rel="nofollow" href="#ulink_3c541c8f-30fd-5733-ad7c-c817b3dc2ae8">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
