FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products

Transcription

1 FOOD AND DRUG LAW JOURNAL Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products Enforcement Marketing Nutrition & Health- Related Benefits of Food & Beverage Products: Enforcement, Litigation & Liability Issues Sarah Roller Raqiyyah Pippins FDLI VOLUME 65 NUMBER

2 2010 FOOD & BEVERAGE PRODUCTS 447 Marketing Nutrition & Health-Related Benefits of Food & Beverage Products: Enforcement, Litigation & Liability Issues SARAH ROLLER * RAQIYYAH PIPPINS ** INTRODUCTION Over the past decade, the liability risks associated with food and beverage product marketing have increased significantly, particularly with respect to nutrition and health-related product benefit claims. While various legal factors have contributed to this trend, these factors include significant limitations in the governing federal standards, which fail to ensure that accurate, well substantiated marketing claims are authorized and adequately protected, and a lack of harmonization and uniformity across the applicable federal and state laws. In addition, persistent political controversies concerning the diet-related public health goals that food and beverage marketing regulation should advance, and the role commercial product marketing should play in relationship to these goals, serve to further amplify the uncertainties and liability risks for marketing claims promoting nutrition and health-related benefits of food and beverage products in distinctive ways. 1 The increasing food liability trend emerged in the wake of the Surgeon General s 2001 call to action to combat obesity, and in conjunction with growing public awareness concerning both the valuable role healthy dietary practices have to play in preventing obesity and other diseases, and the valuable role commercial food and beverage marketing claims have to play in fostering healthy dietary practices. 2 The increasing food liability trend has accelerated since January 2009 for nutrition and health-related marketing claims, and may be an unintended consequence of food and nutrition policies implemented by federal agencies during this period. Food and nutrition-related public health policy issues have been given an unprecedented level of priority in the administration of President Obama. Within months after taking office, the President established a Food Safety Working Group comprised of Cabinet Secretaries and senior administration officials to address how the nation s food laws should be strengthened to protect public health. 3 Soon * Sarah Taylor Roller, J.D., R.D., M.P.H. is a Partner in the law firm of Kelley Drye & Warren LLP in Washington, D.C., and Chair of the firm s Food & Drug Law Practice. ** Raqiyyah Pippins is an Advertising, Consumer Protection, and Food & Drug Law Associate in the law firm of Kelley Drye & Warren LLP. 1 See, Sarah Taylor Roller, Theodore Voorhees, Jr., and Ashley K. Lukenheimer, Obesity, Food Marketing, and Consumer Litigation: Threat or Opportunity?, 61 FOOD AND DRUG LAW JOURNAL (2006). 2 See, e.g., Former Surgeon General David Satcher Call to Action To Prevent and Decrease Overweight and Obesity ; see also Institute of Medicine s reports entitled, Action Plan for Obesity Prevention (2005) and Food Marketing to Children and Youth: Threat or Opportunity? (2005). 3 See, White House Office of the Press Secretary, President Obama Announces Key FDA Appointments and Tougher Food Safety Measures, available at ( noting just this year, bad peanut products led to hundreds of illnesses and cost nine people their lives a painful reminder of how tragic the consequences can be when food producers act irresponsibly and government is unable to do its job, and establishing the Food Safety Working Group to bring together cabinet secretaries and senior officials to advise [President Obama] on how we can upgrade our food safety laws for the 21st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them ). 447

3 448 Food and Drug Law Journal Vol. 65 afterward, First Lady Michelle Obama reestablished the White House Kitchen Garden, 4 showcasing the valuable role home gardening can play in fostering healthy dietary practices among children and youth. In 2010, the First Lady launched the Let s Move! Campaign (Campaign), a program designed to promote public awareness and engagement in obesity prevention and health promotion strategies, particularly concerning children and youth. 5 Notably, a key policy objective of the Let s Move! Campaign aims to empower consumers to adopt healthy dietary practices through nutrition and health-related information disseminated through commercial food and beverage product labeling and advertising, including through easy-to-understand claims appearing on the front of packages and inside retail stores. The Campaign also contemplates more fundamental changes in the policies that govern food and beverage product marketing as part of an overall policy framework designed to strengthen public access to healthy food products and ensure consumers have genuine opportunities to adopt healthy dietary practices in schools, daycare facilities, and other settings. 6 In conjunction with the Let s Move! Campaign, President Obama established the Task Force on Childhood Obesity to develop an interagency plan designed to solve the problem of childhood obesity among our Nation s children within a generation. 7 Three months later, the Task Force published its report, which recommended policy changes concerning food and beverage product marketing, and suggested standards for evaluating the effectiveness of such policy changes in achieving diet-related public health policy goals. 8 The heightened priority of food and nutrition-related public health policy matters in the administration of President Obama not only is reflected in the food and nutrition policy reform initiatives that have been launched since January 2009, 4 See, The White House, First Lady Michelle Obama Launches Let s Move: America s Move to Raise a Healthier Generation of Kids, February 9, 2010, available at the-press-office/first-lady-michelle-obama-launches-lets-move-americas-move-raise-a-healthier-genera (stating, Michelle Obama began a national conversation about the health of America s children when she broke ground on the White House Kitchen Garden with students from Bancroft Elementary School in Washington, DC. Through the garden, she began a discussion with kids about proper nutrition and the role food plays in living a healthy life. That discussion grew into the Let s Move campaign ). 5 Id. 6 See, Let s Move! Campaign website at (describing policy recommendations describing the policy recommendations for empowering consumers, healthier schools, and access to affordable healthy food). 7 Twelve federal agencies participate actively in the Task Force, including the Departments of Agriculture, Defense, Education, Health and Human Services, Housing and Urban Development, Interior, Justice, and Transportation, as well as the Corporation for National and Community Service, the Environmental Protection Agency, the Federal Communications Commission, and the Federal Trade Commission. 8 See, White House Task Force on Childhood Obesity Report, available at gov/taskforce_childhoodobesityrpt.html. The Task Force report reinforces the authoritative public health recommendations that have developed in the United States since 2001, when Former Surgeon General David Satcher issued the nation s Call to Action To Prevent and Decrease Overweight and Obesity, including recommendations made in the Institute of Medicine s reports entitled, Action Plan for Obesity Prevention (2005) and Food Marketing to Children and Youth: Threat or Opportunity? (2005). It also extends the range of specific public health intervention strategies considered to include regulation of obesogenic chemical exposures, front-of-package and menu labeling, and various economic incentives (taxes, subsidies, licensing standards) to encourage the marketing of food products that support dietary patterns that meet U.S. Dietary Guidelines standards. In addition, the Task Force report recommends concrete actionable benchmarks for marking progress and determining success. For example, the Task Force defines solving the problem of childhood obesity in a generation as returning to a childhood obesity rate of just 5 percent by 2030, which was the rate before childhood obesity first began to rise in the late 1970s.

