Functional foods: Regulatory and marketing developments

Food and Drug Law Journal

Volumn 56, Issue 2, 2001, Pages 197-220

  Heller, Ilene Ringel ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; FOOD PROCESSING; FOOD SAFETY; HEALTH FOOD; QUALITY CONTROL;

HEALTH FOOD; HUMANS; LEGISLATION, FOOD; MARKETING OF HEALTH SERVICES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034889656     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (171)

1. General Accounting Office, Food Safety Improvements Needed in Overseeing the Safety of Dietary Supplements and "Functional Foods," (GAO/RCED-00-156) July 2000, at 3.
2. Id. at 6.
3. Functional food sales increased from $11.3 billion to an estimated $16.2 billion from 1995-1999. Projected sales are expected to reach $49 billion by 2010. See id. at 6-7.
4. FDCA §§ 201(f) (food), 201(ff) (dietary supplements), 201(g) (drugs), 411(c) (foods for special dietary use); Orphan Drug Act § 5(b) (medical foods); 21 C.F.R. §§ 321(f), (ff), and (g), 350 (c), 360ee(b)(3).
5. FDA has issued a handful of letters on functional foods containing ingredients that it does not recognize to be "generally recognized as safe" for use in foods. See Foret Letters, infra note 118.
6. FDA Labeling Policy "Established Through Enforcement": Campbell, FOOD REG. WKLY., Jan. 4, 1999, at 4 (reporting on speech by Betty Campbell, acting director of the Office of Food Labeling (retired), Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA), to the FDLI annual meeting (December 1998).
7. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
8. 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. In the case of substances used in food prior to 1958, however, general recognition of safety can be based simply on common experience gained from use of the substance in food within or outside of the United States. 21 U.S.C. § 321 (FDCA § 201(s)).
9. 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. 21 U.S.C. § 321(s) (FDCA § 201(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. pt 181.
10. 21 U.S.C. § 348.
11. Pub. L. No. 103417, 108 Stat 4325 (codified at 21 U.S.C. § 301 note (1994)).
12. The term dietary supplement: 1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); 2) means a product that . . . (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement . . . . 3) . . . except for purposes of section 201(g) [definition of a drug] a dietary supplement shall be deemed a food within the meaning of this Act. 21 U.S.C. § 321 (ff).
13. Id. § 350b.
14. I. SCOTT B ASS & ANTHONY L, YOUNG, DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: A LEGISLATIVE HISTORY & ANALYSIS 43-44 (FDLI 1996).
15. 21 U.S.C § 342(f)(1)(A)&(B).
16. Id. § 342(f)(1)(C).
17. See, e.g., FDA, FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol (Nov. 21, 2000), FDA Concerned About Botanical Products, Including Dietary Supplemente, Containing Aristolochic Acid (Apr. 11, 2001); FDA Public Health Advisory: Risk of Drug Interactions With St. John's Wort and Indinavire and Other Drugs (Feb. 10, 2000); FDA Warns Against Consuming Metabolic Accelerator (Nov. 11, 1999) available at (last visited June 1, 2001) vm.cfsan,fda.gov/~dms/ds-warn.html.
18. See, e.g., FDA, FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol (Nov. 21, 2000), FDA Concerned About Botanical Products, Including Dietary Supplemente, Containing Aristolochic Acid (Apr. 11, 2001); FDA Public Health Advisory: Risk of Drug Interactions With St. John's Wort and Indinavire and Other Drugs (Feb. 10, 2000); FDA Warns Against Consuming Metabolic Accelerator (Nov. 11, 1999) available at (last visited June 1, 2001) vm.cfsan,fda.gov/~dms/ds-warn.html.
19. See, e.g., FDA, FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol (Nov. 21, 2000), FDA Concerned About Botanical Products, Including Dietary Supplemente, Containing Aristolochic Acid (Apr. 11, 2001); FDA Public Health Advisory: Risk of Drug Interactions With St. John's Wort and Indinavire and Other Drugs (Feb. 10, 2000); FDA Warns Against Consuming Metabolic Accelerator (Nov. 11, 1999) available at (last visited June 1, 2001) vm.cfsan,fda.gov/~dms/ds-warn.html.
