of the Unregulated Dietary Supplement Industry, 42 N.Y.L. SCH. L. REV. 261, 268-71 (1998).
3. See, e.g., Mark A, Kassel, From A History of Near Misses: The Future of Dietary Supplement Regulation, 49 FOOD & DRUG L.J. 237,254-61 (1994) (chronicling the history of congressional and FDA efforts to regulate dietary supplements); see also Note, Where There's Smoke There's Fire: The Dangers of the Unregulated Dietary Supplement Industry, 42 N.Y.L. SCH. L. REV. 261, 268-71 (1998).
4. See Kassel, supra note 2, at 254-63.
5. Pub. L. No. 101-535, 104 Stat. 1213 (codified at 49 U.S.C, § 521 (1994); 49 U.S.C App. §§ 1814, 2501 note, 2801 notes, 2802-12 (1994)).
6. 21 C.F.R. § 101.14(1996).
7. 21 U.S.C. § 343(r)(1)(B).
8. Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir. 1998), cert. denied, 119 S. Ct. 589 (1998); National Council for Improved Health v. Shalala, 122 F.3d 878 (10th Cir. 1997); Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).
9. Id.
10. Nutritional Health, 144 F.3d 220; National Council, 122 F.3d 878.
11. Pearson, 164 F.3d 650.
12. Id. at 655.
13. Id. at 657.
14. Id. at 659.
15. Id. at 659-60.
16. Pearson v. Shalala, 172 F.3d 72 (D.C. Cir. 1999).
17. See Jenna Greene, FDA Waging War of Words: Definition of "Disease" Sparks Furor, XXII (10) LEGAL TIMES WASH, 1 (July 19, 1999).
18. See, e.g., Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985).
19. 136 CONG. REC. H12953 (daily ed. Oct. 26, 1990) (remarks of Rep. Waxman); see also H.R. REP. No. 538, 101st Cong., 2d Sess. 7, reprinted in 1990 U.S.C.C.A.N. 3336, 3337.
20. It can be argued that the NLEA actually weakened FDA's authority over dietary supplements. Prior to the passage of the NLEA, a food or dietary supplement that carried a health claim was subject to regulation as a drug under the Federal Food, Drug, and Cosmetic Act (FDCA). A health claim is, in fact, a disease prevention claim, and all products claiming to prevent disease are classified as "drugs" under the FDCA. See 21 U.S.C. § 321 (g) (1972 & Supp. 1997). Such claims were forbidden unless the "drug" had been tested extensively by the manufacturer (see 21 U.S.C. § 355) and either approved by FDA or generally recognized as safe and effective. Accordingly, before the NLEA, a food or dietary supplement making an unsubstantiated health claim would be subject to an FDA seizure action, because it would be both "misbranded" under 21 U.S.C. §§ 331(a), 352(a), and an unapproved "new drug" under 21 U.S.C. § 355(a).See Kellogg v. Mattox, 763 F. Supp. 1369 (N.D. Tex. 1991), aff'd without opinion sub nom., Kellogg v. Morales, 940 F.2d 1530 (5th Cir. 1991) (upholding the complete prohibition of health claims against First Amendment attack). See Kassel, supra note 2, at 249-53.
21. Pub. L. No. 75-717, 52 Stat 1040 (1938) (as amended 21 U.S.C. §§ 301 et seq.).
22. 21 U.S.C. § 343(r)(1)(B).
23. The NLEA applies to health claims made on actual product labels and on "labeling," i.e., other written materials distributed by manufacturers or retailers in conjunction with the promotion and sale of dietary supplements. This requirement is consistent with a long-standing provision in the FDCA that defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or its containers or wrappers, or (2) accompanying such article." 21 U.S,C. § 321 (m) (emphasis added). FDA's regulations under § 321(m) do not apply to the dissemination of scientific or other literature in non-commercial fora. Moreover, Congress amended the NLEA in 1994 to permit dietary supplement manufacturers and retailers to distribute such literature in limited situations, 21 U.S.C. § 343-2(a).
24. Id. § 343(r)(3)(B).
25. Id. § 343(r)(5)(D).
26. See 136 CONG. REC. H12953 (daily ed. Oct. 26, 1990) (statements of the House Floor Managers of both parties that dietary supplements "covered by this provision should be subject to at least as strong a standard as is applicable to other foods"); see also 136 CONG. REC: S16608 (daily ed. Oct. 24, 1990) (statement of Sen. Metzenbaum, sponsor of the bill).