4 2010 FOOD & BEVERAGE PRODUCTS 449 but also in the enforcement priorities that have been implemented by the federal agencies responsible for regulating food and beverage product marketing: namely, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). FDA and FTC enforcement priorities concerning nutrition and health-related benefit claims have in turn inspired private litigation and generated ripple effects that have disturbing food liability implications for companies that market healthy food and beverage products. This article examines key enforcement and litigation developments involving conventional food and beverage product marketing claims during the first 18 months of President Obama s administration. Part I considers FDA enforcement priorities and recent warning letters; Part II considers FTC enforcement priorities, warning letters and consent orders; 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. This examination of recent enforcement and litigation developments suggests that FDA and FTC enforcement priorities have contributed to increasing liability trends associated with nutrition and health-related product benefit claims. It also suggests that food and beverage marketing claims promoting taste, convenience, economic value, or other product attributes unrelated to nutrition and health are unlikely to be affected by comparable liability trends. The apparent chilling effects current food liability trends have for healthy food and beverage product marketing may yield perverse product marketing incentives. In view of the obesity prevention and other public health priorities of the Obama administration, the potential adverse public health consequences of current food liability trends merits careful consideration in the further development of national policies to prevent obesity and other diet-related diseases. A. FDA Enforcement Priorities I. FOOD AND DRUG ADMINISTRATION In March 2009, President Obama appointed Drs. Margaret A. Hamburg and Joshua M. Sharfstein as Commissioner and Principal Deputy Commissioner of the Food and Drug Administration, respectively. Notably, both appointees previously served as the Commissioner of Health for prominent American cities. 9 Early in her term, Commissioner Hamburg conveyed her intentions to make FDA stronger, more vigilant, strategic, quick to act and visible with the public, emphasizing that FDA must be prepared to take swift and aggressive action to protect the public health. 10 She stressed that FDA s new enforcement priorities included not only public health threats presented by unsafe food products, but also included false and misleading nutrition information presented to consumers through product labeling. Commissioner Hamburg explained that the agency s enforcement priorities in this area were justified in part by the nation s obesity crisis. 9 Commissioner Hamburg previously served as Commissioner of Health for the City of New York, New York while Principal Deputy Commissioner Sharfstein previously served as Commissioner of Health for Baltimore, Maryland. See, White House Office of the Press Secretary, President Obama Announces Key FDA Appointments and Tougher Food Safety Measures, supra note See, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, Commissioner of Food and Drugs on Effective Enforcement and Benefits to Public Health at Food and Drug Law Institute, August 6, 2009.

5 450 Food and Drug Law Journal Vol. 65 [T]he sad fact [is] that the public health problems of overweight and obesity have reached crisis proportions in our nation Some 65% of Americans are obese or overweight, and almost 17% of youngsters under 20 are obese, putting millions at much greater risk of diabetes, cardiovascular disease, and other serious health problems. 11 In addition, Commissioner Hamburg implemented a number of organizational and policy changes within the agency. Among these changes was the creation of an Office of Foods 12 within the Office of the FDA Commissioner, which is headed by the Deputy Commissioner for Foods and charged with the responsibility for strengthening and modernizing FDA food safety and nutrition programs across the agency. 13 Commissioner Hamburg appointed Michael R. Taylor as the first Deputy Commissioner for Foods, and announced that he would be responsible for FDA s food safety programs and lead[] FDA efforts to ensure that food labels contain clear and accurate information on nutrition. 14 Shortly thereafter, FDA issued the first of two letters to the industry which addressed the agency s enforcement priorities with greater clarity. 15 First, in October 2009, FDA issued a Letter to Manufacturers conveying the agency s concern that certain types of front-of-package (FOP) labeling may be misleading. The letter explained FDA s plans to initiate enforcement action against products bearing FOP information that violates the requirements of the Federal Food, Drug & Cosmetic Act (FDCA). 16 Second, on March 2, 2010, the Commissioner issued an Open Letter to the Industry, expressing concern that certain types of label information may not be adequately substantiated by appropriate scientific evidence. The March letter further emphasized that improving the scientific accuracy and usefulness of food labeling is a top priority for the agency, signaling the agency s intent to subject the scientific evidence companies rely upon to support product information to increasing enforcement scrutiny See, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, Remarks at the Atlantic Food Summit, March 4, The FDA Foods Program includes three major operating units the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the foods-related activities of the Office of Regulatory Affairs (ORA) and draws on the resources and expertise of FDA s National Center for Toxicological Research and key Office of Commissioner staff offices. See, FDA Website, Office of Foods, available at 13 Id. 14 FDA Website, Meet Michael R. Taylor, Deputy Commissioner of Foods, available at fda.gov/aboutfda/centersoffices/oc/officeoffoods/ucm htm. 15 These were not FDA s first letters regarding food labeling. See, e.g., FDA Letter to Smart Choices Program, August 19, They were, however, the first letters formally directed to the entire conventional food and beverage industry, declaring the Agency s priorities with regard to food labeling claims. 16 FDA Guidance for Industry: Letter Regarding Point of Purchase Food Labeling, Issued October 2009, available at GuidanceDocuments/FoodLabelingNutrition/ucm htm. The guidance emphasizes that nutrition-related FOP and shelf labeling are subject to the provisions of the FDCA that prohibit false or misleading claims and restrict nutrient content claims to those defined in FDA regulations, warning industry that FDA will proceed with enforcement action against products that bear FOP labeling that are explicit or implied nutrient content claims that are not consistent with current nutrient content claim requirements [and] also proceed with enforcement action where such FOP labeling systems are used in a manner that is false or misleading. Id. 17 See, Open Letter to Industry from Dr. Hamburg, March 2, 2010, available at gov/food/labelingnutrition/ucm htm.

6 2010 FOOD & BEVERAGE PRODUCTS 451 Notably, during the intervening period between the Commissioner s October 2009 and March 2010 industry letters, FDA issued no less than 23 warning letters to major food and beverage product manufacturers making allegations that FOP label information rendered their products misbranded in violation of FDCA requirements and FDA implementing regulations. FDA issued 17 of these warning letters on February 22, 2010 alone, and some companies received more than one warning letter. A summary of key FDA warning letters issued since January 2009 is provided in the following section. B. FDA Enforcement Activities 1. Claims Concerning Nutrients & Food Components a. Nutrient Content Claims and Foods for Young Children i. Nutrient Content Claims FDA has issued a number of warning letters to companies alleging that the use of nutrient content claims on food products commonly consumed by young children is prohibited by FDA regulations codified at 21 CFR (b). That section provides that, except for claims regarding the percent [Reference Daily Intake] RDI for vitamins and minerals described in FDCA section 403(q)(3), no nutrient content claims may be made on food intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of this chapter. FDA has issued warning letters to seven manufacturers of children s foods which make labeling claims such as no sugar added, low sodium, excellent source of iron, vitamin D, calcium, zinc [and] 7 B-vitamins on food products commonly consumed by young children, alleging that the claims cause the products to be misbranded because the products are specifically intended for children under two. 18 The intent of FDA s regulation restricting the use of nutrient content claims in foods for young children appears to be aimed at deterring the use of marketing claims that are at odds with dietary recommendations for young children. The breadth of FDA s policy banning nutrient content claims for foods specifically intended for children under two, as applied in these cases, is remarkable in view of the relevant FDA rulemaking record. The record suggests that the class of 18 See e.g., FDA Warning Letter to Beech-nut Corporation, Feb. 22, The FDA warning letter alleges that the following claims also are prohibited nutrient content claims on similar grounds: no added refined sugar, fortified for enhanced functional benefits, plus vitamin and minerals, low sodium, plus fiber, plus vitamins & minerals, and excellent source of iron, vitamin D, calcium, zinc [and] 7 B-vitamins ; FDA Warning Letter to DS Waters of America, Feb. 22, 2010 (regarding tooth decay -related labeling on its bottled water for which the label represents or purports that the food [e.g., bottled water] is for infants or toddlers less than two years of age ); FDA Warning Letter to First Juice, Inc., Feb. 22, 2010 (regarding the labeling statement 50% less sugar as an unauthorized nutrient content claims ); FDA Warning Letter to Nestle Nutrition, Feb. 22, 2010 (regarding the labeling statements as healthy as fresh, good source, excellent source, and no sugar added claims ). FDA Warning Letter to Want Want Foods, Feb. 22, 2010 (regarding the labeling statements low in fat, and no added fats or oils ), FDA Warning Letter to Nestle U.S.A., Dec. 4, 2010 (regarding the labeling statements no sugar added and naturally lower in sugar ), FDA Warning Letter to PBM Products LLC, Feb. 22, 2010 (regarding the labeling statement good source ).

