1 Cordain, Loren et al., Origins and Evolution of the Western Diet: Health Implications for the 21st Century, 81 Am. J. Clinical Nutrition 341, 341 (2005).CrossRefGoogle ScholarPubMed

2 CYNTHIA L. OGDEN ET AL., CTRS. FOR DISEASE CONTROL & PREVENTION, PREVALENCE OF OBESITY IN THE UNITED STATES, 2009-2010, 1-2 (2012); Ogden, Cynthia L. et al., Prevalence of Obesity and Trends in Body Mass Index Among U.S. Children and Adolescents, 1999-2010, 307 J. Am. Med. Ass’N 483, 485 (2012).Google ScholarPubMed

3 Asfaw, Abay, Does Consumption of Processed Foods Explain Disparities in the Body Weight of Individuals? The Case of Guatemala, 20 Health Econ. 184, 184 (2011);CrossRefGoogle ScholarPubMed Mozaffarian, Dariush et al., Changes in Diet and Lifestyle and Long-Term Weight Gain in Women and Men, 364 New Eng. J. Med. 2392, 2392 (2011).CrossRefGoogle ScholarPubMed

4 Cutler, David M. et al., Why Have Americans Become More Obese?, 17 J. Econ. Persp. 93, 93–95 (2003);CrossRefGoogle Scholar see also MacInnis, Bo & Rausser, Gordon, Does Food Processing Contribute to Childhood Obesity Disparities?, 87 Am. J. Agric. Econ., 1154, 1154 (2005).CrossRefGoogle Scholar

5 FOOD & NUTRITION SERV., USDA, IMPLICATIONS OF RESTRICTING THE USE OF FOOD STAMP BENEFITS SUMMARY 3 (2007), available at www.fns.usda.gov/ora/menu/Published/snap/FILES/ProgramOperations/FSPFoodRestr ictions.pdf.

6 KELLY BROWNELL, FOOD FIGHT: THE INSIDE STORY OF THE FOOD INDUSTRY, AMERICA's OBESITY CRISIS, AND WHAT WE CAN DO ABOUT IT 27 (2004); cf. Ng, Shu Wen et al., Use of Caloric and Noncaloric Sweeteners in U.S. Consumer Packaged Foods, 2005-2009, 112 J. Acad. Nutrition & Diet 1828, 1828, 1833 (2012)CrossRefGoogle ScholarPubMed (noting that because caloric sweeteners represented seventy-seven percent of all calories purchased from consumer packaged goods from 2005-2009, it is critical to focus legislative and research efforts on this issue).

7 See Nestle, Marion & Ludwig, David S., Front-of-Package Food Labels: Public Health or Propaganda?, 303 J. Am. Med. Ass’N 771, 771-72 (2010).CrossRefGoogle ScholarPubMed

8 See Michelle Meadows, Promoting Safe and Effective Drugs for 10 Years, FDA CONSUMER MAG. (Jan.-Feb. 2006), http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm.

9 Compare LISA SHAMES ET AL., U.S. GOV't ACCOUNTABILITY OFFICE, GAO-08-597, FOOD LABELING: FDA NEEDS TO BETTER LEVERAGE RESOURCES, IMPROVE OVERSIGHT, AND EFFECTIVELY USE AVAILABLE DATA TO HELP CONSUMERS SELECT HEALTHY FOODS 13, 18 (2008), with A Brief Overview of the Federal Trade Commission's Investigative and Law Enforcement Authority, FED. TRADE COMM’N (revised July 2008), http://www.ftc.gov/ogc/brfovrvw.shtm.

10 SHAMES ET AL., U.S. GOV't ACCOUNTABILITY OFFICE, GAO-08-597, FOOD LABELING, at 5-7, 61-64.

11 15 U.S.C. § 1125(a)(1) (2012).

12 For example, one of the more notable cases of a regulatory response to a questionable claim occurred when the FTC reprimanded Kellogg's for its immunity claims in June 2010. During that month, the company's stock prices did not significantly dip and Kellogg's remains a Fortune 500 company. See Fortune 500: Kellogg, CNN MONEY, http://money.cnn.com/magazines/fortune/fortune500/2012/snapshots/242.html (last visited Oct. 23, 2013); Kellogg Company (K): Historical Prices, YAHOO FIN., http://finance.yahoo.com/q/hp?s=K&a=04&b=30&c=2010&d=06&e=1&f=2010&g=m (last visited Oct. 23, 2013). In 2012, Kellogg's ranked number four out of fourteen food companies on the Fortune 500 List. Fortune 500 Industries: Food Consumer Products, CNN MONEY, http://money.cnn.com/magazines/fortune/fortune500/2012/industries/198/index.html (last visited Oct. 14, 2013).

13 21 U.S.C. § 331(a) (2012).

14 Id. § 343.

15 Id.

16 For example, food products are permitted to make claims about “whole grain” content, whether or not the product is high in sugar, calories, or contains trans fat. 21 C.F.R. § 101.13 (2013); id.§101.54. Given the current emphasis on consuming a diet rich in whole grains, many products with whole grain claims might be attractive to consumers despite the fact that they contain other ingredients rendering them not healthful. Mozaffarian, Rebecca S. et al., Identifying Whole Grain Foods: A Comparison of Different Approaches for Selecting More Healthful Whole Grain Products, 15 Pub. Health Nutrition 2 (2013).Google Scholar

17 Martinez, Steve, USDA, Introduction of New Food Products With Voluntary Health- and Nutrition-related Claims, 1989-2010, 108 Econ. Info. Bull. i, iii (2013).Google Scholar

18 Harris, Jennifer L. et al., Nutrition-Related Claims on Children's Cereals: What Do They Mean to Parents and Do They Influence Willingness to Buy?, 14 Pub. Health Nutrition 2207, 2207 (2011).CrossRefGoogle ScholarPubMed

19 See Chandon, Pierre & Wansink, Brian, The Biasing Health Halos of Fast-Food Restaurant Health Claims: Lower Calorie Estimates and Higher Side-Dish Consumption Intentions, 34 J. Consumer Res. 301, 302 (2007);CrossRefGoogle Scholar Drewnowski, Adam et al., Testing Consumer Perception of Nutrient Content Claims Using Conjoint Analysis, 13 Pub. Health Nutrition 688, 692 (2010).CrossRefGoogle ScholarPubMed

20 See Chandon & Wansink, supra note 19, at 301-02, 311.

21 Id. at 311.

22 Harris, supra note 18, at 2207.

23 Press Release, Acad. of Nutrition and Dietetics, How Important Is It to You? Diet and Physical Activity Differ for Men and Women, Says American Dietetic Association Survey (Sept. 27, 2011), available at http://www.eatright.org/nutritiontrends/.