27. 21 C.F.R. §§ 101.14, 101.70.
28. Although there are semantic differences, the "significant scientific agreement" standard is not significantly different than the standard that applies to new drugs, and the health claims that can be made for drugs. The FDCA does not define what constitutes general recognition of a drug's safety and effectiveness under § 201(p)(1). Based on the structure and purpose of the statutory scheme, however, the Supreme Court in Weinberger v. Hynson. Westcott & Dunning Inc., 412 U.S. 609, 629-34 (1973), interpreted § 201 (p)(1) to require an "expert consensus" on safety and effectiveness founded upon "substantial evidence" as defined in FDCA § 505(d), 21 U.S.C, § 355(d), Health claims are forbidden for unapproved new drugs, as well as for unapproved indications for approved drugs.
29. 21 U.S.C § 343(r)(1)(B).
30. 21 C.F.R. § 101.70.
31. Id. § 101.14(a)(1).
32. Id. § 101.70(j)(2).
33. Id. § 101.70(j)(3).
34. Id. § 101.70(j)(4).
35. See id. §§ 101.72-101.81.
36. Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note).
37. 21 U.S.C. § 201(ff)(3)(B).
38. See id.
39. Under DSHEA, dietary supplement manufacturers may make claims, without FDA approval, concerning how a supplement affects the structure or function of the human body (e.g., calcium helps build strong bones). 21 U.S.C. § 343(r)(6). Unlike health claims (e.g., calcium may prevent osteoporosis), structure and function claims do not promise to prevent, mitigate, or cure disease; indeed, a structure or function claim may not even mention a disease. See 63 Fed. Reg. 23,624 (Apr. 29, 1998).
40. Commission on Dietary Supplement Labels, Report to the President, the Congress and the Secretary of the Department of Health and Human Services 31, 35 (Nov. 1997) (visited Nov. 12, 1999) 〈web.health.gov/ dietsupp/〉.
41. Id.
42. Id. These recommendations were echoed by the Congressional Commission on Risk Assessment and Risk Management, in its examination of the standards imposed by the NLEA and FDA's implementing rules. The Commission informed Congress that "FDA's authority to require scientific evidence to justify manufacturers' claims of safety and health benefits from nutritional supplements should be reaffirmed and strengthened," Presidential/Congressional Commission on Risk Assessment and Management, Risk Assessment and Risk Management in Regulatory Decision-Making, 139 (Washington, D.C. 1997).
43. Pearson v. Shalala, 14 F. Supp. 2d 10 (D.D.C. 1998).
44. Id. at 17.
45. Id. at 18.
46. Id.
47. Id.
48. Id. at 19.
49. Id.
50. Id.
51. Id.
52. Id.
53. Id.
54. Id. at 20-21.
55. Id. at 20.
56. Id.
57. Id. at 21.
58. 164 F.3d at 657-58.
59. Id. at 656-57.
60. Id. at 659-60.
61. See, e.g., Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976); Edenfield v. Fane, 507 U.S. 761 (1993);44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484(1996).
62. Edenfield, 507 U.S. at 770.
63. 21 U.S.C. § 343-2(a).
64. For a detailed discussion of the limits on the use of "puffery" by advertisers, see Ivan L. Preston, Puffery and Other "Loophole" Claims: How the Law's "Don't Ask Don't Tell" Policy Condones Falsity in Advertising, 18 J.L. & COM. 49 (1998).
65. See Brief of Amici Curiae American Cancer Society, et al., in Pearson, 14 F. Supp. 2d at 10-11.
66. 447 U.S. 557 (1980).
67. Id. at 563-64. Accord Florida Bar v. Went for It, Inc., 515 U.S. 618, 623-24 (1995); Rubin v. Coors Brewing Co., 514 U.S. 476, 482 (1995).