20. See, e.g., FDA, FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol (Nov. 21, 2000), FDA Concerned About Botanical Products, Including Dietary Supplemente, Containing Aristolochic Acid (Apr. 11, 2001); FDA Public Health Advisory: Risk of Drug Interactions With St. John's Wort and Indinavire and Other Drugs (Feb. 10, 2000); FDA Warns Against Consuming Metabolic Accelerator (Nov. 11, 1999) available at (last visited June 1, 2001) vm.cfsan,fda.gov/~dms/ds-warn.html.
21. Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. §§ 301 note, 321, 337, 343, 343 notes, 343-1, 343-1 note, 345, 371 (1994)).
22. 21 U.S.C. §§ 343(r)(1)(B), (r)(3)(C) (FDCA §§ 403(r)(1)(B), (r)(3)(C)).
23. Id. § 343(r)(3)(B)(i).
24. U.S. law further permits claims about how foods and dietary supplement ingredients can affect the structure of the body or the functioning of bodily systems (structure/function claims), 21 U.S.C. §§ 321(g)(1)(C), 343(r)(6) (FDCA §§ 201(g)(1)(C), 403(r)(6)).
25. 52 Fed. Reg. 28,843 (Aug. 4, 1987).
26. Zachary Schiller et al., Can Cornflakes Cure Cancer?, BUS. WK., Oct. 9, 1989, at 114.
27. 21 U.S.C. §§ 343(r)(1)(B), (r)(5)(D) (FDCA §§ 403(r)(1)(B), (r)(5)(D)).
28. See, e.g., Passage of the Dietary Supplement Health and Education Act, supra note 11. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). See infra note 41 and accompanying text.
29. Pub. L. No. 105-115, 111 Stat. 2296 (1997) (amending 21 U.S.C §§ 201 et seq. (1994)).
30. 21 U.S.C. § 343(r)(3)(C).
31. Id. § 343 (r)(3)(C)(ii).
32. Id. § 343(r)(3)(C)(i).
33. Id.
34. Office of Food Labeling, CFSAN, 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).
35. 63 Fed. Reg. 34,084-34,117 (June 22, 1998).
36. 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." Id. at 34,095-96. 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. Id. at 34,108-09, Other claims were disqualified because FDA already had 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. Id. at 34,094-102.
37. FDA, Health Claim Notification for Whole Grain Foods (July, 1999) available at (last visited Dec. 5, 2000) vm.cfsan.fda.gov/~dms/flgrains.html. Congressional attempts to modify the health claims provisions continue. For example, Representative Frank Pallone (D-NJ) introduced legislation, The Nutraceutical Research and Education Act, H.R. 3001, 106th Cong. (1999), that would permit manufacturers who successfully have petitioned FDA to approve a health claim based on at least one clinical study to have the exclusive right to use that health claim for a period of 10 years. The bill is important because it reflects an increasingly popular view that research on the safety and efficacy of dietary supplements, functional foods, and medical foods must be done, but that manufacturers do not have the incentive to conduct such research unless they receive some sort of competitive advantage, such as exclusivity. Id.
38. FDA, Health Claim Notification for Whole Grain Foods (July, 1999) available at (last visited Dec. 5, 2000) vm.cfsan.fda.gov/~dms/flgrains.html. Congressional attempts to modify the health claims provisions continue. For example, Representative Frank Pallone (D-NJ) introduced legislation, The Nutraceutical Research and Education Act, H.R. 3001, 106th Cong. (1999), that would permit manufacturers who successfully have petitioned FDA to approve a health claim based on at least one clinical study to have the exclusive right to use that health claim for a period of 10 years. The bill is important because it reflects an increasingly popular view that research on the safety and efficacy of dietary supplements, functional foods, and medical foods must be done, but that manufacturers do not have the incentive to conduct such research unless they receive some sort of competitive advantage, such as exclusivity. Id.