24 MARTINEZ, supra note 17, at 27.

25 See Open Letter from Margaret A. Hamburg, Comm’r of Food & Drugs, FDA, to Industry (Mar. 3, 2010), available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm202733.htm (“Today, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States.”). Whether or not one views diet and obesity as a personal responsibility issue, truthful factual information is a prerequisite to making an informed choice. Consumers’ decisions to purchase the product should be based on the actual properties of the food. Industry associations have publicly stated that nutrition education and information are the best solutions to obesity. See Press Release, Am. Beverage Ass’n, Beverage Industry Addresses Sugar-Sweetened Beverages and Obesity Articles in the New England Journal of Medicine (Sept. 21, 2012), available at http://www.ameribev.org/news-media/news-releases-statements/more/285/ (“Taxes, bans and other forms of government regulation are not the solution to childhood obesitynutrition education, information and support for physical education are.”); The Industry's Commitment to Keeping Kids Healthy, GROCERY MFRS. ASS’N, http://www.gmaonline.org/issues-policy/health-nutrition/responsible-public-policy-solutions/the-industrys-commitment-to-keeping-kids-healthy/ (last visited Oct. 24, 2013) (“The Healthy Weight Commitment Foundation helps kids and adults achieve a healthy weight through energy balance and focuses on three critical areasthe marketplace, the workplace and schools. The key component is a public education campaign aimed at 6-11 year olds and their parents.”).

26 U.S. GOV't ACCOUNTABILITY OFFICE, GAO-11-102, FOOD LABELING: FDA NEEDS TO REASSESS ITS APPROACH TO PROTECTING CONSUMERS FROM FALSE OR MISLEADING CLAIMS 13 (2011).

27 Id.

28 21 C.F.R. § 101.13(b) (2013).

29 Id. § 101.13(j). Nutrient content claims characterize the level of a nutrient of the type required to be disclosed in nutrition labeling, such as “low sodium.” Id. § 101.13.

30 Id.§ 101.14.

31 Id. § 101.79.

32 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health ClaimsFinal, FOOD & DRUG ADMIN. (Jan. 2009), http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm073332.htm.

33 Id.; Summary of Qualified Health Claims Subject to Enforcement Discretion, FOOD & DRUG ADMIN., http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073992.htm (last updated Mar. 13, 2013) (“Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”).

34 U.S. GOV't ACCOUNTABILITY OFFICE, GAO-11-102, FOOD LABELING: FDA NEEDS TO REASSESS ITS APPROACH TO PROTECTING CONSUMERS FROM FALSE OR MISLEADING CLAIMS 11 (2011) (reporting that the FDA has spent at least 12.8 million dollars implementing just health claims and qualified health claims between 2000 and 2010).

35 Claims That Can Be Made for Conventional Foods and Dietary Supplements, FOOD & DRUG ADMIN. (Sept. 2003), http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm111447.htm.

36 Id.

37 See U.S. GOV't ACCOUNTABILITY OFFICE, GAO-11-102, FOOD LABELING, at 40-41; see also Structure/Function Claims, FOOD & DRUG ADMIN., http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm2006881.htm (last updated Aug. 21, 2013).

38 U.S. GOV't ACCOUNTABILITY OFFICE, GAO-11-102, FOOD LABELING, at 13 (suggesting that the FDA should provide clear guidance to companies for structure function claims so they are not false or misleading and that the FDA should provide food inspectors with clear instructions to identify false and misleading claims). This is a valid suggestion; however, without the authority to enforce the guidance or obtain substantiation documents, it may not go all the way to change industry practices. See alsodiscussion infra Part III.B.

39 21 C.F.R. § 101.14(a)(4) (2013).

40 See id.

41 Id. § 101.13(h)(1). Disclaimers are also required if the statement implicitly characterizes the level of the nutrient in the food but is not consistent with the allowance for the claim, such as “only 200 mg of sodium per serving, not a low sodium food.” Id.§ 101.13(i).

42 See id. § 101.13(h).

43 Harris et al., supra note 18, at 2207-08.

44 JENNIFER L. HARRIS ET AL., YALE UNIV., RUDD CTR. FOR FOOD POL’Y AND OBESITY, EVALUATING THE NUTRITION QUALITY AND MARKETING OF CHILDREN's CEREALS 76-77 (2009), available at http://www.cerealfacts.org/media/Cereal_FACTS_Report_2009.pdf.

45 Mozaffarian et al., supra note 16, at 7-8.

46 The candy bar Baby Ruth states that it has “4 grams protein per bar” (which is accurate due to peanuts as an ingredient), but, because it is a candy bar, it contains thirty-three grams of added sugar. Baby Ruth Touts Protein Content, Archived in Worst Food Marketing Practices, YALE RUDD CENTER FOR FOOD POL’Y AND OBESITY (May 2012), http://www.yaleruddcenter.org/bestandworstfoodmarketingarchive.aspx?t=w. Goobers also has packaging stating that it contains 5 grams of protein, which, as with Baby Ruth, comes from its peanut content. See Nestle Goobers Candy, WEGMANS, http://www.wegmans.com/webapp/wcs/stores/servlet/ProductDisplay?productId=391582&storeId=10052&langId= (last visited Oct. 17, 2013).

47 Chandon & Wansink, supra note 19, at 301-03, 311.

48 Pearson v. Shalala, 164 F.3d 650, 653 (D.C. Cir. 1999).

49 Id. at 654.

50 Id. at 661.

51 Id. at 658-59.

52 Guidance for Industry, supra note 32; Summary of Qualified Health Claims, supra note 33 (“Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”).

53 See, e.g., Notice Regarding Implementation of Pearson Court Decision, 65 Fed. Reg. 59,855, 59,856 (Oct. 6, 2000) (stating that the FDA will use its enforcement discretion to allow certain health claims in appropriate circumstances).

54 Rubin v. Coors Brewing Co., 514 U.S. 476, 481 (1995).

55 In re R.M.J., 455 U.S. 191, 203 (1982).

56 Id.

57 Id.

58 Id.

59 LISA SHAMES ET AL., U.S. GOV't ACCOUNTABILITY OFFICE, GAO-08-597, FOOD LABELING: FDA NEEDS TO BETTER LEVERAGE RESOURCES, IMPROVE OVERSIGHT, AND EFFECTIVELY USE AVAILABLE DATA TO HELP CONSUMERS SELECT HEALTHY FOODS 5 (2008); see alsoHarris et al., supra note 18, at 2209.

