JapanThe Inventor of Functional Foods
United StatesA Good System Gone Bad
United KingdomChaos Reigns Supreme
4. Jack Winkler, Food Vigilantes: European Codes of Practice on Food Claims, in Functional Foods, IBC, London (1999); See also, From Patent Medicines to Functional Foods, Low & Lite Digest, Sept. 1996, at 11-12. Mr. Winkler is director of Food & Health Research. (back)
5. The FOSHU system is authorized by the Nutrition Improvement Law (Law No. 248, July 31, 1952, Amended by Law No. 101, May 24, 1995) and the Nutrition Improvement Law Enforcement Regulations (Ministerial Ordinance No. 41, July 1991, Amendment to Ministerial Ordinance No. 33, May 25, 1996). (back)
6. For example, on foods containing oligosaccharides a warning is required: "excess intake causes a loosening of the bowels." On some foods, a precautionary statement must appear on labels: "This food cannot cure disease." Office of Health Policy on Newly Developed Food in Environmental Health Bureau, Ministry of Health and Welfare, Information Regarding Permission to Use FOSHU Label, May 20, 1998 (in Japanese). (back)
9. One estimate places the total functional foods market, including FOSHU and unapproved foods at about US$8 billion in annual sales. Paul Yamaguchi & Associates, Inc., Japans Nutraceuticals Foods and Beverages That Provide Medical and Health Benefits, 3 (Oct. 1998). (back)
10. Michael Heasman & Julian Mellentin, Japan the Regulation and Marketing of Functional Foods and Beverages in The Business of Healthy Eating Global Trends, Developments and Strategies in Functional Foods and Nutraceuticals, 127. (Financial Times Business Ltd., London Oct. 1998)[hereinafter Heasman]. (back)
11. It is also now possible to make changes in the scope of a FOSHU-approved product after approval has been granted without submitting a new application, and manufacturers no longer have to submit separate applications for products that are substantially similar. (back)
14. Interestingly, two large U.S.-based companies, Coca-Cola and Kellogg, have contributed to the "hit product" culture in Japan where functional foods are introduced on the basis of intense, but short-lived, consumer demand. Heasman, supra note 10, at 134. (back)
17. Telephone Interview with Dr. Hiroyuki Toyokawa, former professor at Toho University and current member of FOSHU Review Panel (Nov. 16, 1998). For example, Nissin Oishisa-plus Psyllium Drink Noodles "Chicken Tanment" has 1,000 mg of sodium per serving and contains a label disclosure stating "If you are concerned about eating too much sodium, eat only the noodles and not the soup." (back)
18. For example, Nissin Oishisa-plus Psyllium Drink Noodles "Chicken Tanmen" received FOSHU approval by the MHW even though it has 1,000 mg of sodium per serving. By contrast, foods containing psyllium, but that also are high in sodium, are not permitted to make any health claims in the United States. (back)
19. Tomohito Hamazaki, M.D., Ph.D. & Yasuko Hirai, M.D. Dangerous Health Foods, Ineffective Health Foods (Tokyo, Ale Publishing 1997) (in Japanese). (Dr. Hamazaki is a professor at Toyama Medical and Pharmaceutical University. Dr. Hirai is a doctor at Toyama Medical and Pharmaceutical University). See also, International Life Sciences Institute of Japan, Current Status and Problems of Functional Foods in Japan, 55 ILSI 18 (1998). [hereinafter ILSI]. (back)
20. Norimasa Hosoya, M.D., Ph.D., Health Claims in Japan, Foods for Specified Health Use and Functional Foods paper prepared for presentation at meeting of Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (Sept. 1998). (Dr. Hosoya is Professor Emeritus, University of Tokyo and Director General of the Japan Health Food & Nutrition Food Association.) (back)
24. Inter/sect Alliance, Inc., A Comparative Analysis of the Regulatory Framework Affecting Functional Food Development and Commercialization in Canada, Japan, the European Union and the United States of America, at Chap. VII. D. (3d page) ( Mar. 31, 1996) <http://aceis.agr.ca/misb/mtrends/nutrareg/nutrareg.html> (visited Aug. 20, 1998). (back)
25. Letter from Kazufumi Yoshida, Director, Office of Health Policy on Newly Developed Foods, Food Sanitation Division, Environmental Health Bureau, MHW to Yoko Taniguchi, CSPI, Jan. 6, 1999 [hereinafter Yoshida Letter]. (back)
33. 600 is "Unhealthy" Tokyo Municipal Government Tested 56 Marketed Health Foods, Tokyo Shimbun, 0ct. 9, 1998 ( in Japanese); Majority of Health Foods Are "Illegal," Yomiuri Shinbum , Oct. 16, 1998 ( in Japanese). (back)
37. Otsuka pharmaceuticals, which produces the leading FOSHU product Fibre-mini, introduced Fibre-mini plus with added beta-carotene in February 1996. Kirin Beverage Co., Ltd. sells a similar product called Vegetake. Kansai Runa sells beta-carotene contained in a lactic drink. Id. at 50, 53, 54. (back)
