The end of paternalism: A new approach to food labeling

Food and Drug Law Journal

Volumn 54, Issue 3, 1999, Pages 401-422

  Steinborn, Steven B ^a   Todd, Kyra A ^a  

^a Hogan and Hartson   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FOOD AND DRUG ADMINISTRATION; FOOD INDUSTRY; FOOD PACKAGING; HUMAN; HUMAN RIGHTS; INFORMATION SERVICE; REVIEW;

ADVERTISING; CIVIL RIGHTS; CONSUMER PRODUCT SAFETY; FOOD LABELING; FORECASTING; HUMANS; LEGISLATION, FOOD; PUBLIC HEALTH; UNITED STATES; UNITED STATES FEDERAL TRADE COMMISSION; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032756366     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (128)

1. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
2. 21 U.S.C. § 343(a) (FDCA § 403(a)).
3. Food Labeling; Tentative Positions of Agencies, 44 Fed. Reg. 75,990, 76,007 (Dec. 21 1979) (emphasis added).
4. Pub. L. No. 101-535, 104 Stat. 2553 (codified at 21 U.S.C. §§ 301 note, 321, 337, 343, 343 notes, 343-1, 343-1 note, 345, 371).
5. 21 U.S.C. § 343(r) (FDCA § 403(r)); 21 C.F.R. § 101.70-101.81 (1998).
6. 164 F.3d 650 (D.C. Cir. 1999).
7. The court also held that FDA's standards violated the Administrative Procedure Act Pub L No 79-404, 60 Stat. 237 (1946) (codified as amended 5 U.S.C. §§ 551 et seq. (1994)), in that it failed to meaningfully articulate and explain its §significant scientific agreement§ standard. Pearson, 164 F.3d at 660. The D.C. Circuit subsequently denied the agency's request for an en banc appeal. Pearson v. Shalala, 172 F.3d 72(D.C. Cir. 1999). The D.C. Circuit's opinion is final because the time has elapsed to file a petition for certiorari before the U.S. Supreme Court.
8. Part IV.B. of this article discusses a few of the relevant cases that encouraged the Federal Trade Commission (FTC) to adopt a more flexible standard of review. This is not intended to be a complete and thorough analysis, however, of the regulation of commercial speech under the First Amendment.
9. A food is defined as "(1) articles used for food or drink . . . (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321 (f) (FDCA § 201(f)).
10. Nutrilab v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983).
11. 21 U.S.C. § 321(g) (FDCA § 201(g)) (emphasis added).
12. 21 U.S.C. § 343(r) (FDCA § 403(r)). In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA), Pub. L. No. 105-115, 111 Stat. 2296, which amended the FDCA to allow foods to bear health claims based on authoritative statements by government scientific bodies. 21 U.S.C. § 343(r)(2)(G) (FDCA § 403(r)(2)(G)).
13. Pub. L. No. 103-417, 108 Stat. 4325 (codified in scattered sections of 21 U.S.C. 42 U.S.C. (1994)).
14. Note that dietary supplements are considered "foods" under the FDCA. DSHEA, however, creates a distinct regulatory scheme for dietary supplements. Thus, for the purpose of this article, a food refers to a traditional food, and a dietary supplement is considered a distinct product regulated primarily under DSHEA.
15. 21 U.S.C. § 343(r) (FDCA § 403(r)).
16. Kellogg obtained NCI's approval before launching its campaign in October 1984. Letter from J. Paul Van Nevel, Assoc. Dir. for Cancer Communications, Nat'l Cancer Inst., to the Kellogg Co. (Aug. 10, 1984).
17. FDA officials testified before the U.S. House of Representatives' Committee on Government Operations that NCI's involvement in approving the All-Bran® label deterred the agency from taking regulatory action. See H.R. REP. NO. 100-561, 100th Cong., 2d Sess., at 2 (1988).
18. Joseph P. Hile, Understanding the Food and Drug Administration's Position on Health Claims, 41 FOOD DRUG COSM. L.J. 101 (1986). Stating that FDA has remained concerned about medical claims, even findings developed by the National Academy of Sciences about nutritional advantages of certain diets, Hile acknowledged that that it was time for "an acceleration of FDA's activities in this area." Id. at 103. He stated that the agency would move rapidly to finalize its ideas to permit health messages on food labels. Id. at 104.
19. The House Committee on Government Operations characterized this change in policy as a "seismic shift." H.R. REP. NO. 100-561, at 2.