7 452 Food and Drug Law Journal Vol. 65 products that are specifically intended for children under two is a narrow one, and that actively promoting [a product] as being for use by infants or children less than 2 years of age, is not sufficient to establish that that a product is specifically intended for children under two, since it may be intended for children spanning a broader range of ages. 19 Despite the rulemaking record, recent FDA warning letters adopt a more expansive reading of the class of products that are specifically intended for children under two years of age. While some warning letters rely on explicit age claims, more often FDA relies on more nuanced claims referring to various developmental stages of young children. For example, in one warning letter FDA alleges that a product is specifically intended for children less than two based on the claim, fruit and vegetable juice for infants and toddlers, 20 a claim which is explicit in representing the product to be intended for toddlers, a population that includes children who are older than two years of age. 21 Recent FDA warning letters also allege that claims such as excellent source of iron, are prohibited, despite the consistency of such claims concerning essential nutrients with information which is permitted in the Nutrition Facts box and directed to parents and other adults who purchase foods to be consumed by young children. In view of First Amendment protections of commercial speech, including food labeling, the breadth of the FDA ban on nutrient content claims is questionable. 22 ii. Other Labeling Claims Recent FDA warning letters targeting nutrition and health-related marketing claims promoting foods for consumption by young children make allegations that extend beyond the technical regulatory standards governing nutrient content claims. For example, in December 2009, FDA issued a warning letter alleging that certain juice products for young children were misbranded foods in violation of FDCA section 403(a)(1) as a result of the color and typesize used on the PDP to identify the characterizing fruit flavors of the juice products. 23 Notably, the U.S. Dietary Guidelines and other key food and nutrition policy guidelines emphasize the importance of fruit and vegetable consumption by children to foster healthy 19 Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definitions of Terms; Definitions of Nutrient Content Claims for Fat, Fatty Acid, and Cholesterol Content of Food, Final Rule, 58 Fed. Reg. 2302, (Jan. 6, 1993) (stating that products aimed primarily at adults and older children, are not specifically intended for children under two when actively promoted either on the label or in the advertising as being for use by infants or children less than two ). 20 See, FDA Warning Letter to First Juice Inc., Feb. 22, First Juice s products also include labeling stating the products were designed specifically for young, developing taste buds. Id. 21 See, American Academy of Pediatrics Website on Toddlers, www. org/english/ages-stages/toddler/pages/default.aspx (defining the toddler age range to encompass children that are two years of age and older). 22 See, Alliance for Natural Health U.S. v. Sebelius, Civ. Action No (ESH) (D.C. Dist. May 27, 2010), Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) and Pearson v. Shalala, 130 F. Supp.2d 105, 118 (D.D.C. 2001) (explaining that under the teachings of Pearson v. Shalala, 164 F.3d 650, , reh g denied 172 F.3d 72 (D.C. Cir. 1999), the agency must shoulder a very heavy burden if it seeks to ban a particular claim); Thompson v. Western States Medical Center, 535 U.S. 357, 122 S.Ct. 1497, 1507 (2002) (stating, [i]f the First Amendment means anything, it means that regulating speech must be the last not first resort [Here] it seems to have been the first strategy the Government thought to try, and holding even where the governmental interest is established to be substantial, a restriction on the content of commercial speech cannot be sustained unless the restriction directly advances the governmental interest and is not more extensive than is necessary to serve that interest ); 23 See, FDA Warning Letter to Nestle USA, Dec. 3, 2009.

8 2010 FOOD & BEVERAGE PRODUCTS 453 dietary practices. In this context, representations concerning the nature or amount of fruit or vegetable ingredients in a food product marketed for consumption by children present sensitive regulatory issues. b. Claims Concerning Food Components for Which No Daily Value Has Been Established i. Antioxidants A number of recent FDA warning letters have challenged labeling claims characterizing food and beverage components that have antioxidant activity, but for which FDA has not established a Daily Value (e.g. Reference Daily Intake (RDI)). In these warning letters, FDA alleges that claims characterizing the presence of antioxidants in food or beverage products are unauthorized nutrient content claims that violate FDA requirements for such claims under FDCA section 403(r)(1)(A) and FDA implementing regulations codified at 21 CFR (g). Specifically, 21 CFR (g) provides that a nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on a label or in labeling of that food when, among other requirements, a reference daily intake has been established for each of the antioxidant nutrients, and the names of the antioxidant nutrients that are the subject of the claim are included either (1) as part of the claim or (2) elsewhere on the same panel of the product label, provided that the nutrient names are linked by a symbol to the claim. The recent FDA warning letters issued to food and beverage product manufacturers regarding use of antioxidant claims are largely the same, alleging that particular antioxidant-related information in product labeling amounts to a nutrient content claim which does not comply with 21 CFR (g) and FDCA section 403(r)(A)(1). For example, FDA issued a warning letter to Pompeian, alleging that the label claim olive oil is rich in antioxidants... caused its olive oil product to be misbranded under FDCA section 403(r)(A)(1) because the label claim failed to appropriately identify the particular antioxidant substance to which the claim refers and characterized the level (e.g., rich ) of an antioxidant substance for which no RDI has been established. 24 Warning letters were sent to POM Wonderful, Redco, and Sunsweet Growers challenging such claims as uniquely high level of powerful antioxidants, full of antioxidants, fortified with antioxidants, and high in antioxidants on similar grounds. 25 The antioxidant food components at issue in the FDA warning letters include phytochemicals, purple antioxidants, grapeskins, rooibos (red tea), and anthocyanins, 26 and expose the heightened level of enforcement scrutiny the agency has given to claims employing such terms as high, and fortified to characterize the level of a substance for which no RDI or other Daily Value has been established. In this regard, FDA enforcement activi- 24 See, FDA Warning Letter to Pompeian, Feb. 22, See, FDA Warning Letter to POM Wonderful LLC, Feb. 23, See also, FDA Warning Letter to Sunsweet Growers, Feb. 22, See, FDA Warning Letter to Redco, Inc., Feb. 22, 2010 (stating there are no RDIs for grapeskins, rooibos (red tea) or anthocyanins, and therefore the claim, Fortified with Purple Antioxidants Grapeskins, Rooibos (red tea), Anthocyanins, is an unauthorized nutrient content claim... ).