38. See, e.g., O.P. Heinonen, M.D., et al, The Effect of Vitamin E and Beta Carotene on the Incidence of Lung Cancer and Other Cancers in Male Smokers, 330 New Eng. J. M. 1029 (1994); Dr. Richard Klausner, Director of the National Cancer Institute (U.S.), presentation at press conference (Jan. 19, 1996). (back)
39. FDA to Evaluate Link Between Beta-Carotene, Lung Cancer, Food Labeling & Nutrition News, Apr. 17, 1997, at 4-5 (FDA evaluating current scientific evidence on association between beta-carotene and lung cancer in response to petition raising concerns about the risk of beta-carotene supplements to smokers). (back)
43. Interview with Kazufumi Yoshida, Director, Office of Health Policy on Newly Developed Foods, Food Sanitation Division, Environmental Health Bureau, MHW (Dec. 1, 1998); Interview with Dr. Norimasa Hosoya, Director General, JHNFA (Nov. 30, 1998). (back)
50. FDA Labeling Policy Established Through Enforcement: Campbell, Food Regulation Weekly, Jan. 4, 1999, reporting on speech by Betty Campbell, acting director of the Office of Food Labeling (retired), Center for Food Safety and Applied Nutrition, Food and Drug Administration, to the Food and Drug Law Institute annual meeting, December, 1998. (back)
51. The United States is one of a minority of countries in the developed world that separates responsibility for regulating food-labeling claims from responsibility for regulating food- advertising claims and applies different standards to each. The Federal Trade Commission (FTC) is responsible for regulating most advertising in the U.S. The FDA and FTC attempt to coordinate standards for food-labeling and food-advertising claims, and the FTC usually defers to the FDAs scientific expertise. The FTC, however, has reserved the right to permit health claims in advertisements that are not permitted on labels when it believes such claims comply with the FTC Act. Federal Trade Commission, Enforcement Policy Statement on Food Advertising, 26-28 (May 1994), published in 59 Fed. Reg. 28,338 (June 1, 1994). (back)
53. General recognition of safety must be based on the views of experts throughout the scientific community who have common knowledge, based on accepted scientific procedure, that a substance is safe. However, in the case of substances used in food prior to 1958, general recognition of safety can simply be based on common experience gained from use of the substance in food within or outside of the U.S. (back)
54. Pesticides, pesticide residues, color additives, "prior-sanctioned" ingredients, new animal drugs, and dietary supplement ingredients are exempted from the food additive classification. Prior sanctions exist for specific uses of particular substances that were explicitly approved by FDA on an informal basis prior to the passage of the 1958 Food Additives Amendment. FDCA § 20l(s), 21 U.S.C. § 321(s). FDA has published a list of prior-sanctioned substances, and manufacturers may petition for the recognition of additional prior sanctions. 21 C.F.R. Part 181. (back)
62. FDAs ability to deny health claims for dietary supplements on the basis of inadequate scientific support may be limited by a U.S. Court of Appeals decision, Pearson v. Shalala, No. 98-5043 (D.C. Cir. Jan. 15, 1999) which has been appealed by the government (motion for rehearing filed March 1, 1999). The court concluded that the FDA should approve claims even where there was conflicting or insufficient scientific evidence so long as claims could be rendered "not misleading" by the inclusion of a disclosure such as "The scientific evidence supporting this claim is inconclusive." The court determined that the FDAs blanket refusal to permit preliminary health claims with such disclosures violates the commercial free speech protections afforded by the First Amendment to the U.S. Constitution. The court also directed the FDA to issue a clarification as to how the agency defines the term "significant scientific agreement." Although a number of First Amendment challenges have been brought against the NLEA, this is the first decision to limit the FDAs authority over health claims. It is not known at this time whether the decision will be reversed. (back)
69. The FDA concluded that the statements on which Weider relied were not authoritative because they were not based on a "deliberative review of all relevant scientific evidence." The FDA explained that the reports from government contractors, press releases, and other informational material on which the company relied did not constitute "authoritative statements" within the meaning of the law. Other claims were disqualified because the FDA had already issued an applicable health claim and the proposed claim was inconsistent with that claim, or the claim itself was not considered to be a health claim. 63 Fed. Reg. 34084-34117 (June 22, 1998).
