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1 ¹ 21 C.F.R. § 101.14(a)(1).

2 ² 21 C.F.R. § 101.14(c).

3 ³ FDA, Qualified Health Claims: Letter of Enforcement Discretion—Walnuts and Coronary Heart Disease (Mar. 9, 2004) (Docket No. 02P‐0292).

4 ⁴ 21 C.F.R. § 101.14(e).

5 ⁵ A disease means damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to dysfunction (e.g., hypertension). See 21 C.F.R. § 101.93(g) regarding disease and dietary supplements.

6 ⁶ FDCA § 403(r)(3)(A)(ii).

7 ⁷ 21 C.F.R. § 101.14(a)(4).

8 ⁸ 21 C.F.R. § 101.14(e)(6).

9 ⁹ 21 U.S.C. § 343(r)(6) and 21 C.F.R. § 101.93.

10 ¹⁰ The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements for structure–function claims with dietary supplement s. These differences are discussed in detail in Chapter 11.

11 ¹¹ “Nutritive value: is defined in 21 C.F.R. § 101.14(a)(3), but this applies only to health claims and not in the context of structure–function claims. This intersection of drug, dietary supplement, and conventional food has become extremely complicated. In a rare moment of regulatory candor, FDA recognized that its distinctions in this area sometimes fly in the face of common sense. See FDA, CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements, Discussion of a Conceptual Framework for Structure and Function Claims For Conventional Foods, Meeting Summary (Feb. 16–17, 2000).

12 ¹² 58 Fed. Reg. 2487 (Jan. 6, 1993).

13 ¹³ See 21 C.F.R. § 101.78 Health claims: fruits and vegetables and cancer.

14 ¹⁴ The distinction between structure/function claims and dietary guidance is a minor one because under the law both are outside of health claim regulation. Therefore, the law does not concern itself whether the statement, “Carrots are good for you,” is dietary guidance or a structure/function claim.

15 ¹⁵ Adapted from Paula Kurtzweil, Staking a Claim to Good Health, FDA CONSUMER, SPECIAL ISSUE, FOCUS ON FOOD LABELING (Nov.–Dec. 1998).

16 ¹⁶ 21 C.F.R. § 101.72.

17 ¹⁷ 21 C.F.R. § 101.73.

18 ¹⁸ 21 C.F.R. § 101.75.

19 ¹⁹ 21 C.F.R. § 101.74.

20 ²⁰ 21 C.F.R. § 101.76.

21 ²¹ 21 C.F.R. § 101.77.

22 ²² 21 C.F.R. § 101.78.

23 ²³ 21 C.F.R. § 101.79.

24 ²⁴ 21 C.F.R. § 101.80.

25 ²⁵ 21 C.F.R. § 101.81.

26 ²⁶ 21 C.F.R. § 101.82.

27 ²⁷ 21 C.F.R. § 101.83.

28 ²⁸ Specifically, §§ 303 and 304, which amend, respectively, FD&C Act §§ 403(r)(3) and 403(r)(2) (21 U.S.C. §§ 343(r)(3) and (2)).

29 ²⁹ FDA, GUIDANCE FOR INDUSTRY, NOTIFICATION OF A HEALTH CLAIM OR NUTRIENT CONTENT CLAIM BASED ON AN AUTHORITATIVE STATEMENT OF A SCIENTIFIC BODY (June 11, 1998), http://www.cfsan.fda.gov/~dms/hclmguid.html (last visited Mar. 15, 2008).

30 ³⁰ FDA, FOOD LABELING GUIDE, APPENDIX C (Revised Nov. 2000) http://www.cfsan.fda.gov/~dms/flg‐6c.html (last visited Mar. 15, 2008). There is also a nutrient‐content claim for choline available based on authoritative statements. See supra the discussion of nutrient content claims.

31 ³¹ FDA, HEALTH CLAIM NOTIFICATION FOR WHOLE GRAIN FOODS WITH MODERATE FAT CONTENT (Dec. 9, 2003), http://www.cfsan.fda.gov/~dms/flgrain2.html (last visited Mar. 15, 2008).

32 ³² 471 U.S. 626 (1985).