20. The adequacy of FDA's legal authority to allow health messages remained a central problem for the agency. The definition of a drug under the FDCA precluded the use of any claims that a food could cure, mitigate, or prevent a disease. The agency struggled to determine whether this definition left FDA with the authority to permit health-related messages on food. See Food Labeling; Public Health Messages on Food Labels and Labeling, Notice of Proposed Rulemaking, 52 Fed. Reg. 28,843, 28,844 (Aug. 4, 1987).
21. Id. at 28,844.
22. Id. at 28,845.
23. In the proposed rule, FDA announced its intention to adopt regulations reflecting its new policy toward health-related claims on food, and to form a Public Health Service committee responsible for develop ing suggested "health messages" appropriate for use on food labeling. FDA did not propose pre-approval of claims. The agency set forth the following basic requirements by which it would evaluate a health message: 1) the information must be truthful and nonmisleading; 2) the claim must be based on valid, reliable scientific evidence that is publicly available; 3) the claim should describe the role of a specific food as a function of total diet; and 4) the food products must meet the nutrition labeling requirements. Id. at 28,845.
24. Critics charged that the 1987 proposal was too broad, did not provide any explanation of how the proposed policy would be implemented, and failed to protect the public from false or misleading claims. See H.R. REP. No. 101-538, 101st Cong., 2d Sess., at 9 (1990).
25. United States v. Undetermined Quantities of an Article of Drug Labeled as "Exachol," 716 F. Supp. 787 (S.D.N.Y 1989). This product contained labeling that stated "[t]he Exachol Program is a preventive plan designed to help you keep your cholesterol under control by a combined approach including moderate exercise, proper eating and Exachol capsules." Id. at 789.
26. Id. at 792.
27. Id. at 794.
28. Id. at 795-96.
29. See Hearing Before a Subcommittee of the Committee on Government Operations, 100th Cong., 2d Sess., at 280-81 (1988).
30. See id.
31. Noting the extreme divergence of opinions on the legal, scientific, and practical aspects of the 1987 proposal, FDA asked for public comment specifically with respect to how the agency reasonably could permit the use of messages on food labels that link food components to reducing the risk of chronic diseases. Food Labeling; Advanced Notice of Proposed Rulemaking. 54 Fed. Reg. 22,610 (Aug. 8, 1989).
32. FDA withdrew the "overly broad" 1987 proposal, and suggested new requirements for health claims on food labels. In addition to being truthful, nonmisleading, and labeled in accordance with nutrition labeling requirements, each claim would have been required to be supported by significant scientific agreement. Each label statement would bave been required to be consistent with generally recognized principles for a sound total dietary pattern, providing some basis for a consumer to determine how the food would fit into that individual's diet. Finally, each label statement would have been required to include a reference to the relevant consumer health message summary (to be prepared by FDA), providing the consumer with more complete information. Food Labeling, Health Messages and Label Statements, Reproposed Rule, 55 Fed. Reg. 5176, 5180 (Feb. 13, 1990).
33. Health claims are defined as any claim characterizing the relationship of any nutrient to a disease or a health-related condition. 21 U.S.C. § 343(r)(3) (FDCA § 403(r)(3)).
34. Id. § 343(r)(4) (FDCA § 403(r)(4)). The law provided for a petition procedure to facilitate FDA's consideration of new health claims. Id. § 343(r)(4)(A) (FDCA § 403(r)(4)(A)).
35. Id. § 343(r)(3)(B)(i) (FDCA § 403(r)(3)(B)(1)) (emphasis added). Congress' intent was to ensure that the Secretary of Health and Human Services approved only those claims in which he or she had "a high level of confidence" for validity. See H.R. REP. NO. 101-538, at 21.
36. See 21 C.F.R. § 101.72-101.78 (1998).
37. See 21 C.F.R. § 101.79-101.81. FDA has issued a proposed rule that would permit a health claim linking consumption of soy protein with reduced risk of coronary heart disease. Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Products on the Structure or Function of the Body, 63 Fed. Reg. 62,977 (Nov. 10, 1998).
38. In the preamble to this rule, the agency recognized its dual responsibility to create a regulatory structure that would "help U.S. consumers maintain healthy dietary practices and to protect these consumers from unfounded health claims." Food Labeling, General Requirements for Health Claims for Food, 58 Fed. Reg. 2478, 2478 (Jan. 6, 1993). FDA also recognized that if private companies were "either prohibited from making certain kinds of claims, or if the incentives are such that firms make fewer valid health claims . . . there is a cost imposed on society in that some valuable information may not be conveyed to consumers." Regulatory Impact Analysis of the Final Rule to Amend the Food Labeling Regulations, 58 Fed. Reg. 2927, 2940 (Jan. 6, 1993).
