1 See, e.g., Editors, Snake Oil in the Supermarket, Sci. Am. (Sept. 1, 2010), http://www.scientificamerican.com/article/snake-oil-in-the-supermarket [https://perma.cc/UCA5-TYDF] (“From cereals that boost immunity to yogurts that regulate digestion and juices that keep heart disease at bay, grocery stores in the U.S. are brimming with packaged foods and beverages that claim to improve health.”); see also Caitlin Yoshiko Kandil, What Food Labels Really Mean, U.S. News & World Rep. Health (Aug. 22, 2012, 12:35 PM), http://health.usnews.com/health-news/articles/2012/08/22/what-food-labels-really-mean (stating that you can “[w]alk into any supermarket, and you'll find rows of packaged foods boasting how healthy they are”).

2 See Michael Taylor, How the FDA Is Picking its Food Label Battles, Atl. (July 19, 2010), http://www.theatlantic.com/health/print/2010/07/how-the-fda-is-picking-its-food-label-battles/59927 [https://perma.cc/M8HM-LWH4].

3 See David C. Vladeck, Director, Fed. Trade Comm'n Bureau of Consumer Protection, Remarks at the Annual Symposium for the Dietary Supplement Industry: Priorities for Dietary Supplement Advertising Enforcement 4 (Oct. 22, 2009), http://www.thenhf.com/pdf/VladedckCRNRemarks.pdf [http://perma.cc/HF6X-6T44]

4 See Hoffmann, Diane, Health Claim Regulation of Probiotics in the USA and the EU: Is There a Middle Way?, 4 Beneficial Microbes 109 (2013)CrossRefGoogle Scholar. In the food arena, these products have been referred to as functional foods, or foods that have a “potentially positive effect on health beyond basic nutrition.” Katherine Zeratsky, I've Heard the Term “Functional Foods,” But I Don't Know What it Means. Can You Explain?, Mayo Clinic (Apr. 11, 2015), http://www.mayoclinic.org/healthy-living/nutrition-and-healthy-eating/expert-answers/functional-foods/faq-20057816 [https://perma.cc/KP4T-846U]. See also infra notes 46-53 and accompanying text.

5 Satine, Leah A., Is My Yogurt Lying? Developing and Applying a Framework for Determining Whether Wellness Claims on Probiotic Yogurts Mislead, 63 Food & Drug L.J. 537, 537 (2008)Google ScholarPubMed.

6 Id. at 537-38. The Academy of Nutrition and Dietetics links the growing demand for these nutritional products to “rising health care costs and scientific research” supporting a connection between “a good diet” and a “lower incidence of chronic disease.” Consumers Union of United States Inc., ‘Functional Food’ is Hot, But Its Claims of Health Benefits Rely on Flimsy Data, Wash. Post (June 18, 2012), http://www.washingtonpost.com/national/health-science/functional-food-is-hot-but-its-claims-of-health-benefits-rely-on-flimsy-data/2012/06/18/gJQAWmxflV_story.html [https://perma.cc/RKL5-YQQ3].

7 See Editors, supra note 1 (stating that “[a]lthough health claims for foods may appear to be authoritative, in many cases science does not support them and the government does not endorse them.”); see also Azizi, Rahi, “Supplementing” the DSHEA: Congress Must Invest the FDA with Greater Regulatory Authority over Nutraceutical Manufacturers by Amending the Dietary Supplement Health and Education Act, 98 Cal. L. Rev. 439, 440 (2010)Google Scholar (“‘Nutraceutical’ products—functional foods taken to enhance health, like vitamins or herbal and botanical products intended for ingestion—often carry labels that claim ambiguous benefits, but fail to demonstrate any measurable degree of efficacy.”); Matthew Herper & Rebecca Ruiz, Snake Oil in Your Snacks, Forbes (May 20, 2010, 12:12 PM), http://www.forbes.com/forbes/2010/0607/health-probiotics-vitamins-supplements-snake-oil-in-snacks.html (quoting Steven Nissen, head of cardiology at the Cleveland Clinic, who notes that “most … claims” about the “perfect additive” that “add[s] to your health or prevent[s] you from getting sick” are “’completely unsubstantiated’”).

8 See Office of Inspector Gen., U.S. Dep't of Health & Human Services, Dietary Supplements: Companies May be Difficult to Locate in an Emergency (Oct. 2012), https://oig.hhs.gov/oei/reports/oei-01-11-00211.pdf [https://perma.cc/EQW2-QQKW]; see also Azizi, supra note 7; Herper & Ruiz, supra note 7.

9 Vladeck, supra note 3, at 2 (“Some marketers of dietary supplements make disease treatment and prevention claims that far exceed the bounds of the structure/function claims that are permitted under the 1994 Dietary Supplement Health and Education Act (DSHEA).”); see also Office of Inspector Gen., U.S. Dep't of Health & Human Services, Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements (Oct. 2012), https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf [https://perma.cc/223R-QTQQ] [hereinafter Structure/Function Claims Fail]; U.S. Gov't Accountability Office, GAO-10-662T, Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice (May 26, 2010), http://www.gao.gov/new.items/d10662t.pdf [http://www.gao.gov/new.items/d10662t.pdf] (recording the testimony of Gregory D. Kutz, Managing Dir., Forensic Audits and Special Investigations, U.S. Gov't Accountability Office before the Special Committee on Aging) [hereinafter Testimony of Gregory D. Kutz].

10 See, e.g., Temple, Norman J., The Marketing of Dietary Supplements in North America: The Emperor is (Almost) Naked, 16 J. Alternative & Complementary Med. 803 (2010)CrossRefGoogle ScholarPubMed.

11 Probiotics are products with live microorganisms that can confer a health benefit. See Joint Food and Agriculture Org. of the U.N. & World Health Org. Expert Consultation: Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria 4-8 (Oct. 1-4, 2001), ftp://ftp.fao.org/es/esn/food/probio_report_en.pdf.

12 See Nandhini Rajagopal, The North American Probiotics Market, Natural Products Insider (Oct. 3, 2012), http://www.naturalproductsinsider.com/articles/2012/10/the-north-american-probiotics-market.aspx [https://perma.cc/RLY8-75KA]; see also Gogineni, Vijaya K. et al., Probiotics: History and Evolution, 1 J. Ancient Diseases & Preventive Remedies 1, 2-3 (2013)CrossRefGoogle Scholar, http://esciencecentral.org/journals/probiotics-history-and-evolution-2329-8731.1000107.pdf [https://perma.cc/C5RP-VVKP] (discussing the “[c]ommercialization of [p]robiotics”); Keith Nunes, United States Poised to Lead Functional Food Market, Food Bus. News (Dec. 10, 2014), http://www.foodbusinessnews.net/articles/news_home/Business_News/2014/12/United_States_poised_to_lead_f.aspx?ID=%7B3E104CB5-F892-46A3-B989-4A798CBB1B66%7D&cck=1 [https://perma.cc/6PG9-KVVH] (stating that the leading product categories that will help the United States surpass Japan as the number one consumer of functional foods in the world are dairy foods that contain probiotics and products containing whole grains).

13 See Reid, Gregor et al., Potential Uses of Probiotics in Clinical Practice, 16 Clinical Microbiology Reviews 658, 658 (2003)CrossRefGoogle ScholarPubMed (stating that “many so-called probiotic products have not been properly identified, documented, manufactured under good manufacturing practices, or proven clinically, yet various companies make claims that lead consumers and caregivers to believe that they are using reliable products”).

14 See Slashinski, Melody J. et al., “Snake-oil,” “Quack Medicine,” and “Industrially Cultured Organisms”: Biovalue and the Commercialization of Human Microbiome Research, 13 BMC Med. Ethics 28, 29 (2012)CrossRefGoogle Scholar.

15 In this article, we use the general term “deceptive” to encompass the making of express or implied health claims that are false, misleading, or unsupported by competent and reliable scientific evidence. The term “unsubstantiated” refers to the last of these unlawful practices. See generally Enforcement Policy Statement on Food Advertising, U.S. Fed. Trade Comm'n (May 13, 1994), https://www.ftc.gov/public-statements/1994/05/enforcement-policy-statement-food-advertising [https://perma.cc/8QMS-V8TA] [hereinafter Food Policy Statement] (explaining the “standard for substantiation of health claims” and that “the Commission will find an advertisement deceptive … and, therefore, unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material”).