33 ³³ Wooley v. Maynard, 430 U.S. 705, 714 (1977) (New Hampshire could not compel citizens to display the state's “Live Free or Die” motto their on license plates over their objections).

34 ³⁴ Zauder, 417 U.S. at 651 (citations omitted).

35 ³⁵ Id.

36 ³⁶ FCC v. Beach Comm., Inc., 508 U.S. 307, 315 (1993).

37 ³⁷ N.Y. State Rest. Ass'n, 556 F.3d at 136.

38 ³⁸ 164 F.3d 650 (D.C. Cir. 1999).

39 ³⁹ Similarly, we see no problem with the FDA imposing an outright ban on a claim where evidence in support of the claim is qualitatively weaker than evidence against the claim—for example, where the claim rests on only one or two old studies.

40 ⁴⁰ See, FDA, QUALIFIED HEALTH CLAIMS: LETTERS OF ENFORCEMENT DISCRETION, www.fda.gov.

41 ⁴¹ FDA, Qualified Health Claims: Letter Regarding “Tomatoes and Prostate, Ovarian, Gastric and Pancreatic Cancers (American Longevity Petition)” (Docket No. 2004Q‐0201) (Nov. 8, 2005).

42 ⁴² Alice H. Lichtenstein & Robert M. Russell, Essential Nutrients: Food or Supplements?: Where Should the Emphasis Be? 294 JAMA 351–58 (2005).

43 ⁴³ See, e.g., David C. Vladeck, Devaluing Truth: Unverified Health Claims in the Aftermath of Pearson v. Shalala, 54 FOOD DRUG L. J. 535 (1999).

44 ⁴⁴ Id.

45 ⁴⁵ 65 Fed. Reg. 59855.

46 ⁴⁶ CFSAN, FDA, GUIDANCE FOR INDUSTRY: QUALIFIED HEALTH CLAIMS IN THE LABELING OF CONVENTIONAL FOODS AND DIETARY SUPPLEMENTS (Dec. 18, 2002), http://www.cfsan.fda.gov/~dms/hclmgui2.html (last visited Sept. 24, 2007)(This document was superseded by later FDA guidance but still contains important background).

47 ⁴⁷ Id. (citing BUREAU OF ECONOMICS STAFF, FTC, ADVERTISING NUTRITION & HEALTH: EVIDENCE FROM FOOD ADVERTISING 1977‐1997 (Sept. 2002)).

48 ⁴⁸ Id.

49 ⁴⁹ CFSAN, FDA, GUIDANCE FOR INDUSTRY: FDA'S IMPLEMENTATION OF “QUALIFIED HEALTH CLAIMS”: QUESTIONS AND ANSWERS (Aug. 27, 2003; May 12, 2006) http://www.cfsan.fda.gov/~dms/labqhcqa.html (last visited Sept. 24, 2007).

50 ⁵⁰ Excerpt adapted from Neal Fortin, United States Food Law: Consumers, Controversies, Current Issues, 1 EUR. CONSUM. LAW J. 15–42 (Stéphanie Mahieu, ed., 2009).

51 ⁵¹ J. Craig Rowlands & James E. Hoadley, FDA Perspectives on Health Claims for Food Labels, 221 TOXICOLOGY 35, 35 (2006) (noting that consumers may not be able to distinguish between a nutrient content claim and a health claim).

52 ⁵² Brenda M. Derby & Alan S. Levy, FDA, Working Paper 1: Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claim 3, 34 (Sept. 2005) (this paper does not represent FDA official position and was only disclosed after a Freedom of Information request).

53 ⁵³ Center for Food Safety & Applied Nutrition (CFSAN), FDA, Questions and Answers, Qualified Health Claims in Food Labeling Report on Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims (Sept. 28, 2005) http://www.cfsan.fda.gov/~dms/qhc‐qa.html (last visited Sept. 23, 2008); see also Derby & Levy supra note 37.

54 ⁵⁴ Andreas C. Drichoutis et al., Consumer' Use of Nutritional Labels: A Review of Research Studies and Issues, 9 ACAD. MKTG. SCI. REV. 1, 1 (2006).

55 ⁵⁵ Derby & Levy supra note 37 (“In some cases conveying more scientific certainty for a claim actually led to more negative perceptions of product health benefits.”)