While the FDA denied the first set of notifications it received under FDAMA, it is not known how companies plan to use the new notification provisions in the law. It is rumored that Kellogg and other companies intend to avail themselves of this new way to make health claims. Larger companies, because of their greater scientific and legal resources, may have better luck convincing the FDA to accept health claims based on authoritative statements, but only time will tell. (back)
72. 21 C.F.R. § 104.20(a). FDA explains that:
The fundamental objective of this [policy] is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nations food supply is an important public health objective. The addition of nutrients to specific foods can be an effective way of maintaining and improving the overall nutritional quality of the food supply. However, random fortification of foods could result in over-or-under fortification in consumer diets and create nutrient imbalances in the food supply. It could also result in deceptive or misleading claims for certain foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce, meat, poultry or fish products, sugars, or snack foods such as candies and carbonated beverages. To preserve a balance of nutrients in the diet, manufacturers who elect to fortify foods are urged to utilize these principles when adding nutrients to food.
73. FDAs ability to regulate products containing vitamins and minerals was severely curtailed by what is commonly known as the Proxmire Amendment. Under the amendments, FDA may not set maximum limits of potency; may not regulate a dietary supplement as a drug because its potency is greater than what the FDA determines to be nutritionally rational and may not limit the combination or number of vitamins or minerals in a product. Pub. L. No. 94-278, 90 Stat. 410, Apr. 23, 1976, adding FDCA § 411, 21 U.S.C. § 350. In fact, more and more products are appearing on the market as candy or sodas filled with vitamins and minerals and herbal remedies implicitly promoted for a multitude of symptoms. Even a popular childrens candy, Gummi Bears, is being marketed as a functional food called Yummi Bears. The product contains concentrates of a variety of vegetables and boasts that two bears contain 50 milligrams of vegetables. But that translates into less than one hundredth of a standard serving of vegetables, and Yummi Bears costs about 10 times as much as the regular gummies.(74) (back)