16 See Health Claims, Fed. Trade Comm'n, https://www.ftc.gov/news-events/media-resources/truth-advertising/health-claims [https://perma.cc/6L2B-V96A] (stating that “[t]he Federal Trade Commission combats this type of deceptive advertising [of health claims] in coordination with the Food and Drug Administration.”); Vladeck, supra note 3, at 4, 7 (“Supplements that purport to provide cures or treatments for serious diseases will continue to be a top priority for our [FTC Bureau of Consumer Protection] enforcement efforts …. Staff from the FTC, FDA, and the Office of Consumer Litigation of the Justice Department are conducting regular telephone conferences to increase coordination with respect to strategic planning and case selection.”). For state efforts, see Julie Ralston Aoki, Nat'l Policy and Legal Analysis Network & Pub. Health Law Center, State AG Enforcement of Food Marketing Laws: A Brief History (2010), http://publichealthlawcenter.org/sites/default/files/resources/phlc-fs-agstatefoodenforce-2010.pdf [https://perma.cc/RKR9-P2TK] (“State AGs have demonstrated their willingness and ability to enforce … laws against food and beverage marketers, particularly in cases involving health or nutritional benefits claims, or involving products that pose a health risk.”).

17 See Vladeck, supra note 3, at 4.

18 See R. Chadwick et al., Functional Foods 6–7 (2003) (stating that “[t]he financial exploitation or misleading of trusting consumers by means of unfounded health claims is one of the main ethical concerns arising from functional foods. Consumers who are concerned about their health are potentially amongst the more vulnerable members of society and under certain circumstances amongst the easiest to deceive.”); Melissa Carroll, UH Research Focuses on How Food Marketing Creates a False Sense of Health, Univ. of Hous. (June 13, 2014), http://www.uh.edu/news-events/stories/2014/June/061314 foodmarketingstudy [https://perma.cc/XDU9-Q4KG] (referencing a study by Assistant Professor Temple Northup, “Truth, Lies, and Packaging: How Food Marketing Creates a False Sense of Health”).

19 See Hasler, Clare M., Functional Foods: Benefits, Concerns and Challenges – A Position Paper from the American Council on Science and Health, 132 J. Nutrition 3772, 3779 (2002)CrossRefGoogle ScholarPubMed (noting that “[t]he tendency for consumers to view the ‘kitchen cabinet as the medicine cabinet’ was initially identified as a leading trend in the food industry in 1994. This ‘self-care’ phenomenon remains a leading consumer trend today” and “76% of consumers strongly or mostly agree that eating healthfully is a better way to manage illness than medication”).

20 In remarks to Congress, David Vladeck, former Director of the FTC Bureau of Consumer Protection, stated that “[c]onsumers suffering from serious health ailments are particularly vulnerable and sometimes desperate. The marketing of unfounded treatments to such people offers a type of false hope that is particularly cruel.” Vladeck, supra note 3, at 4. Vulnerable populations often include senior citizens and adolescents. See Azizi, supra note 7, at 447.

21 Vladeck, supra note 3, at 2–3 (“Such disease claims may deter consumers from seeking necessary medical treatment for serious conditions such as cancer, diabetes, and HIV.”).

22 See Tsai, H.-H. et al., Evaluation of Documented Drug Interactions and Contraindications Associated with Herbs and Dietary Supplements: A Systematic Literature Review, 66 Int'l J. Clinical Prac. 1056, 1066-70 (2012)CrossRefGoogle ScholarPubMed.

23 See infra Part III.

24 Advertisements include claims made in newspapers and magazines, on television or radio, on the internet, in the mail, or on billboards or buses. See Truth in Advertising, U.S. Fed. Trade Comm'n, http://www.ftc.gov/news-events/media-resources/truth-advertising [https://perma.cc/6P5D-E5PU].

25 See 21 U.S.C. § 343(a) (2012); see also infra Part III.A.

26 See 15 U.S.C. § 45(a)(1) (2012); see also infra Part III.B.

27 See, e.g., Vladeck, supra note 3; Taylor, supra note 2; see also Sarah Klein, POM-Boozled: Do Health Drinks Live Up to Their Labels?, CNN (Oct. 27, 2010, 8:16 AM), http://www.cnn.com/2010/HEALTH/10/27/health.pom.drink.labels [https://perma.cc/8TWV-KDBQ] (noting that the FTC and FDA have been “cracking down on food and beverage makers for allegedly overselling the health benefits of their products”); infra Part III.C.

28 See Natasha Singer, Foods with Benefits, or So They Say, N.Y. Times (May 14, 2011), http://www.nytimes.com/2011/05/15/business/15food.html; see also infra Part IV.

29 Editors, supra note 1; see David Vinjamuri, POM Wonderful's Deception is the Tip of the Iceberg, Forbes (May 23, 2012, 4:06 PM), http://www.forbes.com/sites/davidvinjamuri/2012/05/23/judge-finds-pom-wonderful-advertising-deceptive-but-thats-just-the-tip-of-the-iceberg; infra Part IV.

30 See infra note 216 and accompanying text.

31 See Garance Burke, Many Health Supplement Claims Misleading, Illegal, Wash. Times (Oct. 3, 2012), http://www.washingtontimes.com/news/2012/oct/3/many-health-supplement-claims-misleading-illegal/?page=all [https://perma.cc/B4EN-LF6V]; Consumers Union of U.S. Inc., supra note 6; Matthew Herper, Wacky Food Health Claims, Forbes (May 19, 2010, 6:00 PM), http://www.forbes.com/2010/05/19/food-claims-supplements-lifestyle-health-yogurt-margarine.html; Herper & Ruiz, supra note 7; Gyorgy Scrinis, That's Not Natural or Organic: How Big Food Misleads, Salon (July 20, 2013, 8:30 AM), http://www.salon.com/2013/07/20/thats_not_natural_or_organic_how_big_food_misleads/ [https://perma.cc/WAY3-XNG2]; Singer, supra note 28.

32 Singer, supra note 28.

33 Editors, supra note 1.

34 See Herper & Ruiz, supra note 7 (describing how Lifeway Foods, the maker of ProBugs, “a yogurtlike beverage for kids,” ignored the results of clinical trials when making its claims).

35 See Zeratsky, supra note 4 (defining “functional foods” as “foods that have a potentially positive effect on health beyond basic nutrition”).

36 Mission Statement, Ctr. for Sci. in the Pub. Int., http://cspinet.org/about/mission.html [https://perma.cc/LF6M-BRE7].

37 See Michael F. Jacobson, Ctr. For Sci. in the Pub. Interest, CSPI'S Year-End Report to the Membership (2013), http://cspinet.org/about/CSPI-Year-End-Report-2013.pdf [https://perma.cc/6MZF-A8NF].

38 E-mail from Michael Jacobson, Exec. Dir., Ctr. for Science in the Pub. Interest, to Diane Hoffmann, Professor of Law, Univ. Maryland Francis King Carey School of Law (Apr. 29, 2013, 08:31 EST) (on file with author).

39 Id. Jacobson provides the following additional examples: “Campbell's misleading labeling about sodium in its soups by pretending that people consume smaller serving sizes … and Dr. Pepper Snapple group's made-up claims of benefits from the antioxidants it adds to some of its 7UP sugar drinks, which promote obesity, not health.” Id.

40 These are “statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function ….” 21 C.F.R. § 101.93(f) (2015). See infra notes 93-98 and accompanying text.

41 See Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide, U.S. Food & Drug Admin. (Jan. 9, 2002), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm [https://perma.cc/GCF7-SSQR]; see infra notes 99–101 and accompanying text.

42 Testimony of Gregory D. Kutz, supra note 9, at 9.

43 Id. at 8.

44 Health Claims, supra note 16.

45 Id.

46 Structure/Function Claims Fail, supra note 9, at 1 (citing Natural Products Foundation, What is the Current Economic Contribution of the Dietary Supplement Industry to the U.S. Economy?, Natural Products Found. (rev. Mar. 2011), https://www.npainfo.org/App_Themes/NPA/docs/policy/Econ%20One%20sheet%203-11%20final.pdf); see also Kamangar, Farin & Emadi, Ashkan, Vitamin and Mineral Supplements: Do We Really Need Them?, 3 Int'l J. Preventive Med. 221 (2012)Google Scholar (estimating total sales of nutritional supplements in the United States in 2010 to have been over $28 billion).