68. Central Hudson, 447 U.S. at 563-64.
69. Friedman v. Rogers, 440 U.S. 1,9-10 (1979) (citations omitted). Accord Florida Bar, 515 U.S. at 623-24 ("[T]he government may freely regulate commercial speech that... is misleading"); Edenfield, 507 U.S. at 768 ("[O]ur cases make clear that the State may ban commercial expression that is fraudulent or deceptive without further justification."). Courts repeatedly have upheld government prohibitions on deceptive advertising and labeling of foods and drugs against First Amendment challenges. See, e.g., Kraft, Inc. v. Federal Trade Comm'n, 970 F.2d 311, 324-26 (7th Cir. 1992), cert. denied, 507 U.S. 909 (1993) (upholding Federal Trade Commission (FTC) ban on deceptive calcium claims for processed cheese products); Bristol-Myers Co. v. Federal Trade Comm'n, 738 F.2d 554, 562 (2d Cir. 1984), cert. denied, 469 U.S. 1189 (1985) (sustaining FTC prohibition against certain advertising claims for analgesics); United States v. General Nutrition, Inc., 638 F. Supp. 556, 562 (W.D.N.Y. 1986) (upholding FDA prohibition of certain nutritional claims on the product label).
70. Brief for Appellees in Pearson v. Shalala, Nos. 98-5043 & 98-5084, at 24-25 (citing H.R. REP. No. 101-538 (1990); 136 CONG. REC. H12,953 (1990); 136 CONG. REC. H5844 (1990); Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 100-561 (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: hearings Before the Human Resources and Integovernmental Relations Subcomm. on the House Comm. on Governmental Affairs, 101st Cong. (1990); Health Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong. (1990).
71. Brief for Appellees, supra note 69, at 16, 24-25.
72. Id. at 25.
73. Id.
74. Id. (citing 58 Fed. Reg. 2562 (Jan. 6, 1993)).
75. Pearson, 164 F.3d at 655.
76. The Pearson court's dismissal of FDA's "Inherently false" argument contrasts sharply with the routine acceptance of the argument that "if FDA does not endorse a claim, then it must be false" in other contexts. Under the Lanham Act, for example, courts have held that a drug claim not approved by FDA - even if supported by scientific studies and journal arguments - is false under the Act and hence actionable. To take one recent example, in Zeneca Inc. v. Eli Lilly & Co., No. 99 CIV. 1452(JGK), 1999 WL 509471 (S.D.N.Y. July 19, 1999), the district court entered an injunction barring Eli Lilly from suggesting that its drug Evista® reduces the risk of breast cancer because, although there is some scientific evidence supporting Lilly's claim, the evidence is inconclusive and thus FDA has not approved Evista® for that use. And as explained above, the necessity of FDA premarketing approval for drug claims long has been accepted, even though FDA requires an "expert consensus" that the drug is safe and effective for its intended use. See, e.g., Weinberger, 412 U.S. at 629-34.
77. 433 U.S. 350 (1976).
78. Id. at 366.
79. 471 U.S. 626 (1985).
80. Id. at 641 n.9.
81. Indeed, the lower courts have upheld state bans on lawyers making quality claims in their advertisements, unless the claim is subject to objective substantiation. See, e.g., Texans Against Censorship v. State Bar, 888 F. Supp. 1328 (E.D. Tex. 1995), aff'd without opinion, 100 F.3d 953 (5th Cir. 1996).
82. C. Lee Peeler & Susan Cohn, The Federal Trade Commission's Regulation of Advertising Claims for Dietary Supplements, 50 FOOD & DRUG L.J. 349, 350-51 (1995).
83. See, e.g., United States v. Edge Broad. Co., 509 U.S. 418,434 (1993); Board of Trustees of the State Univ. of New York v. Fox, 492 U.S. 469, 480 (1989).
84. See, e.g., American Home Prods. Corp. v. Federal Trade Comm'n, 698 F.2d 681, 695 (3d Cir. 1982); United States v. Rutherford, 442 U.S. 544 (1979).
85. Id.
86. See, e.g., Rutherford, 442 U.S. at 555-57. Nor was the Court correct in trivializing the risks from dietary supplements. The court proclaims that "the government does not assert that appellants' dietary supplements in any fashion threaten consumer's health and safety." Pearson, 164 F.3d at 656 (emphasis in original; footnote omitted). This statement is wrong because, as discussed below, FDA in fact argued that the health claims appel-lants wanted to make for their folate products did jeopardize public health. More disquieting, however, is the court's implication that dietary supplements generally pose little health risks to the public - a suggestion that is quite wide of the mark. See, e.g., Kassel, supra note 2, at 241-50 (canvassing serious public health risks posed by use of dietary supplements).
87. 436 U.S. 447 (1978).