56 ⁵⁶ Id. at 37 (“The crucial perspective applicable here is the idea that the claim/disclaimer on the product label is perceived by consumers as an explicit influence attempt. This suggests that rather than assuming that consumers view health claims/disclaimers on product labels as authoritative and authorless information, it may be that consumers think of health claims as marketing, intended to influence them to buy the product.”)

57 ⁵⁷ Id.

58 ⁵⁸ See, Bryan Endres, United States Food Law Update: Labeling Controversies, Biotechnology Litigation, and the Safety of Imported Food, 3 J. FOOD L. & POL'Y 253, 254 (2007). at 260‐261 (citing Winning the Claim Game: Confused by Label Claims for Health Benefits for Everything from Walnuts to Corn Oil? Here's How to Read the Fine Print, 25 TUFTS UNIV. HEALTH & NUTRITION LETTER S1 (Aug. 1, 2007) (noting consumers blurring the fine distinction between disclaimers and the “confusing maze of health labeling rules.”)

59 ⁵⁹ Id.

60 ⁶⁰ See Press Release, Center Science Public Interest, FDA Study Proves FDA Confuses Consumers by Allowing Dubious Health Claims on Foods (Sept. 29, 2005) and Parke Wilde, New study on FDA website casts doubt on qualified health claims (Sept. 30, 2005) http://usfoodpolicy.blogspot.com/2005/09/new‐study‐on‐fda‐website‐casts‐doubt.html.

61 ⁶¹ Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999) At (“The government disputes that consumers would be able to comprehend appellants' proposed health claims in conjunction with the disclaimers we have suggested—this mix of information would, in the government's view, create confusion among consumers. But all the government offers in support is the FDA's pronouncement that ‘consumers would be considerably confused by a multitude of claims with differing degrees of reliability.' 59 Fed. Reg. at 405.”)

62 ⁶² Id. at 659‐660 (“Nor do we rule out the possibility that where evidence in support of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a disclaimer and ban it outright… . Finally, while we are skeptical that the government could demonstrate with empirical evidence that disclaimers similar to the ones we suggested above would bewilder consumers and fail to correct for deceptiveness, we do not rule out that possibility.”)

63 ⁶³ See BUREAU OF CONSUMER PROTECTION, FEDERAL TRADE COMMISSION, DIETARY SUPPLEMENTS: AN ADVERTISING GUIDE FOR INDUSTRy (Apr. 2001) (hereinafter referred to as “FTC Advertising Guide”) www.ftc.gov.

64 ⁶⁴ For example, a study using a conventional food or a multi‐nutrient supplement would not substantiate a single ingredient dietary supplement claim. When the substance studied contains many nutrients and substances, it is difficult to study the nutrient or food components in isolation. It is not possible to accurately determine whether any observed effects of the substance were due to: 1) the substance alone; 2) interactions between the substance and other nutrients; 3) other nutrients acting alone or together; or 4) decreased consumption of other nutrients or substances contained in foods displaced from the diet by the increased intake of foods rich in the substance at issue … an observational study based on food does not provide competent and reliable scientific evidence for a dietary supplement and, and therefore, cannot substantiate a claim made under § 403(r)(6).

65 ⁶⁵ Orphan Drug Act § 5(b) [21 U.S.C. 360ee (b) (3)].

66 ⁶⁶ 21 U.S.C. 343(r).

67 ⁶⁷ Id. at 343(r)(5)(A).

68 ⁶⁸ FD&C Act § 505(a) [21 U.S.C. § 355(a)].

69 ⁶⁹ FD&C Act § 502(f)(1) [21 U.S.C. § 352(f)(1)].

70 ⁷⁰ FD&C Act § 201(g)(1)(B) [21 U.S.C. § 321(g)(1)(B)].

71 ⁷¹ FD&C Act § 201(p) [21 U.S.C. § 321(p)].

72 ⁷² FD&C Act § 505(a) [21 U.S.C. § 355(a)].

73 ⁷³ “An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 CONG. REC. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible.” U.S. v Rutherford, 442 U.S. 544, 556 (1979).

74 ⁷⁴ 21 U.S.C. § 352(f)(1).