Abstract
This Article offers a thorough analysis of an important public health issue, namely how to confront the growing problem of deceptive claims regarding foods and dietary supplements, including increasingly prevalent but unverifiable claims. The authors call for the creation of a limited private right of action under the Federal Trade Commission (FTC) Act for deceptive health-related claims for these products. The proposal responds to the growing market for these products and the inadequacy of current laws and enforcement actions to prevent such claims. In crafting the limited private right of action, the authors attempt to enhance consumer protection without undermining federal agency primacy in enforcement. The Article ends with an appendix setting forth proposed language for a statutory amendment to the FTC Act incorporating the authors' proposal. ††
I. INTRODUCTION
Consumers are currently facing a torrent of new health-related claims as they shop for foods and dietary supplements (hereinafter referred to as “nutritional products”) in grocery stores, pharmacies, health food stores, and on the Internet. 1 Some of these products make claims that they support immunity, improve memory, 2 and even cure cancer. 3 Such claims appear to be a response to increasing popularity among consumers of nutritional products that improve or maintain health and wellness. 4 Surveys have shown that United States consumers base decisions to purchase these foods and dietary supplements almost exclusively on “product labeling claims” 5 that describe health benefits. 6
Claims about health benefits are more persuasive to consumers when they appear to be authoritative. The problem with seemingly authoritative claims, however, is that most of them are neither based on rigorous clinical studies nor vetted by any government agency. 7 Some lack any evidence of effectiveness; 8 others go beyond what is permitted by law. 9 Although this is not a new problem, 10 it is compounded by the vigorous marketing of new product lines, such as probiotics, claiming a wide variety of health benefits. 11 The growing market for these new products, 12 coupled with the lack of reliable studies of their efficacy, 13 creates additional challenges for consumers and regulators. 14
Preventing deceptive claims 15 about the health-related benefits of nutritional products is an important goal of both federal and state consumer protection policies. 16 Promoting nutritional products through deceptive claims can cause a variety of harms. 17 The most obvious is the financial exploitation of consumers through deceptively induced sales. 18 Even more troubling is the potential for harm caused by giving consumers false hope that nutritional products are the best solution to their health problems. 19 In the case of some nutritional products, Internet advertisements claim that the products can improve symptoms related to serious illnesses, including chronic diseases and chronic pain. 20 Such claims might lead consumers to forgo medically recommended therapies. 21 Consumers who are taking prescription drugs face the additional risk that some of these nutritional products, in particular dietary supplements, may result in harmful interactions. 22
Both the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) regulate claims made by food and dietary supplement manufacturers. 23 FDA regulates labeling, while the FTC regulates advertising. 24 Under the Food, Drug and Cosmetic (“FD&C”) Act, labels on these products must not be false or misleading. 25 Under the FTC Act, claims in advertising made about foods and dietary supplements may not be “unfair” or “deceptive.” 26
While FDA and the FTC have made some efforts to challenge companies making deceptive health claims, 27 the lack of resources for enforcement, the difficulty of policing advertising on the Internet, and the lure of profit by food and dietary supplement manufacturers make it virtually impossible for FDA and the FTC to keep pace with the marketing strategies for these products. 28 Moreover, FDA's regulatory power over these manufacturers has actually declined over the last few decades due to limitations placed on the agency by Congress and the courts. 29 In addition, it is unlikely that these enforcement mechanisms adequately deter “quick hit” marketers who are not concerned about long-term business or reputation. 30
In order to bolster the enforcement tools available to combat the problem of deceptive health claims for nutritional products, we propose a limited private right of action under the Federal Trade Commission Act. As background to this proposal, in Part II of this article we expand on the problem of deceptive health-related claims for foods and dietary supplements amidst the growing demand for these products. In Part III, we describe the current legal standards under the FD&C Act, the FTC Act, and state consumer protection laws governing deceptive claims made by nutritional product manufacturers. Part III also examines current enforcement efforts aimed at ensuring compliance with the laws. In Part IV, we describe the limits of existing law and enforcement capabilities of the relevant federal agencies as well as the limits and shortcomings of state laws and their use by consumers. Part V describes the benefits, risks, and contours of the proposed limited private right of action, with an emphasis on creating an approach that will augment existing enforcement tools and lead to more effective consumer protection without undermining important federal agency control and enforcement goals. Finally, Appendix A offers suggested language for a statutory amendment to the FTC Act establishing the proposed private right of action.
II. THE PROBLEM OF DECEPTIVE CLAIMS IN THE MARKETING OF NUTRITIONAL PRODUCTS
Several prominent news stories have reported a growing prevalence of deceptive health claims for nutritional products sold at grocery and drug stores. 31 For example, a 2011 New York Times article quotes consumer advocates and nutritionists as stating that “shoppers are being bamboozled by slick marketing” of these products and that these products are not about health but about marketing. 32 Similarly, a 2010 Scientific American article warned consumers that many supermarket health claims are not supported by science and that the government does not endorse them. 33 These articles and others provide numerous examples of companies that lack substantiation for their claims, and at times even ignore evidence that shows their product clearly does not do what they claim it does. 34 The claims are being made for two types of products: foods with alleged health benefits (also called functional foods 35 ) and dietary supplements; such as vitamins, minerals, and herbs; intended to add nutritional value to the diet. Both consumer groups and government agencies have weighed in on the extent of the problem.
The Center for Science in the Public Interest (“CSPI”), a consumer advocacy organization with a mission to carry out “innovative research and advocacy programs in health and nutrition, and to provide consumers with current, useful information about their health and well-being,” 36 has made food labeling and deceptive health claims a priority in its advocacy program. In 2013, the organization initiated its “Stop the Lying Labels” campaign. 37 In an email to members of a CSPI listserv, Michael Jacobson, the organization's executive director, stated that in his forty-plus years of dealing with the food industry, he has “never encountered such bold deception and disregard for the law” as he sees now in the area of food labeling. 38 He cites as examples claims by General Mills “that some of its corn-syrup-drenched products are ‘natural’” and claims by Coca-Cola about its “Vitamin water (which [he states] would be better called Sugar water).” 39
Similarly, government reports and statements have been critical of claims being made by dietary supplement manufacturers—in particular, structure/function claims. 40 The criticism is that these claims go outside the bounds of the regulatory limits on them and bleed into the disease claim (i.e., drug) category, 41 thus requiring premarket approval by FDA, and that manufacturers have not done the studies necessary to substantiate their claims. In 2010, the Government Accountability Office (“GAO”) issued a report in which it described numerous examples of deceptive or questionable marketing practices by dietary supplement manufacturers and retailers. 42 Of the questionable practices they found, the most egregious were “suspect marketing claims that a dietary supplement prevented or cured extremely serious diseases, such as cancer and cardiovascular diseases” or that it reduced the symptoms of Alzheimer's disease. 43
The FTC has also asserted that the food and dietary supplement industries are making health-related claims that are often “false or unproven.” 44 In particular, the agency cites a “trend in food advertising toward making unproven claims that eating certain foods can improve health and even reduce the risk of serious illnesses such as prostate cancer and heart disease.” 45
While there is little hard evidence of the extent of the problem, a walk through a supermarket or pharmacy reveals the pervasiveness of health claims on product labels. Moreover, the growing demand for these products suggests that the problem will increase over the next several years. Markets for both dietary supplements and functional foods are booming. A 2012 Department of Health and Human Services (“DHHS”) Office of Inspector General (“OIG”) report on structure/function claims about dietary supplements states that in this country, “dietary supplements are a $20 billion-per-year industry and are used by 80 percent of adults for a wide range of purposes.” 46 The worldwide market for these products is also flourishing. According to a 2013 article in Forbes, “[o]ne of the fastest growing industries in the world is the nutritional supplement group…. Producing about $32 billion in revenue for just nutritional supplements alone in 2012, it is projected to double that by topping $60 billion in 2021.” 47 The FTC suggests on its website that consumers have turned to supplements as a result of a “downturn in the economy” and as a way to “avoid expensive doctor visits and prescription medications.” 48
The market for functional foods and beverages is growing at an even greater rate than dietary supplements, with the global market for these products reaching over $170 billion in 2013. 49 According to one source, “this booming category now accounts for 5% of the overall food market and is driving growth for the food industry as a whole.” 50 The same source also attributes this sales growth to consumers looking to these products as a health solution. In particular, consumers are looking to functional foods as a way to manage “chronic conditions, such as diabetes, [cardio-vascular disease] or obesity.” 51 Claimed benefits of these foods include boosting energy levels, improving or maintaining gut, bone and heart health, managing weight, and sharpening mental faculties. 52 One of the fastest growing segments of both the dietary supplement and functional food markets is probiotics, in large part due to manufacturers' claims about the role of probiotics in wellness and health improvement. 53
The functional food market consists of a number of large multinational companies who are the “key functional food players,” 54 but “smaller participants are successfully creating and defending niches in the market.” 55 Large segments of the market include soft drinks (primarily enhanced water and energy drinks) and dairy products, especially yogurts. 56 Both consumer demand and the potential for premium pricing by manufacturers and retailers 57 are attracting suppliers to this market.