60 U.S. GOV't ACCOUNTABILITY OFFICE, GAO-11-102, FOOD LABELING: FDA NEEDS TO REASSESS ITS APPROACH TO PROTECTING CONSUMERS FROM FALSE OR MISLEADING CLAIMS 13 (2011).

61 See, e.g., Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2672 (2011).

62 Seediscussion infra Part II.C.

63 21 C.F.R. § 101.3(a) (2013).

64 Id.§ 101.3(b).

65 Guidance for Industry: A Food Labeling Guide (4. Name of Food), FOOD & DRUG ADMIN. (Oct. 2009), http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm064872.htm.

66 21 C.F.R. § 102.5(a).

67 See, e.g., Blueberry Cereal, KELLOG's FROSTED MINI WHEATS, http://www.frostedminiwheats.com/Products/Blueberry-muffin (last visited Sept. 17, 2013) (“Ingredients: Whole grain wheat, sugar, contains 2% or less of milled corn, brown rice syrup, corn syrup, natural and artificial flavor, modified corn starch, gelatin, soybean oil, glycerin, sorbitol, blue 2 lake, red 40 lake, red 40, BHT for freshness.”).

68 21 C.F.R. § 102.33(c).

69 Pom Wonderful L.L.C. v. Coca-Cola Co., 679 F.3d 1170, 1173 (9th Cir. 2012) (showing the label of Coca-Cola's Pomegranate Blueberry Juice which includes both the description “Flavored Blend of 5 Juices” in relatively small type font and a picture of an equally large apple and pomegranate surrounded by berries).

70 Id. at 1174.

71 Id. at 1177 (citing 21 C.F.R. § 102.33(c), (d)).

72 Pom Wonderful L.L.C. v. Coca Cola Co., 727 F. Supp. 2d 849, 857 n.8 (C.D. Cal. 2010), aff’d in part and vacated in part, 679 F.3d 1170 (9th Cir. 2012) (“According to Pom, ‘36% of the test group in the Field Survey indicated that they believed the Juice mainly contains pomegranate and blueberry juice, and not other types of fruit juice,’ … ‘32% of the test group in the Field Survey indicated that they believed the Juice mainly contains pomegranate and blueberry juice, and not other types of fruit juice, because of the words ‘pomegranate blueberry’ on the label.’”).

73 Pom Wonderful L.L.C., 679 F.3d at 1178 (stating that by holding that the Lanham Act claim is barred, the court does “not hold that Coca-Cola's label is non-deceptive,” instead putting the onus on the FDA to act if “the FDA believes that more should be done to prevent deception, or that Coca-Cola's label misleads consumers”); see also Pom Wonderful L.L.C.,727 F. Supp. 2d at 872 (noting that Pom's only recourse was to “lobby Congress or petition FDA to change its rules”).

74 21 C.F.R. § 104.20(a).

75 Id. §§ 101.54(e)(ii), 101.65(d)(2)(iv).

76 SeeCaroline Scott-Thomas, Fortification Drives Consumer Definition of “Healthy”,FOOD NAVIGATOR-USA.COM (July 25, 2011), http://www.foodnavigator-usa.com/content/view/print/388462.

77 See id. (noting that in a nationally representative poll, the four ingredients that grocery shoppers said they looked for most in a product were fiber, whole grain, protein, and omega-3).

78 21 C.F.R. § 104.20(a) (“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.”). This policy is weakly stated and includes “snack foods” in the list of products that should not be fortified but does not define the term. See § 104.20. Regardless, the FDA does not seem to enforce this regulation outside the two products listed, carbonated beverages and candy, because snack products are regularly fortified and bear nutrient content claims. See, e.g., POPTARTS, http://www.poptarts.com/flavors/chocolate/hot-fudge-sundae (touting Pop-Tarts as a good source of 7 vitamins and minerals).

79 See Warning Letter from Roberta F. Wagner, Dir., Office of Compliance, Ctr. For Food Safety & Applied Nutrition, FDA, to Muhtar Kent, Pres. and Chief Exec. Officer, The Coca-Cola Co. (Dec. 10, 2008), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048050.htm.

80 SeeSteve Tanner, Review: Cherry 7Up Antioxidant, BEVREVIEW (May 4, 2009), http://www.bevreview.com/2009/05/04/cherry-7up-antioxidant/.

81 See Warning Letter, supra note 79.

82 An antioxidant claim can be a permissible nutrient content claim when all the conditions of use are met; this includes the conditions for the nutrient claim and those imposed by the FDA's Fortification Policy. See 21 C.F.R. §§ 101.54(g), 104.20. In regards to these two regulations, the 7Up antioxidant claim violated the latter. See id.§ 104.20(a).

83 Mason v. Coca-Cola Co., 774 F. Supp. 2d 699, 705 n.4 (D.N.J. 2011) (“At its core, the complaint is an attempt to capitalize on an apparent and somewhat arcane violation of FDA food labeling regulations. But not every regulatory violation amounts to an act of consumer fraud … . The complaint does not allege that consumers bought the product because they knew of and attributed something meaningful to the regulatory term ‘Plus’ and therefore relied on it. Rather, they allege merely that they thought they were buying a ‘healthy’ product that happened to apparently run afoul of FDA regulations.”).

84 CSPI sued Dr. Pepper Snapple Group, with Dr. Pepper Snapple Group recently agreeing to stop fortifying with vitamins some of its 7UP drinks as well as to stop claiming that its fortified 7UP drinks contain antioxidants. See 7UP To Drop “Antioxidant” Marketing, CTR. FOR SCIENCE IN THE PUB. INTEREST (July 22, 2013), http://www.cspinet.org/new/201307221.html.

85 Food Trends: The Most Successful Packaged Food Brands of 2010, FOOD PROCESSING (Mar. 29, 2011), http://www.foodprocessing.com/industrynews/2011/020.html; see also A. Elizabeth Sloan, Top 10 Food Trends, INST. OF FOOD TECHNOLOGISTS (Apr. 2011), http://www.ift.org/food-technology/past-issues/2011/april/features/food-trends.aspx?page=viewall (food trend number five: “Get Real”).