39. FDA, Health Claim Notification for Potassium-Containing Foods (Oct. 31, 2000) (last visited Nov. 17, 2000) vm.cfsan.fda.gov/~dms/hclm-k.html.
40. 21 U.S.C. § 343(r)(3)(A)(ii), 21 C.F.R. §§ 101.14(e)(3) and (4).
41. 21 C.F.R. § 101.14(e)(6).
42. Id. § 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 nation's 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. Id.
43. FDA's ability to regulate products containing vitamins and minerals was curtailed severely 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 FDA determines to be nutritionally rational, and may not limit the combination or number of vitamins or minerals in a product. Health Research and Health Services Amendments, Pub. L. No. 94-278, 90 Stat. 410 (Apr. 23, 1976), adding FDCA § 411 (21 U.S.C. § 350 (as amended)). 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 children's 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. See also Karen Springen, Candy and Coffee Are the New Health Foods? We Wish, NEWSWEEK, May 25, 1998, at 14. The product sends a misleading message to children and adults alike, i.e., that junk foods with added ingredients are healthy.
44. 21 C.F.R. § 101.14(b)(3)(i).
45. 164 F.3d 650 (D.C. Cir.) reh'g en banc denied, 1999 U.S. App. LEXIS 5954 (1999).
46. Id. at 659.
47. U.S. CONST. amend. I.
48. Pearson, 164 F.3d, at 660.
49. 64 Fed. Reg. 71,794 (Dec. 22, 1999).
50. 65 Fed. Reg. 59,855-57 (Oct. 6, 2000).
51. Letter from Christine J. Lewis, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, FDA, to Jonathan W. Emord, Counsel to Pearson plaintiffs (Feb. 16, 2000) available at (last visited Mar. 7, 2001) vm.cfsanm.gov/~dms/ds-Itr20.html (clarifying conditions for a dietary supplement health claim for Omega-3 fatty acids and coronary heart disease).
52. Joint Notice of Dismissal Without Prejudice to Refiling, Julian M. Whitaker, M.D. et al. v. Tommy Thompson, Civ. Action No., 00-0123 (PLF) (Mar. 29, 2001).
53. Letter from Christine J. Lewis, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, FDA, to Jonathan W. Emord, Counsel to Pearson plaintiffs (Apr. 3, 2001) available at (Last visited May 11, 2001) vm.cfsan.fda.gov/~dms/ds-ltr22.html (regarding a health claim for folic acid and neural tube defects); FDA issued this disclaimer pursuant to a court order in Pearson v. Shalala, 130 F. Supp 2d 105 (D D.C. 2001). FDA's attempt to challenge the court order was unsuccessful. Pearson v. Thompson, Civ. Action No. 00-2724 (GK) (D.D.C. May 9, 2001).
54. 21 U.S.C § 350(c)(3) (FDCA § 411).
55. Id. § 360ee(b)(3).
56. 21 C.F.R. §§ 105.62, 105.65, 105.66.
57. 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. Any additional statements relating to the relationship between a nutrient and a disease or health-related condition, however, are considered to be health claims and are subject to FDA approval requirements. 58 Fed. Reg. 2478, 2482 (Jan. 6, 1993).
58. 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 & DRUG L.J., 421, 434 (1998).
59. 21 U.S.C. § 360ee(b)(3) (emphasis added).
60. Telephone interview with Robert Moore, Division of Special Nutritionals, CFSAN, FDA (Jan. 1999).
61. Id.
62. Id.
63. Lisa Benavides, NiteBite Snack Bar Gives Diabetics a Sweet Solution, B. Bus. J., Aug. 30, 1996, at 3; Martha Groves, Preventive Measures; Search for Therapeutic Foods Picks Up Steam, L.A. TIMES, Nov. 7, 1996, at D2. The labeling for ZBar specifically stated that it is a new medical food; Conference Notice, Promoting Functional Foods, Medical Foods and Nutritionals, NUTRIMARKET '97, Pharmaceutical Division of the Institute for International Research (Mar. 24-25, 1997), at 5.