Some observers differentiate between major manufacturers of nutritional products with significant investments in brand reputations and smaller manufacturers, some of which operate on the fringe of legality. Steve Mister, president of the Council for Responsible Nutrition, a trade association representing dietary supplement and functional food manufacturers, describes the supplement business as a “tale of two industries. There's a mainstream, responsible industry. Then there is this sort of shadow industry, the smaller guys playing around the fringes. The problem is how we distinguish between the two.” 58 He characterizes some members of the industry as “rogue players [who] are poisoning the reputation of the industry” for everyone. 59
III. REGULATION OF HEALTH CLAIMS AND RECENT EFFORTS TO COMBAT DECEPTIVE CLAIMS
Federal statutes regulating deceptive health claims include the Federal Food, Drug, and Cosmetic Act, 60 the Dietary Supplement Health and Education Act (“DSHEA”), 61 the Nutrition Labeling and Education Act (“NLEA”), 62 and the Federal Trade Commission Act. 63 Each statute, augmented by agency regulations and guidance documents, has a separate framework for establishing when claims violate the law. In addition to these federal laws, state consumer protection laws provide standards for making claims about consumer products and function as another enforcement avenue for consumers harmed by deceptive advertising.
A. FDA
FDA is responsible for ensuring that foods and dietary supplements are properly labeled and, if they make claims about the products, that such claims are not false or misleading. 64 Food labeling is in large part governed by the NLEA, which requires most foods to include nutrition labeling and “requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements.” 65 In addition, under the FD&C Act, foods and dietary supplements may not be adulterated or misbranded. 66 A product is misbranded if its label is “false or misleading in any particular” 67 or if the product is not in compliance with labeling requirements. 68 As to claims, FDA statutes and regulations permit manufacturers of foods and dietary supplements to make three types of claims on their labels: health, nutrient content, and structure/function. 69 Foods and dietary supplements may not make disease claims, which are claims that describe the effect of a substance on the diagnosis, treatment, mitigation, cure, or prevention of disease. 70 Any product that makes a disease claim is considered a drug and must go through the extensive and costly drug approval process prior to marketing. 71
Of the three types of claims permissible for dietary supplements and foods, only claims in the health category require premarket FDA approval. 72 Such claims include “health claims” 73 and “qualified health claims.” 74 Prior to 1990, health claims on food products were prohibited. It was only after the passage of the NLEA 75 that health claims were permitted. 76
FDA defines health claims as claims made on the label of a food or dietary supplement that characterize the relationship between the labeled substance and the reduced risk of a disease or health-related condition. 77 FDA may approve health claims for foods and dietary supplements only if the claimed relationship between the nutritional product and reduction of risk of disease is based on “significant scientific agreement among experts.” 78 FDA responds to a petition for approval and authorizes these types of health claims only after an extensive review of the scientific literature and the promulgation of a specific regulation permitting the claim. 79 An example of a health claim approved through this process is “adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.” 80
Manufacturers of foods (but not dietary supplements) may also make health claims if the claim is based on an “‘authoritative statement’ from certain scientific bodies of the United States government 81 or the National Academy of Sciences.” 82 A food manufacturer or distributor that intends to make such a claim must submit a notification to FDA, which then has 120 days to respond if it finds that the notification does not comply with the Food and Drug Administration Modernization Act. 83 This type of marketing does not require promulgation of a regulation; however, FDA may prohibit or modify such a claim by regulation. 84
An additional type of health claim, the “qualified health claim” (“QHC”), was established by FDA in response to the D.C. Circuit court's decision that a dietary supplement manufacturer has a First Amendment right to make health claims based on less scientific evidence than the “significant scientific agreement” standard requires, as long as such claims do not mislead consumers. 85 QHCs can be made for both foods and dietary supplements, and they differ from other health claims “in that they must be accompanied by a disclaimer or otherwise qualified.” 86 Manufacturers or distributors wishing to make a QHC must submit a petition to FDA summarizing the scientific data in support of the claim the petitioner wishes to make, including copies of computer literature searches, all research articles relied upon to support the petition, and information about any adverse consequences from the food or dietary supplement for any segment of the United States population. 87
Food manufacturers may make a second type of claim, “nutrient content claims.” 88 Subject to FDA's criteria, 89 a manufacturer may make claims, for example, that a product is good, excellent, enriched/fortified, or high potency with respect to vitamins, minerals, fiber, or protein; that a product is “lite” or “light” with regard to calories or sodium; or even that a product is “healthy.” 90 Such claims can be used on labels without review by FDA, as long as they comply with all FDA definitions and rules. 91 All other nutrient content claims are prohibited. 92
Food and dietary supplement manufacturers can also make structure/function claims, 93 which are claims that describe the role of a nutrient or dietary ingredient intended to affect the normal structure or functions of the human body. 94 While these claims do not require premarket approval, the manufacturer must ensure their accuracy and must have substantiation to support its claims. 95 For dietary supplements (but not foods) making structure/function claims, the manufacturer must notify FDA within thirty days of placing the product on the market. 96 The notification must include an attestation by the manufacturer that the “[manufacturer] has substantiation that the claim is truthful and not misleading.” 97 In addition, dietary supplement manufacturers making structure/function claims must include a disclaimer that the claim has not been evaluated by FDA and that the product is “not intended to ‘diagnose, treat, cure or prevent any disease.’” 98
Of each of the three types of claims that nutritional product manufacturers may make, structure/function claims are especially problematic in terms of consumer deception. The fact that these claims do not require premarket approval creates the opportunity for claims that lack scientific support and even make outright false statements. 99 Structure/function claims are also used much more frequently than health claims apparently because they allow companies to bypass the approval process required for health claims. 100 The OIG and GAO have issued several reports criticizing structure/function claims, especially as they relate to dietary supplements. 101
B. The FTC
The FTC's requirements regarding substantiation for health-related product claims differ from those of FDA. Unlike FDA, the FTC does not require premarket approval of claims, does not make regulatory distinctions between product categories (e.g., drug, supplement, food), and does not make regulatory distinctions between types of claims (e.g., health, nutrient content, structure/function). 102 However, the FTC does have legal authority to take action against false or misleading claims for many types of products and services. 103 These include foods, drugs, and dietary supplements. 104
The FTC's jurisdiction over health claims stems from three provisions of the FTC Act. Section 5 of the Act prohibits “unfair or deceptive acts or practices in or affecting commerce.” 105 Section 12 prohibits false advertisements for “food, drugs, devices, services, or cosmetics,” 106 and Section 15 defines false advertisement for the purpose of Section 12 as one that is “misleading in a material respect.” 107 In a separate policy statement, the FTC has explained that in its enforcement of these provisions, it looks first to whether the claim contains a misrepresentation or omission of fact that is likely to mislead a consumer acting reasonably under the circumstances. 108 Second, the agency considers whether that representation is material to the consumer's purchasing decision. 109 Thus both false claims, claims made without disclosure of material facts, and unsubstantiated claims may violate the law.