88. Id. at 466 (assuming "that in-person solicitation by lawyers more often than not will be injurious to the person solicited").
89. Id. at 465-67; see also In re R.M.J., 455 U.S. 191, 202 (1982); Friedman v. Rogers, 440 U.S. 1 (1979).
90. 515 U.S. 618 (1995).
91. Once again, there was no question in Florida Bar that the anti-solicitation rule would bar valuable, non-intrusive communications as well as invasive ones, and hence was considerably overinclusive. Nonetheless, as both Ohralik and Florida Bar show, the Court's commercial speech cases make it clear that, contrary to the implication in Pearson, the Court will sustain restrictions on commercial speech that are significantly overinclusive, so long as they are "reasonable," Accord Fox, 492 U.S. at 480; Edge Broadcasting, 509 U.S. at 429.
92. Once again, there was no question in Florida Bar that the anti-solicitation rule would bar valuable, non-intrusive communications as well as invasive ones, and hence was considerably overinclusive. Nonetheless, as both Ohralik and Florida Bar show, the Court's commercial speech cases make it clear that, contrary to the implication in Pearson, the Court will sustain restrictions on commercial speech that are significantly overinclusive, so long as they are "reasonable," Accord Fox, 492 U.S. at 480; Edge Broadcasting, 509 U.S. at 429.
93. Brief for Appellees, supra note 69, at 24-26.
94. Id.
95. The court's silence on this issue is especially puzzling in light of the judgment made in the FDCA that, until proven to FDA's satisfaction, health claims for drugs flatly are prohibited because of the health risks unverified claims pose to consumers. See, e.g., Rutherford, 442 U.S. at 555-57, and Zeneca, 1999 WL 509471. Why a categorical, prophylactic ban is acceptable for unverified health claims for drugs but is wholly unacceptable for dietary supplements is left unanswered.
96. Brief for Appellees, supra note 69, at 25.
97. Pearson, 164 F.3d at 659-60.
98. Id. This later point was echoed in an editorial in the New England Journal of Medicine: [B]efore we lend our imprimatur to the widespread use of a still unproved treatment, one that requires the patient only to pop a few pills, we should ask how many patients will slack off on their adherence to better-established, but somewhat more onerous, preventative measures such as a cholesterol-lowering diet, regular exercise, and smoking cessation. Daniel Steinberg, M.D., Ph.D., Anti-Oxidant Vitamins and Coronary Heart Disease, 328 NEW ENG. J. MED. 1487 (1993). See also C. Hennekens, M.D., Antioxidant Vitamins - Benefits Not Yet Proven, 330 NEW ENG. J. MED. 1080 (1994) ("Despite the lack of reliable evidence, exaggerated health claims are being made forantioxidant vitamins.").
99. Id. This later point was echoed in an editorial in the New England Journal of Medicine: [B]efore we lend our imprimatur to the widespread use of a still unproved treatment, one that requires the patient only to pop a few pills, we should ask how many patients will slack off on their adherence to better-established, but somewhat more onerous, preventative measures such as a cholesterol-lowering diet, regular exercise, and smoking cessation. Daniel Steinberg, M.D., Ph.D., Anti-Oxidant Vitamins and Coronary Heart Disease, 328 NEW ENG. J. MED. 1487 (1993). See also C. Hennekens, M.D., Antioxidant Vitamins - Benefits Not Yet Proven, 330 NEW ENG. J. MED. 1080 (1994) ("Despite the lack of reliable evidence, exaggerated health claims are being made forantioxidant vitamins.").
100. Brief for Appellees, supra note 69, at 33, 35.
101. Pearson, 164 F.3d at 656 (emphasis in original).
102. Id. n.6.
103. Indeed, the Supreme Court's opinion in Rutherford rests mainly on this consumer-protective function of the food and drug laws. Yet the Pears on court never mentions Rutherford, let alone grapples with FDA's contention that unverified and overblown health claims for dietary supplements will lead some consumers to forego conventional and effective treatments in favor of unproven remedies.
104. See 58 Fed. Reg, 54,595 (Oct. 22, 1993) (rejecting health claim petition on anti-oxidants); see also 58 Fed, Reg. 2622 (Jan. 6, 1993).
105. Press Statement of the National Cancer Institute, National Institutes of Health, Beta Carotene and Vitamin A Halted in Lung Cancer Prevention Trial, Jan. 18, 1996.