9 454 Food and Drug Law Journal Vol. 65 ties have not been confined to antioxidant substances. For example, FDA relied on similar legal reasoning in a recent warning letter challenging the claim high in good monosaturated fat on the grounds that no Daily Value has been established for good monosaturated fat. 27 In addition, as discussed further below, other recent FDA warning letters challenge claims concerning substances for which no Daily Value has been established, including trans fat and digestible or net carbohydrates. ii. Trans Fat Historically, claims which describe the amount of a substance in food by weight (e.g., grams or percentage), have been authorized under FDA regulations codified at 21 CFR (i)(3), and have been distinguished from claims characterizing the level of a nutrient in food which are subject to FDA requirements for nutrient content claims. Under this regulation, manufacturers have been permitted to employ such claims as 5 grams or 0 grams to describe the amount of a substance in food for which no Daily Value has been established. 28 It is in this context that such claims as 0 grams trans fat, zero grams trans fat, and zero trans fat, were employed in accordance with 21 CFR (i)(3). In contrast to established policies and labeling practices under 21 CFR (i)(3), recent FDA warning letters have challenged zero trans fat and 0 Trans Fat claims, alleging that such claims characterize the level of a nutrient in food, and thus constitute nutrient content claims which are subject to the nutrient disclosure requirements specified in 21 CFR (h)(1) (i.e. referral statement ) when the claim is made for a food containing significant amounts of saturated fat, sodium, or other risk-increasing nutrients. For example, FDA issued a warning letter to Gorton s Inc, alleging that the failure to include a saturated fat referral statement on the label of a fish product with a zero trans fat claim caused the product to be misbranded in violation of 21 CFR (h)(1). 29 FDA also issued warning letters objecting to 0g Trans Fat claims for certain dessert products on similar grounds. 30 iii. Digestible (Net) Carbohydrates Over the past decade, FDA has implemented an enforcement policy prohibiting such claims as low carb or net carb in food labeling. 31 Consistent with this policy, in a recent warning letter to Today s Temptations, FDA alleges that the claim Only 2g Digestible Carbs qualifies as an unauthorized nutrient content 27 See e.g., FDA warning letter to Pompeian, (alleging the label statement high in good monounsaturated fat, is violative of FDA regulations codified at 21 CFR (b) because FDA has not established a Daily Value for good monosaturated fat ). 28 See, Guidance for Industry: A Food Labeling Guide, Section VIII. Claims. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements, April 2008 (discussing the manner in which a company can inform consumers that a product contains nutrients without Daily Values in Q&As N21 and N22). 29 FDA Warning Letter to Gorton s, Inc., Feb. 22, See, FDA Warning Letter to Dreyers, Feb. 22, 2010 (regarding ice cream products bearing the phrase 0g Trans Fat ); see also, FDA Warning Letter to Schwan s Consumer Brands North America, Feb. 22, 2010 ( regarding a dessert bearing the phrase 0g TRANS FAT PER SERVING ). 31 See e.g., FDA Warning Letter to Carbolite, June, 20, 2001; FDA Warning Letter to EAS, June 25, 2001.

10 2010 FOOD & BEVERAGE PRODUCTS 455 claim which violates FDCA section 403(r)(1)(A), 32 because FDA has not defined this claim for use on food products. Pending citizen petitions ask FDA to adopt a more flexible policy regarding carbohydrate claims on First Amendment and other grounds. 33 c. Extra Light Claims A recent FDA warning letter issued to Pompeian challenges the use of extra light claims to characterize its olive oil product, alleging that the claim amounts to an unapproved nutrient content claim because it does not satisfy the nutritional standards FDA has established for light claims under 21 CFR (b). 34 FDA takes the position that Pompeian s use of extra light olive oil suggests that the olive oil may have fewer calories or fat than regular olive oil. While the FDA letter acknowledges that the term light may be used to describe the physical or organoleptic attributes of olive oil, the letter alleges that the Pompeian product nonetheless violates FDCA requirements because product labeling failed to include qualifying language disclosing that the term light refers to a physical or organopletic product attribute as required by 21 CFR (e). The letter does not address the exemption for use of light provided by 21 CFR (f). Notably 21 CFR (f) provides, if a manufacturer can demonstrate that the word light has been associated, through common use, with a particular food to reflect a physical or organoleptic attribute (e.g., light brown sugar, light corn syrup, or light molasses) to the point where it has become part of the statement of identity, such use of the term light shall not be considered a nutrient content claim subject to the requirements in this part. The FDA warning letter does not recognize the distinctive history of use of the extra light term in naming olive oil products under FDCA section 403(i) to distinguish olive oil products on the basis of organoleptic and functional properties. d. Healthy Claims A number of FDA warning letters issued by the agency since January 2009 challenge the use of healthy as part of a product or brand name, alleging that foods bearing such names must comply with the nutritional criteria specified in FDA regulations governing healthy claims, codified at 21 CFR (d). For 32 See, FDA Warning Letter to Today s Temptations, Feb. 22, 2010 (stating under Section 403(r)(1)(A) of the Act, a claim that characterizes the level of nutrient which is of the type required to be in the label or labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such claim. Characterizing the level of nutrient in food labeling of product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under Section 403(r)(1)(A) of the Act ). 33 See e.g., Carbolite Foods Inc. Petition for the Use of an Implied Nutrient Content Claim in the Brand Name Carbolite, submitted to FDA October 4, 2002, petition for reconsideration filed February 23, 3003; Petition Labeling Claims Using Net Effective Carbohydrates and Similar Terms, filed October 25, 2004; see also, Grocery Manufacturers of America, Petition regarding Nutrient Descriptor Claims for the Carbohydrate Content of Food, submitted to FDA Feb. 2, In its letter to Pompeian, Inc., FDA alleges that the labeling statement Extra Light Olive Oil, causes its Imported Extra Light Olive Oil product to be misbranded within the meaning of section 403(r)(1)(A) of the Act because the product does not comply with the regulation governing claims using the term light to describe a food.