86 See Kacey Kulliney, The Power of Organic: Turning Snacks into Health Foods?,FOODNAVIGATORUSA (Oct. 18, 2012), http://www.foodnavigator-usa.com/Market/The-power-of-organic-Turning-snacks-into-health-foods; Caroline Scott-Thomas, Study Reveals the ‘Health Halo’ of Organic Foods, BAKERYANDSNACKS.COM (Apr. 12, 2011), http://www.bakeryandsnacks.com/R-D/Study-reveals-the-health-halo-of-organic-foods; Caroline Scott-Thomas, Too Many Eco-Labels Could Hinder Uptake, Says Organic Monitor, FOODNAVIGATOR-USA (Jan. 10, 2013), http://www.foodnavigator-usa.com/Market/Too-many-eco-labels-could-hinder-uptake-says-Organic-Monitor?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright.

87 See Ashby Jones, Is Your Dinner ‘All Natural’?, WALL ST. J. (Sept. 20, 2011), http://online.wsj.com/article/SB10001424053111903374004576580671156407598.html.

88 See, e.g., Holk v. Snapple Bev. Corp., No. 07-3018 (MLC), 2010 U.S. Dist. LEXIS 81596, at *8 (D.N.J. Aug. 10, 2010). Recognizing that the FDA had not officially defined the term “natural,” the court stayed the case for six months and deferred to the FDA to determine if the presence of HFCS disqualifies a product from calling itself “natural.” Id. Nonetheless, the FDA declined to address the issue. See Holk v. Snapple Bev. Corp., No. 07-3018 (MLC), 2010 U.S. Dist. LEXIS 110024, at *1 (D.N.J. Oct. 15, 2010). The plaintiff later became a putative class member of a similar action alleging Snapple's “natural” claim violated New York consumer protection laws. SeeWeiner v. Snapple Beverage Corporation, No. 07 Civ. 8742 (DLC), 2011 U.S. Dist. LEXIS 6094 (S.D.N.Y. Jan. 21, 2011).

89 See Ries v. Arizona Beverages, No. 10-01139 RS, 2013 U.S. Dist. LEXIS 46013, at *5, *15 (N.D. Cal. Mar. 28, 2013) (decertifying the class previously granted in Ries v. Arizona Beverages, No. 10-01139 RS, 2012 U.S. Dist. LEXIS 169853 (N.D.C.A Nov. 27, 2012)).

90 Among other groups, the Sugar Association petitioned the FDA for clarification of the term “natural.” See Letter from Andrew C. Briscoe III, Pres. & CEO, Sugar Association, to Docket Mgmt. Branch, Food & Drug Admin. (Feb. 28, 2006), available at http://www.fda.gov/ohrms/dockets/dockets/06p0094/06p-0094-let0001-vol2.pdf. Significantly, the Corn Refiners Association, producers of high fructose corn syrup, submitted comments opposing such a clarification, stating that the FDA should not “waste scarce agency resources” to define the term but rather should let the marketplace resolve the issue. SeeLetter from Audrae Erikson, Pres., Corn Refiners Association, to Dockets Mgmt. Branch, Food & Drug Admin. (Nov. 14, 2006), available at http://www.fda.gov/ohrms/dockets/dockets/06p0094/06p-0094-c000004-vol1.pdf; see alsoJones, supra note 87.

91 58 Fed. Reg. 2302, 2407 (Jan. 6, 1993) (to be codified at 21 C.F.R. pts. 5, 101).

92 Id.; seeOliver Neiburg, Frito Lay Hit with Lawsuit on All-Natural Claims, FOODNAVIGATOR-USA (Dec. 20, 2011), http://www.foodnavigator-usa.com/Regulation/Frito-Lay-hit-with-lawsuit-on-all-natural-claims (FDA repeating that it had no plans to define the term “all-natural” due to a lack of agency resources).

93 For example, alcoholic whipped cream. Sarah Schwartz, Groceries Get Odd: 10 Weird New Food Products, DELISH, http://www.delish.com/food-fun/new-food-products#slide-1 (last visited Oct. 24, 2013). In addition to energy drinks, other drinks touting functional benefits are emerging in the marketplace, including drinks that promise you bliss, increased sex drive, and better sleep. SeeNEURO, http://drinkneuro.com/ (last visited Oct. 23, 2013).

94 Hansen Bev. Co. v. Innovation Ventures, LLC, No. 08-CV-1166 IEG (POR), 2008 U.S. Dist. LEXIS 76243, at *8 (S.D. Cal. Sept. 28, 2008). According to the expert representing an energy shot company, the ingredients contained in the drink 5-Hour Energy give users a “perception of ‘energy’” that is comparable to illegal drugs, such as methamphetamines, because they similarly “give users the perception of increased energy by suppressing the brain's receipt of fatigue signals.”). Id. at *11 n.3.

95 See Pomeranz, Jennifer L. et al., Energy Drinks: An Emerging Public Health Hazard for Youth, 34 J. Pub. Health Pol’Y 254, 254-71 (2013).CrossRefGoogle ScholarPubMed

96 See Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods, FOOD & DRUG ADMIN. (Dec. 2009), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm192702.htm (explaining that even if a liquid product characterizes itself as a dietary supplement, it may be a beverage for regulatory purposes and can be distinguished based on factors such as packaging, volume, advertising, name, and similarity to other recognized beverages (e.g., soda and juice)). A dietary supplement, on the other hand, is defined as “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” Q&A On Dietary Suppelements, FOOD & DRUG ADMIN., http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ (last updated Aug. 28, 2013).

97 See Draft Guidance for Industry, supra note 96.

98 The FDA has stated that it will issue finalized non-binding guidance. Letter from Jeanne Ireland, Assistant Comm’r for Legislation, Dep't of Health & Human Servs., to Richard J. Durbin, Senator, U.S. Senate (Aug. 10, 2012), available at http://www.durbin.senate.gov/public/index.cfm/files/serve?File_id=17eadaa1-85e7-4ceb-a827-be244fbddfa5.

99 Hansen Bev. Co. v. Innovation Ventures, LLC, No. 08-CV-1166-IEG (POR), 2009 U.S. Dist. LEXIS 127605 at *29 (S.D. Cal. Dec. 22, 2009).

100 The FDA sent a Warning Letter to another energy drink manufacturer, Rockstar, warning the company that its Roasted Coffee & Energy varieties violated the FDCA, were not dietary supplements, and the addition of Ginkgo to the product rendered it adulterated within the meaning of the Act. See Warning Letter No. 20120NOL-22 from Patricia K. Schafer, Dist. Dir., New Orleans Dist., Food & Drug Admin., to Russell Weiner, CEO, Rockstar, Inc. (May 23, 2012), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309080.htm.