64. Lisa Benavides, NiteBite Snack Bar Gives Diabetics a Sweet Solution, B. Bus. J., Aug. 30, 1996, at 3; Martha Groves, Preventive Measures; Search for Therapeutic Foods Picks Up Steam, L.A. TIMES, Nov. 7, 1996, at D2. The labeling for ZBar specifically stated that it is a new medical food; Conference Notice, Promoting Functional Foods, Medical Foods and Nutritionals, NUTRIMARKET '97, Pharmaceutical Division of the Institute for International Research (Mar. 24-25, 1997), at 5.
65. Lisa Benavides, NiteBite Snack Bar Gives Diabetics a Sweet Solution, B. Bus. J., Aug. 30, 1996, at 3; Martha Groves, Preventive Measures; Search for Therapeutic Foods Picks Up Steam, L.A. TIMES, Nov. 7, 1996, at D2. The labeling for ZBar specifically stated that it is a new medical food; Conference Notice, Promoting Functional Foods, Medical Foods and Nutritionals, NUTRIMARKET '97, Pharmaceutical Division of the Institute for International Research (Mar. 24-25, 1997), at 5.
66. 61 Fed. Reg, 60,661, 60,663-64 (Nov. 29, 1996).
67. Id. at 60,661.
68. 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. § 343(a) (FDCA § 403(a).
69. The structure/function provision originated in 1938 when Congress added it to the definition of a "drug" in section 201(g)(I)(C) of the FDCA. Prior to this revision, a product was considered a drug if it was recognized as such in the U.S. Pharmacopoeia or was intended to have a therapeutic effect, i.e., it was used in the "diagnosis, cure, mitigation, treatment or prevention of disease." CHARLES WESLEV DUNN, FEDERAL FOOD, DRUG, AND COSMETIC ACT, A STATEMENT OF ITS LEGISLATIVE RECORD 1053 (1938) (G.E. Stechert & Co. 1987). 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. Id. at 239, 1053, 1126, 1247. With the passage of DSHEA, dietary supplements can also avoid regulation as a drag 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.
70. The structure/function provision originated in 1938 when Congress added it to the definition of a "drug" in section 201(g)(I)(C) of the FDCA. Prior to this revision, a product was considered a drug if it was recognized as such in the U.S. Pharmacopoeia or was intended to have a therapeutic effect, i.e., it was used in the "diagnosis, cure, mitigation, treatment or prevention of disease." CHARLES WESLEV DUNN, FEDERAL FOOD, DRUG, AND COSMETIC ACT, A STATEMENT OF ITS LEGISLATIVE RECORD 1053 (1938) (G.E. Stechert & Co. 1987). 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. Id. at 239, 1053, 1126, 1247. With the passage of DSHEA, dietary supplements can also avoid regulation as a drag 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.
71. 21 U.S.C § 343(r)(6) (FDCA § 403(r)(6)).
72. 21 C.F.R. § 101.93(a).
73. 21 U.S.C. § 343(r)(6)(C).
74. See U.S. General Accounting Office, supra note 1, at 11, 26.
75. 21 U.S.C. § 403(r)(6)(A).
76. Id. § 343(r)(I)(B). In its regulations implementing the NLEA, 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)(1).
77. Id.
78. Id. § 101.14(a)(2).
79. Id. § 101.14(a)(2), (b)(3)(i). "The substance must, regardless of whether the food is a conventional food or a dietary supplement, contribute taste, aroma, or nutritive value, or any other technical effect . . . to the food and must retain that attribute when consumed at levels that are necessary to justify a claim." Id. § 101.14(b)(3)(i).
80. FDA Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Final Rule, 65 Fed. Reg. 999, 1019 (Jan. 6, 2000) (codified at 21 C.F.R. § 101.93).