47 David Lariviere, Nutritional Supplements Flexing Muscles as Growth Industry, Forbes (Apr. 18, 2013, 7:09 PM), http://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/ (citing figures from the Nutritional Business Journal).

48 Health Claims, supra note 16.

49 Maggie Hennessy, What's Driving Growth in Functional Food and Beverages? A Convergence of Nutrition, Convenience and Taste, Nutraingredients-usa.com (Sept. 27, 2013), http://www.nutraingredients-usa.com/Markets/What-s-driving-growth-in-functional-food-and-beverages-A-convergence-of-nutrition-convenience-and-taste [https://perma.cc/NC2K-Z9JN].

50 Id.

51 Id.

52 PricewaterhouseCoopers, Leveraging Growth in the Emerging Functional Foods Industry: Trends and Market Opportunities 9 (2009).

53 See Hank Schultz, Supplement Sales Hit $11.5 Billion in U.S., Report Says, Nutraingredients-usa.com (Sept. 20, 2012), http://www.nutraingredients-usa.com/Markets/Supplement-sales-hit-11.5-billion-in-U.S.-report-says [https://perma.cc/9HK7-KHUX] (“In terms of different segments [of the dietary supplement market], digestive supplements are doing very well right now, especially probiotics.”); see also Jane E. Brody, Putting Good Bacteria to Work, N.Y. Times (Sept. 14, 2004), http://www.nytimes.com/2004/09/14/health/14brod.html; International Probiotics (Functional Foods, Dietary Supplements, Specialty Nutrients, Animal Feed) Market – Forecasts to 2019, Marketwired (July 2, 2014), http://www.marketwired.com/press-release/international-probiotics-functional-foods-dietary-supplements-specialty-nutrients-animal-1926353.htm [https://perma.cc/4273-PFSS] (predicting that an increase in consumer demand will cause the probiotics industry “to witness remarkable growth in the coming years”); sources cited supra note 12.

54 Multinationals in the functional food market include PepsiCo, Coca-Cola, General Mills, Kellogg, Kraft, Nestle, Danone, Unilever and Yakult. See PricewaterhouseCoopers, supra note 52, at 8.

55 Id. at 5.

56 Id. at 9.

57 See id. at 10 (“Although these products typically require greater initial R&D and ingredient costs, price premiums may reach 30 percent or higher, depending on the product.”).

58 Alison Young, Unmasking the People Behind Risky Pills: A USA Today Investigation, USA Today (Dec. 20, 2013, 9:57 AM), http://www.usatoday.com/story/news/nation/2013/12/19/dietary-supplements-executives-criminal-records-spiked/4114451/ [https://perma.cc/6K3K-YV2D].

59 Steve Mister, The Supplement Industry's ‘Identity’ Crisis, Nat. Prods. Insider (Feb. 10, 2012), http://www.naturalproductsinsider.com/articles/2012/02/the-supplement-industry-s-identity-crisis.aspx [https://perma.cc/WD3W-W7AF] (describing mislabeling and the use of substandard ingredients).

60 Federal Food, Drug, & Cosmetic Act, 21 U.S.C. §§ 301–399 (2012).

61 Dietary Supplement Health & Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 321, 331, 342, 343, 350 and 42 U.S.C. § 287).

62 Nutrition Labeling & Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. § 343).

63 Federal Trade Commission Act, 15 U.S.C. §§ 41-58 (2012). The Lanham Act also establishes a cause of action for false advertising. See 15 U.S.C. § 1125(a) (2012). However, only those who allege an injury to commercial interests have standing to bring a Lanham Act false advertising claim; consumers do not have such standing. Lexmark Int'l, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014). See also POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2234 (2014) (explaining that only competitors can bring a claim under the Lanham Act for “misleading advertising or labeling”). Although consumers do not have a right of action under the Lanham Act, theories of Lanham Act liability and related burden of proof obligations may be pertinent to analysis of a false advertising claim based in state law. See In re GNC Corp., 789 F.3d 505, 514 (4th Cir. 2015).

64 21 U.S.C. §§ 331(a), 343(a), 371(a) (2012).

65 U.S. Food & Drug Admin., A Food Labeling Guide 4 (Jan. 2013), http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf [https://perma.cc/8EHW-HNYE] [hereinafter A Food Labeling Guide].

66 21 U.S.C. §§ 342-343 (2012).

67 21 U.S.C. § 343(a)(1).

68 See 21 U.S.C. § 343(a)(2) (defining noncompliance as “false or misleading in a material respect” or in violation of 21 U.S.C. § 350(b)(2)).

69 See Label Claims for Conventional Foods and Dietary Supplements, U.S. Food & Drug Admin., http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm111447.htm [https://perma.cc/D2A4-NQ3H] (last updated Nov. 26, 2014) [hereinafter Label Claims].

70 See 21 U.S.C. § 321(g)(1) (defining “drug”); Fed. Trade Comm'n, Dietary Supplements: An Advertising Guide for Industry 24 (2001), https://www.ftc.gov/system/files/documents/plain-language/bus09-dietary-supplements-advertising-guide-industry.pdf [https://perma.cc/JV3L-RBQZ].

71 See Development & Approval Process (Drugs), U.S. Food & Drug Admin., http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ [https://perma.cc/8PEV-E99B] (last updated Oct. 27, 2014) (describing the drug approval process). But see Dietary Supplements: An Advertising Guide for Industry, supra note 70.

72 See Label Claims, supra note 69.

73 See 21 C.F.R. § 101.14(a)-(d) (2015).

74 See Guidance for Industry: Evidence Based Review System for the Scientific Evaluation of Health Claims - Final, U.S. Food & Drug Admin. (Jan. 2009), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm073332.htm#system [http://perma.cc/2WYE-C8K6] [hereinafter Guidance for Industry] (defining “qualified health claims” as health claims with a disclaimer disclosing limits on scientific support).

75 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. § 343).

76 Id; see also Geiger, Constance J., Health Claims: History, Current Regulatory Status, and Consumer Research, 98 J. Am. Dietetic Ass'n 1312, 1313 (1998)CrossRefGoogle ScholarPubMed.

77 A Food Labeling Guide, supra note 65, at 80.

78 Guidance for Industry, supra note 74.

79 See Label Claims, supra note 69. This mechanism of approval for health claims was established by the Nutrition Labeling and Education Act of 1990. Id.

80 21 C.F.R. § 101.72(e) (2015).

81 Label Claims, supra note 69, at 1. These scientific bodies may include the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). 21 U.S.C. § 343(r)(2)(G)(i) (2012). In addition, FDA has stated that scientific bodies may include the Surgeon General within the Department of Health and Human Services, the Food and Nutrition Service, the Food Safety and Inspection Service, and the Agricultural Research Service within the Department of Agriculture. See Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, U.S. Food & Drug Admin. (June 11, 1998), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm056975.htm [https://perma.cc/UJM9-7R7Y] [hereinafter Notification of a Health Claim].

82 Label Claims, supra note 69, at 1.

83 In such a case, the submitter may revise the notification and resubmit it. Notification of a Health Claim, supra note 81. The food may not be marketed with the revised claim until at least 120 days after resubmission. Id.

84 Id.

85 See Pearson v. Shalala, 164 F.3d 650, 658 (D.C. Cir. 1999) (holding that under the First Amendment, the FDA may not reject health claims that it determines to be only potentially misleading unless the agency determines that no disclaimer would eliminate the misleading nature of the claim).

86 Guidance for Industry: FDA's Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance, U.S. Food & Drug Admin. (May 12, 2006), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm053843.htm [https://perma.cc/9V8C-4RZF]. An example of a QHC is: “One small study suggests that chromium picolinate may reduce the risk of insulin resistance…. FDA concludes, however, that the existence of such a relationship … is highly uncertain”. Qualified Health Claims: Letter of Enforcement Discretion – Chromium Picolinate and Insulin Resistance (Docket No. 2004Q-0144), U.S. Food & Drug Admin. (Aug. 25, 2005), http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073017.htm [https://perma.cc/5TSH-PGMT].