When claims are targeted to a specific group, the FTC interprets the claims from the perspective of a reasonable consumer in the target group. 110 For some advertising, this audience is the general population. If, however, a manufacturer targets its product to a particular subgroup, the advertisement will be evaluated from the perspective of how it is likely to be interpreted by a reasonable member of that subgroup. 111 Because advertisements may have more than one reasonable interpretation, where an advertisement conveys more than one meaning, only one of which is false or misleading, a “seller is liable for the misleading interpretation.” 112 The agency considers the interpretation reasonable if it is the one the seller “intended to convey.” 113 Consumers may be especially susceptible to health claims, because they usually lack the knowledge to assess claims referring to physiology or metabolic processes and may be especially impressed by purported scientific evidence bolstering the claims. 114
In the FTC's long-held view, making claims without a reasonable basis is a deceptive practice. In determining whether there is a “reasonable basis” for a claim, the FTC will consider: “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts in the field believe is reasonable.” 115 Where an advertisement represents, either expressly or by implication, that the claim is supported by a certain amount of substantiation, the advertiser must possess, at the time the claim is made, at least that amount of support for the claim. 116
Although the FTC does not have separate rules governing foods and dietary supplements, it has issued industry guidance documents for both products. 117 The Commission's Enforcement Policy Statement on Food Advertising was made public in May 1994. 118 This was prior to the passage of DSHEA, which, as discussed above, allows dietary supplement manufacturers to make structure/function claims without FDA approval prior to marketing. As a result, the statement focuses on health claims and nutrient content claims. The subsequent passage of DSHEA raised numerous questions about the FTC's approach to applying its consumer protection laws to dietary supplements. The guidance document for dietary supplement manufacturers states that the FTC's “approach to supplement advertising is best illustrated by its Enforcement Policy Statement on Food Advertising” and that in general the FTC gives “great deference to an FDA determination of whether there is adequate support for a health claim.” 119
Both guidance documents provide that health-related claims must be substantiated by competent and reliable scientific evidence. 120 More specifically, this must be evidence consisting of: “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” 121 In evaluating health claims for foods and dietary supplements, the FTC will look to “well-designed studies, including clinical research and other forms of reliable and probative scientific evidence.” 122 Furthermore, the FTC states that it will apply the same “significant scientific agreement” standard applied by FDA to claims “about the relationship between a nutrient or substance in a food and a disease or health-related condition.” 123
In evaluating a structure/function claim for a dietary supplement, the FTC will assess whether the claim might convey an implication that the product will treat a disease. If so, the manufacturer will need to provide substantiation of the implied disease treatment claim. 124 The industry guidance document for dietary supplements states that for substantiation there “is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration. There are, however, a number of considerations to guide an advertiser in assessing the adequacy of the scientific support for a specific advertising claim.” 125 These include whether the advertiser has the level of support it claims to have; whether experts in the relevant area of study would generally agree that the amount and type of evidence for the particular claim is sufficient; whether any research conducted was well designed, implemented and analyzed; whether the totality of the evidence supports the claim; and whether the evidence is relevant to the specific claim. 126
Although FDA regulates labeling, the FTC will also evaluate dietary supplement labels if they are being used by an advertiser to promote the product, and the FTC will follow an approach similar to FDA's review of such materials with regard to labeling. 127
C. Recent Enforcement Efforts by FDA and the FTC Against Nutritional Product Manufacturers for Deceptive Claims
Under a memorandum of understanding (“MOU”) originally executed in 1954, FDA and the FTC share jurisdiction for enforcement of claims made by manufacturers of health-related products. 128 FDA has primary authority for overseeing the advertising of prescription drugs and the labeling 129 of drugs, supplements, foods, devices, and cosmetics. With the exception of prescription drugs, the FTC has primary authority for overseeing advertising of health-related products. 130 The MOU did not address claims made on the Internet, but “both agencies have asserted jurisdiction over claims appearing on company websites.” 131 The agencies coordinate closely on food and dietary supplement policy issues. 132
FDA and the FTC have a variety of enforcement tools available to address deceptive claims. For example, FDA can ask companies to voluntarily recall any product that has already entered the distribution chain. 133 In addition, FDA can send a warning letter to a firm stating that “enforcement actions may be forthcoming if corrections are not made.” 134 If violations are not corrected, FDA can seize and remove the product from the marketplace. 135 Both FDA and the FTC can enjoin a firm from continuing a practice that violates labeling or advertising statutes and regulations by seeking an injunction or sending a cease and desist order. 136 In addition, FDA can recommend criminal prosecution of a company engaging in criminal conduct, 137 and the FTC can assess civil monetary penalties, order refunds to consumers, and require corrective advertising, disclosures, or other informational remedies aimed at rectifying the deception. 138
During the mid-2000s, FDA was criticized by public interest groups, Congress, and the GAO for its inability to keep up with the prevalence of food labeling violations. 139 CSPI pointed out the small number of warning letters issued by the agency in light of the apparent growing numbers of labels that did not comply with the law and asserted that FDA had “all but abdicated its responsibility to police inaccurate nutrition statements and misleading health-related claims on food labels.” 140 In 2009 and 2010, FDA issued two open letters to the food industry urging manufacturers to comply with labeling requirements, and in 2010, as part of an enforcement initiative, FDA issued seventeen Warning Letters in one day to food manufacturers that were alleged to have made unsubstantiated or misleading health and nutrient content claims. 141 From January 2011 to June 2012, FDA issued “numerous warning letters” to food manufacturers for failure to comply with requirements for food labeling and health claims. 142 Since June 2012, FDA has continued to issue warning letters at the rate of about sixty per year 143 to food and dietary supplement manufacturers whose labels or claims violate the law, but FDA has generally not engaged in other methods of enforcement against these companies. 144 Moreover, FDA has issued very few warning letters for certain types of claims, specifically qualified health claims. According to a recent article, “FDA has issued only seven warning letters referencing qualified health claims” and “promotional health-related claims are not a high enforcement priority.” 145
The FTC has been somewhat more active in enforcement of laws under its jurisdiction regarding deceptive health claims. 146 In a prepared statement given to the Senate Special Committee on Aging as part of a hearing on deceptive marketing of dietary supplements in 2010, the FTC stated that between 2000 and 2010, it had filed “well over 100 law enforcement actions challenging claims about the efficacy or safety of a wide variety of supplements,” 147 and that it “focused its enforcement on national advertising campaigns for products with unproven benefits, products promoted to treat or cure serious diseases, products that may present significant safety concerns to consumers, and products that are deceptively marketed to vulnerable populations, such as children or the elderly.” 148 Recent examples of major FTC enforcement actions include cases against Nestlé Healthcare Nutrition, Inc. (a subsidiary of Nestlé S.A.), the Dannon Company, Inc., and POM Wonderful, LLC.
In 2010, the FTC brought an action against Nestlé Healthcare Nutrition, Inc. for claims made about its product, Boost Kid Essentials. 149 The product is a nutritional drink for children with probiotics embedded in a straw that comes with the drink. 150 Advertisements for the product claimed that consumption of the drink would reduce illness in children, protect children from colds and flu by strengthening their immune system, and help children up to age thirteen recover more quickly from diarrhea. 151
The FTC alleged in a complaint brought against the manufacturer that these claims were unsubstantiated and thus violated the FTC Act. 152 This was the agency's first complaint challenging deceptive advertising of a probiotic product. 153 In response, the company agreed, as part of a settlement, to stop claiming that Boost Kid Essentials would (1) “reduce the risk of colds, flu, and other upper respiratory tract infections” unless the FDA approved the claim; 154 and (2) “reduce children's sick-day absences and the duration of acute diarrhea in children up to age 13, unless the claims [were] true and backed by at least two well-designed human clinical studies.” 155
In a second action in 2010, the FTC entered into a settlement with the Dannon Company, Inc. after alleging in a complaint that the company had engaged in deceptive advertising by exaggerating the health benefits of its Activia yogurt and DanActive dairy drink. 156 In its complaint, the FTC stated that “Dannon claimed in nationwide advertising campaigns that DanActive helps prevent colds and flu, and that one daily serving of Activia relieves temporary irregularity and helps with ‘slow intestinal transit time’” without sufficient evidence to back these claims. 157 Similar to the settlement with Nestlé Healthcare Nutrition, Inc., the FTC required that Dannon refrain from claiming that “any yogurt, dairy drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu, unless the claim is approved by the Food and Drug Administration.” 158
Another enforcement action involved the pomegranate juice products marketed by POM Wonderful, LLC. On September 24, 2010, the FTC issued an administrative complaint alleging that POM Wonderful engaged in deceptive acts and practices and disseminated false advertising in violation of Sections 5(a) and 12 of the FTC Act, through the marketing of its juice and related products. 159 On review of an administrative law judge's initial decision, the FTC found that POM Wonderful had made deceptive claims in thirty-six advertisements. 160 The FTC held that POM Wonderful, without adequate substantiation, had made disease efficacy claims—namely, that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, and that their products were clinically proven to work. 161 For example, several advertisements claimed that “eight ounces of POM a day can reduce plaque in the arteries by up to 30%!” 162 The FTC wrote that “[s]uch references tend to communicate that the product's attributes are supported by scientific research because a reduction in the amount of plaque in an individual's arteries cannot be known through casual observation, i.e., it must be measured by a medical professional.” 163