101 The FDA has not sent a similar letter to Monster regarding its Java energy drink line although it existed simultaneously and suffered from the same problems as Rockstar's coffee variety: they were labeled as dietary supplements despite being coffee-like drinks (containing coffee extract) and containing the unapproved food additives taurine and panax ginseng. Since at least June 2007, Monster has had a Monster Java line. See Java Monster, BEVNET, http://www.bevnet.com/reviews/Java_Monster (last visited Oct. 27, 2013). The CEO announced on February 13, 2013 that the company would begin labeling its beverages correctly as beverages and include a nutrition facts panel. SeeKaren Bleier, Monster Beverage changes label to qualify as “drink”, CBS MONEY WATCH (Feb. 13, 2013), http://www.cbsnews.com/8301-505123_162-57569295/monster-beverage-changes-label-to-qualify-as-drink/. However, this will not fix the problems with unapproved additives in the drink.

102 See Stephanie Strom, Drink Ingredient Gets a Look, N.Y. TIMES, Dec. 12, 2012, http://www.nytimes.com/2012/12/13/business/another-look-at-a-drink-ingredient-brominated-vegetable-oil.html?pagewanted=all&_r=0 (“A company can create a new additive, publish safety data about it on its Web site and pay a law firm or consulting firm to vet it to establish it as ‘generally recognized as safe’without ever notifying the F.D.A., Mr. Neltner said.”).

103 See Jennifer L. Harris et al., supra note 18 at 2208.

104 See Sarah L. Brew et al., Food Labeling Remains Ripe for Consumer Fraud Class Actions, HB LITIG. CONFERENCES, http://litigationconferences.com/?p=25005 (last visited Sept. 27, 2013).

105 See What We Do, FOOD & DRUG ADMIN. (Sept. 19, 2013), http://www.fda.gov/AboutFDA/WhatWeDo/default.htm.

106 See Janssen, Wallace F., The Story of the Laws Behind the Labels, FDA CONSUMER (Food & Drug Admin., Washington, D.C.), June 1981Google Scholar, available at http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm.

107 Enforcement Policy Statement on Food Advertising, FED. TRADE COMM’N (May 1994), http://www.ftc.gov/bcp/policystmt/ad-food.shtm#5.

108 See Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, (104 Stat. 2353) (codified in part at 21 U.S.C. § 343 (2012)).

109 See 15 U.S.C. § 45(m) (2012).

110 See id. §§ 52, 54.

111 See 21 U.S.C. § 333(g) (2012).

112 See id. § 333(d).

113 Id. § 321(n) (“If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the articles to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.”).

114 Id. § 333(f)(2)(A).

115 Id. § 351(a) (adulterated pursuant to § 342 or misbranded under § 343(w)).

116 See id.§ 342.

117 See id.

118 DANIEL R. LEVISON, OFFICE OF INSPECTOR GEN., FOOD & DRUG ADMIN., INSPECTIONS OF DOMESTIC FOOD FACILITIES 4 (Apr. 2010).

119 FOOD & DRUG ADMIN., REGULATORY PROCEDURES MANUAL, PROCEDURES FOR CLEARING FDA WARNING LETTERS AND UNTITLED LETTERS, 5 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM176965.pdf.

120 Inspections, Compliance, Enforcement, and Criminal Investigations, Regulatory Procedures Manual, FOOD & DRUG ADMIN. (Sept. 13, 2011), http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176733.htm.

121 21 U.S.C. § 334(a)(1).

122 See id. § 335. The FDA must issue a Warning Letter to the company before reporting a violation to the DOJ for criminal proceedings. Id.

123 See FOOD & DRUG ADMIN., REGULATORY PROCEDURES MANUAL, CHAPTER 6: JUDICIAL ACTIONS 47-50 (2011), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074317.pdf

124 21 U.S.C. § 336.

125 But see United States v. Randazzo, 80 F.3d 623, 626-27 (1st Cir. 1996).

126 See Inspections, Compliance, Enforcement, and Criminal Investigations: Press Releases, FOOD & DRUG ADMIN., http://www.fda.gov/ICECI/CriminalInvestigations/ucm123086.htm (last updated Aug. 15, 2013).

127 FOOD & DRUG ADMIN., PROCEDURES FOR CLEARING FDA WARNING LETTERS AND UNTITLED LETTERS, REGULATORY PROCEDURES MANUAL Exhibit 4-1, at § 4.1 (2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM176965.pdf (“Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.”).

128 Id.

129 Warning Letter from Roberta F. Wagner, Dir., Office of Compliance, Ctr. for Food Safety & Applied Nutrition, to Brad Alford, Chairman and CEO, Nestle U.S.A. (Dec. 4, 2009) (failing to mention Juicy Juice's “brain development” claim despite the fact that this claim is likely an unsupported structure function claim), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm194122.htm.

130 See 7Up Maker Sued Over Antioxidant Claims, CBS NEWS (Nov. 8, 2012, 3:44 PM), http://www.cbsnews.com/8301-204_162-57547263/7up-maker-sued-over-antioxidant-claims/. This is another example of fortification of a soda.

131 Mitchell Polinsky, A. & Shavell, Steven, The Economic Theory of Public Enforcement of Law, 38 J. Econ. Literature 45, 60–61 (2000).Google Scholar

132 Inspections, Compliance, Enforcement, and Criminal Investigations: About Warning and Close-Out Letters, FOOD & DRUG ADMIN., http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm278624.htm (last updated Dec. 8, 2011).

133 Id.

134 The FDA has closed out 779 Warning Letters as of September 28, 2013. See List of Warning Letters that have Close-Out Letters, FOOD & DRUG ADMIN., http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?company=&_1_issueDt=&_2_issueDt=&office=&subject=&hasResponseLetter=Both&hasCloseoutLetter=Yes&recsPerPageDef=500&Search=Search&errMsg= (last visited Sept. 28, 2013).

135 The FDA has received 92 response letters as of September 28, 2013. See List of Warning Letters with Response Letters Posted, FOOD & DRUG ADMIN, http://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?company=&_1_issueDt=&_2_issueDt=&office=&subject=&hasResponseLetter=Yes&hasCloseoutLetter=Both&recsPerPageDef=500&Search=Search&errMsg= (last visited Sept. 28, 2013).