87 See A Food Labeling Guide, supra note 65, at 83. This guidance document states:

88 Id. at 27 (defining Nutrient Content Claims as nutrition information cited on packaging outside of the Nutrition Facts label).

89 Id. at 87-94.

90 Id. at 91-94. Historically, “healthy” is “a claim that has received special scrutiny and guidelines from the FDA because [it] is a very useful advertising term. According to FDA guidelines, a product must have low total fat content as well as low levels of saturated fat, sodium, and cholesterol to qualify as a ‘healthy’ food.” Parker, Betty J., Food for Health: The Use of Nutrient Content, Health, and Structure/Function Claims in Food Advertisements, J. Advert. 47, 48–49 (2003)Google Scholar (citation omitted); see also 21 C.F.R. § 101.65(d)(2) (2015) (explaining conditions limiting use of the term “healthy”).

91 For example, FDA deems a food misbranded if it bears a nutrient content claim unless the agency has issued a regulation authorizing the claim and the claim is made consistent with the regulations. See 21 U.S.C. § 343(r)(2)(A) (2012) (requiring that nutrient content claims “[use] terms which are defined in regulations of the Secretary,” along with other requirements); A Food Labeling Guide, supra note 65, at 72 (“Only those claims, or their synonyms, that are specifically defined in the regulations may be used.”).

92 A Food Labeling Guide, supra note 65, at 72 (citing 21 C.F.R. § 101.13(b)).

93 Along with structure/function claims, the Dietary Supplement Health and Education Act of 1994 (DSHEA) also permits general well-being and nutrient deficiency disease claims for dietary supplements. See Label Claims, supra note 69, at 4. Neither of these claims is subject to premarket approval by FDA. Id. at 2.

94 Structure/Function Claims Fail, supra note 9, at 4 (“For example, a supplement may claim that it ‘curbs appetite to help with weight loss,’ but it may not claim to ‘aid weight loss to treat obesity’ because obesity is a disease. Similarly, a supplement may claim to ‘support immunity,’ but may not claim to ‘boost the immune system against colds and flu’ because the latter references specific diseases.” (citing 21 U.S.C. § 343(r)(6)(A)).

95 See id. FDA has set forth guidance on what types of evidence can be used for claim substantiation. See Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, U.S. Food & Drug Admin. (Dec. 2008), http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm073200.htm [https://perma.cc/6KS7-SLRF]. To meet the substantiation requirement, “competent and reliable scientific evidence” must be provided. Id. In determining whether the standard is met, FDA considers: “(1) The meaning of the claim(s) being made; (2) The relationship of the evidence to the claim; (3) The quality of the evidence [e.g., randomized controlled trials are given considerable weight although manufacturers may use other human or nonhuman studies]; and (4) The totality of the evidence [both favorable and unfavorable].” Id.

96 Structure/Function Claims Fail, supra note 9, at 6.

97 Id. (citing 21 C.F.R. § 101.93(a)(2) (2014)).

98 Label Claims, supra note 69, at 4.

99 See CSPI, United States—A Good System Gone Bad: Marketplace Implications and Consumer Impact, in Functional Foods: Public Health Boon or 21st Century Quackery? (1998), https://cspinet.org/reports/functional_foods/usa_market.html [https://perma.cc/3T6A-MW95].

100 See Parker, supra note 90, at 49; see also CSPI, supra note 99 (“To avoid FDA approval requirements, some companies have begun making structure/function claims in lieu of health claims.”).

101 See Structure/Function Claims Fail, supra note 9; Office of Inspector Gen., U.S. Dep't of Health & Human Servs., Dietary Supplement Labels: An Assessment (2003), https://oig.hhs.gov/oei/reports/oei-01-01-00121.pdf [https://perma.cc/89ZS-U49A]; Testimony of Gregory D. Kutz, supra note 9; U.S. Gov't Accountability Office, GAO-09-250, Report to Congressional Requesters: Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding (2009), http://www.gao.gov/assets/290/285372.pdf [https://perma.cc/T8RJ-ENJC].

102 Michelle Rusk, Att'y, U.S. Fed. Trade Comm'n, Div. of Advert. Practices, Staff Presentation at the Inst. of Medicine Food Forum Workshop: Health Claims and FTC Advertising Law (Feb. 23, 2012), http://iom.nationalacademies.org/~/media/1EBC076FE7CC4AC0BB922166367899FC.ashx [https://perma.cc/7D5P-5M2C].

103 See Anne V. Maher, Marketing Dietary Supplements and Functional Foods in the USA: The Federal Trade Commission's Advertising Substantiation Requirements, in Nutraceutical and Functional food Regulations in the United States and Around the World 47, 48 (Debasis Bagchi ed., 2008).

104 See id. (stating that the FTC “has authority to take legal action against false and misleading claims for nearly every type of product and service, including products which are also regulated by the … FDA, such as dietary supplements and functional foods”).

105 15 U.S.C. § 45(a)(1) (2012).

106 15 U.S.C. § 52 (2012).

107 15 U.S.C. § 55(a)(1) (2012).

108 U.S. Fed. Trade Comm'n, FTC Policy Statement on Deception (1983), https://www.ftc.gov/system/files/documents/public_statements/410531/831014deceptionstmt.pdf (opinion letter).

109 Id.

110 Id.

111 Id.

112 Id.

113 Id.

114 For example, POM Wonderful, the marketer of pomegranate juice products claimed to have various health benefits, “thought their products [sic] impact on health was such a strong selling point that they invested over $35 million to develop supporting evidence that they could use in marketing.” POM Wonderful LLC, 155 F.T.C. 1, 63 (2013).

115 FTC Policy Statement Regarding Advertising Substantiation, U.S. Fed. Trade Comm'n (Mar. 11, 1983), https://www.ftc.gov/public-statements/1983/03/ftc-policy-statement-regarding-advertising-substantiation [https://perma.cc/4QWS-SCZH]; see also Pfizer Inc., 81 F.T.C. 23, 56 (1972) (finding 50 to 70 years of dermatological use of sunburn lotion active ingredients constitutes a “reasonable” basis for efficacy claims in “Un-burn” product); Dietary Supplements: An Advertising Guide for Industry, supra note 70, at 8-9 (listing factors used to determine “reasonable basis”).

116 FTC Policy Statement Regarding Advertising Substantiation, supra note 115; see also Food Policy Statement, supra note 15 (requiring a reasonable basis at the time the claim is made). FTC's Bureau of Consumer Protection website on “Health Claims” states that “[c]ompanies must support their advertising claims with solid proof. This is especially true for businesses that market food, over-the-counter drugs, dietary supplements, contact lenses, and other health-related products.” Health Claims, U.S. Fed. Trade Comm'n, http://business.ftc.gov/advertising-and-marketing/health-claims [https://perma.cc/F5PG-CMUC].

117 See Dietary Supplements: An Advertising Guide for Industry, supra note 70; Food Policy Statement, supra note 15.

118 See Food Policy Statement, supra note 15.

119 Dietary Supplements: An Advertising Guide for Industry, supra note 70, at 1.

120 Id. at 9; Food Policy Statement, supra note 15.

121 Dietary Supplements: An Advertising Guide for Industry, supra note 70, at 9 (quoting Food Policy Statement, supra note 15).

122 Food Policy Statement, supra note 15.

123 Id.

124 The FTC industry guidance document on advertising dietary supplements provides an example of this:

Dietary Supplements: An Advertising Guide for Industry, supra note 70, at 5.

125 Id. at 9.

126 See id. at 9-18.

127 Food Policy Statement, supra note 15 (“[The FTC] recognizes the importance of consistent treatment of nutrient content and health claims in food advertising and labeling and seeks to harmonize its advertising enforcement program with FDA's food labeling regulations to the fullest extent possible under the statutory authority of the FTC Act.”).

128 The allocation of responsibility for enforcement of food and dietary supplement labels and claims is set forth in the MOU between the two agencies. See Memorandum of Understanding Between the Federal Trade Commission and The Food and Drug Administration, MOU 225-71-8003 (Apr. 21, 1971), http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm [https://perma.cc/2KKG-GKEP].

