Are functional foods the solution to dysfunctional diets? A review of U.S. regulatory requirements and lessons from abroad

Food and Drug Law Journal

Volumn 52, Issue 3, 1997, Pages 313-321

  Silverglade, Bruce A ^a   Heller, Ilene Ringel ^a  

^a Center for Science in the Public Interest   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; CHINESE HERB; DIET SUPPLEMENTATION; FOOD AND DRUG ADMINISTRATION; FOOD COMPOSITION; FOOD INDUSTRY; FOOD PROCESSING; FOOD QUALITY; POLICY; QUALITY CONTROL; REVIEW; SAFETY;

CHINA; EATING; FOOD INDUSTRY; FOOD LABELING; FOOD, FORTIFIED; GREAT BRITAIN; HUMANS; JAPAN; NUTRITIONAL REQUIREMENTS; NUTRITIVE VALUE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031398818     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (53)

1. Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, § 201(f), 52 Stat. 1040, 1040 (1938) (codified as amended 21 U.S.C. §§ 301, 321(f) (1994)).
2. 21 U.S.C, § 350(c) (FDCA § 411(c)); 21 C.F.R. § 105.3 (1996).
3. 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8).
4. 21 U.S.C. § 321 (ff) (FDCA § 201 (ff)).
5. Id. § 321(g) (FDCA § 201(g)).
6. Laura Yee, Predictions for Scientists, Marketing Experts, PLAIN DEALER, Jan. 1. 1997, at 2E.
7. Conference Notice, Pharmaceutical Div., Institute for Int'l Res. Promoting Functional Foods, Medical Foods and Nutritionals, NUTRIMARKET '97. See also Conference Notice, Public Voice for Food and Health Policy, 20th Annual National Food Policy Conference Innovations in Food and Agriculture: Are Consumers Leading or Being Led?, Demystifying Functional Foods: What Are They? How Should They Be Regulated?; Conference Notice, Global Bus. Res., Ltd., Dietary Supplements, Functional & Medical Foods for Chronic Diseases of Aging.
8. Letter from Clare M. Hasler, Ph.D., Dir., Univ. of Ill. Functional Foods for Health Program, to Center for Sci. in the Public Interest (Feb. 6, 1997); Brochure, Univ. of III., Functional Foods for Health Program.
9. 21 U.S.C. §§ 321(s), 348 (FDCA §§ 201(s), 409).
10. Id. § 321(s) (FDCA § 201(s)).
11. If the added ingredient cannot be considered GRAS, the manufacturer must petition FDA to approve the added ingredient as a food additive. The food additive petition process is a lengthy one - detailed scientific studies on the safety of the proposed additive at intended levels of use must be submitted to the agency for review. 21 C.F.R. pt. 171.
12. 21 U.S.C. § 350b (FDCA § 413).
13. Pub. L. No. 103-417, 108 Stat 4325 (codified at 21 U.S.C. §§ 321 et seq.).
14. Anthony L. Young, What a Difference A Label Makes, NNFA TODAY, Jan. 1997, at 1, 6 (published by Nat'l Nutritional Foods Ass'n) ("Think of food products as potential dietary ingredient delivery systems. The possibilities are many and exciting.").
15. Assuming the new dietary ingredient in the functional food is not GRAS, it would be risky, from a product liability standpoint, for any manufacturer to relabel a food product as a supplement solely to avoid the assurances of safety provided by the food additive approval process. Moreover, a manufacturer could be liable for adulteration under the FDCA to the extent it contains "a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury." 21 U.S.C. § 402(f)(l)(B).
16. At the present time, health claims for medical foods do not have to be approved by FDA prior to marketing. FDA is considering whether to require some form of preapproval in the future. 61 Fed. Reg. 60,661 (Nov. 29, 1996).
17. Pub. L. No. 101-535, 104 Stat. 2353 (1990).
18. 21 U.S.C. § 343(r)(3)(B)(i) (FDCA §403(r)(3)(B)(i)).
19. 52 Fed. Reg. 2478, 2522 (Jan. 6, 1993).
20. Under the FDCA, the definition of a "drug" specifically exempts from drug regulation food "intended to affect the structure or any function of the body." 21 U.S.C. § 321(g)(C) (FDCA § 20) (g)(C)). Although dietary supplements are deemed "food" for purposes of the Act, they are not treated as food for purposes of the drug definition. Id. §§ 32(ff)(3), (g)(D) (FDCA §§ 201(ff)(3), (g)(D)).
21. Id. § 343(a) (FDCA § 403(a)).
22. Id. § 343(r)(6) (FDCA § 403(r)(6)).
23. Id. § 343(r)(6)(C) (FDCA § 403(r)(6)(C)).
24. 21 C.F.R. § 104.20(a).
25. Id. § 10420 (g)(2).
26. Functional Foods Make a Fool of the Law, FOOD MAGAZINE, Apr./June 1996, at 1.
27. Id.; Functional Foods: What Should We Believe?, FOOD MAGAZINE, Apr./June 1996, at 9.
28. Id.; Functional Foods: What Should We Believe?, FOOD MAGAZINE, Apr./June 1996, at 9.
29. Functional Foods, THE INDEPENDENT CONSUMER GUIDE, Oct. 1996, at 27.
30. Dr. Tim Lobstein, The Food Comm'n, Functional Foods Serve Commercial, Not Consumer Needs, presentation at the British Nutrition Foundation Conference Health Claims and Food; Science, Law and Practice, London (1996).