11 456 Food and Drug Law Journal Vol. 65 example, an FDA warning letter issued to Ken s Foods, Inc., 35 alleges that its HealthyOptions brand name used in combination with statements describing the calorie, fat, and sodium content of the company s salad dressing products amounts to a healthy nutrient content claim which is subject to the nutritional criteria specified in FDA regulations codified at 21 CFR (d)(2). FDA further alleges that, because the Ken s products at issue did not comply with the fat and other nutritional criteria, the products bearing the brand name were misbranded under FDCA section 403(r)(1)(A). 36 B. Disease Prevention and Health Promotion Benefit Claims Recent FDA warning letters have challenged health-benefit claims in product labeling, and health information disseminated through websites, alleging that the targeted claims constitute unauthorized health claims and/or unauthorized disease prevention claims which render the food product to be an unapproved new drug. The FDA warning letters target a range of product types and marketing claims, including food products bearing health claims which have been authorized under FDA s premarket clearance procedures. For example, although FDA has authorized specific health claims characterizing the benefits of consuming foods like Cheerios and walnuts in reducing the risk of heart disease, recent FDA warning letters challenge heart health-related benefit claims for these foods, taking the position that the particular claim language employed in product labeling in these cases is not authorized by the existing scope of FDA approved claims. 37 The allegations FDA has made in the Cheerios and Diamond Walnut warning letters expose the heightened level of regulatory scrutiny to which health-benefit claims have been subjected, and key enforcement priorities of the new administration. As discussed further below, the legal bases for the allegations FDA makes in the Cheerios, Diamond Walnut, and other recent warning letters are open to question, and susceptible to challenge on First Amendment and other grounds Whole Grains and Dietary Fiber Claims Under 21 CFR , the labeling for whole grain food products meeting specified nutritional criteria may bear a health claim characterizing the relationship between soluble fiber and reduced heart disease risk provided that: (A) The claim states that diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods may or might reduce the risk of heart disease. (B) In specifying the disease, the claim uses the following terms: heart disease or coronary heart disease; 35 FDA Warning Letter to Ken s Food, Inc., Feb. 22, Id CFR (providing the approved health claim regarding soluble fiber); Walnuts & Heart Disease, FDA Docket No. 02P-0292 (stating FDA will consider exercising enforcement discretion for a qualified claim as presented below: Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content ). 38 See, Alliance for Natural Health U.S., Pearson and Western States supra note 22.

12 2010 FOOD & BEVERAGE PRODUCTS 457 (C) In specifying the substance, the claim uses the term soluble fiber qualified by the name of the eligible source of soluble fiber (provided in paragraph (c)(2)(ii)) of this section. Additionally, the claim may use the name of the food product that contains the eligible source of soluble fiber; (D) In specifying the fat component, the claim uses the terms saturated fat and cholesterol; (E) The claim does not attribute any degree of risk reduction for CHD to diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section; (F) The claim does not imply that consumption of diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section is the only recognized means of achieving a reduced risk of CHD; and (G) The claim specifies the daily dietary intake of the soluble fiber source that is necessary to reduce the risk of coronary heart disease and the contribution one serving of the product makes to the specified daily dietary intake level. The regulation also permits the use of certain optional labeling information, including information: stat[ing] that the relationship between intake of diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources and reduced risk of heart disease is through the intermediate link of blood cholesterol or blood total- and LDL-cholesterol; 39 summariz[ing] the relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and coronary heart disease and the significance of the relationship 40 [or] specify[ing] the name of the eligible soluble fiber 41. In May 2009, FDA issued a warning letter to General Mills 42 alleging that certain statements made in Cheerios product labeling caused the product to be a misbranded food under FDCA section 403(r) and an unapproved drug under FDCA section 505. The Cheerios product label at issue in the warning letter included the claim statement You can Lower Your Cholesterol 4% in 6 Weeks in a banner in the center of the front label; the FDA-approved health claim for soluble fiber in the lower left corner of the front label; and a description of the clinical study upon which the statement You can Lower Your Cholesterol 4% in 6 Weeks was based, on the back of the box CFR (d)(2) CFR (d)(3). The summary must be based on the overview of the relationship between soluble fiber and coronary heart disease, and related discussion of the prevalence of coronary heart disease in the United States, provided at 21 CFR (a)-(b) CFR (d)(4). 42 FDA Warning Letter to General Mills, May 5, The warning letter also made allegations that placement of the website causes the website to be labeling and as a result, certain statements on the website constitute unauthorized health claims in violation of FDCA section violative of FDCA section 403(r)(1)(B). General Mills has objected to the FDA position that placement of the website on the product label in and of itself causes the website to be labeling, and submitted that the company designed the website to be an educational site providing general dietary guidance to assist consumers in identifying whole grain foods and incorporating them into healthy diets, and that the statements subject to FDA s warning letters are dietary guidance statements meeting the criteria FDA has articulated for such statement. See, General Mills Initial Response to Warning Letter of May 5, 2009, dated May 14, 2009, available at UCM pdf.

13 458 Food and Drug Law Journal Vol. 65 In the warning letter, FDA alleges that the Cheerios product is a misbranded food because, while 21 CFR (d) permits health claims characterizing the relationship between soluble fiber and coronary heart disease to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol, 44 the Cheerios lowering cholesterol claim language did not meet the requirements for optional information under 21 CFR (d). The letter alleges that the Cheerios lowering cholesterol claims amount to standalone claims through their location on the package and other label design features, which fail to meet the requirements for soluble fiber-related health claims codified at 21 CFR (c) or optional information under 21 CFR (d). 45 In its response, General Mills respectfully disagrees with FDA s position, noting First Amendment considerations, 46 and explaining that the company carefully crafted the communications that are the subject of FDA s warning letter to comply with the applicable FDA regulations and to ensure that its use of the lower cholesterol claims is consistent with 21 CFR (d). 47 More specifically, the General Mills submission explains that its Cheerios product label presents truthful and substantiated statements of fact regarding the results of a clinical trial which are authorized by FDA regulations codified at 21 CFR (d)(2)-(3). These regulations permit health claims to include additional optional information, designed to summarize the significance of the relationship between diet and coronary heart disease and explain that the relationship between intake of diets containing soluble fiber (that are also low in saturated fat and cholesterol) and reduced risk of heart disease is through the intermediate link of blood cholesterol or blood total- and LDL-cholesterol. The General Mills submission further explains that, contrary to FDA s position concerning the label statements, the company considers the cholesterol statements and the model health claim language on its label to be integrated and mutually reinforcing, noting that it believes the banner with the cholesterol statement on the Cheerios label attracts consumers to important information about the relationship between diet and health more than use of the model claim alone. 48 In addition to alleging that the product labeling bears an unauthorized health claim which causes the Cheerios product to be a misbranded food under FDCA section 403(r)(1)(B), the warning letter further alleges that certain statements provide evidence of General Mills intent to market Cheerios for disease prevention pur- 44 FDA Warning Letter to General Mills, May 5, Id. 46 See, General Mills Initial Response to Warning Letter of May 5, 2009, supra note 44 (noting it is well settled the First Amendment protects the right of food marketers to communicate truthful, nonmisleading, and substantiated health-related information to consumers, including a strong presumption against the government s ability to suppress such communications and citing Pearson v. Shalala, 130 F. Supp.2d 105, 110 (D.D.C. 2001) and Whitaker v. Thompson, 248 F. Supp. 2d (D.D.C. 2002)). 47 Id. 48 Id. Note, FDA s warning letter to General Mills, also alleges that the claim regarding soluble fiber fails to comply with the claim specific requirements of 21 CFR More specifically, the Agency alleges that the claim that Cheerios can lower cholesterol by four percent in six weeks, is a claim regarding a degree of risk reduction for coronary heart disease prohibited by 21 CFR Supra note 44. General Mills objects to this allegation, stating that the statement about 4% reduction in LDL cholesterol levels does not convey to consumers a specific degree of risk reduction, but, instead is a way to communicate to consumers in a concrete and substantiated way that they can readily understand that [the study] is part of the factual science undergirding the health claim, and is made in conjunction with the complete model health claim language. General Mills, Initial Response to Warning Letter of May 5, 2009, supra note 46.