129 Labeling is interpreted broadly to include “visual, audio or other material that bears a strong contextual relationship to the product.” Villafranco, John E. & Lustigman, Andrew B., Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission and National Advertising Division, 62 Food & Drug L.J. 709, 711 (2007)Google ScholarPubMed (referencing 21 U.S.C. § 321(m) and Kordel v. United States, 335 U.S. 345 (1948)).

130 See id. at 711.

131 Maher, supra note 103, at 48.

132 See John E. Villafranco et al., Nutritional Outlook, Working Together: How Growing FDA And FTC Collaboration Changes the Regulatory Landscape for Food and Dietary Supplement Marketers 32, 34 (2011), http://www.kelleydrye.com/publications/articles/1485/_res/id=Files/index=0/Villafranco_Pippins_Wolff_Working%20Together_Nutritional%20Outlook_%20May%202011.pdf [https://perma.cc/WE36-VAZ6] (“Early in the Obama Administration, the FDA and FTC expressed a commitment to interagency collaboration in regulating the promotion of food, beverage, and dietary supplement products, and established ‘working groups’ to share information regarding marketing activities for such products.”); see also Roller, Sarah & Pippins, Raqiyyah, Marketing Nutrition & Health-Related Benefits of Food & Beverage Products: Enforcement, Litigation & Liability Issues, 65 Food & Drug L.J. 447, 449 (2010)Google ScholarPubMed (“Part III considers the relationship between FDA and FTC enforcement priorities and recent false advertising cases brought by private parties challenging nutrition and health-related marketing claims for food and beverage products.”).

133 See 21 CFR §§ 7.40-7.42, 7.45 (2014).

134 See U.S. Gov't Accountability Off., GAO-08-597, Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods 2 (2008), http://www.gao.gov/assets/290/280466.pdf [https://perma.cc/22QR-2DXD].

135 See U.S. Food & Drug Admin., Seizure in Regulatory Procedures Manual, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm [https://perma.cc/ZBT4-AJ38].

136 See Advertising FAQ's: A Guide for Small Business, U.S. Fed. Trade Comm'n (Apr. 2011), https://www.ftc.gov/tips-advice/business-center/guidance/advertising-faqs-guide-small-business [https://perma.cc/EK9E-4S95]; U.S. Food & Drug Admin., Injunctions, in Regulatory Procedures Manual, http://www.fda.gov/ICECI/|ComplianceManuals/RegulatoryProceduresManual/ucm176734.htm [https://perma.cc/ME3T-UZK6].

137 See 21 U.S.C. § 333(a)(1) (2012); U.S. Food & Drug Admin., Prosecution, in Regulatory Procedures Manual, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176738.htm [https://perma.cc/DD2Y-XEU6]; see also John W. Lundquist & Sandra L. Conroy, Defending Against Food & Drug Prosecutions, The Champion (July 1997), http://www.nacdl.org/CHAMPION/ARTICLES/97jul02.htm [https://perma.cc/KR58-VC3Q]. While the law allows for civil monetary penalties against drug and medical device manufacturers, it does not provide for civil penalties for violations by food and dietary supplement manufacturers. See 21 U.S.C. § 335b (2012).

138 See Advertising FAQ's: A Guide for Small Business, supra note 136.

139 See Nicole E. Negowetti, Governance Studies at Brookings, Food Labeling Litigation: Exposing Gaps in the FDA'S Resources and Regulatory Authority 8 (2014), http://www.brookings.edu/~/media/research/files/papers/2014/06/26-food-labeling-litigation/negowetti_food-labeling-litigation.pdf [https://perma.cc/T8JA-WX3D] (citing Center for Science in the Public Interest, Rebuttal to FDA Report to Congress on Agency Enforcement Actions Regarding Health-Related Claims on Food Labels (2006), http://cspinet.org/new/pdf/fn5rep.pdf [https://perma.cc/V3KV-UX2A] [hereinafter Rebuttal to FDA Report]); see also H.R. Rep. No. 109-102, at 83 (2005); S. Rep. No. 109-92, at 153 (2005); U.S. Gov't Accountability Off., supra note 134.

140 Negowetti, supra note 139, at 8 (quoting Rebuttal to FDA Report).

141 Id; see also Food Labeling: How to Avoid an FDA or FTC Enforcement Action, ABA Section of Litigation 3 (June 12, 2012), http://www.americanbar.org/content/dam/aba/administrative/litigation/materials/2012_food_supplements_2nd_annual_cle_wrkshp/2012_aba_panel3_food_labeling_how_to_avoid_an_fda_or_ftc_enforcement_action.authcheckdam.pdf [https://perma.cc/98BT-PUFY] (“In a food labeling enforcement initiative executed in 2010, FDA issued no less than 17 warning letters on a single day which challenged food labeling claims, including a notable number of ‘front-of-pack’ label claims and marketing claims disseminated through internet websites which FDA determined to qualify as food ‘labeling.’”); Summary of 17 Warning Letters Issued by FDA on February 22, 2010 for Alleged Food Labeling Violations, Keller & Heckman LLP (Feb. 22, 2010), http://www.khlaw.com/3640 [https://perma.cc/8CW9-BXPN].

142 Food Labeling: How to Avoid an FDA or FTC Enforcement Action, supra note 141, at 3.

143 See Warning Letters, U.S. Food & Drug Admin. (2015), http://www.fda.gov/ICECI/EnforcementActions/|WarningLetters/default.htm [https://perma.cc/EUE2-4R3G]; see also 2014 Year-End FDA Compliance and Enforcement Update-Food and Dietary Supplements, Gibson, Dunn & Crutcher LLP 10-11 (2015), http://www.gibsondunn.com/publications/Documents/2014-Year-End-FDA-Compliance-and-Enforcement-Update-Food-and-Dietary-Supplements.pdf [https://perma.cc/9V42-Y5AQ] (stating that in 2014 FDA issued 252 warning letters for conventional foods and 58 for dietary supplements; the letters for foods primarily cited violations of current good manufacturing practices while those for dietary supplements were for what has been described in this Article as deceptive health claims, i.e., improperly marketing products as dietary supplements when those products were actually new drugs).

144 See Warning Letters, supra note 143.

145 Peter E. Masaitis & Evan W. Woolley, Enforcement of FDA Qualified Health Claims: Who's on the Case?, Inside Counsel (Jan. 9, 2015), http://www.insidecounsel.com/2015/01/09/enforcement-of-fda-qualified-health-claims-whos-on [https://perma.cc/GWH5-QP2W].

146 See Food Labeling: How to Avoid an FDA or FTC Enforcement Action, supra note 141.

147 U.S. Fed. Trade Comm'n, Deceptive Marketing of Dietary Supplements: FTC Enforcement Activities 4 (May 26, 2010), https://www.ftc.gov/sites/default/files/documents/public_statements/prepared-statement-federal-trade-commission-deceptive-marketing-dietary-supplements/100526dietarysupplementstatement.pdf [https://perma.cc/7E4V-E54Z] (citing a statement prepared for a hearing before the Senate Special Committee on Aging); see also Health Claims, supra note 16 (stating that “[o]ver the last decade, the FTC has filed one hundred and twenty cases challenging health claims made for supplements”).

148 Deceptive Marketing of Dietary Supplements, supra note 147, at 4.

149 Complaint at 1, filed by the U.S. Federal Trade Commission (2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/07/100714nestlecmpt.pdf [https://perma.cc/Y8XS-U472].

150 Id. at 2.

151 Id. at 6.

152 Id.

153 See FTC Approves Final Order Settling Charges That Nestlé Subsidiary Made Deceptive Health Claims for BOOST Kid Essentials, U.S. Fed. Trade Comm'n (Jan. 18, 2011), https://www.ftc.gov/news-events/press-releases/2011/01/ftc-approves-final-order-settling-charges-nestle-subsidiary-made [https://perma.cc/U6RY-YWDG].

154 Id. The FTC further required that the regulation be based on a finding that “there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, considering the totality of publicly available scientific evidence.” Nestlé HealthCare Nutrition, Inc.; Analysis of Proposed Consent Order to Aid Public Comment, 75 Fed. Reg. 42,752, 42,753 (July 22, 2010).

155 FTC Approves Final Order, supra note 153. The settlement also prohibits Nestlé HCN from “mak[ing] any claims about the health benefits, performance, or efficacy of any probiotic or nutritionally complete drinks that it sells at retail, unless the claims are true and backed by competent and reliable scientific evidence” and from “misrepresenting any tests or studies.” Id.