39. 21 C.F.R. § 101.14(a)(6).
40. FDA recognized the inherent difficulty of defining what constitutes an implied health claim. In response, it adopted a relatively flexible approach whereby it would evaluate what, if any, claim is conveyed by examining the information in the context of the overall label. This case-by-case analysis considered the label in its entirety, as well as the impact it would have on consumers. 58 Fed. Reg. at 2482-83.
41. FDA determined that high serum cholesterol was itself a "disease" because it was so closely linked in consumers' minds to coronary heart disease. See id. at 2482.
42. Letter from Ilisa B.G. Bernstein, Pharm.D., J.D., Senior Sci. Pol'y Advisor, FDA, to Stuart Pape, Patton Boggs, L.L.P. (Sept. 30, 1997).
43. Id. at 10.
44. Regulations on Statement Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body. 63 Fed. Reg. 23,624, 23,626 (Apr. 29, 1998).
45. Id. at 23,625-28. On May 20, 1998, a month after the agency published its proposed rule on structure/ function claims, it issued a follow-up letter to the manufacturers of Cholestin®. Letter from William B. Schultz, Deputy Comm'r for Pol'y, FDA, to Stuart Pape, Patton Boggs, L.L.P., at 29 (May 20, 1998). In that letter, the agency relied on other grounds to determine that Cholestin® was a drug, dropping its opposition to Cholestin® on the basis that its name implied it is intended for use in the mitigation or prevention of a disease.
46. Citizen Petition, Nat'l Food Processors Ass'n, FDA Dkt. No. 94P-0390 (Apr. 20, 1994) (submitted to FDA).
47. Id. at 15-16. With the recent passage of FDAMA, which permitted the agency to approve health claims based on an official authoritative statement from a scientific body of the U.S. government, FDA now has an opportunity to implement a !ess restrictive approach toward health claim regulation.
48. Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims, 60 Fed. Reg. 66,206 (Dec. 21, 1995). Responding to petitions submitted by the Nat'l Food Processors Ass'n and the Am. Bakers Ass'n, FDA proposed to: 1) permit health claims on certain foods that do not currently qualify because they do not contain ten percent of certain required nutrients; 2) permit the use of shortened versions of authorized health claims under certain circumstances; 3) eliminate some of the required elements for health claims; and 4) provide additional guidance for petitioners seeking exemption from the disqualification of some foods from bearing a health claim because they contain high levels of certain nutrients. Id.
49. 58 Fed. Reg. at 2526-27.
50. 58 Fed. Reg. at 2524 ("Because FDA case law makes clear that a label statement that misbrands a food product is not subject to First Amendment protection, an unapproved health claim on a food label would not be protected speech.").
51. 13 F. Supp.2d 51 (D.D.C. 1998).
52. See Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800 (Oct. 8, 1996); and Final Guidance on Industry Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074 (Dec. 3, 1997) (collectively referred to by the court in Washington Legal Found. as the "Guidances").
53. 447 U.S. 557, 566 (1980).
54. Id.
55. Holding that the restrictions imposed by FDA were unconstitutional under the First Amendment, the court enjoined FDA from enforcing its current guidelines restricting the dissemination of peer-reviewed and independent studies in connection with off-label recommended use of prescription drugs or medical devices. Washington Legal Found., 13 F. Supp.2d at 68. FDA was not precluded from sanctioning the dissemination of false or misleading materials, nor from requiring the labels to carry disclosures regarding the financial interest of any pharmaceutical/medical device manufacturer or the fact that the off-label recommended use is not approved by FDA. Id.
56. Id. at 67 (emphasis added).
57. Id. Particularly noteworthy for the court was the fact that FDA does not object when the same materials it prohibits a manufacturer from distributing are disseminated by other channels. This demonstrated to the court that even FDA does not believe that the materials are inherently misleading. Id.
58. Id. at 73.
59. Id.
60. Washington Legal Found. v. Henney, CIV. A. No. 94-1306 (RCL), 1999 WL 557679 (D.D.C. July 28, 1999). A copy of the decision also may be found online. U.S. District Court for the District of Columbia, District Court Opinions (visited Sept. 1, 1999) 〈www.dcd.usacourts.gov/94-1306.pdf〉.
61. Pearson, 164 F.3d at 658-59.
62. Id. at 653-54.
63. 447 U.S. at 566.