106. Brief for Appellees, supra note 69, at 52.
107. Id.
108. Id. at 10-12, 51-53. Without belaboring the point, it is astonishing how little attention the court paid to the public health imperative that lies at the core of the NLEA. The examples cited in the text are just the tip of the iceberg. One need only recall the 38 deaths and 1500 injuries associated with L-tryptophan to understand the risks that indiscriminate use of untested dietary supplements pose to public health. See, e.g., Stuart L. Nightingale, Update on EMS and L-Tryptophan, 268 JAMA 1828 (1992); see also Kassel, supra note 2, at 241-43 (recounting health problems posed by a wide range of dietary supplements).
109. Pearson, 164 F.3d at 656 n.6.
110. See, e.g., Comment, 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, 81 (1996) (pointing out the widespread usage of melatonin to combat sleeping disorders and to reduce jet lag, despite the fact that it is a powerful hormone whose "long-term effects... are completely unknown"); Kassel, supra note 2, at 243 (observing that for many of the 24 amino acids taken as dietary supplements, that the Federation of American Societies for Experimental Biology, working under a contract from FDA, concluded that there "no safe level of intake exists," in large measure because of uncertainties over the public health risk).
111. See generally supra note 101; see also Huijeong Hahm, et al., Comparison of Melatonin Products Against UPS's Nutritional Supplements Standard and Other Criteria, 39(1) J. AM. PHARM. ASS'N 27 (Jan./Feb. 1999) (concluding that significant quality control problems persist in the formulation and manufacturing of dietary supplements).
112. Perhaps most problematic is the court's assumption that there is a clear dividing line between supplements on the one hand and drugs on the other. That is not the case. Many dietary supplements that have potent pharmacological effects are also sold as prescription medications. For instance, the herbal product Atropa Belladonna is used to treat a variety of heart problems, including arrhythmia and cardiac insufficiency, and liver and gallbladder complaints; Ephedra Sinica (often sold as Ma-Huang) is used for respiratory tract ailments and as a stimulant. See PHYSICIAN'S DESK REFERENCE FOR HERBAL PRODUCTS at 677-80, 826-27 (1998 ed.). Both are also the main ingredients in prescription medications; Atropha Belladonna is an active ingredient in Bellatol and Donnatol, and Ephedra Sinica is an active ingredient in Marax. See PHYSICIAN'S DESK REFERENCE at 2211 (Bellatol), 2234 (Donnatol), and 2015 (Marax) (1997 ed.).
113. Perhaps most problematic is the court's assumption that there is a clear dividing line between supplements on the one hand and drugs on the other. That is not the case. Many dietary supplements that have potent pharmacological effects are also sold as prescription medications. For instance, the herbal product Atropa Belladonna is used to treat a variety of heart problems, including arrhythmia and cardiac insufficiency, and liver and gallbladder complaints; Ephedra Sinica (often sold as Ma-Huang) is used for respiratory tract ailments and as a stimulant. See PHYSICIAN'S DESK REFERENCE FOR HERBAL PRODUCTS at 677-80, 826-27 (1998 ed.). Both are also the main ingredients in prescription medications; Atropha Belladonna is an active ingredient in Bellatol and Donnatol, and Ephedra Sinica is an active ingredient in Marax. See PHYSICIAN'S DESK REFERENCE at 2211 (Bellatol), 2234 (Donnatol), and 2015 (Marax) (1997 ed.).
114. Pearson, 164 F.3d at 656.
115. 492 U.S. 469 (1989).
116. Fox is a pivotal case in commercial speech jurisprudence. There the Court laid to rest any argument that states were obligated to impose the "least restrictive measure" or less "drastic" means in regulating commercial speech to safeguard against deception. Rather, the Court emphasized that "reasonableness," not perfection, is the touchstone of analysis under the commercial speech doctrine. Id. at 480, The Court recognized that ordinarily "reasonableness" is the touchstone of rational basis review, the least stringent constitutional review the Court applies. Id. The difference, the Court observed, is that, unlike rational basis review, intermediate scrutiny demands that "the State bears the burden of justifying its restrictions... [and] it must establish the reasonable fit we require." Id. (citations omitted).