31. Functional Foods: What Should We Believe?, supra note 27, at 9.
32. John Winkler, From Patent Medicines to Functional Foods, LOW/LITE DIGEST, Sept 1996, at 11-12.
33. Christine Doyle, Wellbeing, THE DAILY TELEGRAPH, Feb. 14, 1997, at 18.
34. Sean Poulter, Difficult to Swallow; Health Claims About Breakfast Cereals Should Be Taken With a Pinch of Salt Say Watchdogs, DAILY MAIL, Feb, 1, 1996, at 27.
35. ASA also stopped claims for Pact, a yellow-fat spread containing fish-oil. ASA determined that there was insufficient evidence that the product benefited the heart and that the manufacturer should "avoid giving the impression that Pact could impart a coronary care benefit." FOOD MAGAZINE, Oct./Dec. 1996, at 4 (pub'd by the Food Comm'n). ASA also halted claims for Gaio soya yoghurt containing Causido culture, which the manufacturer claimed reduced cholesterol levels. ASA determined that the claims were unsupported by scientific trials and that graphs promoting the product exaggerated the effects." Functional Foods, supra note 28.
36. ASA also stopped claims for Pact, a yellow-fat spread containing fish-oil. ASA determined that there was insufficient evidence that the product benefited the heart and that the manufacturer should "avoid giving the impression that Pact could impart a coronary care benefit." FOOD MAGAZINE, Oct./Dec. 1996, at 4 (pub'd by the Food Comm'n). ASA also halted claims for Gaio soya yoghurt containing Causido culture, which the manufacturer claimed reduced cholesterol levels. ASA determined that the claims were unsupported by scientific trials and that graphs promoting the product exaggerated the effects." Functional Foods, supra note 28.
37. Difficult to Swallow, supra note 33.
38. Alan Mitchell, Where Extra Healthy Is Stirred Into the Mix, THE TIMES, Aug. 9, 1995.
39. Functional Foods: What Should We Believe?, supra note 27, See also FDA to Evaluate Link Between Beta-Carotene, Lung Cancer, FOOD LABELING & NUTRITION NEWS, Apr. 17, 1997 at 4-5 (FDA evaluat'ing current scientific evidence on association between beta-carotene and lung cancer in response to petition raising concerns about risks of beta-carotene supplements to smokers).
40. Functional Foods: What Should We Believe?, supra note 27, See also FDA to Evaluate Link Between Beta-Carotene, Lung Cancer, FOOD LABELING & NUTRITION NEWS, Apr. 17, 1997 at 4-5 (FDA evaluat'ing current scientific evidence on association between beta-carotene and lung cancer in response to petition raising concerns about risks of beta-carotene supplements to smokers).
41. Functional Foods: What Should We Believe?, supra note 27, at 1, 11.
42. T. Oku & M. Okazaki, SYSTEM OF HEALTH CLAIMS OF PROCESSED FOODS AND POINTS AT ISSUE ON UTILIZATION OF FOODS FOR SPECIFIED HEALTH USES IN JAPAN (1995). For a description of the program, see THE JAPAN HEALTH FOOD AND NUTRITION FOOD ASSOCIATION, A QUICK GUIDE TO FOOD FOR SPECIFIED HEALTH USE.
43. T. Oku & M. Okazaki, SYSTEM OF HEALTH CLAIMS OF PROCESSED FOODS AND POINTS AT ISSUE ON UTILIZATION OF FOODS FOR SPECIFIED HEALTH USES IN JAPAN (1995). For a description of the program, see THE JAPAN HEALTH FOOD AND NUTRITION FOOD ASSOCIATION, A QUICK GUIDE TO FOOD FOR SPECIFIED HEALTH USE.
44. Dr. Kohei Kojima, Control of Health Claim on Foods in Japan, in FIRST INTERNATIONAL CONFERENCE ON EAST-WEST PERSPECTIVES ON FUNCTIONAL FOODS (PLENARY ABSTRACTS) 75 (1995).
45. Id. at 75-76.
46. See, e.g., Functional Lift for Eggs, LOW/LITE DIGEST, Nov. 1996, at 14.
47. Chiyono Sugiyama, Food Containing DHA Is No Cure-All; Some Products Come Up Short of Claims on Labels, DAILY YOMIURI, May 4, 1995, at 10.
48. Steven Pratt, That Something Extra; FDA Slowly Opens the Door to Functional Foods, CHI. TRIB., Mar. 27, 1996, at 3.
49. T. Oku & M. Okazaki, supra note 39.
50. China Bans Use of Superlatives in Food Advertising, WORLD FOOD CHEM, NEWS, Feb. 19, 1997, at 15.
51. Id.; China Bans Superlatives in Ad Claims, May Prohibit Sale of Thousands of Health Food Products, FOOD LABELING & NUTRITION NEWS, Feb. 20, 1997 at 4; Chinese Authorities to Ban Nearly All Health Food Products, WORLD FOOD REG. REV., Jan. 1997, at 3.
52. Id.; China Bans Superlatives in Ad Claims, May Prohibit Sale of Thousands of Health Food Products, FOOD LABELING & NUTRITION NEWS, Feb. 20, 1997 at 4; Chinese Authorities to Ban Nearly All Health Food Products, WORLD FOOD REG. REV., Jan. 1997, at 3.
53. Id.; China Bans Superlatives in Ad Claims, May Prohibit Sale of Thousands of Health Food Products, FOOD LABELING & NUTRITION NEWS, Feb. 20, 1997 at 4; Chinese Authorities to Ban Nearly All Health Food Products, WORLD FOOD REG. REV., Jan. 1997, at 3.