81. Id. at 1022.
82. For example, some Kellogg's products, such as Special K, claim that "scientific studies from around the world suggest that an adequate intake of folie acid (a B-vitamin), B6, and B12 helps maintain a healthy cardiovascular system." Prior to the time Kellogg attempted to make this structure/function claim, FDA had denied requests to approve a "health claim" version of this statement, FDA stated it could not conclude that "based on the totality of publicly available scientific evidence, there is significant scientific agreement among experts qualified by training and experience to evaluate such evidence that a relationship between folic acid, vitamin B6, and vitamin B12 dietary supplements and risk of vascular disease is supported by the available evidence." Letter from Elizabeth Yetley, Director, Office of Special Nutritionals, FDA, to Jonathan W. Emord, attorney for Julian Whitaker, M.D., Durk Pearson, and Sandy Shaw, American Preventive Medical Association, and Pure Encapsulations, Inc. (Nov. 30, 1999) (on file with author). FDA ultimately authorized a health claim that must state that "the evidence in support of the claim is inconclusive." See Joint Notice of Dismissal, supra note 48 and accompanying text.
83. Carole Sugarman, Magic Bullets Pumped-Up Foods Promise to Make Us Happier and Healthier, We'll See, WASH, POST, Oct. 21, 1998, at El; Vanessa O'Connell, Food for Thought: How Campbell Saw a Breakthrough Menu Turn into Leftovers, WALL ST. J., Oct. 6, 1998, at A1; Kellogg's Will Ask FDA to Approve New Health Claims for Functional Foods Line, FOOD LABELING & NUTRITION NEWS, Mar. 4, 1998, at 1.
84. Carole Sugarman, Magic Bullets Pumped-Up Foods Promise to Make Us Happier and Healthier, We'll See, WASH, POST, Oct. 21, 1998, at El; Vanessa O'Connell, Food for Thought: How Campbell Saw a Breakthrough Menu Turn into Leftovers, WALL ST. J., Oct. 6, 1998, at A1; Kellogg's Will Ask FDA to Approve New Health Claims for Functional Foods Line, FOOD LABELING & NUTRITION NEWS, Mar. 4, 1998, at 1.
85. Carole Sugarman, Magic Bullets Pumped-Up Foods Promise to Make Us Happier and Healthier, We'll See, WASH, POST, Oct. 21, 1998, at El; Vanessa O'Connell, Food for Thought: How Campbell Saw a Breakthrough Menu Turn into Leftovers, WALL ST. J., Oct. 6, 1998, at A1; Kellogg's Will Ask FDA to Approve New Health Claims for Functional Foods Line, FOOD LABELING & NUTRITION NEWS, Mar. 4, 1998, at 1.
86. 62 Fed. Reg. 28,234, 28,235 (May 22, 1997).
87. Id. at 28,235.
88. CSPI, Functional Foods: Public Health Boon or 21st Century Quackery (Mar. 1999) (last visited June 5, 2001) www.cspinet.org/reports/functional_foods/index.html.
89. See Health Claims Authorized in the United States, infra Appendix. These include claims linking diets low in saturated fat and cholesterol to a reduced risk of heart disease, low-fat diets rich in fruits and vegetables are linked to a reduced risk of cancer, sugar alcohols, and a reduced risk of dental caries. Authorized health claims like these are estimated to appear on several hundred products found in a typical supermarket. Data from FDA's 1995 Food Labeling and Packaging Survey (FLAPS) indicates that 24 out of 1,030 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. FDA, 1995 FLAPS (Oct. 25, 1995), computations performed by CSPI based on data provided by FDA.
90. See supra notes 46-49 and accompanying text.
91. 21 C.F.R. § 101.75.
92. 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, See Sugarman, supra note 76, at El.
93. 62 Fed. Reg. 3584 (Jan. 23, 1997) (codified at 2.1 C.F.R. § 101.81).
94. 63 Fed. Reg. 8103 (Feb. 18, 1998).
95. FDA, Health Claim Notification for Whole Grain Foods (July 1999) available at (last visited Dec. 5, 2000) vm.cfsan.fda.gov/~dms/flgrains.html.