117. Id. at 480 (citations omitted). The Pearson court's quick trigger in rejecting the legislative judgments underlying the NLEA and FDA's implementing rule may pose a real dilemma for agencies engaged in health and safety regulation. Most statutes that delegate authority to set health and safety standards direct agencies to apply a "precautionary principle" - namely to err on the side of over-regulation when addressing risks that are not well understood. As one commentator has putit, the "precautionary principle simply reflects the classic adage: Better safe than sorry," Frank B. Cross, Paradoxical Perils of the Precautionary Principle, 53 WASH. & LEE L. REV. 851 (1996); see also Richard C. Revesz, Environmental Regulation, Cost Benefit Analysis, and the Discounting of Human Lives, 99 COLUM. L. REV. 941, 1013 (1999). But Pearson suggests that when an agency engages in health and safety regulation by limiting expressive activity, the precautionary goal of the regulation will count little in assessing the regulation's validity under the First Amendment
118. Id. at 480 (citations omitted). The Pearson court's quick trigger in rejecting the legislative judgments underlying the NLEA and FDA's implementing rule may pose a real dilemma for agencies engaged in health and safety regulation. Most statutes that delegate authority to set health and safety standards direct agencies to apply a "precautionary principle" - namely to err on the side of over-regulation when addressing risks that are not well understood. As one commentator has putit, the "precautionary principle simply reflects the classic adage: Better safe than sorry," Frank B. Cross, Paradoxical Perils of the Precautionary Principle, 53 WASH. & LEE L. REV. 851 (1996); see also Richard C. Revesz, Environmental Regulation, Cost Benefit Analysis, and the Discounting of Human Lives, 99 COLUM. L. REV. 941, 1013 (1999). But Pearson suggests that when an agency engages in health and safety regulation by limiting expressive activity, the precautionary goal of the regulation will count little in assessing the regulation's validity under the First Amendment
119. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
120. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
121. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
122. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
123. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
124. See Fox, 492 U.S. at 480; see also Edge Broadcasting, 509 U.S. at 434 ("Within the bounds of the general protection provided by the Constitution to commercial speech, weallow room for legislative judgments."). Congress' judgment in the NLEA was informed by an enormous record amassed before the passage of the Act. See, e.g., FDA Proposals to Permit the Use of Disease-Specific Health Claims on Food Labels: Hearing Before a Subcomm. of the House Comm. on Government Operations, 100th Cong., 1st Sess. (1987); House Comm. on Government Operations, Disease-Specific Health Claims on Food Labels: An Unhealthy Idea, H.R. REP. No. 561, 100th Cong., 2d Sess, (1988); FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Government Operations, 101st Cong., 1st Sess. (1989); House Comm. on Government Operations. FDA's Continuing Failure to Prevent Deceptive Health Claims for Food, H.R. REP. No. 980, 101st Cong., 2d Sess (1990); Health and Nutrition Claims in Food Advertising and Labeling: Hearings Before the Senate Comm. on Governmental Affairs, 101st Cong., 2d Sess, (1990). The evidence compiled by FDA when it promulgated its implementing regulations is equally substantial and compelling. See 59 Fed. Reg. 395 (Jan. 4, 1994).
125. 21 U.S.C. § 343(r)(1)(B).
126. Pearson, 164 F.3d at 659-60.
127. Id. at 658-59.
128. Id.
129. Friedman, 440 U.S. 1.
130. Id. at 12 n.11.
131. 471 U.S. 626 (1985).
132. The main issue presented in Zauderer was whether the Ohio Bar could punish a lawyer for running an advertisement seeking clients injured by the Dalkon Shield. To distinguish between the Shield and other intrauterine devices, the lawyer's advertisement included a drawing of the Dalkon Shield. The Ohio courts had sustained disciplinary action against Zauderer because the advertisement - and especially the drawing-solicited a particular client group and therefore sought to stir up litigation. The Supreme Court reversed, holding that, because of its expressive content, the drawing was just as entitled to First Amendment protection as verbal commercial speech. Id. at 647-49.
133. 123 Id. at 650.