14 2010 FOOD & BEVERAGE PRODUCTS 459 poses, causing the product to be an unapproved drug in violation of FDCA section 505. In this regard, the FDA warning letter relies on label statements concerning clinical trial results (e.g., You can Lower Your Cholesterol 4% in 6 Weeks ). 49 In response, the General Mills submission defends the Cheerios claims, explaining that the label statements concerning the clinical trial results are truthful and nonmisleading, and that providing consumers with factual information concerning the results of a clinical trial conducted on a conventional food product does not cause the food to be a drug product within the meaning of the FDCA. 50 In defense of the Cheerios label statements, the company documents Congressional and FDA statements which encourage the dissemination of valuable health information in ways that are easy for the public to comprehend, explaining that by reporting the results of the clinical trial on [the] product label, [the company] aimed to help convey specific and relevant information to consumers that meets [Congress intent for use of health claims] and is much more accessible than simply publishing the results in a scientific journal consumers are not likely to see. 51 Notably, the General Mills submission in response to the FDA warning letter includes references to studies published in peer reviewed scientific journals, which the company relied on to substantiate its Cheerios health-benefit claims. Since General Mills submitted its initial response to the FDA warning letter, the agency and company have exchanged further correspondence detailing their respective positions concerning the allegations made in the FDA warning letter Claims Concerning Walnuts, Omega-3 Fatty Acids, and Coronary Heart Disease Benefits A recent FDA warning letter issued to Diamond Food, Inc. 53 concerning its use of FDA authorized health claims to market its shelled walnut product raises First Amendment and other legal issues that are not unlike those presented by the Cheerios warning letter discussed above. The warning letter to Diamond Food challenges nutrition and health-related information concerning the walnut products, taking the position that unapproved health claims resulted from combining FDAauthorized health claim language with other nutrition information concerning the omega 3 fatty acid content of walnuts. The FDA warning letter alleges that placing the label statement OMEGA g per serving by a heart symbol on the 49 See, FDA Warning Letter to General Mills, supra note See, General Mills, Initial Response to Warning Letter of May 5, Id. (citing FDCA section 403(r)(3)(B)(iii) language requiring that health claims be stated so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet, and stating that its Cheerios labeling is consistent with the goal of the FDA s Consumer Health Information for Better Nutrition Initiative of making available better, easily understood, up-to-date scientific information about how dietary choices can effect health ). 52 See, FDA Response to General Mills Addressing the Scientific Basis for Cheerios Cholesterol Claims, October 9, 2009 available at see also General Mill s Reply to FDA s October 9, 2009 Response to General Mills Addressing the Scientific Basis for Cheerios, November 3, 2009 (correspondence on file with the authors). 53 FDA Warning Letter to Diamond Foods, Inc., Feb. 22, 2010 (e.g., Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses. )..

15 460 Food and Drug Law Journal Vol. 65 product label, 54 combining a FDA-approved health claim regarding walnuts and coronary heart disease with a statement regarding omega-3 fatty acids, and posting information describing emerging scientific research concerning potential omega-3 fatty acids and walnuts on the company website 55 constitute unauthorized health and disease claims in violation of FDCA section 403(r)(1)(B). The letter also alleges that the posting of certain information regarding the relationship between walnuts, omega-3s, and disease on a company sponsored website causes the products to be unapproved drugs marketed in violation of FDCA section 505(a). Notably, the warning letter does not challenge the accuracy or scientific support for the 2.5 g per serving claim, or the heart health-related benefits of walnut consumption. The letter states that within the context of th[e] label, the heart symbols adjacent to the information about the amount of omega-3 in the product, and the statement, [t]he omega-3 in walnuts can help you get the proper balance of fatty acids your body needs for promoting and maintaining heart health, amount to a new and unauthorized health claim impliedly characterizing a relationship between walnuts and a reduced risk of heart disease that is related to the omega-3 fatty acid content of walnuts. While a response from Diamond Food, Inc. regarding FDA s February 2010 letter has not been made publicly available, as noted above, the allegations FDA makes in its warning letter appear to be susceptible to challenge on First Amendment and other grounds. 3. Website Claims A number of recent warning letters have alleged FDCA violations based on scientific information that is posted on company websites. 56 For example a recent warning letter issued to Dr. Lee s TeaForHealth company alleges that claims appearing on the company s website, and an educational website, which was linked to the company s website, provided evidence that the company intends for its green tea products to be used under conditions that are permitted only for approved new drugs under FDCA section 201(p) and related provisions. 57 The letter also alleges that the company website contains unauthorized health claims and nutrient content claims causing the tea products to be misbranded foods under both the premarket clearance provisions of the FDCA and the general misbranding provisions, codified at FDCA section 403(a)(1). While it will be established that FDA has jurisdiction over information 54 The letter alleges that within the context of th[e] label, the heart symbols adjacent to the information about the amount of omega-3 in the product, constitute implied health claims about consumption of omega-3 and a reduced risk of coronary heart disease. Id. 55 Id. 56 See also, FDA Letter to POM Wonderful citing several therapeutic claims made regarding pomegranate juice on POM Wonderful s website as evidence of the company s intent to market the product as a drug intended for use in the cure, mitigation, treatment or prevention of disease; FDA Warning Letter to Pompeian (stating therapeutic claims such as olive oil is a major component of the Mediterranean diet, which protects the heart, may lower inflammation and coagulation, and may reduce mortality in the elderly, and may increase insulin sensitivity in people prone to diabetes as compared to saturated fat, which increases insulin resistance, on the product website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. ) 57 FDA Warning letter to Dr. Lee s TeaForHealth, Feb. 22, 2010 (stating therapeutic claims on [the] website establish that the products are drugs under section 201(g)(1) of the Act, because they are intended for use in the cure, mitigation, treatment, or prevention of disease ).