96. 65 Fed. Reg. 64,686 (Sept. 8, 2000). This marked the first time FDA approved a health claim as "an interim final rule" and only permitted public comment after the issuance of the final rule. Previously, public comment was invited on proposed rules, and the comments were taken into account in revising final regulations. This health claim is also controversial because for the first time it exempted a category of foods from the 13-gram total fat disqualifying level that has been established for other substances making health claims.
97. FDA, Health Claim Notification for Potassium-Containing Foods, (Oct. 31, 2000) available at (last visited Dec. 5, 2000) vm.cfsan.fda.gov/~dms/hdm-k.html.
98. 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 Cl.
99. Sixteen of the products made the FDA-approved health claim. Six other items in the product line, such as cakes and potato crisps, however, made structure/function claims instead of health claims. The similarity between these two types of claims, and the fact that both claims would appear under the Ensemble product-line logo, could have misled consumers into believing that all of the products in the line were equally healthful.
100. See Yetley Letter, supra note 75.
101. 63 Fed. Reg. 34,097 (June 22, 1998).
102. Kellogg Press Release, Using New FDA Regulations, Kellogg Takes the Lead in Promoting Heart-Health Benefits of Folic Acid, April 5, 2000 (on file with author).
103. Id.
104. See supra notes 41, 42.
105. FDA stated that it would consider the following claim to be "appropriately qualified"; "It is known that diets low in saturated fat and cholesterol may reduce the risk of heart disease. The scientific evidence about whether folic acid, vitamins B6 and B12 may also reduce the risk of heart disease and other vascular diseases is suggestive, but not conclusive. Studies in the general population have generally found that these vitamins lower homocysteine, an amino acid found in the blood. It is not known whether elevated levels of homocysteine may cause vascular disease or whether high homocysteine levels are caused by other factors. Studies that will evaluate directly whether reducing homocysteine may also reduce the risk of vascular disease are not yet complete." Letter from Christine J. Lewis, Director, Office of Nutritional Products, Labeling and Dietary Supplements, FDA, to Jonathan W. Emord, Counsel for Pearson plaintiffs (Nov. 28, 2000) (last visited Dec. 1, 2000) available at vm.cfsan.fda.gov.
106. Products carrying health claims must contain no more than 480 milligrams of sodium per reference amount customarily consumed. 21 C.F.R, § 101.14(a)(4). An 8-ounce serving of V8 contains 620 mg.
107. 21 C.F.R. § 101.7400(2).
108. See, e,g., Nancy Hellmich, Supplement or Additive? Issue Is on FDA's Plate, USA TODAY, Oct. 30, 1998, at ID ("The [Benecol] spread is one of the highest-profile entries into an exploding area of new products known in nutrition circles as 'functional foods.'").
109. Letter from Joseph A. Levitt, Director, CFSAN, FDA to Brian D. Perkins, President, McNeil Consumer Products Co. (Oct. 28, 1998) (on file with author).
110. 21 U.S.C. §§ 321(s), 348 (FDCA §§ 201 (s), 409).
111. See Levitt Letter, supra note 100.
112. Agreement Reached on Regulatory Approach for Benecol, FOOD LABELING & NUTRITION NEWS, Feb. 3, 1999, at 3. Johnson & Johnson also is releasing Benecol snack bars containing the recommended serving of the stanol esters. McNeil Benecol Broadening With Snack Bars, Tub, F-D-C REP. ("The Tan Sheet"), Oct. 25, 1999, at 9.
113. Agreement Reached on Regulatory Approach for Benecol, FOOD LABELING & NUTRITION NEWS, Feb. 3, 1999, at 3. Johnson & Johnson also is releasing Benecol snack bars containing the recommended serving of the stanol esters. McNeil Benecol Broadening With Snack Bars, Tub, F-D-C REP. ("The Tan Sheet"), Oct. 25, 1999, at 9.
114. R.M., The Margarine Wars, "Benecol," "Take Control" Hit the Shelves, NUTRACEUTICALS WORLD, July/Aug. 1999, at 92.
115. 62 Fed. Reg. 49,859, 49,861 (Sept. 23, 1997).