The FTC prohibited POM Wonderful from making disease-related efficacy claims unless the claims were supported by “competent and reliable scientific evidence,” which the FTC defined as at least two clinical trials that were “randomized, well controlled, based on valid end points, and conducted by persons qualified by training and experience to conduct such studies.” 164 The agency further required that the studies “yield statistically significant results, and … be double-blinded unless [POM Wonderful could] demonstrate that blinding [could not] be effectively implemented given the nature of the intervention.” 165 POM Wonderful appealed the FTC's order, arguing that the FTC erred in its findings, imposed an unlawful remedy by requiring two randomized clinical trials, and transgressed First Amendment protection of commercial speech. 166 The D.C. Circuit, however, largely rejected POM Wonderful's contentions, holding that the FTC had substantial evidence in support of its findings and that POM Wonderful's claims were not entitled to First Amendment protection. 167 One modification ordered by the appellate court related to the remedy: the FTC's requirement for two clinical trials in support of disease-related claims was deemed unjustifiably rigid and hence a First Amendment violation; one high-quality trial might suffice to substantiate a claim. 168 This modification is significant because it pushed back on the agency's efforts to harmonize its regulation of health claims with FDA, in particular with its substantiation requirement. 169
The FTC has continued to bring high-profile enforcement actions against other food and dietary supplement manufacturers over the past few years. According to the 2014 Year-End FDA Compliance and Enforcement Update on foods and dietary supplements, prepared by the law firm Gibson Dunn, in 2014 the FTC “stepped up its scrutiny of health-related claims,” in particular for weight loss products, and announced that deceptive health claims remained “an ongoing FTC priority with respect to deceptive advertising practices.” 170
D. State Consumer Protection Laws
Every state has what are commonly called “mini-FTC” Acts or Unfair or Deceptive Acts or Practices (“UDAP”) laws. 171 While these laws vary across states, most state UDAP laws provide state attorneys general with an array of remedies to combat consumer fraud and deception. 172 Private litigants have also used UDAP statutes in class action suits for “alleged unfair and deceptive business practices.” 173
UDAP statutes generally allow a state enforcement agency, usually the attorney general, to obtain a court order “prohibiting a seller or creditor from engaging in a particular unfair or deceptive practice.” 174 An attorney general may also ask the court to impose civil monetary penalties for violations of the law and to order the seller to return payments to consumers. 175 For example, the California Attorney General used California's UDAP law to seek injunctive relief and civil penalties for allegedly unsubstantiated claims that certain ingredients in a multi-vitamin pill could protect against prostate cancer. 176 Despite differences in state UDAP laws, it is possible for attorneys general to act collectively if a national marketer is engaged in the same practices in all states. 177
Most statutes also allow consumers to seek similar remedies, for example, “return of payments or compensation for … consumer loss, … injunction[s] against repetition of the fraudulent practices, and, in most states, reimbursement for attorney fees.” 178 In 2009, the National Consumer Law Center issued a report stating that “[b]efore the adoption of state UDAP statutes in the 1970s and 1980s, neither consumers nor state agencies had effective tools against fraud and abuse in the consumer marketplace.” 179 Moreover, in most states, there was no state agency responsible for combatting consumer fraud and abuse. 180 Claims based on common law fraud posed numerous obstacles to consumers who would have to, for example, establish the seller's state of mind. 181 Even if a consumer had a reasonable chance of success, finding an attorney to take the case was challenging because few states had any provisions for reimbursing consumers for attorneys’ fees. 182
In recent years, consumers and public interest groups have used state UDAP laws to challenge food labeling and health claims. The Center for Science in the Public Interest has been a leader in these legal actions, often initiating a lawsuit or joining with other plaintiffs. In several cases the Center's legal action preceded suits filed by state attorneys general. Examples of the latter include cases against Coca-Cola for making fraudulent claims about Enviga, an artificially sweetened green tea soda, 183 and Bayer Healthcare, for claims that its “One A Day” men's multivitamins reduced the risk of prostate cancer. 184 While very few CSPI cases have gone to final adjudication, they have resulted in numerous settlements with food and dietary supplement manufacturers. 185 Moreover, in some cases CSPI threatened, but did not file, suit and was able to negotiate a change in labeling or claims with the manufacturer. 186
In addition to the legal actions brought by CSPI and state attorneys general, consumer advocacy groups have brought numerous suits. Between 2011 and 2014, consumers filed “more than 150 … class action lawsuits against food and beverage companies.” 187 Most of the suits have been for alleged violations of food labeling laws. Others have been for claims that, although not in direct violation of FDA food labeling laws, are allegedly misleading under state law. Many of the suits have involved foods labeled as “all natural,” 188 “nutritious,” or “healthful.” 189 Although almost none of these lawsuits have been adjudicated yet, 190 in some instances, the litigation has resulted in significant settlements. For instance, in 2010, the Dannon Company settled a false advertising lawsuit and agreed to establish a thirty-five million dollar fund to reimburse consumers who bought its Activia and DanActive yogurts. 191 The class action lawsuit alleged that Dannon made misrepresentations when marketing its Activia and DanActive yogurts by claiming nonexistent health benefits. 192 The settlement may have paved the way for subsequent lawsuits. 193
IV. LIMITATIONS OF LAW AND ENFORCEMENT CAPACITY
A. FDA
While FDA has stepped up its actions against food and dietary supplement manufacturers, the agency is hindered in its ability to curtail illegal claims in part because of limitations on its enforcement authority and enforcement methods. FDA's “principal enforcement tool” when confronted with a noncompliant food label “is to issue a Warning Letter to notify the manufacturer.” 194 Although FDA has other enforcement mechanisms that are more severe, including recall, seizure, civil monetary penalties, and injunctive relief, the law significantly limits their use in misbranding cases. 195 As a result, according to one author, “FDA primarily seeks voluntary compliance from food companies when food products are misleading or mislabeled,” and these “Warning Letters provide little incentive or threat for companies to avoid or discontinue use of misleading claims on food labels.” 196
FDA is also limited in its ability to monitor health claims that bypass required premarket approval or nutrient content claims that are not consistent with pre-approved claims. In addition, because structure/function claims do not require premarket approval, FDA is stymied in its ability to ensure that these claims are backed up by scientific evidence. Although dietary supplement manufacturers must submit a notification to FDA of their claim thirty days prior to marketing their product, “[t]he number of manufacturers that do not submit structure/function claims to FDA is unknown.” 197 FDA reviews all notifications submitted by dietary supplement manufacturers to ensure that they meet “the definition of a structure/function claim. If [they do] not, FDA sends a letter to the manufacturer notifying it that the claim is not in compliance and follows up as needed.” 198 A fundamental gap in the agency's enforcement ability is that the law does not require manufacturers to submit the substantiation the manufacturer relied on to make its claim, and unlike the FTC, FDA “may not compel manufacturers to produce substantiation upon request.” 199 As a result, FDA is limited in its ability to enforce the substantiation requirement, 200 and many manufacturers do not have adequate substantiation for their claims. 201 Moreover, once a product is on the market, if FDA believes that a structure/function claim is not truthful or is misleading, in any legal proceeding the burden is on FDA to prove that the claim is false or misleading, 202 rather than on the manufacturer to prove that the claim is true and not deceptive.
FDA has also been limited in its enforcement efforts by First Amendment protections of commercial speech. As discussed in Part III.A. above, the entire category of “qualified health claims” was a result of litigation establishing that FDA must allow claims with less than substantial evidence of their truth as long as they include disclaimers. The agency cannot simply bar such claims unless it can meet the burdensome test of demonstrating the inadequacy of the disclaimer. 203
A further constraint on FDA's enforcement capabilities is lack of resources. In order to weed out noncompliant food labels and deceptive claims, FDA must rely on consumer complaints, proactive monitoring of Internet advertising, and physically reviewing labels at retail stores. 204 The latter two methods might root out more regulatory violations, but they are extremely labor-intensive. FDA has conceded that it is overwhelmed, and it is “struggling to police this booming market.” 205 In a letter published in The Atlantic in 2010, Michael Taylor, FDA Deputy Commissioner for Foods, confirmed that the agency can only reach the tip of the iceberg of noncompliant claims. Although FDA issued twenty enforcement letters to food companies that were marketing misbranded products in February 2010, these letters “addressed just a small subset of the universe of products making dubious marketing claims.” 206 Mr. Taylor further stated that although FDA would undoubtedly issue more letters on labeling violations, he did not see FDA “eradicating questionable health claims … any time soon,” given that FDA has “no pre-market review authority over such claims, and, under prevailing legal doctrines concerning ‘commercial free speech,’ the evidentiary requirements placed on FDA to prove that such claims are misleading are significant and costly to meet.” 207 Moreover, he acknowledged that FDA is “conscious of the cleverness of marketing folks, … Going after them one-by-one with the legal and resource restraints [the agency] work[s] under is a little like playing Whac-a-Mole, with one hand tied behind your back.” 208
Mr. Taylor's reference to “resource constraints” reflects a mismatch between FDA's statutory responsibilities and its budget, a constraint that has been noted by former Health and Human Services Secretary Tommy Thompson. According to Thompson, who spoke at an Institute of Medicine meeting on Challenges for the FDA, the FDA has been chronically underfunded in carrying out its responsibilities for ensuring the safety of drugs, medical devices, and the nation's food supply. While the FDA is commonly viewed as the global gold standard for consumer protection, it faces stiff competition for scarce resources and over the past 20 years has been tasked to do far more with its limited resources.