16 2010 FOOD & BEVERAGE PRODUCTS 461 companies present on the internet when the information either functions as product labeling, or constitutes evidence of the company s intent that a food be used for purposes reserved for approved drugs, this warning letter is noteworthy because it relies entirely on internet content to support its allegations, including content appearing on a separate website linked to the company s website. The scope of FDA s asserted jurisdiction to restrict the dissemination of scientific information concerning the potential disease-related benefits of food and beverage products like tea under the drug definition codified at FDCA section 201(g)(1)(B) is open to question in view of First Amendment considerations. A. FTC Enforcement Priorities II. FEDERAL TRADE COMMISSION In February 2009, Obama appointed John Leibowitz as Chairman of the FTC who, in turn, appointed David Vladeck as Director of the Bureau of Consumer Protection (BCP). 58 The BCP includes the Commission s Advertising Division. From the beginning of his tenure as Bureau Director, Mr. Vladeck has expressed his intent to address issues presented by food advertising, beginning with efforts to strengthen the substantiation standards for health-benefit claims. In a presentation to an industry organization, Mr. Vladeck conveyed disappointment that FTC had not prevailed in the FTC v. Lane Labs decision issued in August In Lane Labs the federal district court of appeals held that Lane Labs had relied on competent and reliable scientific evidence to support certain health-benefit claims, rejecting the Commission s arguments that the evidence the company had relied upon was inadequate to support its clam under the same evidence standard. In response to the Lane Labs decision, Mr. Vladeck indicated that the Commission would use more precise language to describe the specific nature of the evidence that would be needed to qualify as competent and reliable scientific evidence in future consent orders. 60 For example, he explained that future orders were likely to specify the actual number and types of scientific research studies that would be needed to adequately substantiate a health-benefit claim, and would define the scope of health-benefit claims covered by the order more broadly. 61 Another priority is to harmonize the FTC s substantiation standards with laws and regulations administered by sister agencies. 62 The FTC has renewed efforts to work closely with the Food and Drug Administration by establishing three working groups to share information regarding conventional foods, dietary 58 Prior to his appointment, Vladeck served as Professor of Law at Georgetown University Law Center, teaching federal courts, government processes, civil procedure, and First Amendment litigation. He co-directed the Center s Institute for Public Representation, a clinical law program for civil rights, civil liberties, First Amendment, open government, and regulatory litigation. Vladeck previously spent almost 30 years with Public Citizen Litigation Group, including 10 years as Director. He has argued a number of First Amendment and civil rights cases before the U.S. Supreme Court, and more than 60 cases before the federal courts of appeal and state courts of last resort. 59 Civil Action No. 00-cv-3174 (D. NJ), decided August 11, FTC Bureau Director David Vladeck, Remarks at Council for Responsible Nutrition, Annual Symposium for the Dietary Supplement Industry, October 22, Id. 62 FTC Bureau Director David Vladeck, Remarks at National Advertising Division Conference, October 5, 2009.

17 462 Food and Drug Law Journal Vol. 65 supplements, and over-the-counter drugs. 63 Mr. Vladeck has warned the food industry to expect increased coordination with respect to strategic planning and case selection to enhance the enforcement efforts of both agencies. 64 Mr. Vladeck also has made clear that health-benefit claims are an enforcement priority for the Commission, specifically including health-benefit claims for functional foods such as claims that foods will boost the immune system, assist with memory and brain function, boost metabolism, protect the heart, or afford other physical or mental health-benefits. 65 In recent speeches before industry and public interest groups, Vladeck stressed the need for food and beverage companies to be very careful when venturing into the realm of health-related marketing claims to make sure that they have good scientific research, that they are not overstating what the research shows, and that they are not making disease prevention or treatment claims not approved by FDA. 66 Another FTC enforcement priority concerns food marketing to children. In 2008, the FTC published a food marketing study, entitled Marketing Food to Children and Adolescents: A Review of Industry Expenditures, Activities, and Self-Regulation. 67 Recommendations made by the FTC in the 2008 report include for companies to: adopt meaningful nutrition-based standards for all products marketed to children under age 12 through all forms of advertising and promotional techniques targeted to children; define marketing to children, for purposes of self-regulatory limitations, to encompass all advertising and promotional techniques, including: television, print, and radio; website, Internet, and digital advertising; word of- mouth and viral advertising; product packaging and retail promotion; movie and video promotion; use of premiums in connection with the sale of a product; product placements, character licensing, and cross-promotion; athletic sponsorship; celebrity endorsements; and in-school marketing; and limit licensing of their characters to healthier foods and beverages that are marketed to children. 68 In 2010, the FTC is expected to commence a study in follow-up to its study findings reported in 2008 concerning food marketing practices targeting children and adolescents. FTC plans to issue compulsory process orders to 48 food, beverage, and quick-service restaurant companies seeking information concerning food marketing activities and expenditures, as well as the nutritional quality of the particular food and beverage products marketed to children and adolescents. 69 The FTC plans to 63 FTC Bureau Director David Vladeck, Remarks at Council for Responsible Nutrition, Annual Symposium for the Dietary Supplement Industry, October 22, Id. 65 FTC Bureau Director David Vladeck, Remarks at National Advertising Division Conference, Oct. 6, Id. 67 FTC Website, FTC Report Sheds New Light on Food Marketing to Children and Adolescents, July 29, 2008, avaialbe at 68 Id. 69 Agency Information Collection, Activities; Submission for OMB Review; Comment Request, 75 Fed. Reg (May 25, 2010) (documenting FTC s request for OMB approval of its proposal to to issue compulsory process orders to major food and beverage manufacturers, distributors, and marketers and quick service restaurant companies for information concerning, among other things, their marketing activities and expenditures targeted toward children and adolescents and nutritional information about the companies food and beverage products marketed to children and adolescents, and noting that the Commission would not issue the information requests until Summer 2010 ). The FTC s authority to issue the requests is granted by Section 6(b) of the FTC Act, 15 U.S.C. 46(b).

18 2010 FOOD & BEVERAGE PRODUCTS 463 evaluate the extent to which the recommendations made in the FTC s 2008 report have been implemented and whether nutritional standards or other requirements should be established for foods marketed to children and adolescents. The FTC is also expected to publish proposed voluntary standards for marketing 70 foods to children ages 2-11 and teens ages 12-17, on behalf of an Interagency Working Group directed by Congress to develop recommendations regarding food marketing to youth under the age of B. FTC Enforcement Activities 1. Structure Function Benefit Claims Concerning Healthy Child Development a. Claims Concerning Omega-3 Fatty Acids and Nutritional Support Benefits for Healthy Brain and Eye Development in Children A convergence in FTC enforcement priorities concerning health-benefit claims and foods marketed for children is evidenced by its recent investigations linked to omega-3 fatty acids. On February 26, 2010, the FTC issued a press release warning marketers of children s omega-3 fatty acid supplements that claims about brain and vision benefits may be deceptive. 72 The FTC sent letters to 11 companies promoting various omega-3 fatty acid supplements, urging them to review their product packaging and labeling, and suggesting that their product packaging and advertising might be in violation of the FTC Act unless they have scientific evidence to support claims that their products boost, improve, enhance, or support brain and vision function and development in children. 73 While the FTC s investigation was centered on dietary supplements, the FTC has recently challenged similar marketing claims for conventional food products For TV advertising purposes, covered food marketing would include food marketing on any program where at least 30% of the viewing population is under the age of 12, any program where at least 20% of the viewing population is between the ages of 12 and 17, or any of the top five viewed programs of the year. 71 As part of the FY 2009 Omnibus Appropriations Act, the FTC, together with FDA, the Center for Disease Control (CDC), and the U.S. Department of Agriculture (USDA), were directed by Congress to establish an Interagency Working Group on Food Marketed to Children [Working Group] to conduct a study and develop recommendations for standards for marketing of food when such marketing targes children that are 17 years old or younger or when such food represents a significant component of the diets of children. The FTC participated in an Interagency Working Group along with FDA, the USDA, and the CDC. The Working Group was also directed to submit a report containing the findings and recommendations of the Working Group to Congress no later than July 15, The proposed standards were designed to limit food marketing to foods designated by the Working Group as either foods [that] are a part of a healthful diet, foods that provide a meaningful contribution to a healthful diet, or foods that do not contain more than [specified] amounts of saturated fat, trans fat, sugar, and sodium. Currently available on the FTC website, at gov/bcp/workshops/sizingup/presentations/schneeman.pdf, 72 FTC Press Release, FTC Warns Marketers of Children s Omega-3 Fatty Acid Supplements that Claims About Brain and Vision Benefits May Be Deceptive, Feb. 26, 2010, at gov/opa/2010/02/omega.shtm. 73 Additional areas of interest included claims relating to intelligence, cognitive function, learning ability, focus, mood, memory, attention, concentration, visual acuity, and eye health. Id.. 74 Discussed infra II.B.1.C.