136 See OFFICE OF INSPECTOR GEN., DEP't OF HEALTH & HUMAN SERVS., FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES iii (2010) (recommending that the FDA “[s]eek statutory authority to allow FDA access to facilities’ records during the inspection process”), available at https://oig.hhs.gov/oei/reports/oei-02-08-00080.pdf; U.S. GOV't ACCOUNTABILITY OFFICE, supra note 34.

137 See U.S. GOV't ACCOUNTABILITY OFFICE, supra note 34, at 25.

138 See id. at 26.

139 Bruce Horovitz, Critics Blast Kellogg's Claim that Cereals Can Boost Immunity, USA TODAY (Nov. 6, 2009), http://www.usatoday.com/money/industries/food/2009-11-02-cereal-immunity-claim_N.htm. This was during the time period when “swine flu” was making headlines.

140 Press Release, Fed. Trade Comm’n, FTC Investigation of Ad Claims that Rice Krispies Benefits Children's Immunity Leads to Stronger Order Against Kellogg (June 3, 2010), available at, http://www.ftc.gov/opa/2010/06/kellogg.shtm (ordering Kellogg's to refrain from making misleading health benefit claims not supported by scientific evidence). Chairman Leibowitz and Commissioner Brill issued a separate opinion expressly admonishing Kellogg's for its actions. SeeConcurring Statement of Commissioner Julie Brill and Chairman Jon Leibowitz, In the Matter of Kellogg Company, FTC Docket No. C-4262 (June 3, 2010), available at http://www.ftc.gov/os/caselist/0823145/100602kelloggstatement.pdf. The FTC did not issue civil fines. Besides the threat of a fine for breaking the settlement, this settlement essentially just requires Kellogg's to abide by the law, which says that manufacturers cannot make claims not backed by scientific evidence or that are misleading. See Susan Carey, Snap Crackle Slap: FTC Objects to Kellogg's Rice Krispies Health Claim, WALL ST. J., June 4, 2010, http://online.wsj.com/article/SB10001424052748703340904575284701223216466.html.

141 Elaine Watson, Improper Nutrient Content Claims Cited in New Wave of Class Action Suits, FOOD NAVIGATOR-USA (Apr. 19, 2012), http://www.foodnavigator-usa.com/Regulation/Improper-nutrient-content-claims-cited-in-new-wave-of-class-action-suits (reporting that according to a “leading” attorney practicing in food law, “class action lawsuits alleging labeling violations [are] now ‘filed almost daily in California …’”).

142 Id. (“[F]ood manufacturers are spending ‘hundreds of thousands of dollars in legal fees and settlement amounts’ to resolve cases that are entirely avoidable [by having someone review their labels], according to one leading food law attorney.”).

143 Id. See alsoElaine Watson, PepsiCo Targeted in New Class Action Lawsuit over Improper Nutrient Content Claim, FOOD NAVIGATOR-USA (Apr. 4, 2012), http://www.foodnavigator-usa.com/Regulation/PepsiCo-targeted-in-new-class-action-lawsuit-over-improper-nutrient-content-claims. The plaintiffs pointed out a clear regulatory violation. However minor, it was easily avoided by Pepsi following the regulation. Defense attorneys not associated with the case stated that these lawsuits are provoked by plaintiffs’ attorneys who scour labels for technical violations. It is unnecessary to take a position on this point. The problem stems from the fact that lax regulatory oversight leads to lax regulatory compliance. The reasons there are so many technical violations is that only plaintiffs’ attorneys are seeking to enforce the FDCA.

144 See, e.g., Sugawara v. PepsiCo, Inc., No. 2:08-cv-01335, 2009 U.S. Dist. LEXIS 43127, at *14 (E.D. Cal. May 21, 2009) (finding that Plaintiffs had failed to state a claim that the labeling of Cap’n Crunch with Crunchberries was misleading, even though the cereal contains no actual berries).

145 See Watson, supra note 143 (“[I]f these cases ever make it to completion, plaintiffs may be hard pressed to prove any significant damage.”).

146 Williams v. Gerber Prods. Co., 552 F.3d 934, 936 (9th Cir. 2008).

147 Id. at 939.

148 Sugawara, 2009 U.S. Dist. LEXIS 43127, at *3 (“This Court is not aware of, nor has Plaintiff alleged the existence of, any actual fruit referred to as a ‘crunchberry.’ Furthermore, the ‘Crunchberries’ depicted on the [principal display panel] are round, crunchy, brightly-colored cereal balls … . Thus, a reasonable consumer would not be deceived into believing that the Product in the instant case contained a fruit that does not exist.”).

149 Mason v. Coca-Cola Co., 774 F. Supp. 2d 699, 705 (D.N.J. 2011).

150 15 U.S.C. § 1125(a)(1) (2012).

151 Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 230 (3d Cir. 1990) (quoting American Home Prods. Corp. v. Johnson & Johnson, 672 F. Supp. 135, 145 (S.D.N.Y. 1987)).

152 Cf. Rechtschaffen, Clifford, Deterrence vs. Cooperation and the Evolving Theory of Environmental Enforcement, 71 S. Cal. L. Rev. 1181, 1233-34 (1998)Google Scholar (explaining that citizen enforcers cannot replace the cooperative system of enforcement in the environment context because, among other reasons, they “do not have the resources, expertise, or access to company information to be consultants” and “do not enjoy continuing relationships with regulated firms”).

153 Lytton, Timothy D., Using Tort Litigation to Enhance Regulatory Policymaking: Evaluating Climate-Change Litigation in Light of Lessons from Gun-Industry and Clergy-Sexual-Abuse Lawsuits, 86 Tex. L. Rev. 1837, 1864-65 (2008).Google Scholar

154 Manufacturers do not seem to be sufficiently threatened by current litigation efforts because they do not invest in the time or resources to confirm that their labels comply with the NLEA prior to releasing the product, as reported by Food Navigator. SeeWatson, supra note 143.

155 Proponents of litigation consider it a viable option to fill the gaps left by regulatory control. See BRUCE SILVERGLADE & ILLENE HELLER, FOOD LABELING CHAOS: THE CASE FOR REFORM VIII-9 (2010); Pomeranz, Jennifer L. et al., Innovative Legal Approaches to Address Obesity, 87 Milbank Q. 185, 199 (2009).CrossRefGoogle ScholarPubMed One legal scholar and co-author noted: “The argument against litigation, however, assumes the existence of an effective regulatory process that renders litigation unnecessary, which does not seem to be the case. Regulatory agencies are notoriously understaffed and underfunded, so they often are unable to carry out their regulatory purpose.” Id. at 199. The current article argues that the better solution is to address the regulatory deficiencies.