209
More recently, David Kessler, former FDA Commissioner and a board member of CSPI, stated that “[t]he importance of CSPI's Stop the Lying Labels campaign is only going to grow in these days of slashed government budgets, when agencies cut back on even their most basic public services.” 210
B. The FTC
While the FTC has recently taken a number of actions against food and dietary supplement manufacturers for deceptive claims, there are also significant limitations on the FTC's approach to these violations of the law. Although the FTC has a broad range of enforcement actions it can take against manufacturers, it frequently relies on voluntary consent orders to gain compliance from offending companies. 211 When a company signs such an order, it need not admit that it violated the law, but only that it will stop the practices identified by the agency. 212
Also, like FDA, the FTC has limited enforcement resources, and, given the number of companies marketing nutritional products, it cannot investigate and prosecute every case. 213 As a result, the FTC tends to target large companies, hoping these actions will function as a deterrent to other companies engaging in similar practices. Whether this strategy actually deters other large companies is unclear, but it is unlikely that it prevents smaller businesses from advertising their products on the Internet with deceptive claims. The bifurcated nutritional product industry—with a handful of multinational corporations and hundreds of smaller businesses, a number of which have been described as “rogue” or “fringe” operators 214 —creates challenges for the federal agencies attempting to regulate that market. 215 To the extent that such fringe players seek quick profits from deceptive practices and then shift corporate identities, these players present a particularly difficult target for FDA and FTC enforcement efforts. 216
C. State consumer protection laws
While consumers are taking advantage of state UDAP laws to bring suits against nutritional product manufacturers that make deceptive claims, there are also problems and inefficiencies to such state-based action. These problems include: (1) limits on the substantive provisions of state laws and differences in what they prohibit; (2) uncertainty about how state courts will rule in these cases; (3) potential inconsistencies in outcomes from state to state as well as potential inconsistencies with federal enforcement policies; and (4) potential for over-reaching by plaintiffs who seek damages by bringing suits without a bona fide claim in hopes of an inflated settlement. As to the first of these, the National Consumer Law Center has observed that state UDAP statutes are too variable and constricted to be a strong deterrent to false health claims: The effectiveness of UDAP laws varies widely from state to state. The holes are glaring. Legislation or court decisions in dozens of states have narrowed the scope of UDAP laws or granted sweeping exemptions to entire industries. Other states have placed substantial legal obstacles in the path of officials charged with UDAP enforcement, or imposed ceilings as low as $1,000 on civil penalties. And several states have stacked the financial deck against consumers who go to court to enforce the law themselves.
217
Also, although the large majority of the claims seem to be brought in California, private litigants in California (and other states) are unable to argue that an advertised health benefit is deceptive because it lacks substantiation. California courts have stated: Claims that rest on a lack of substantiation, instead of provable falsehood, are not cognizable under the California consumer protection laws…. Challenges based on a lack of substantiation are left to the Attorney General and other prosecuting authorities; private plaintiffs, in contrast, have the burden of proving that advertising is actually false or misleading.
218
This can be a significant burden. 219
As to the second and third problems, while over 100 cases have been brought against food manufacturers by litigants using state laws, 220 almost none have been decided, 221 thereby creating uncertainty as to whether the state laws will actually be interpreted in a way that will lead to positive outcomes for plaintiffs, or indeed whether state courts will play a positive role in developing sound public policy regarding health claims. The latter is of particular concern to FDA and the FTC, which seek consistency across enforcement actions. The proliferation of suits, in the absence of some overarching framework, potentially undermines the federal agencies' goals of a coherent and authoritative set of laws and policies to guide the regulated community. From the perspective of risk-averse nutritional product manufacturers, inconsistencies in outcomes from state to state would create costly uncertainty, 222 as well as the burden of having to market their products differently in different states.
Finally, regarding the fourth problem, the opportunity for generous damages for plaintiffs, and contingency fees for their attorneys, may lead to overreaching, or bringing suits that lack legitimacy. A manufacturer might make a business judgment to settle such claims, despite their lack of merit, in order to avoid the costs associated with protracted litigation. 223
V. A LIMITED FEDERAL PRIVATE RIGHT OF ACTION AS A SUPPLEMENT TO GOVERNMENT ENFORCEMENT
A. The Need for a New Law
Laws that empower government agencies to protect consumers are predicated on market failure; in many areas, this means “key information necessary for consumers to make a sensible choice between rival brands, or to decide whether to buy the product at all, is absent.” 224 Yet, government agency protection can fail when the federal enforcement regime is disproportionately small, measured against the size or nature of the marketplace to be policed. “[R]egulation is only as good as the enforcement mechanisms underlying it.” 225
One congressional response to the problem of insufficient federal protection of statutory consumer rights has been to enlist state attorneys general as additional law enforcers. For example, the Consumer Product Safety Act authorizes state attorneys general to seek injunctive relief for a violation “that affects or may affect such State or its residents ….” 226 Similar provisions may be found, for instance, in the Telemarketing and Consumer Fraud and Abuse Prevention Act, 227 the Children's Online Privacy Protection Act, 228 and the Restore Online Shoppers' Confidence Act. 229 A second strategy is to broaden enforcement even more by granting rights of action to non-governmental actors. One commentator's summary of the rationale for private rights of action to vindicate civil rights laws is no less persuasive for consumer protection laws: “Even [a] … well-funded, vigorous public enforcement agency [can] only do so much. Private litigation engages a multitude of private actors to bring their resources to rooting out [unlawful activity].” 230
Within the broad category of consumer protection laws, Congress has previously authorized private rights of action in, for example, the Consumer Product Safety Act, 231 the Fair Credit Reporting Act, 232 the Equal Credit Opportunity Act, 233 and the Real Estate Settlements Procedures Act. 234 Within the narrower category of consumer protection laws aimed at preventing deceptive marketing practices, private rights of action are found in the Hobby Protection Act, 235 the National Gold and Silver Stamping Act, 236 and the Truth in Lending Act (“TILA”). 237 Referring to TILA, the FTC has stated as follows: “Since the Act provides for a private right of action, use of that provision should be encouraged where the public interest and the cost benefit [sic] indicate that Commission action is not warranted.” 238
B. A Proposed New Private Right of Action
As discussed in Parts II and IV above, the market for nutritional products is marred by claims of benefit that consumers are unable to evaluate on their own and that government enforcement agencies are unable to police adequately—in FDA's case, because of limitations on its regulatory authority over many of these products; in both FDA's and the FTC's case, because their resources are insufficient given the breadth of their responsibilities. Nor are state consumer protection laws sufficient, given nationwide marketing and the difficulty of pursuing elusive out-of-state defendants. 239 Hence, correcting abuses in this market segment entails augmented enforcement of existing federal law through the grant of a right of action to non-federal parties.
Set against this point is the argument that such a right of action poses risks to the agencies' role in setting policy. State attorneys general have different constituencies and political incentives, “open[ing] up new outlets for state-centered policy” at variance with what federal agencies might perceive to be in the broader national interest. 240 Non-federal litigants, too, might seek to apply the broad standard of “unfair or deceptive” conduct in ways inconsistent with criteria developed by the FTC. 241 In addition, private litigants may have economic incentives to bring actions primarily for the purpose of extracting settlements from possibly innocent defendants, akin to the concern about “strike suits” in class action securities fraud litigation. 242
Seeking to balance the competing considerations of expanding enforcement opportunities for non-federal agencies and concerns of federal agencies about developing a set of coherent laws and consistent policies, we propose that Congress allow a limited group of non-governmental plaintiffs to seek enforcement of FTC Act standards in the advertising and marketing of nutritional products. Creating a federal private right of action but limiting those who may bring actions to state attorneys general and consumer protection organizations should make it easier for these public interest oriented plaintiffs to coordinate and work together. This federal private right of action should be an attractive and more efficient alternative to bringing actions under each state's consumer protection laws.
The following are the key features of the proposed Nutritional Products Consumer Protection Act. Appendix A provides draft statutory language for an amendment to the Federal Trade Commission Act embodying these features:
Products covered (§(a)(1) and (2)). The Act would apply to “nutritional products,” a term encompassing “food” and “dietary supplements.” The latter two terms would be defined as they are in the FD&C Act.
Substantive requirement (§(b)). The Act would prohibit those who sell nutritional products in interstate commerce from engaging in “an unfair or deceptive act or practice, within the meaning of Section 5 of [the FTC] Act.” This incorporation of FTC Act standards allows the extensive body of law developed over the last century to be applied to the marketing of nutritional products and would deter plaintiffs from advancing novel theories of liability unmoored from this body of law. This provision is also drafted to ensure against encroachments on FDA's authority by providing that a seller's “use of any material that has been reviewed and approved by [FDA] may not be deemed to be a violation” of the Act.
Plaintiffs authorized (§(a)(3)). As discussed above, Congress has frequently empowered state attorneys general to bring enforcement actions under statutes otherwise reserved for federal agency enforcement. We propose a similar role in this statute. Consumer protection lawyers in the offices of state attorneys general are experienced litigators, familiar with the “unfair or deceptive” standard. Given competing priorities and shrinking budgets, however, state attorneys general may not themselves be able to achieve the desired deterrent effect. Hence, we propose that the right of action be extended to a limited group of private attorneys general: non-profit organizations. Non-profits such as the Center for Science in the Public Interest 243 and the Consumer Federation of America 244 have relevant expertise concerning food and nutrition and an organizational commitment to preventing the harm of false or unsubstantiated claims. 245 Affording a right of action to attorneys general and expert non-profit organizations would harness their resources to protect consumers in a marketing arena badly needing additional enforcement without serious risk of “overzealous or otherwise socially undesirable enforcement efforts.” 246
Remedies (§(c)). Injunctive relief and damages would be authorized. To provide the incentive common in consumer protection legislation, the proposed Act would allow for the award of attorneys' fees to a prevailing plaintiff.