156 See In re The Dannon Company, Inc. Agreement Containing Consent Order (2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/12/101215dannonagree.pdf [https://perma.cc/Z3QV-Y3V8].

157 Press Release, U.S. Fed. Trade Comm'n, Dannon Agrees to Drop Exaggerated Health Claims for Activia Yogurt and DanActive Dairy Drink (Dec. 15, 2010), https://www.ftc.gov/news-events/press-releases/2010/12/dannon-agrees-drop-exaggerated-health-claims-activia-yogurt [https://perma.cc/GG2B-JMRV].

158 Id. Prior to this action by the FTC, in 2009 the Dannon Co. settled a false advertising lawsuit brought by private plaintiffs regarding these products; see Timothy Williams, Dannon Settles With F.T.C. Over Some Health Claims, N.Y. Times (Dec. 15, 2010), http://www.nytimes.com/2010/12/16/business/16yogurt.html; see also infra notes 191-193 and accompanying text.

159 Complaint at 19, In re POM Wonderful LLC, 155 F.T.C. 1 (Sept. 24, 2010) (No. 9344), http://www.ftc.gov/sites/default/files/documents/cases/2010/09/100927admincmplt.pdf [https://perma.cc/6NTP-GE8R].

160 In re POM Wonderful LLC, 155 F.T.C. 1, 1 (2013).

161 Id. at 4.

162 Id. at 21.

163 In re POM Wonderful LLC, 155 F.T.C. 1, app. A, at A1-A2 (2013), http://www.ftc.gov/sites/default/files/documents/cases/2013/01/130116pomappendixa.pdf [https://perma.cc/6AEU-V3CX].

164 Complaint at 22, In re POM Wonderful LLC, 155 F.T.C. 1 (Sept. 24, 2010) (No. 9344), http://www.ftc.gov/sites/default/files/documents/cases/2010/09/100927admincmplt.pdf [https://perma.cc/6NTP-GE8R].

165 In re POM Wonderful LLC, 155 F.T.C. 1, 192 (2013).

166 See POM Wonderful, LLC v. Fed. Trade Comm'n, 777 F.3d 478, 484 (D.C. Cir. 2015).

167 Id. at 492, 499.

168 Id. at 503.

169 See Villafranco, Pippins, & Wolff, supra note 132, at 35; see also Hyman, Douglas W., The Regulation of Health Claims in Food Advertising: Have the FTC and the FDA Finally Reached a Common Ground?, 51 Food & Drug L.J. 191, 198 (1996)Google ScholarPubMed (“Not surprisingly, the FDA rejected the FTC's flexible substantiation approach in favor of its ‘significant agreement’ approach.”).

170 2014 Year-End FDA Compliance and Enforcement Update-Food and Dietary Supplements, supra note 143, at 6. During the year the agency entered into “multiple weight-loss product settlements, most of which required the defendants to substantiate any future weight-loss claims with at least two adequate and well-controlled human studies.” Id.

171 Carolyn L. Carter, Nat'l Consumer Law Ctr. Inc., Consumer Protection in the States: A 50-State Report on Unfair and Deceptive Acts and Practices Statutes 5 (2009), http://www.msfraud.org/law/lounge/UnfairandDeceptiveActs09.pdf [https://perma.cc/YTP8-FT64].

172 Id. at 6.

173 Christopher J. Willis & Stefanie H. Jackman, Strafford, What is an Attorney General's Burden of Proof? Evidentiary Requirements in UDAP Actions Brought by State Attorneys General 1 (2010), http://media.straffordpub.com/products/udap-litigation-against-financial-institutions-merging-theories-and-the-foreclosure-documentation-crisis-2010-11-30/reference-material.pdf [https://perma.cc/YK2T-SUDP].

174 CARTER, supra note 171, at 6.

175 Id.

176 See Complaint for Injunction, Civil Penalties, and Other Equitable Relief at 2, California v. Bayer Healthcare LLC (Cal. Super. Ct. Oct. 26, 2010) (No. 37-2010-0010-3098-CU-MC-CTL), http://oag.ca.gov/system/files/attachments/press_releases/n2007_bayer_complaint.pdf [https://perma.cc/9USD-PBV5]. Soon after it was filed, the case was settled for $3.3 million. See Press Release, Cal. Office of the Att'y Gen., Brown Announces $3 Million Settlement over Misleading Claims that Multivitamins Can Reduce Cancer Risk (Oct. 26, 2010), http://oag.ca.gov/news/press-releases/brown-announces-3-million-settlement-over-misleading-claims-multivitamins-can [https://perma.cc/6BD9-PQBJ].

177 See, e.g., Assurance of Voluntary Compliance, In re Warner Lambert Company LLC (May 11, 2004), http://apps.americanbar.org/antitrust/at-committees/at-state/pdf/settlements/cp/warner-lambert.pdf [https://perma.cc/6KYZ-3UCZ] (describing a settlement with fifty states regarding promotional and marketing practices for off-label uses of a prescription drug).

178 See Carter, supra note 171, at 6.

179 Id. at 5.

180 See id.

181 See id.

182 Id. at 5–6.

183 Coca-Cola marketed the drink as a weight loss product, claiming that it had “negative calories” and labeling it as “the calorie burner” on its cans. Watchdog Group Sues Coke, Nestlé, for Bogus “Enviga” Claims, Ctr. For Science In The Pub. Interest (Feb. 1, 2007), http://www.cspinet.org/new/200702011.html [https://perma.cc/U9V9-PPDF]. CSPI scientists reviewed the studies relied on by Coke and determined that Enviga was simply “a highly caffeinated and overpriced diet soda.” Id. In 2007, CSPI filed suit alleging that the claims “were made without prior substantiation and no evidence that most consumers would realize any calorie-burning benefit.” Negowetti, supra note 139, at 17 (“Following the filing of this lawsuit, approximately 28 state attorneys general investigated the claims and ultimately settled for $650,000.”). The company also agreed to stop making overt weight-loss claims for the product. Id.

184 CSPI sued Bayer in 2009 alleging that the claims were deceptive and lacked scientific evidence. Litigation Project-Closed Cases, Ctr. for Science in the Pub. Interest, http://cspinet.org/litigation/closed.html [https://perma.cc/62JQ-LUGT] (“That lawsuit was dismissed on procedural grounds. CSPI was preparing to refile when the Attorneys General of Oregon, California, and Illinois announced a broad settlement with Bayer on the same issues.”).

185 See id. (describing cases against Airborne for deceptive claims regarding its cold remedy, against Aurora Dairy for selling its non-organic dairy products as “organic”, against Dr. Pepper Snapple Group for misleading antioxidant claims on its labels, and General Mills for misleading claims about “the nutritional and health qualities of its ‘fruit’ snacks”).

186 See id. (listing agreements with Pfizer Consumer HealthCare for health claims made about Centrum Dietary Supplements, Pepsico for claims that its IZZE sparkling juices are “natural and fortified,” Quaker Oats for claims that its oatmeal lowered cholesterol, and Smart Balance for claims that its Blended Butter Sticks help block cholesterol).

187 Negowetti, supra note 139, at 1.

188 The majority of cases (over 100) have alleged that food products have inappropriately used the label “natural” and that use of the term is misleading. See id. at 11.

189 Id. at 10.

190 Id. at 1 (finding this to be true as of June 2014).

191 See Amended Stipulation of Settlement at 8, Gemelas v. The Dannon Company, Inc., 2010 WL 377068, at *11-15 (N.D. Ohio Jan. 20, 2010) (No. 1:08-cv-00236). The complaint alleged violations of two Ohio consumer protection statutes and breach of express warranty. Class Action Complaint, Gemelas v. The Dannon Company, Inc., 2008 WL 824363 (N.D. Ohio Jan. 29, 2008) (No. 1:08-cv-00236).

192 Class Action Complaint, Gemelas v. The Dannon Company, Inc, 2008 WL 824363, at *4. As part of the settlement, the company agreed to make changes to the labeling and advertising of Activia and DanActive. Stipulation of Settlement, Gemelas v. The Dannon Company, Inc., 2009 WL 3197886, at *12-*15 (N.D. Ohio Sept. 18, 2009) (No. 1:08-cv-00236). DanActive labels that said the yogurt has “a positive effect on your digestive tract's immune system” were reworded to say the yogurt will “interact with your digestive tract's immune system.” Id.