156 LISA SHAMES ET AL., U.S. GOV't ACCOUNTABILITY OFFICE, GAO-08-597, FOOD LABELING: FDA NEEDS TO BETTER LEVERAGE RESOURCES, IMPROVE OVERSIGHT, AND EFFECTIVELY USE AVAILABLE DATA TO HELP CONSUMERS SELECT HEALTHY FOODS 42-43 (2008).

157 FOOD & DRUG ADMIN., FISCAL YEAR 2013, JUSTIFICATION OF ESTIMATES FOR APPROPRIATIONS COMMITTEES 548 (2012).

158 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. 2302, 2407 (Jan. 6, 1993) (to be codified at 21 C.F.R. pts. 5, 101); see alsoOliver Nieburg, Frito Lay Hit with Lawsuit on All-Natural Claims, FOOD NAVIGATOR-USA (Dec. 20, 2011), http://www.foodnavigator-usa.com/Regulation/Frito-Lay-hit-with-lawsuit-on-all-natural-claims (noting “the FDA told [another publication] that it had no plans to define the term ‘all-natural’ because of limited resources”).

159 Polinsky & Shavell, supra note 131, at 71; see alsoWatson, supra note 141.

160 See Harris et al., supra note 18, at 2207-08.

161 See Watson, supra note 143.

162 Rechtschaffen, supra note 152, at 1193.

163 Id. at 1189.

164 Crumley, Diana, Achieving Optimal Deterrence in Food Safety Regulation, 31 Rev. Litig. 353, 400 (2012)Google Scholar; Gunningham, Neil A. et al., Motivating Management: Corporate Compliance in Environmental Protection, 27 Law & Pol’Y 289, 289 (2005)CrossRefGoogle Scholar; Polinsky & Shavell, supra note 131; Rechtschaffen, supra note 152; Thornton, Dorothy et al., General Deterrence and Corporate Environmental Behavior, 27 Law & Pol’Y 262, 262 (2005).CrossRefGoogle Scholar

165 Rechtschaffen, supra note 152, at 1189 (noting that many enforcement agencies use a hybrid of cooperative-compliance and deterrence-based strategies).

166 Steinzor, Rena, The Future of Regulation: The Truth About Regulation in America, 5 Harv. L. & Pol’Y Rev. 323, 325 (2011)Google Scholar (identifying six protector agencies with the mission to safeguard people and the environment, including the FDA and EPA).

167 SeeRechtschaffen, supra note 152, at 1184.

168 Id. at 1188.

169 Id. at 1191, 1195.

170 SeeGunningham et al., supra note 164, at 295-96; see also Rechtschaffen, supra note 152, at 1204.

171 Gunningham et al., supra note 164, at 309. Note also that unlike under the FDCA, in the environmental context, the Clean Water Act expressly permits citizen suits with the potential for civil monetary penalties or injunctive relief. 33 U.S.C. § 1365 (2012). The citizen enforcement provision has been found to play “an extremely valuable role in achieving compliance with environmental law, including … provid[ing] an important deterrent to non-compliance when government agencies fail to act either because of lack of resources or political will.” Rechtschaffen, supra note 152, at 1231.

172 Rechtschaffen, supra note 152, at 1186.

173 Id. at 1222-23; see also Arnold, Thomas M. & Stevens, Jerry L., Mixed Agendas and Government Regulation of Business: Can We Clean Up the Mess? 45 U. Rich. L. Rev. 1059, 1068 (2011).Google Scholar

174 Rechtschaffen, supra note 152, at 1188, 1226-27.

175 Hank Schultz, Protecting Against Label Claims Lawsuits, FOOD NAVIGATOR-USA (Jan. 19, 2013), http://www.foodnavigator-usa.com/Regulation/Protecting-against-label-claims-lawsuits; see alsoWatson, supra note 143.

176 This presumes the regulatory overhaul discussed below, where cooperative resolution of the underlying permissible and non-permissible claims would be achieved. However, after the revised claim regulations are enacted, post-market cooperative compliance would not effectuate the purpose behind the regulatory overhaul.

177 Council Regulation 1924/2006, 2006 O.J. (L 404) 9 (EC).

178 Health and Nutrition Claims, EUROPEAN COMM’N, http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm (last updated Aug. 8, 2013).

179 EUROPEAN RESPONSIBLE NUTRITION ALLIANCE, THE APPLICATION OF THE NUTRITION AND HEALTH CLAIMS REGULATION 1924/2006: GUIDANCE FOR FOOD OPERATORS 17 (2012).

180 Id. at 20.

181 Health and Nutrition Claims, supra note 178.

182 EU Register of Nutrition and Health Claims Made on Foods, EUROPEAN COMM’N, http://ec.europa.eu/nuhclaims/?event=register.home (last updated June 12, 2013).

183 Council Regulation 1924/2006, 2006 O.J. (L 404) 9, 14-15.

184 General Conditions for Use of Nutrition and Health Claims, FOOD SAFETY AUTH. OF IR., http://www.fsai.ie/science_and_health/nutrition_and_health_claims/conditions_for_use.html (last updated Sept. 20, 2012).

185 Council Regulation 1924/2006, 2006 O.J. (L 404) 9, 14. The Commission has progressed by conducting consultations with stakeholders to establish nutrient profiles. Nutrient Profiles, EUROPEAN COMM’N, http://ec.europa.eu/food/food/labellingnutrition/claims/nut_profiles_en.htm (last updated Sept. 1, 2009).

186 21 U.S.C. § 321(n) (2012) (“If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the articles to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.”).

187 See Jennifer L. Harris et al., supra note 18, at 14. Health representations also create a health halo, which leads to over-consumption of the products carrying such claims. Wansink, Brian, How Do Front and Back Package Labels Influence Beliefs About Health Claims?, 37 J. Consumer Aff. 305, 313-15 (2003).Google Scholar

188 Council Regulation 1924/2006, 2006 O.J. (L 404) 9, 14.

189 See LISA SHAMES ET AL., supra note 9, at 62.

190 See, e.g., Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 765 (1976) (“It is a matter of public interest that [private economic] decisions, in the aggregate, be intelligent and well informed. To this end, the free flow of commercial information is indispensable.”).