64. See, e.g., Pearson, 164 F.3d at 655.
65. Id.
66. Id. at 657.
67. Id. at 658.
68. Id.
69. Id.
70. Id. at 657-58.
71. Id. at 658.
72. Id.
73. Id. at 659.
74. Id.
75. FDA has expressed the view that "in the past, food labeling with information of this type [health claims] could have been viewed as subject to action under 21 C.F.R. § 101.9(i) and the new drug provisions of the act." 52 Fed. Reg. at 28,844.
76. See, e.g., National Council for Improved Health v. Shalala, 893 F. Supp. 1512 (D. Utah 1995).
77. Citizens for Health announced in a press release the first filing of health supplement claims petitions with FDA since the Pearson decision. The petitions represent a direct test of FDA policies post-Pearson. Citizens for Health, Citizen's Chairman Joins Congressional Leaders and Health Professionals on Capitol Hill: Turner Urges FDA to Abide by U.S. Appeals Court's Decision (posted May 26, 1999) 〈www.citizens.org/ FDApressconference.htm〉.
78. 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996).
79. Id. at 497.
80. 542 F.2d 611 (3d Cir. 1976).
81. Id. at 614.
82. Id. at 613-14.
83. Id. at 619 (citing Jacob Siegel Co. v. FTC, 327 U.S. 608 (1946) (holding that FTC abused its discretion in ordering excision from advertising of trade name without considering whether modification of message would eliminate the objectionable portion); FTC v. Royal Milling Co., 288 U.S. 212 (1933) (similar holding)).
84. Beneficial, 542 F.2d at 620.
85. Id. at 619.
86. Id. ("[W]here qualifying explanatory language does not inherently contradict the advertiser's identifying language it should be accepted in preference to requiring excision.").
87. National Comm'n on Egg Nutrition v. FTC, 570 F.2d 157 (7th Cir. 1977).
88. Id. at 159-60.
89. Id. at 161.
90. Id. at 161-63.
91. Id. at 164.
92. Id.
93. Id. On other occasions, courts have found FTC orders requiring a specific affirmative disclosure, or not allowing an affirmative disclosure, to fail First Amendment scrutiny. See Porter & Dietsch, Inc. v. FTC, 605 F.2d 294 (7th Cir. 1979) (holding that a particular affirmative disclosure required by an FTC order was overly broad and insufficiently specific); Brown & Williamson Tobacco Corp. v. FTC, 778 F.2d 35 (D.C. Cir. 1985) (holding that an FTC order prohibiting an advertisement of tar content and disallowing an affirmative disclosure as to the method of determining the tar content of a new cigarette was impermissible).
94. Although some commentators may express concern that FDA cannot regulate structure/fonction claims and "functional foods" effectively unless it develops a new regulatory structure, the analysis in this article is premised on the notion that devising an entirely new regulatory framework is unnecessary. Rather, FDA can address this emerging product category effectively within its existing regulatory framework.
95. FDA, in proposing a definition of "disease" for dietary supplements, would amend the definition of "disease" with respect to health claims, to ensure consistency between the two provisions. 63 Fed. Reg. at 23,631.
96. Id. at 23,631-32.
97. See 21 U.S.C. § 343(r)(6) (FDCA § 403(r)(6)).
98. 62 Fed. Reg. at 49,860-61.
99. Nutrilab, 713 F.2d at 338.
100. See 21 U.S.C. § 321(g) (FDCA § 201(g)).
101. Nutrilab, 713 F.2d at 338; see also American Health Prods. Co. v. Hayes, 574 F. Supp. 1498 (S.D.N.Y.), aff'd, 744 F.2d 912 (2d Cir. 1984).
102. See American Health Prods., 574 F. Supp. at 1507.
103. 21 C.F.R. § 101.14(a)(3).
104. In the preamble to the proposed health claim regulations, the agency suggests that it may in fact view this definition expansively. FDA described the breadth of the nutritive value definition, as it applied to a food ingredient, as inclusive of a wide array of substances. FDA provides the example of a substance which, "as a component ofa food is of value for cellular functions" such that it provides "catalytic support for protective reactions (e.g., inhibiting harmful processes)." 56 Fed. Reg. at 60,542.
105. Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements, 62 Fed. Reg. 49,859, 49,860 (Sept. 23, 1997).
106. Letter from Joseph A. Levitt, Dir., Ctr. for Food Safety and Nutrition, to Brian D. Perkins, Pres., McNeil Consumer Products Co. (Oct. 28, 1998).