193 Negowetti, supra note 139, at 9.

194 Id. at 3.

195 See id. at 4 (citing 21 U.S.C. §§ 333(f)(2)(a), 334 (a)(1), 336) (“The FDA may enforce compliance with a recall order or impose civil monetary fines when adulteration or misbranding of food ‘will cause serious adverse health consequences [or] death,’ such as when a label is missing allergen information. The FDA may condemn and seize misbranded foods only after the company receives proper notice and the opportunity to respond and the FDA has ‘probable cause to believe … that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer.’ Injunctions or criminal prosecutions are rarely used for food misbranding because the FDCA expressly provides that these enforcement actions should not be initiated for ‘minor violations’ when the ‘public interest’ may be adequately served by a written warning.”).

196 Id.

197 Structure/Function Claims Fail, supra note 9, at 6 n.34.

198 Id. at 6.

199 Id. at 5; see also U.S. Gov't Accountability Off., GAO-11-102, Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims 25 (2011), http://www.gao.gov/assets/320/314473.pdf [http://perma.cc/MA2P-YG67].

200 Structure/Function Claims Fail, supra note 9, at 18.

201 This was confirmed by the OIG in a 2012 report describing its analysis of structure/function claims and related substantiation documents “on a purposive sample of 127 dietary supplements marketed for weight loss or immune system support in retail stores and on the Internet.” Id. at 7. The OIG found that “[i]n contrast to FDA guidance, most substantiation was not derived from human studies,” and “10 percent of the documents appeared to have no significance in supporting structure/function claims.” Id. at 11–12. Furthermore, only 2% of the human studies that the OIG reviewed examined the products in the sample; 4% had results that contradicted the claims made; 85% were not randomized clinical trials; 49% “were not based on populations similar to those that will be consuming the supplements”; and 34% focused on a disease, rather than a structure/function endpoint, and of these, 20% “had prohibited disease claims” including treating diseases “such as influenza, the common cold, herpes, and HIV.” Id. at 12–16. Ten percent of the documents submitted did not qualify as substantiation—for example, one was a “30-year-old handwritten college term paper.” Id. at 15.

202 Id. at 4-5; see also U.S. Gov't Accountability Off., supra note 199, at 27.

203 See Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999); see also Alliance for Natural Health v. Sebelius, 786 F. Supp. 2d 1, 13-14 (D.D.C. 2011); Alliance for Natural Health v. Sebelius, 714 F. Supp. 2d 48, 61–62 (D.D.C. 2010).

204 While the agency conducts internet surveillance to find supplements making such claims, it has not expanded its surveillance to retail stores. Structure/Function Claims Fail, supra note 9, at 3.

205 Singer, supra note 28.

206 Taylor, supra note 2.

207 Id.

208 Id.

209 Inst. of Medicine, Nat'l Acads., Challenges for the FDA: The Future of Drug Safety 15 (2007) (ebook), http://www.ncbi.nlm.nih.gov/books/NBK52930/pdf/TOC.pdf [https://perma.cc/S7KZ-V4Z5]; see also Associated Press, FDA Commissioner Margaret Hamburg: 2013 Budget Cuts Mean Less Safe Food, Politico (Feb. 28, 2013, 12:43 PM), http://www.politico.com/story/2013/02/fda-commissioner-margaret-hamburg-2013-budget-cuts-mean-less-safe-food-88241.html.

210 E-mail from Michael Jacobson, Exec. Dir., Ctr. for Science in the Pub. Interest, supra note 38; see also Taylor, supra note 2 (quoting a CSPI press release which stated that “establishing ‘a systematic regulatory framework to prohibit misleading health-related claims’ … is a noble goal and one we can readily embrace conceptually. But it's a tall order, especially considering the other high-priority nutrition and food safety initiatives that compete for FDA's finite resources.”).

211 Ledyard, Alexandra, Snake Oil in Your Pomegranate Juice: Food Health Claims and the FTC, 47 U.S.F. L. REV. 783, 794 (2013)Google Scholar.

212 Id. at 794 & n.95; see also Carol Brophy, An Agency “Warning Letter” Does Not a Lawsuit Make: Sometimes a “Warning Letter” is Really Just a Warning, Sedgwick Law (Nov. 2012), http://www.sedgwicklaw.com/an-agency-warning-letter-does-not-a-lawsuit-make-sometimes-a-warning-letter-is-really-just-a-warning-11-13-2012/ [https://perma.cc/4E7J-R799]; Fed. Trade Comm'n, The Enforcers: Guide to Antitrust Laws, https://www.ftc.gov/tips-advice/competition-guidance/guide-antitrust-laws/enforcers [https://perma.cc/QWE8-LAA5] (“If the FTC believes that a person or company has violated the law …, the agency may attempt to obtain voluntary compliance by entering into a consent order with the company. A company that signs a consent order need not admit that it violated the law, but it must agree to stop the disputed practices outlined in an accompanying complaint ….”).

213 Health Fraud and the Elderly: A Continuing Health Epidemic, Prepared Statement Before the S. Spec. Comm. on Aging, Fed. Trade Comm'n (Sept. 10, 2001), http://www.ftc.gov/sites/default/files/documents/public_statements/prepared-statement-federal-trade-commission-dietary-supplement-fraud/healthfraud.pdf (presenting prepared testimony of Howard Beales, Dir. of the Bureau of Consumer Protection, FTC).

214 See Young, supra note 58 and accompanying text.

215 Fringe operators, unconcerned about long-term reputational damage, are also unlikely to be deterred by a self-regulatory regime operated by the National Advertising Division (NAD), a project of the Council of Better Business Bureaus. The NAD is responsible for receiving, investigating, and resolving complaints “involving the truth or accuracy of national advertising.” Advert. Self-Reg. Council, The Advert. Indus.'s Process of Voluntary Self-Reg. at 1 (revised Nov. 1, 2015), http://www.asrcreviews.org/wp-content/uploads/2015/10/NAD-CARU-NARB-Procedures-Final-11.01.15.pdf [https://perma.cc/P3T6-QSH4]. Since 2006, the NAD has received grants from the Council on Responsible Nutrition (CRN), a trade association of the dietary supplement industry, to hire an attorney whose sole focus is national advertising of dietary supplements. Advert. Disputes & Litig. & Consumer Protection Comms., Am. Bar Ass. Sec. of Antitrust L., Self-Reg. of Advert. in the U.S.: An Ass'n of the Nat'l Advert. Div. 8 (2015), https://www.venable.com/files/Publication/f7325425-0603-4738-8b66-732e9b5da137/Presentation/PublicationAttachment/91913809-b459-4ee3-9f84-98cf193539cd/Assessment_of_the_NAD.pdf [https://perma.cc/F35D-V9H9]. CRN files challenges before the NAD when it believes that advertising for dietary supplements may be misleading or unsubstantiated. Id. Because compliance with NAD decisions is voluntary, the only recourse when advertisers refuse to cooperate is referral to the FTC. Advert. Self-Reg. Council, Dietary Supplements Digest 1 (2014), http://www.asrcreviews.org/wp-content/uploads/2014/02/Dietary-Supplement-Digest-2-11-14.pdf [https://perma.cc/MH5Y-X686].

216 See, e.g., Ward, Michael R. & Lee, Michael J., Internet Shopping, Consumer Search and Product Branding, 9 J. Product & Brand Mgmt. 6, 8 (2000)CrossRefGoogle Scholar (“Because of the low costs of setting up a Web site, unreputable [sic] firms offering low quality products could potentially claim their products are of high quality, earn a profit before the ruse is uncovered, and then quickly disappear.”).

217 Carter, supra note 171, at 3; see also Nat'l Consumer Law Center, Protection in the States app. B (Jan. 10, 2009), https://www.nclc.org/images/pdf/udap/analysis-state-summaries.pdf [https://perma.cc/8QVE-K3WK].

218 Bronson v. Johnson & Johnson, Inc., No. C 12-04184 CRB, 2013 WL 1629191, at *8 (N.D. Cal. Apr. 16, 2013); see also, e.g., Scheuerman v. Nestlé Healthcare Nutrition, Inc., Nos. 10-3684(FSH)(PS), 10-5628(FSH)(PS), 2012 WL 2916827, at *6 (D.N.J. July 17, 2012).