74. Karen Springen, Candy and Coffee are the new Health Foods? We Wish., Newsweek, May 25, 1998.
76. FDA regulations require such foods to make specific label statements concerning the use of the product. Such statements are not considered to be health claims. However, any additional statements relating to the relationship between a nutrient and a disease or health-related condition are considered to be health claims and are subject to FDA approval requirements. 58 Fed. Reg. 2482 (Jan. 6, 1993). (back)
77. Stephen H. McNamara, So You Want to Market a Food and to Make Health-Related Claims How Far Can You Go? What Rules of Law Will Govern the Claims You Want to Make? 53 Food and Drug L.J., 421, 434 (1998). (back)
81. In addition, dietary supplements are permitted to make statements of general well-being without being classified as drugs. 21 U.S.C. § 343(r)(6). Like any statement on a food label, such claims must not be false or misleading in any particular. 21 U.S.C. § 403(a). (back)
82. The structure/function provision originated in 1938 when Congress added it to the definition of a "drug" in section 201(g)(l)(C) of the FDCA. Prior to this revision, a product would be considered a drug if it was recognized as such in the U.S. Pharmacopeia or was intended to have a therapeutic effect, i.e., it was used in the "diagnosis, cure, mitigation, treatment or prevention of disease." Congress was troubled that the drug definition did not encompass products that had only physiologic effects, such as anti-fat products. Congress, therefore, broadened the reach of the drug definition so that FDA could appropriately regulate products having only a physiologic effect i.e., those affecting a structure or function of the body as opposed to a therapeutic one. At the same time, however, Congress specifically exempted foods that make structure/function claims from the definition of a drug. Charles Wesley Dunn, Federal Food, Drug, and Cosmetic Act, A Statement of Its Legislative Record, 239, 1053, 1126, 1247 (Food and Drug Law Institute 1987). With the passage of DSHEA, dietary supplements can also avoid regulation as a drug so long as the claims made fall within the parameters of a structure/function claim or claim of general well-being, and the products follow other labeling requirements applicable to dietary supplements. (back)
86. 21 U.S.C. §343(r)(1)(B). In its regulations implementing the NLEA, the FDA defines a "health claim" as "any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including "third party" references, written statements (e.g., a brand name including a term such as heart), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. . . ." 21 C.F.R. § 101.14(a)(l). (back)
91. Letter from Stacey A. Zawel, Ph.D., Director Scientific and Regulatory Affairs, James H. Skiles, Vice President and General Counsel, Grocery Manufacturers of America, to FDA Docket No. 98N-044 (Sept. 23, 1998). (back)
92. Carole Sugarman, Magic Bullets Pumped-Up Foods Promise to Make us Happier and Healthier. Well See,Wash. Post, Oct. 21, 1998, at E1; Vanessa OConnell, Food for Thought How Campbell Saw a Breakthrough Menu Turn into Leftovers, Wall St. J., Oct. 6, 1998, at A1; Kelloggs will ask FDA to approve new health claims for functional foods line, Food Labeling & Nutrition News, Mar. 4, 1998, at 1. (back)
93. Data from FDAs 1995 Food Labeling and Packaging Survey (FLAPS) indicates that 24 out of 1030 products surveyed included a health claim stating the relationship between a component of the product and a disease. While these findings are based on non-sales weighted raw data, they indicate that a typical supermarket stocked with 15,000 food items may contain as many as 345 food items that bear health claims. (back)
95. The Campbell Soup Company experimented with a line of mail-order frozen meals and snacks designed to reverse such medical conditions as high blood pressure and elevated cholesterol and blood sugar levels. The line, called Intelligent-Cuisine, was in compliance with FDA health claim requirements, but was discontinued after poor results. Carole Sugarman, Magic Bullets Pumped-Up Foods Promise to Make us Happier and Healthier. Well See, Washington post, Oct. 21, 1998, at E1. (back)
96. Kellogg has started a $65-million nutraceutical/functional food division, the W.K. Kellogg Institute for Food and Nutritional Research. Nancy Millman, Campbell Cooks Up Health Food for the Masses; Firm will be First Giant to Serve Up Meal Plans to Lower Blood Pressure, Blood Sugar and Cholesterol Levels, Chi. Trib. Dec. 29, 1996, at C1. (back)
97. Sixteen of the products make the FDA-approved health claim. However, six other items in the product line, such as cakes and potato crisps, make structure/function claims instead of health claims. The similarity between these two types of claims, and the fact that both claims will appear under the Ensemble product-line logo, will likely mislead consumers into believing that all of the products in the line are equally healthful. (back)
102. 62 Fed. Reg. at 49,861. Dietary supplements making health claims, however, must meet the "taste, aroma, or nutritive value, or technical effect" requirement that applies to foods.