107. FDA opposed the marketing of these two products, Take Control® and Benacol®, as dietary supplemerits. FDA took the position that the spreads were conventional foods because the products represented themselves as doing more than supplementing the diet. FDA advised the two companies planning to market these products that the plant stenol esters must be deemed appropriate for use in food based on either a generally recognized as safe (GRAS) determination or as an approved food additive. Id.
108. Id. at 2.
109. FDA requested information regarding the stenol esters ingredient, particularly whether it could be found in the food supply, at what level, and what the effect of the ingredient at that level would be when compared to the level of stenol esters in the margarine, FDA also asked for information on the mechanism of action. Letter from Elizabeth A. Yetley, Ph.D., Dir., Off. of Special Nutritionals, CFSAN, to Kathy Schroeher, Assoc. Gen. Counsel, Johnson & Johnson Co. (Nov. 25, 1998).
110. 21 U.S.C. § 321(s) (FDCA § 201(s)).
111. FDA issued a proposed rule in April 1997, that would replace the current GRAS affirmation petition process with a streamlined GRAS premarket notification process. FDA indicated in the proposed rule that it would accept premarket notifications prior to the fmalization of the proposal. Substances Generally Recognized as Safe; Proposed Rule, 62 Fed. Reg. 18,938 (Apr. 17, 1997).
112. 21 U.S.C. § 321(s) (FDCA § 201(s)).
113. 62 Fed. Reg. at 18,949-50.
114. Since 1983, FTC successfully has issued over 60 consent orders prohibiting the sale of food products whose labels made deceptive or misleading health-related claims. See, e.g., Gracewood Fruit Co., 116 F.T.C. 1262 (1993) (advertising claims regarding health benefits of grapefruit, such as reduction of risk of cancer, stroke, heart attack and reduced serum cholesterol found deceptive) (consent order); Campbell Soup Co., 115 F.T.C. 788 (1992) (advertisements for Campbell's soups touted as low in fat and cholesterol and helpful in reducing the risk of heart disease allegedly deceptive because they failed to disclose that Campbell's soups are high in sodium and, therefore, may increase the risk of heart disease) (consent order). On the few occasions when FTC's actions have been challenged in court by a food company, FTC has prevailed. Kraft v. FTC, 970 F.2d 311 (7th Cir. 1992) (upholding FTC's determination that advertisements for cheese slices deceptive on grounds that they implied product contains same amount of calcium as five ounces of milk and that imitation cheese slices are inferior).
115. See Ad Substantiation Policy Statement, appended to Thompson Medical Co., 104 F.T.C. 648, 839-42 (1983), aff'd, 791 F.2d 189 (D.C. Cir. 1986). The text is available online. Federal Trade Comm'n, Consumer Protection: Guidelines (visited Sept. 1, 1999) 〈www/ftc.gov/bcp/guides/ad3subst.html〉.
116. 104 F.T.C. at 839-42.
117. See 21 U.S.C. § 343(r)(3),(4) (FDCA § 403(r)(3),(4)).
118. Comments of the Staff Bureaus of Competition, Consumer Protection, and Economics, Federal Trade Commission, FDA Dkt. No. 85N-0061, at 2 (undated) (submitted in response to FDA's original 1987 health claim proposal).
119. FEDERAL TRADECOMM'N, HEALTH CLAIMS IN ADVERTISING AND LABELING, A STUDY OF THE CEREAL MARKET (Aug. 1989).
120. Id. at 117.
121. Id.
122. Id. at xiii-xix.
123. FEDERAL TRADE COMM'N, BUREAU OF ECON. STAFF REP.. INFORMATION AND ADVERTISING POLICY, A STUDY OF FAT AND CHOLESTEROL CONSUMPTION IN THE UNITED STATES (Sept. 1996).
124. Id. at E-1.
125. Id.
126. Id. at E-3. It should be noted, however, that the evidence cannot be read to support a causal relationship between the various events, and that indeed public education and related efforts played a positive role as well.
127. Id. at E-5. The study uses one-day recall data on all food eaten during a 24-hour period from the U.S. Dep't of Agriculture's consumption surveys.
128. Many experts praised this study. See Federal Trade Comm'n, Off. of Public Affairs, Press Release, at 1 (Oct. 7, 1996) (W. Kip Viscusi, Professor of Law and Economics, Harvard Law School, said, "[t]his report is truly outstanding. I would rank this study among the most important assessments of information provision. Moreover, the findings are of tremendous policy importance, since they provide solid evidence concerning the constructive role that information policies have had and can potentially have in the future.").