134. Id. at 651 (quoting In re R.M.J., 455 U.S. at 201).
135. The Court's decision in 44 Liquormart, Inc. v. Rhode Island also rests on the pro-information goal of the First Amendment, and does not support thePearson decision. The Pearson court says that 44 Liquormart undermined "the proposition that a court should not second guess a legislative decision to restrict speech rather than to require more speech." 164 F.3d at 658. To be sure, the 44 Liquormart Court criticized a prior Supreme Court ruling, Posadas de Puerto Rico Assocs. v. Tourism Co. of Puerto Rico, 478 U.S. 328(1986), for failing to review the rationality of the legislature's judgment that all casino gambling advertising directed toward Puerto Rican residents should be banned outright. But nothing in 44 Liquormart goes as far as the Pearson court suggests and counsels disregard for legislative judgments. Indeed, in post-44 Liquormart commercial speech decisions, the Court again emphasized the need for deference, albeit not blind deference, to legislative judgments. See Greater New Orleans Broad. Ass'n v. United States, 119 S. Ct 1923 (1999).
136. Applying the logic of Pearson, the disclaimers in Ohralik might have read as follows: "The Ohio State Bar takes no position on whether the statement concerning fees and costs is accurate" or "The Ohio State Bar does not approve this claim."
137. Pearson, 164 F.3d at 658-59.
138. The same conclusion almost certainty will apply to food products. Although Pearson involved only dietary supplements, it is hard to see how FDA will be able to enforce its parallel restrictions on health claims for food products. The court's opinion suggests that it might treat drugs differently, but nothing in the opinion indicates that the court would reach a different outcome for health claims for food products. Indeed, because foods are seen to pose even less risk than dietary supplements, foods might be an a fortiori case. Although to date the question has not been the subject of litigation, it is reasonable to assume that post-Pearson food sellers will be permitted to make disease prevention, mitigation, and cure claims based on unverified data, as long as the claims are accompanied by a suitable disclaimer.
139. See, e.g., Pharmanex, Inc. v. Shalala, 35 F. Supp. 2d 1341 (D. Utah) (rejecting FDA's contention that Cholestin, a dietary supplement consisting of red yeast rice marketed to lower cholesterol, was a "drug" subject to the new drug requirements of the FDCA because Cholestin's active ingredients are identical to those in prescription medication used to reduce cholesterol levels; Sheryl Gay Stolberg, FDA Issues a Health Warning on Weight-Loss Supplement, N.Y. TIMES, Nov. 12, 1999, at A19 (reporting FDA warning that Triax Metabolic Accelerator, a dietary supplement made from a derivative of thyroid hormone and sold for weight loss, should be considered an unapproved new "drug"). Perhaps the best-known illustration of this point is the extraordinary success of the supplement called SAM-e (S-adenosylmethionine), which is touted as a treatment for both depression and arthritis. See, e.g., Karen S. Peterson, Self-Prescribed Antidepressant Highly Touted But Untested, USA TODAY, Aug. 10, 1999, at 5D;Shari Roan, A Wonder Pill Raises Doubt As Well As Hope, THE RECORD (Bergen County NJ), July 12, 1999, at Hl; Jenny Deam, Problem or Solution? Medical Professionals Debate the Safety of Supplements, DENVER ROCKY MOUNTAIN NEWS, Aug. 24, 1999, at 3D. SAM-e was briefly studied as an anti-depressant in the United States, but FDA halted trials because of concerns about the compound's stability. Despite FDA'S concerns, and a hefty price-tag of $1 per pill, SAM-e appears to be the fastest growing supplement on the market. Thus far, SAM-e's manufacturers have not made explicit health claims on the produces label, but instead have maintained, among other things, that it helps "mental well-being." Elsewhere, however, the supplement is being touted as a treatment for depression, arthritis, and a host of other ailments. After Pearson, however, it is only a matter of time before SAM-e is marketed to consumers as a treatment for depressions arthritis, and who knows what else. This illustration brings into focus two problems triggered by Pearson. First, where the product in question is a naturally occurring one that can be sold as a dietary supplement, manufacturers no longer will bother to undergo the NDA process. As a result, neither the scientific community nor the public will have access to basic and reliable scientific information about the safety and efficacy of the product because none will be produced. Second, and equally troubling, SAM-e is being sold to treat depression. Self-medication to treat a disease as complex and debilitating as depression introduces an entirely separate layer of complex concerns, especially because physical illnesses, such as anemia or malfunctioning thyroid, often present themselves as depression. Even assuming that SAM-e shows promise in treating depression, one must ask whether consumers are really better off in having this product available in health food stores instead of through a prescription, which ensures the intervention of a trained health care professional and guarantees that the product will be made subject to FDA manufacturing rules.