116. 21 U.S.C. §§ 350(b), 321(s)(6) (FDCA §§ 413(a), 201(s)(6)).
117. Letter from John B, Foret, Director, Division of Programs and Enforcement Policy, Office of Food Labeling, FDA, to Myron Cooper, Hain Food Group (June 21, 1999) (on file with author).
118. Id. The label of another product, "Think! Interactive Bar," (manufactured by Personal Health Development) contains ginkgo 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 FDA to be unapproved food additives or drugs.
119. See Foret Letter, supra note 107.
120. 21 C.F.R. § 182.1180.
121. Id. § 340.10.
122. Letter from Lynn A. Larsen, Director, Division of Programs and Enforcement Policy, Office of Special Nutritionals, FDA, to The Dannon Company, Inc. (Aug. 26, 1999) (on file with author). See also (last visited May 11, 2001) www.dannon.com.
123. Id.
124. Pharmanex Inc. Press Release, Pharmanex, Inc. Introduces the Cholestin Bar Natural Health-Promoting Benefits of Cholestin Now Available in a Tasty, Ready-to-Eat Bar (Oct. 25, 1999), PRN Newswire (on file with author).
125. Pharmanex, Inc. v. Shalala, 35 F. Supp. 1341 (C.D. Utah 1999), rev'd and remanded, 221 F.3d 1151 (10th Cir. 2000); Pharmanex, Inc. v. Shalala, Memorandum Decision and Order (unpublished) Case No: 2:97CV262(K) (Mar. 30, 2000) available at (last visited June 5, 2001) www.findlaw.com (District Court of Utah file).
126. See Memorandum Decision and Order, supra note 115.
127. 21 U.S.C, § 321(s) (FDCA § 201(s)).
128. Warning Letters from John B. Foret, Director, Division of Compliance and Enforcement, Office of Nutritional Products, Labeling, and Dietary Supplements, to Vitamin Classic's, Inc. (Feb. 21, 2001); South Beach Beverage Co. (Feb. 1, 2000); Robert's American Gourmet (Jan. 27, 2000); Langer Juice Co. (Sept. 28, 1999) available at (last visited May 11, 2001) www.fda.gov/scripts/wlcfm/ indexissuer.cfm. See also Courtesy Letter from John B. Foret, Office of Nutritional Products, Labeling, and Dietary Supplements, to Hain Food Group (June 21, 1999) (on file with author).
129. Id.
130. Letter from Christine J, Lewis, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, FDA, to manufacturers of functional foods (Jan. 30, 2000), at 1 (on file with author).
131. Id.
132. Id. at 1-2.
133. Warning Letters from John B. Foret, Director of Compliance and Enforcement, CFSAN, FDA, available at (last visited Jun. 28, 2001) www.fda.gov/scripts/wlcfm/indexissuer.cfm to Julia Sabin, President Smucker Quality Beverages, Inc. (June 8, 2001 ONPLDS 14-01); Cynthia Davis, Executive Vice President, US Mills Inc. (June 5, 2001 ONPLDS 1301); Doug Levin, CEO, Fresh Samantha, Inc. (June 4, 2001 ONPLDS 13-01); Doug Levin, CEO, Fresh Samantha, Inc. (June 4, 2001 ONPLDS 11-01); Rodney C. Stacks, Chairman, Hansen Beverage Co. (June 4, 2001 ONPLDS 12-01).
134. Warning Letter NWE-08-01W from Gail T. Costello, District Director, New England District Office, FDA, to Robert Hawthorne, President, Ocean Spray Cranberries, Inc. (Jan. 19, 2001) available at (last visited May 11, 2001) www.fda.gov/scripts/wlcfm/indexissuer.cfm.
135. Id.
136. Id.
137. FTC, Advertsing and Marketing on the Internet: The Rules of the Road (Apr. 1998).
138. Statement of Connecticut Attorney General Richard Blumenthal at Press Conference (July 18, 2000) ("I'm recommending that state attorney generals make functional foods a top consumerprotection initiative.") CSPI Press Release, FDA Urged to Halt Sale of Functional Foods Containing Illegal Ingredients, July 18, 2000.