219 See, e.g., In re GNC Corp. 789 F.3d 505, 513–16 (4th Cir. 2015) (holding that a claim cannot be literally false (as distinct from misleading) if even one reasonable expert agrees with it). But see also Fed. Trade Comm'n v. Pantron I Corp., 33 F.3d 1088, 1100 (9th Cir. 1994) (holding that the FTC “is not required to prove that a product is ‘wholly ineffective’ in order to carry its burden of showing that the seller's representations of product efficacy are ‘false’”).

220 See Dale J. Giali, Are State-Law Claims for Violating Federal Food Labeling Law Preempted?, Class Defense Blog (June 12, 2013), https://www.classdefenseblog.com/2013/06/are-state-law-claims-for-violating-federal-food-labeling-law-preempted/ [https://perma.cc/5VM4-STJW].

221 Many of the cases have been dismissed on preemption grounds or because the plaintiff fails to have standing. Others have been settled and some are going through the steps of class certification. See U.S. Chamber Institute for Legal Reform, The New Lawsuit Ecosystem 97 (2013), http://www.instituteforlegalreform.com/uploads/sites/1/The_New_Lawsuit_Ecosystem_pages_web.pdf [https://perma.cc/5HZT-5EML].

222 See Roller & Pippins, supra note 132, at 447.

223 See Brophy, supra note 212 (asserting that plaintiffs' attorneys often bring these suits based on FDA or FTC “press releases, warning letters and complaints” which do not establish the law).

224 Pitofsky, Robert, Beyond Nader: Consumer Protection and the Regulation of Advertising, 90 Harv. L. Rev 661, 664 (1977)CrossRefGoogle Scholar.

225 Glover, J. Maria, The Structural Role of Private Enforcement Mechanisms in Public Law, 53 Wm. & Mary L. Rev. 1137, 1142 (2012)Google Scholar.

226 15 U.S.C. § 2073(b)(1) (2012).

227 15 U.S.C. § 6103 (2012).

228 15 U.S.C. § 6504 (2012).

229 15 U.S.C. § 8405 (2012).

230 Johnson, Olatunde C.A., Beyond the Private Attorney General: Equality Directives in American Law 1, 9 (Columbia Law Sch. Pub. Law & Legal Theory, Working Paper No. 9204, 2012)Google Scholar, http://lsr.nellco.org/columbia_pllt/9204/ [https://perma.cc/78LE-4J5X]. Versions of this argument have likewise been presented in support of unsuccessful claims for judicial recognition of an implied private right of action under the FTC Act. See, e.g., Carlson v. Coca-Cola Co., 483 F.2d 279, 281 (9th Cir. 1973) (Solomon, J., dissenting). It is well established that there is no private right of action under the FTC Act. See, e.g., Holloway v. Bristol-Myers Corporation, 485 F.2d 986 (D.C. Cir. 1973).

231 15 U.S.C. § 2072(a) (2012) (“Any person who shall sustain injury by reason of any knowing (including willful) violation of a consumer product safety rule, or any other rule or order issued by the [Consumer Product Safety] Commission may sue any person who knowingly (including willfully) violated any such rule or order ….”). The statute provides for attorneys' and expert witnesses' fees. Id.

232 “Any consumer” with respect to whom certain willful violations of the Fair Credit Reporting Act (FCRA) occurred may be awarded actual damages (within statutory limits), punitive damages, and costs including attorneys' fees. 15 U.S.C. § 1681n (2012). Not all provisions of the FCRA, however, are encompassed by this private right of action. See Longman v. Wachovia Bank, N.A., 702 F.3d 148, 151–52 (2d Cir. 2012).

233 A creditor that violates statutory or regulatory requirements is liable to “an aggrieved applicant” for actual damages, punitive damages (within statutory limits), and costs including attorneys' fees. 15 U.S.C. § 1691e (2012).

234 This statute contains three private causes of action: (1) Anyone who violates certain notice requirements is liable to “the borrower” for actual damages, additional damages in cases of a pattern or practice of noncompliance (within statutory limits), and costs including attorneys' fees. 12 U.S.C. § 2605(f) (2012); (2) Anyone who gives or receives kickbacks or unearned fees in connection with settlement services is liable to “the person or persons charged for the settlement service” for treble damages and costs including attorneys' fees. 12 U.S.C. § 2607(d)(2), (5) (2012); (3) Any seller who requires the purchase of title insurance from a particular title company is liable to “the buyer” for treble damages. 12 U.S.C. § 2608(b) (2010).

235 The statute specifies certain requirements for “imitation political item[s]” and “imitation numismatic item[s]” and provides that violations of these requirements are violations of the Federal Trade Commission Act. 15 U.S.C. § 2101(a), (b) (2012). The statute authorizes “any interested person” to seek injunctive relief and damages for violations and provides for costs and attorneys' fees. 15 U.S.C. § 2102 (2012).

236 “Customer[s],” as well as competitors, of precious metal manufacturers or dealers who violate certain requirements related to markings and tolerance from stated quality may sue for injunctive relief and damages and may be awarded costs and attorneys' fees. 15 U.S.C. § 298(b) (2012).

237 Violations of the Truth in Lending Act or its implementing regulation (adopted by the Federal Reserve Board) are deemed to be violations of the Federal Trade Commission Act. 15 U.S.C. § 1607(c) (2012). Individual and class actions are authorized against creditors who fail to comply with the Act; actual damages, statutory damages under certain circumstances, and costs and attorneys' fees may be awarded. 15 U.S.C. § 1640(a) (2012).

238 Fed. Trade Comm'n, Operating Manual Chapter 9: Special Statutes 2, https://www.ftc.gov/sites/default/files/attachments/ftc-administrative-staff-manuals/ch09specialstatutes.pdf [https://perma.cc/C8DY-JWJ8].

239 See supra notes 214-15 and accompanying text regarding “fringe” manufacturers.

240 Lemos, Margaret H., State Enforcement of Federal Law, 86 N.Y.U. L. Rev. 698, 702 (2011)Google Scholar.

241 See Butler, Henry N. & Wright, Joshua D., Are State Consumer Protection Acts Really Little-FTC Acts?, 63 Fla. L. ReV. 163, 188 (2011)Google Scholar (presenting evidence that State Consumer Protection Acts “may allow consumers to pursue different types of claims, including many that do not involve conduct that would be illegal under FTC standards for consumer protection”).

242 See, e.g., Conklin, Richard F., Why “Or” Really Means “Or”: In Defense of the Plain Meaning of the Private Securities Reform Act's Safe Harbor Provision, 51 B.C. L. Rev. 1209, 1209-10 (2010)Google Scholar.

243 CSPI's litigation docket includes several cases alleging false or misleading claims in the marketing of foods and beverages. Litigation Project – Current Docket, Ctr. for Science in the Pub. Interest, http://www.cspinet.org/litigation/current.html [https://perma.cc/3TKY-ZD45].

244 Nutrition is one of the Federation's areas of focus. Nutrition, Consumer Fed. of Am. (2015), http://www.consumerfed.org/issues/food-and-agriculture/nutrition [https://perma.cc/E87M-GYYL].

245 We assume that suits authorized under the proposed statute would ordinarily meet the criteria for associational standing. See, e.g., United Food & Commercial Workers Local 751 v. Brown Group Inc., 517 U.S. 544, 553 (1996) (citing the finding in Hunt v. Wash. St. Apple Advert. Com'n, 432 U.S. 333, 342 (1977) that there are three criteria: (1) the members would have standing to sue in their own right; (2) “the interests it seeks to protect are germane to the organization's purpose”; and (3) “neither the claim asserted nor the relief requested requires the participation of individual members”).

246 Engstrom, David Freeman, Harnessing the Private Attorney General: Evidence from Qui Tam Litigation, 112 Colum. L. Rev. 1244, 1253 (2012).Google Scholar

247 This provision is adapted from a provision in the Consumer Financial Protection Act of 2010. 12 U.S.C. § 5301 (2010). It is based on the assumption that in these cases state Attorneys General would be advocating theories of liability that are different from those embraced by the FTC.