191 Rubin v. Coors Brewing Co., 514 U.S. 476, 478 (1995) (invalidating Section 5(e)(2) of the Federal Alcohol Administration Act, which prohibited beer labels from displaying alcohol content, because it was “inconsistent with the protections granted to commercial speech by the First Amendment …”).

192 Virginia State Bd. of Pharmacy, 425 U.S. at 772 n.24.

193 Id.

194 See Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 562-63 (1980) (“The Constitution therefore accords a lesser protection to commercial speech than to other constitutionally guaranteed expression. The protection available for particular commercial expression turns on the nature both of the expression and of the governmental interests served by its regulation.”).

195 Id. at 576.; In reR.M.J., 455 U.S. 191, 203 (1982).

196 See In re R.M.J., 455 U.S. at 203 (“[W]hen the particular content or method of the advertising suggests that it is inherently misleading … the States may impose appropriate restrictions … . [T]he Court in Batessuggested that the remedy in the first instance is not necessarily a prohibition but preferably a requirement of disclaimers of explanation.”) (citing Bates v. State Bar of Arizona, 433 U.S. 350, 375 (1977)).

197 Id.

198 See Corn Products Refining Co. v. Eddy, 249 U.S. 427, 431 (1919) (stating that commercial entities have “no constitutional right to sell goods without giving to the purchaser fair information of what it is that is being sold”); Cf.Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 628 (1985).

199 Zauderer, 471 U.S. at 651 (“[W]e hold that an advertiser's rights are adequately protected as long as disclosure requirements are reasonably related to the State's interest in preventing deception of consumers.”); see also Milavetz v. United States, 559 U.S. 229, 249-50 (2010) (citing Zauderer, 471 U.S. at 651).

200 User Fees, U.S. FOOD & AND DRUG ADMIN., http://www.fda.gov/ForIndustry/UserFees/default.htm (last updated June 17, 2013) (The user fees include: Animal Drug User Fee Act, Animal Generic Drug User Fee Act, Biosimilar User Fee Act, Color Certification, Exports Certificate, Family Smoking Prevention and Tobacco Control Act, Food Safety Modernization Act, Freedom of Information Act Fees, Generic Drug User Fee Act, Mammography Quality Standards Act, Medical Device User Fee and Modernization Act, Prescription Drug User Fee Act, Tobacco Product Fees.).

201 President's Fiscal Year 2013 Budget Request for the FDA: Hearing Before the Subcomm. On Agric., Rural Develop., Food & Drug Admin., and Related Agencies of the H. Comm. on Appropriations, 112th Cong. (2012) (statement of Margaret A. Hamburg, Comm’r, Food & Drug Admin.).

202 Id.

203 Id.

204 21 C.F.R. § 1.231(d) (2013).

205 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm274176.htm (last updated Aug. 16, 2013).

206 21 U.S.C. § 379j-31(a) (2012); see also Food Safety Modernization Act Reinspection Fee Rates, 77 Fed. Reg. 45,636, 45,638 (Aug. 1, 2012).

207 77 Fed. Reg. at 45,637-38.

208 The only other food-related user fee is assessed on color additives. Entities seeking to use color additives for food, drugs, devices and cosmetics must obtain batch certification (unless they are exempt) from the FDA. 21 U.S.C. § 379e(a) (2012). The agency will only admit a color additive to the listing subject to certification upon payment of a fee, determined according to the weight of the batch. Id.§ 379e(e); see also 21 C.F.R. § 80.10(a), (b) (2013); Listing of Color Additives Subject to Certification, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ColorAdditiveListingRegulations/ListingofColorAdditivesSubjecttoCertification/default.htm (last updated May 19, 2009).

209 Family Smoking Prevention and Tobacco Control Act of 2009, Pub L. No. 111-31, § 919, 123 Stat. 1776, 1826 (codified as amended at 21 U.S.C. § 387s (2012)).

210 21 U.S.C. § 387c(a)(1), (7).

211 Id. § 387s(c)(2)(A) (including the manufacture, distribution, and marketing of tobacco products); Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm246129.htm (last updated Apr. 30, 2013).

212 21 C.F.R. § 1.225.

213 Id. (requiring registrants to list applicable food product categories as identified in 21 C.F.R. § 170.3); see 21 C.F.R. § 170.3(n) (listing 43 general food categories that group specific related foods together, including the following: baked goods; non-alcoholic beverages, including soft drinks; frozen dairy desserts; snack foods, including chips, pretzels; and soft candy).

214 21 U.S.C. § 387s(c)(2)(A).

215 21 C.F.R. § 1.226.

216 Calculation of these fees would need to consider whether the manufacturers would pass the cost on to consumers. Consumer access to whole foods and differing responses to potential increased prices stemming from the fee provision due to socio-economic variation is beyond the scope of this paper. For a relevant discussion of strategies to address this point, see Pomeranz, Jennifer L., A Conditional Funding Strategy to Address the Modern Food Environment: From Public Health Prevention to State and Local Preemption, 40 Duke Forum For L. & Soc. Change 39, 41–44 (2013).Google Scholar

217 See User Fees, supra note 200.

218 28 U.S.C. § 2461 (2006); see Friends of the Earth, Inc. v. Laidlaw Env. Servs., Inc., 528 U.S. 167, 169-72 (2000).

219 28 U.S.C. § 2461.

220 Id. § 2461(2)(a)(1) (requiring federal agencies to issue regulations to adjust their civil monetary penalties upward due to inflation).

221 Id. § 2461(2)(b)(2); see also Federal Civil Penalties Inflation Adjustment, 69 Fed. Reg. 43,299, 43,299 (July 20, 2004) (In responding to a comment requesting higher penalties in the context of violations of regulations regarding drugs, the FDA noted that the FCPIAA did not authorizeincreases in penalties greater than ten percent, even though “higher civil monetary penalties might be a better deterrent.”).

222 Friends of the Earth, 528 U.S. at 185.

223 Id.

224 Polinsky & Shavell, supra note 131, at 60-62.

225 Elaine Watson, supra note 141 (quoting a lawyer stating that some manufacturers believe the worst thing that can happen from an “improper labeling claim is that they would receive a warning letter [sic] and then they would fix it and move on”).

226 Gunningham et al., supra note 164, at 295.

227 Crumley, supra note 164, at 383-84; Rechtschaffen, supra note 152, at 1188.

228 Polinsky & Shavell, supra note 131, at 72; Rechtschaffen, supra note 152, at 1215.