139. NAD Press Release, NAD Recommends That Arizona Iced Tea Discontinue Its "Rx Memory Label," Apr. 2, 2001.
140. 0Id.
141. HeartBar is an example of a product sold to consumers directly that states, "Use under the supervision of a physician."
142. See Benavides, supra note 59, at 3.
143. See Conference Notice, supra note 59.
144. Elizabeth Seay, New Salt Substitute Seeks Same Status on Shelf as Aspirin, WALL ST. J., Apr. 1, 1996, at A7D.
145. See Conference Notice, supra note 59.
146. See Benavides, supra note 59, at 3.
147. Martha Groves, Preventive Measures; Search for Therapeutic Foods Picks Up Steam, L.A. TIMES, Nov. 7, 1996, at D2. The labeling for Zbar states specifically that "Zbar is a new medical food."
148. There is no specific exemption from the NLEA for health claims made on these products. Some, but not all of the foods for special dietary use regulations have been amended in light of the NLEA. FDA has indicated that any label statements used in accordance with FDA regulations for foods for special dietary use will not be regulated as health claims. 58 Fed. Reg. 2578, 2482 (Jan. 6, 1993).
149. FOOD LABELING & NUTRITION NEWS, Oct. 28, 1998, at 2.
150. Id.
151. 61 Fed. Reg. 60,661, 60,663 (Nov. 29, 1996).
152. Id.
153. Id. at 60,661.
154. 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. FTC is responsible for regulating most advertising in the United States. FDA and FTC attempt to coordinate standards for food-labeling and food-advertising claims, and FTC usually defers to FDA's scientific expertise, 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. FTC, Enforcement Policy Statement on Food Advertising, 59 Fed, Reg. 28,338 (June 1, 1994).
155. FTC, Enforcement Policy Statement on Food Advertising (May 1994) available at (last visited May 11. 2001) www.ftc.gov ("The Commission recognizes that there may be certain limited instances in which carefully qualified health claims may be permitted under section 5 [of the FTC Act] although not yet authorized by the FDA.") (emphasis added).
156. Working Agreement Between FTC and FDA, 3 TRADE REG. REP. (CCH) ¶ 9,851 (1971).
157. 59 Fed. Reg. at 28,388.
158. NEWSWEEK, Sept. 27, 1999.
159. 58 Fed. Reg. 2,622, 2,630-31 (Jan. 6, 1993).
160. N.Y. TIMES MAG., Jan. 10, 1999, at 55.
161. Letter from C. Lee Peeler, Associate Director, Division of Advertising Practices, FTC, to Edward P. Henneberry, Counsel for H.J. Heinz Co. (Dec. 15, 1999) (on file with author).
162. Id.
163. Campbell's Classics: Woman in Kitchen With Tomato Wallpaper, Storyboard 001-05646, (NBC television broadcast, Jan. 20, 2000) available from Video Monitoring Services of America (New York, NY).
164. See, e.g., Letter from C. Lee Peeler, Associate Director, Director of Advertising Practices, FTC, to Bruce Silverglade, Director of Legal Affairs, CSPI (Mar. 21, 2001) (denial of petition to prohibit health claims about the relationship of almond consumption to the reduced risk of heart disease by the Almond Board of California).
165. Psyllium is the active ingredient in such over-the-counter laxatives as Metamucli, and also is the subject of an approved health claim. 21 C.F.R. § 101.81.
166. Id. § 172.5(a)(1). The leading definition of food has been set forth in Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983).
167. 21 C.F.R. § 101.14(b)(3)(i).
168. 62 Fed. Reg. at 49,860-61.
169. FDA stated in its Oct. 28, 1998 letter to McNeil: 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. Id.
170. FDA also should set disqualifying levels for added sweeteners.
171. 21 C.F.R. § 101.14(e)(6). FDA should consider adding additional nutrients like folate to this list.