Preservation of FDA/FTC authority (§(d) and (e)(1)). The Act would require advance notice of an action to FDA and the FTC and would afford the two agencies an unconditional right to intervene. 247 All existing FDA and the FTC enforcement authority would be unaffected.
Non-preemption (§(e)(2)). State UDAP laws would be unaffected by the Act.
VI. CONCLUSION
The number of deceptive health claims being made by nutritional product manufacturers is already large and still growing. The federal agencies tasked with enforcing the laws that prohibit such claims are limited in their enforcement actions by statutory and First Amendment constraints, but more significantly by insufficient resources to adequately police this market. State consumer protection laws are helping in some states to curtail these wrongful claims, but enforcement via different state laws is likely to lead to inconsistencies across states and among federal enforcement policies. In response to this expanding problem, we propose a limited private right of action under the Federal Trade Commission Act to allow state attorneys general and non-profit organizations to bring enforcement actions in federal court to enforce provisions of the FTC Act prohibiting deceptive nutritional product claims. Such a right would augment badly needed protection for consumers without impairing the federal agencies' enforcement efforts and goals.
Footnotes
††
The impetus for this article came from a project funded by the National Human Genome Research Institute (NHGRI) at the National Institutes of Health (NIH) to make recommendations about the regulation of probiotics, an expanding area of the food and dietary supplement markets. The project brought together a working group of scientific researchers (conducting research on the potential therapeutic benefits of probiotics), legal academics and practicing foods and drug law attorneys, industry and consumer representatives, regulators and bioethicists, to examine the adequacy of the current framework for regulation of these products. Results of the working group deliberations were first described in a White Paper, see Diane E. Hoffmann & Claire M. Fraser et al., Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks (Univ. of Md. Francis King Carey School of Law, NIH Grant Number: 5R01HG005171-02, last revised 2016) (on file with the authors). The White Paper formed the basis for two published articles: Probiotics: Finding the Right Regulatory Balance, 342 S
1
See, e.g., Editors, Snake Oil in the Supermarket, S
(stating that you can “[w]alk into any supermarket, and you'll find rows of packaged foods boasting how healthy they are”).
2
See Michael Taylor, How the FDA Is Picking its Food Label Battles, A].
3
See David C. Vladeck, Director, Fed. Trade Comm'n Bureau of Consumer Protection, Remarks at the Annual Symposium for the Dietary Supplement Industry: Priorities for Dietary Supplement Advertising Enforcement 4 (Oct. 22, 2009), http://www.thenhf.com/pdf/VladedckCRNRemarks.pdf []
4
See Diane Hoffmann, Health Claim Regulation of Probiotics in the USA and the EU: Is There a Middle Way?, 4 B]. See also infra notes 46-53 and accompanying text.
5
Leah A. Satine, Is My Yogurt Lying? Developing and Applying a Framework for Determining Whether Wellness Claims on Probiotic Yogurts Mislead, 63 F
6
Id. at 537-38. The Academy of Nutrition and Dietetics links the growing demand for these nutritional products to “rising health care costs and scientific research” supporting a connection between “a good diet” and a “lower incidence of chronic disease.” Consumers Union of United States Inc., ‘Functional Food’ is Hot, But Its Claims of Health Benefits Rely on Flimsy Data, W].
7
See Editors, supra note 1 (stating that “[a]lthough health claims for foods may appear to be authoritative, in many cases science does not support them and the government does not endorse them.”); see also Rahi Azizi, “Supplementing” the DSHEA: Congress Must Invest the FDA with Greater Regulatory Authority over Nutraceutical Manufacturers by Amending the Dietary Supplement Health and Education Act, 98 C (quoting Steven Nissen, head of cardiology at the Cleveland Clinic, who notes that “most … claims” about the “perfect additive” that “add[s] to your health or prevent[s] you from getting sick” are “’completely unsubstantiated’”).
8
See Office of Inspector Gen., U.S. Dep't of Health & Human Services, Dietary Supplements: Companies May be Difficult to Locate in an Emergency (Oct. 2012), https://oig.hhs.gov/oei/reports/oei-01-11-00211.pdf []; see also Azizi, supra note 7; Herper & Ruiz, supra note 7.
9
Vladeck, supra note 3, at 2 (“Some marketers of dietary supplements make disease treatment and prevention claims that far exceed the bounds of the structure/function claims that are permitted under the 1994 Dietary Supplement Health and Education Act (DSHEA).”); see also O [http://www.gao.gov/new.items/d10662t.pdf] (recording the testimony of Gregory D. Kutz, Managing Dir., Forensic Audits and Special Investigations, U.S. Gov't Accountability Office before the Special Committee on Aging) [hereinafter Testimony of Gregory D. Kutz].
10
See, e.g., Norman J. Temple, The Marketing of Dietary Supplements in North America: The Emperor is (Almost) Naked, 16 J. A
11
Probiotics are products with live microorganisms that can confer a health benefit. See J
12
See Nandhini Rajagopal, The North American Probiotics Market, N] (stating that the leading product categories that will help the United States surpass Japan as the number one consumer of functional foods in the world are dairy foods that contain probiotics and products containing whole grains).
13
See Gregor Reid et al., Potential Uses of Probiotics in Clinical Practice, 16 C
14
See Melody J. Slashinski et al., “Snake-oil,” “Quack Medicine,” and “Industrially Cultured Organisms”: Biovalue and the Commercialization of Human Microbiome Research, 13 BMC M
15
In this article, we use the general term “deceptive” to encompass the making of express or implied health claims that are false, misleading, or unsupported by competent and reliable scientific evidence. The term “unsubstantiated” refers to the last of these unlawful practices. See generally Enforcement Policy Statement on Food Advertising, U.S. F] [hereinafter Food Policy Statement] (explaining the “standard for substantiation of health claims” and that “the Commission will find an advertisement deceptive … and, therefore, unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material”).
16
See Health Claims, F] (“State AGs have demonstrated their willingness and ability to enforce … laws against food and beverage marketers, particularly in cases involving health or nutritional benefits claims, or involving products that pose a health risk.”).
17
See Vladeck, supra note 3, at 4.
18
See R. C] (referencing a study by Assistant Professor Temple Northup, “Truth, Lies, and Packaging: How Food Marketing Creates a False Sense of Health”).
19
See Clare M. Hasler, Functional Foods: Benefits, Concerns and Challenges – A Position Paper from the American Council on Science and Health, 132 J. N
20
In remarks to Congress, David Vladeck, former Director of the FTC Bureau of Consumer Protection, stated that “[c]onsumers suffering from serious health ailments are particularly vulnerable and sometimes desperate. The marketing of unfounded treatments to such people offers a type of false hope that is particularly cruel.” Vladeck, supra note 3, at 4. Vulnerable populations often include senior citizens and adolescents. See Azizi, supra note 7, at 447.
21
Vladeck, supra note 3, at 2–3 (“Such disease claims may deter consumers from seeking necessary medical treatment for serious conditions such as cancer, diabetes, and HIV.”).
22
See H.-H. Tsai et al., Evaluation of Documented Drug Interactions and Contraindications Associated with Herbs and Dietary Supplements: A Systematic Literature Review, 66 I
23
See infra Part III.
24
Advertisements include claims made in newspapers and magazines, on television or radio, on the internet, in the mail, or on billboards or buses. See Truth in Advertising, U.S. F].
25
See 21 U.S.C. § 343(a) (2012); see also infra Part III.A.
26
See 15 U.S.C. § 45(a)(1) (2012); see also infra Part III.B.
27
See, e.g., Vladeck, supra note 3; Taylor, supra note 2; see also Sarah Klein, POM-Boozled: Do Health Drinks Live Up to Their Labels?, CNN (Oct. 27, 2010, 8:16 AM), http://www.cnn.com/2010/HEALTH/10/27/health.pom.drink.labels [] (noting that the FTC and FDA have been “cracking down on food and beverage makers for allegedly overselling the health benefits of their products”); infra Part III.C.
28
29
30
See infra note 216 and accompanying text.
31
See Garance Burke, Many Health Supplement Claims Misleading, Illegal, W]; Singer, supra note 28.
32
Singer, supra note 28.
33
Editors, supra note 1.
34
See Herper & Ruiz, supra note 7 (describing how Lifeway Foods, the maker of ProBugs, “a yogurtlike beverage for kids,” ignored the results of clinical trials when making its claims).