21 C.F.R. § 101.14(b)(3)(i). (back)
103. Constance I. Hays, Its Not Just Food, Its a Supplement, N.Y. Times, Feb. 9, 1999, at F6. The article quotes a leading dietary supplement industry lawyer as saying, "Its not valid to have a box of cereal that says Dietary Supplement." (back)
105. The label of another product, "Think! Interactive Bar," (manufactured by Personal Health Development) contains ginko biloba and choline and states that it will promote "concentration, calmness and stamina." The product, however, resembles a candy bar. Thus, the added ingredients may be considered by the FDA to be unapproved food additives or drugs. (back)
109. Conference Notice, Promoting Functional Foods, Medical Foods and Nutritionals, NUTRIMARKET 97 at 5, Pharmaceutical Division of the Institute for International Research (Mar. 24 & 25, 1997). (back)
111. Martha Groves, Preventive Measures; Search for Therapeutic Foods Picks Up Steam, Los Angeles Times, Nov. 7, 1996, at D2. The labeling for Zbar specifically states that "Zbar is a new medical food." (back)
120. In its Oct. 28, 1998 letter to McNeil, FDA stated:
The label for Benecol spread, through statements that the product replaces butter or margarine, vignettes picturing the product in common butter or margarine uses, statements promoting the flavor and texture of the product, and statements such as "...help(s) you manage your cholesterol naturally through the foods you eat," represents this product for use as a conventional food.
127. Ministry of Agriculture, Fisheries and Food, The System of Control on Food Additives in the UK and the European Union, Factsheet 5 (visited Mar. 11, 1999) <http://www.maff.gov.uk/food/foodsens/factshee/no5.htm>. (back)
128. Local Authorities Coordinating Body on Food and Trading Standards, Medicinal Claims Applied to Foods, guidance on status and enforcement responsibilities in relation to foods and medical products 12 n. 9 (Sept. 1998).
Health claim means any direct, indirect or implied claim in food labelling, advertising, advertorial, promotion or presentation that consumption of a food carries a specific health benefit, including nutrient function claims describing the physiological role of nutrients in growth, development and normal functions of the body e.g. calcium aids in the development of strong bones and teeth.
132. 63 Fed. Reg. at 23,627. The proposal concluded that use of the words energizer, rejuvenative, revitalizer, or adaptogen is permissible. It is interesting to note that the Advertising Standards Authority, an industry-sponsored watchdog service for ads (see discussion, infra, p.69)
provides in its codes that "Unqualified claims such as . . . rejuvenate are generally not acceptable." Advertising Standards Authority, Health and Beauty A survey of standards in health and beauty, slimming and nutrition advertisements, July 1998. (back)
133. The guidelines defined "health claim" as express or implied statements in food labelling or advertising that a food is beneficial to health. It did not include nutrient content claims (e.g., low fat, high fiber) nor medicinal claims (e.g., that a food can cure, treat or prevent a disease.) The guidelines stated that references to specific disease would be interpreted by consumers as implying that the food will have a medicinal effect. The guidelines supported claims that "make links between foods and health [and] may help purchasers to maintain or move towards a healthy diet." Examples of such claims, include: "calcium aids in the development of strong bones and teeth;" "iron is a factor in red blood cell formation;" "protein helps build and repair body tissues." Ministry of Agriculture, Fisheries and Food, Food Advisory Committee Review of Functional Foods and Health Claims, Draft Guidelines on Health claims on Foodstuffs, Dec. 16, 1996. (back)
153. But public debate about the agencys role has been dominated by Britains prolonged national trauma with BSE, plus a succession of other food poisoning episodes. So food safety will undoubtedly be the first priority. How much work the FSA will do on nutrition and claims, and if so, when, are still undetermined. Market developments, in the form of yet more exaggerated and unsubstantiated claims for unusual new functional foods, may force prompt action. (back)
155. Action and Information on Sugars, Ribena Claims Untrue New "Tooth Kind"
Drink Can Cause Tooth Decay, Press Release (July 20, 1998). (back)
160. Although these claims were made in advertisements, they often include phrases that also appear on labels. An MD Foods graph showing the benefits of Gaio appeared both in leaflets and product labels. (back)
161. Advertising Standards Authority, ASA Monthly Report No. 58, at 20
(Mar. 1996). (back)
Copyright © 1998 by the Center for Science in the Public Interest. References available by request.