19 464 Food and Drug Law Journal Vol. 65 b. Claims Concerning Antioxidants and Essential Vitamins and Minerals and Nutritional Support Benefits for Healthy Brain, Eye, and Immune System Development The FTC warning letters concerning omega-3 fatty acids and nutritional support benefits for healthy brain and eye development stemmed from an earlier FTC investigation which evaluated similar structure function claims used by Northwest Natural Products (NNP) to promote its L il Critters line of children s vitamin and mineral supplements. Specifically, the FTC investigation focused on marketing claims describing ways in which the essential vitamins and minerals in NNP s product formulation could help promote healthy development of the brain, eyes, and immune system in children, and characterizing particular functional and healthrelated benefits associated with adequate nourishment and healthy functioning of brain, eye, and immune system tissues. The FTC investigation focused on product representations, including the following: Boosts the immune system and prevents or treats colds or other types of illnesses in children ; Boosts, improves, or promotes brain function (e.g., attentiveness), brain development, intelligence, or academic achievement in children ; or Enhances or promotes brain or eye function in children. 75 Importantly, the FTC challenges similar claims in three consent orders regarding conventional food products which were marketed for consumption by children issued since January 2009, discussed below. c. Claims Concerning Antioxidants, Essential Vitamins, and Probiotic Ingredients of Conventional Foods and Nutritional Support Benefits for Healthy Brain and Immune System Function Notably, since January 2009, FTC has issued four consent orders that have resulted from FTC investigations of structure function claims promoting conventional food and beverage products, and in three cases, the marketing claims at issue were comparable to dietary supplement claims the FTC has challenged characterizing nutritional support for healthy development of the brain, immune system, and functional benefits. 76 For example, in July 2010, the FTC published a proposed consent order in a matter involving a children s probiotic beverage product in which the Commission alleges that certain immune system benefit claims concerning a probiotic ingredient were unsubstantiated, including the claims prevents upper respiratory tract infections in children, strengthens the immune system, thereby providing protection against cold and flu viruses, and reduces absences from daycare or school due to illness FTC Closing Letter to Northwest Natural Products, FTC File No , (October 30, 2009). 76 See, In the Matter of Nestle Healthcare Nutrition, Inc., File No (July 14, 2010) (involving allegations regarding the use of implied immunity-related claims that the product prevents upper respiratory tract infections in children, strengthens the immune system, thereby providing protection against cold and flu viruses, and reduces absences from daycare or school due to illness ); In the Matter of Kellogg Company, Docket No. C-4262 (June 10, 2010)(modified order)(involving an investigation of immunity-related claims including now helps support your child s immunity, 25 percent Daily Value of Antioxidants and Nutrients Vitamins A, B, C, and E, and improved to include antioxidants and nutrients that your family needs to help them stay healthy ); and In the Matter of Kellogg Company, Docket No. C-4262 (Jul. 27, 2009) (involving allegations regarding the use of mental performance benefit claims concerning focus and attentiveness). 77 See, In the Matter of Nestle Health Care Nutrition, Inc. Id.

20 2010 FOOD & BEVERAGE PRODUCTS Structure Function Claims Concerning Mental Performance Benefits of Caffeinated Alcoholic Beverage Products In June 2009, the FTC published a consent order in a matter in which the FTC challenged certain mental performance benefit claims used to market a caffeinated alcoholic beverage product, which included claims concerning mental alertness benefits. 78 Notably, the FTC filed its complaint against the company shortly after FDA received a formal letter from 18 State Attorney Generals (AGs letter) 79 expressing grave concerns about the health and safety hazards posed by alcoholic energy drinks, also known as caffeinated alcoholic beverages, believed to be growing in popularity amongst college students. 80 A month after the Commission filed its complaint regarding the mental performance claims made for a caffeinated alcoholic beverage, FDA issued a guidance document notifying the industry of FDA s intent to examine the safety and legality of caffeinated alcoholic beverage products, and whether caffeine can lawfully be added to alcoholic beverages. 81 While FDA has yet to publish the results of its investigation into the safety of caffeine in alcoholic beverages, caffeinated alcoholic beverages remain a priority for both agencies. III. PRIVATE LITIGATION A. Recent False Advertising Cases The following discussion addresses key litigation developments since January 2009 concerning false advertising lawsuits challenging marketing claims relating to nutrition and health-related product benefits, or ingredients (e.g., high fructose corn syrup) which present sensitive issues in the context of obesity prevention and other diet-related public health policy issues. 78 In the matter of Constellation Brands, Inc., Docket No. C-4266 (June 10, 2009). 79 Letter from AGs to FDA regarding Alcoholic Energy Drinks, September 25, 2009 available at The letter requested that FDA use its authority under the FDCA to cause the immediate removal of [caffeinated alcoholic beverages] from the marketplace on the grounds that use of caffeine (and other stimulants that are metabolized as caffeine) as an additive to alcohol is not generally recognized as safe, under FDA regulations. The letter also included a list of 27 manufactures of caffeinated alcoholic beverages, and was accompanied by a letter from scientists discussing the scientists opinion regarding the safety of combining alcohol with caffeine. FDA sent letters to the 27 manufactures listed in the AGs letter, notifying the companies that FDA is investigating the safety of their caffeinated alcoholic beverage products and was unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages was GRAS or prior sanctioned. The FTC s complaint was filed against Constellation Brands on October 6, The letters included a request that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. Notably, FDA only sent letter to the 27 companies included on the list provided by the state attorney generals. See FDA Website, Q&As on Caffeine in Alcoholic Beverages, available at (noting the list of manufacturers [sent FDA letters] was provided to FDA in a letter from the co-chairs of the National Association of Attorneys General Youth Access to Alcohol Committee, and that at this point, FDA has no information regarding any additional products, other than the additional list ). 81 The investigation is limited to products in which caffeine has been intentionally added to alcoholic beverages by manufacturers and is not directed at products that are flavored with coffee. See FDA Website, Q&As on Caffeine in Alcoholic Beverages, available at FoodIngredientsPackaging/ucm htm. While FDA approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million, FDA has not approved caffeine for use at any level in alcoholic beverages.