35
See Zeratsky, supra note 4 (defining “functional foods” as “foods that have a potentially positive effect on health beyond basic nutrition”).
36
Mission Statement, C].
37
See M].
38
E-mail from Michael Jacobson, Exec. Dir., Ctr. for Science in the Pub. Interest, to Diane Hoffmann, Professor of Law, Univ. Maryland Francis King Carey School of Law (Apr. 29, 2013, 08:31 EST) (on file with author).
39
Id. Jacobson provides the following additional examples: “Campbell's misleading labeling about sodium in its soups by pretending that people consume smaller serving sizes … and Dr. Pepper Snapple group's made-up claims of benefits from the antioxidants it adds to some of its 7UP sugar drinks, which promote obesity, not health.” Id.
40
These are “statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function ….” 21 C.F.R. § 101.93(f) (2015). See infra notes 93-98 and accompanying text.
41
See Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide, U.S. Food & Drug Admin. (Jan. 9, 2002), http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm103340.htm []; see infra notes 99–101 and accompanying text.
42
Testimony of Gregory D. Kutz, supra note 9, at 9.
43
Id. at 8.
44
Health Claims, supra note 16.
45
Id.
46
S); see also Farin Kamangar & Ashkan Emadi, Vitamin and Mineral Supplements: Do We Really Need Them?, 3 I
47
48
Health Claims, supra note 16.
49
Maggie Hennessy, What's Driving Growth in Functional Food and Beverages? A Convergence of Nutrition, Convenience and Taste, N].
50
Id.
51
Id.
52
P
53
See Hank Schultz, Supplement Sales Hit $11.5 Billion in U.S., Report Says, N] (predicting that an increase in consumer demand will cause the probiotics industry “to witness remarkable growth in the coming years”); sources cited supra note 12.
54
Multinationals in the functional food market include PepsiCo, Coca-Cola, General Mills, Kellogg, Kraft, Nestle, Danone, Unilever and Yakult. See P
55
Id. at 5.
56
Id. at 9.
57
See id. at 10 (“Although these products typically require greater initial R&D and ingredient costs, price premiums may reach 30 percent or higher, depending on the product.”).
58
Alison Young, Unmasking the People Behind Risky Pills: A USA Today Investigation, USA T].
59
Steve Mister, The Supplement Industry's ‘Identity’ Crisis, N] (describing mislabeling and the use of substandard ingredients).
60
Federal Food, Drug, & Cosmetic Act, 21 U.S.C. §§ 301–399 (2012).
61
Dietary Supplement Health & Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 321, 331, 342, 343, 350 and 42 U.S.C. § 287).
62
Nutrition Labeling & Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. § 343).
63
Federal Trade Commission Act, 15 U.S.C. §§ 41-58 (2012). The Lanham Act also establishes a cause of action for false advertising. See 15 U.S.C. § 1125(a) (2012). However, only those who allege an injury to commercial interests have standing to bring a Lanham Act false advertising claim; consumers do not have such standing. Lexmark Int'l, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014). See also POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2234 (2014) (explaining that only competitors can bring a claim under the Lanham Act for “misleading advertising or labeling”). Although consumers do not have a right of action under the Lanham Act, theories of Lanham Act liability and related burden of proof obligations may be pertinent to analysis of a false advertising claim based in state law. See In re GNC Corp., 789 F.3d 505, 514 (4th Cir. 2015).
64
21 U.S.C. §§ 331(a), 343(a), 371(a) (2012).
65
U.S. F] [hereinafter A F
66
21 U.S.C. §§ 342-343 (2012).
67
21 U.S.C. § 343(a)(1).
68
See 21 U.S.C. § 343(a)(2) (defining noncompliance as “false or misleading in a material respect” or in violation of 21 U.S.C. § 350(b)(2)).
69
See Label Claims for Conventional Foods and Dietary Supplements, U.S. F] (last updated Nov. 26, 2014) [hereinafter Label Claims].
70
See 21 U.S.C. § 321(g)(1) (defining “drug”); F].
71
See Development & Approval Process (Drugs), U.S. F] (last updated Oct. 27, 2014) (describing the drug approval process). But see D
72
See Label Claims, supra note 69.
73
See 21 C.F.R. § 101.14(a)-(d) (2015).
74
See Guidance for Industry: Evidence Based Review System for the Scientific Evaluation of Health Claims - Final, U.S. F] [hereinafter Guidance for Industry] (defining “qualified health claims” as health claims with a disclaimer disclosing limits on scientific support).
75
Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. § 343).
76
Id; see also Constance J. Geiger, Health Claims: History, Current Regulatory Status, and Consumer Research, 98 J. A
77
A F
78
Guidance for Industry, supra note 74.
79
See Label Claims, supra note 69. This mechanism of approval for health claims was established by the Nutrition Labeling and Education Act of 1990. Id.
80
21 C.F.R. § 101.72(e) (2015).
81
Label Claims, supra note 69, at 1. These scientific bodies may include the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). 21 U.S.C. § 343(r)(2)(G)(i) (2012). In addition, FDA has stated that scientific bodies may include the Surgeon General within the Department of Health and Human Services, the Food and Nutrition Service, the Food Safety and Inspection Service, and the Agricultural Research Service within the Department of Agriculture. See Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, U.S. F] [hereinafter Notification of a Health Claim].
82
Label Claims, supra note 69, at 1.
83
In such a case, the submitter may revise the notification and resubmit it. Notification of a Health Claim, supra note 81. The food may not be marketed with the revised claim until at least 120 days after resubmission. Id.
84
Id.
85
See Pearson v. Shalala, 164 F.3d 650, 658 (D.C. Cir. 1999) (holding that under the First Amendment, the FDA may not reject health claims that it determines to be only potentially misleading unless the agency determines that no disclaimer would eliminate the misleading nature of the claim).
86
Guidance for Industry: FDA's Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance, U.S. F].
87
See A F Within 15 days of receipt, FDA will acknowledge the petition. Within 45 days of receipt, FDA will file the petition and a docket number will be assigned…. At the time of filing, FDA will post the petition on the FDA webpage for a 60-day public comment period. During this time, written comments may be submitted to the docket. On or before 270 days after receipt of the petition, a final decision will be sent to the petitioner in the form of a letter as to whether FDA intends to exercise enforcement discretion with respect to a QHC or deny the petition. The letter will be posted on FDA's website. Extensions beyond 270 days can be granted upon mutual agreement between the petitioner and the agency. Id.
88
Id. at 27 (defining Nutrient Content Claims as nutrition information cited on packaging outside of the Nutrition Facts label).
89
Id. at 87-94.
90
Id. at 91-94. Historically, “healthy” is “a claim that has received special scrutiny and guidelines from the FDA because [it] is a very useful advertising term. According to FDA guidelines, a product must have low total fat content as well as low levels of saturated fat, sodium, and cholesterol to qualify as a ‘healthy’ food.” Betty J. Parker, Food for Health: The Use of Nutrient Content, Health, and Structure/Function Claims in Food Advertisements, J. A
91
For example, FDA deems a food misbranded if it bears a nutrient content claim unless the agency has issued a regulation authorizing the claim and the claim is made consistent with the regulations. See 21 U.S.C. § 343(r)(2)(A) (2012) (requiring that nutrient content claims “[use] terms which are defined in regulations of the Secretary,” along with other requirements); A F
92
A F
93
Along with structure/function claims, the Dietary Supplement Health and Education Act of 1994 (DSHEA) also permits general well-being and nutrient deficiency disease claims for dietary supplements. See Label Claims, supra note 69, at 4. Neither of these claims is subject to premarket approval by FDA. Id. at 2.
94
S
95
See id. FDA has set forth guidance on what types of evidence can be used for claim substantiation. See Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, U.S. F]. To meet the substantiation requirement, “competent and reliable scientific evidence” must be provided. Id. In determining whether the standard is met, FDA considers: “(1) The meaning of the claim(s) being made; (2) The relationship of the evidence to the claim; (3) The quality of the evidence [e.g., randomized controlled trials are given considerable weight although manufacturers may use other human or nonhuman studies]; and (4) The totality of the evidence [both favorable and unfavorable].” Id.
96
S
97
Id. (citing 21 C.F.R. § 101.93(a)(2) (2014)).
98
Label Claims, supra note 69, at 4.
99
See CSPI, United States—A Good System Gone Bad: Marketplace Implications and Consumer Impact, in F].
100
See Parker, supra note 90, at 49; see also CSPI, supra note 99 (“To avoid FDA approval requirements, some companies have begun making structure/function claims in lieu of health claims.”).
101
See S].
102
Michelle Rusk, Att'y, U.S. Fed. Trade Comm'n, Div. of Advert. Practices, Staff Presentation at the Inst. of Medicine Food Forum Workshop: Health Claims and FTC Advertising Law (Feb. 23, 2012), http://iom.nationalacademies.org/~/media/1EBC076FE7CC4AC0BB922166367899FC.ashx [].
103
See Anne V. Maher, Marketing Dietary Supplements and Functional Foods in the USA: The Federal Trade Commission's Advertising Substantiation Requirements, in N
104
See id. (stating that the FTC “has authority to take legal action against false and misleading claims for nearly every type of product and service, including products which are also regulated by the … FDA, such as dietary supplements and functional foods”).
105
15 U.S.C. § 45(a)(1) (2012).
106
15 U.S.C. § 52 (2012).
107
15 U.S.C. § 55(a)(1) (2012).
109
Id.
110
Id.
111
Id.
112
Id.
113
Id.
114
For example, POM Wonderful, the marketer of pomegranate juice products claimed to have various health benefits, “thought their products [sic] impact on health was such a strong selling point that they invested over $35 million to develop supporting evidence that they could use in marketing.” POM Wonderful LLC, 155 F.T.C. 1, 63 (2013).
115
FTC Policy Statement Regarding Advertising Substantiation, U.S. F]; see also Pfizer Inc., 81 F.T.C. 23, 56 (1972) (finding 50 to 70 years of dermatological use of sunburn lotion active ingredients constitutes a “reasonable” basis for efficacy claims in “Un-burn” product); D
116
FTC Policy Statement Regarding Advertising Substantiation, supra note 115; see also Food Policy Statement, supra note 15 (requiring a reasonable basis at the time the claim is made). FTC's Bureau of Consumer Protection website on “Health Claims” states that “[c]ompanies must support their advertising claims with solid proof. This is especially true for businesses that market food, over-the-counter drugs, dietary supplements, contact lenses, and other health-related products.” Health Claims, U.S. F].
117
See D
118
See Food Policy Statement, supra note 15.
119
D
120
Id. at 9; Food Policy Statement, supra note 15.
121
D
122
Food Policy Statement, supra note 15.
123
Id.
124
The FTC industry guidance document on advertising dietary supplements provides an example of this: An ad for a dietary supplement called “Arthricure” claims that the product maintains joint health and mobility into old age. The ‘before’ picture shows an elderly woman using a walker. The “after” picture shows her dancing with her husband. The images and product name likely convey implied claims that the product is effective in the treatment of the symptoms of arthritis, and may also imply that the product can cure or mitigate the disease. The advertiser must be able to substantiate these implied claims.
D
125
Id. at 9.
126
See id. at 9-18.
127
Food Policy Statement, supra note 15 (“[The FTC] recognizes the importance of consistent treatment of nutrient content and health claims in food advertising and labeling and seeks to harmonize its advertising enforcement program with FDA's food labeling regulations to the fullest extent possible under the statutory authority of the FTC Act.”).
128
The allocation of responsibility for enforcement of food and dietary supplement labels and claims is set forth in the MOU between the two agencies. See Memorandum of Understanding Between the Federal Trade Commission and The Food and Drug Administration, MOU 225-71-8003 (Apr. 21, 1971), http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm [].
129
Labeling is interpreted broadly to include “visual, audio or other material that bears a strong contextual relationship to the product.” John E. Villafranco & Andrew B. Lustigman, Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission and National Advertising Division, 62 F
130
See id. at 711.
131
Maher, supra note 103, at 48.
132
See J] (“Early in the Obama Administration, the FDA and FTC expressed a commitment to interagency collaboration in regulating the promotion of food, beverage, and dietary supplement products, and established ‘working groups’ to share information regarding marketing activities for such products.”); see also Sarah Roller & Raqiyyah Pippins, Marketing Nutrition & Health-Related Benefits of Food & Beverage Products: Enforcement, Litigation & Liability Issues, 65 F
133
See 21 CFR §§ 7.40-7.42, 7.45 (2014).
134
See U.S. G].
135
See U.S. F].
136
See Advertising FAQ's: A Guide for Small Business, U.S. F].
137
See 21 U.S.C. § 333(a)(1) (2012); U.S. F]. While the law allows for civil monetary penalties against drug and medical device manufacturers, it does not provide for civil penalties for violations by food and dietary supplement manufacturers. See 21 U.S.C. § 335b (2012).
138
See Advertising FAQ's: A Guide for Small Business, supra note 136.
139
See N] [hereinafter R
140
N
141
Id; see also Food Labeling: How to Avoid an FDA or FTC Enforcement Action, ABA S].
142
Food Labeling: How to Avoid an FDA or FTC Enforcement Action, supra note 141, at 3.
143
See Warning Letters, U.S. F] (stating that in 2014 FDA issued 252 warning letters for conventional foods and 58 for dietary supplements; the letters for foods primarily cited violations of current good manufacturing practices while those for dietary supplements were for what has been described in this Article as deceptive health claims, i.e., improperly marketing products as dietary supplements when those products were actually new drugs).
144
See Warning Letters, supra note 143.
145
Peter E. Masaitis & Evan W. Woolley, Enforcement of FDA Qualified Health Claims: Who's on the Case?, I].
146
See Food Labeling: How to Avoid an FDA or FTC Enforcement Action, supra note 141.
147
U.S. F] (citing a statement prepared for a hearing before the Senate Special Committee on Aging); see also Health Claims, supra note 16 (stating that “[o]ver the last decade, the FTC has filed one hundred and twenty cases challenging health claims made for supplements”).
148
D
149
Complaint at 1, filed by the U.S. Federal Trade Commission (2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/07/100714nestlecmpt.pdf [].
150
Id. at 2.
151
Id. at 6.
152
Id.
153
See FTC Approves Final Order Settling Charges That Nestlé Subsidiary Made Deceptive Health Claims for BOOST Kid Essentials, U.S. F].
154
Id. The FTC further required that the regulation be based on a finding that “there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, considering the totality of publicly available scientific evidence.” Nestlé HealthCare Nutrition, Inc.; Analysis of Proposed Consent Order to Aid Public Comment, 75 Fed. Reg. 42,752, 42,753 (July 22, 2010).
155
FTC Approves Final Order, supra note 153. The settlement also prohibits Nestlé HCN from “mak[ing] any claims about the health benefits, performance, or efficacy of any probiotic or nutritionally complete drinks that it sells at retail, unless the claims are true and backed by competent and reliable scientific evidence” and from “misrepresenting any tests or studies.” Id.
156
See In re The Dannon Company, Inc. Agreement Containing Consent Order (2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/12/101215dannonagree.pdf [].
157
Press Release, U.S. Fed. Trade Comm'n, Dannon Agrees to Drop Exaggerated Health Claims for Activia Yogurt and DanActive Dairy Drink (Dec. 15, 2010), https://www.ftc.gov/news-events/press-releases/2010/12/dannon-agrees-drop-exaggerated-health-claims-activia-yogurt [].
158
Id. Prior to this action by the FTC, in 2009 the Dannon Co. settled a false advertising lawsuit brought by private plaintiffs regarding these products; see Timothy Williams, Dannon Settles With F.T.C. Over Some Health Claims, N.Y. T; see also infra notes 191-193 and accompanying text.
159
Complaint at 19, In re POM Wonderful LLC, 155 F.T.C. 1 (Sept. 24, 2010) (No. 9344), http://www.ftc.gov/sites/default/files/documents/cases/2010/09/100927admincmplt.pdf [].
160
In re POM Wonderful LLC, 155 F.T.C. 1, 1 (2013).
161
Id. at 4.
162
Id. at 21.
163
In re POM Wonderful LLC, 155 F.T.C. 1, app. A, at A1-A2 (2013), http://www.ftc.gov/sites/default/files/documents/cases/2013/01/130116pomappendixa.pdf [].
164
Complaint at 22, In re POM Wonderful LLC, 155 F.T.C. 1 (Sept. 24, 2010) (No. 9344), http://www.ftc.gov/sites/default/files/documents/cases/2010/09/100927admincmplt.pdf [].
165
In re POM Wonderful LLC, 155 F.T.C. 1, 192 (2013).
166
See POM Wonderful, LLC v. Fed. Trade Comm'n, 777 F.3d 478, 484 (D.C. Cir. 2015).
167
Id. at 492, 499.
168
Id. at 503.
169
See Villafranco, Pippins, & Wolff, supra note 132, at 35; see also Douglas W. Hyman, The Regulation of Health Claims in Food Advertising: Have the FTC and the FDA Finally Reached a Common Ground?, 51 F
170
2014 Y
171
C].
172
Id. at 6.
173
C].
174
CARTER, supra note 171, at 6.
175
Id.
176
See Complaint for Injunction, Civil Penalties, and Other Equitable Relief at 2, California v. Bayer Healthcare LLC (Cal. Super. Ct. Oct. 26, 2010) (No. 37-2010-0010-3098-CU-MC-CTL), http://oag.ca.gov/system/files/attachments/press_releases/n2007_bayer_complaint.pdf [https://perma.cc/9USD-PBV5]. Soon after it was filed, the case was settled for $3.3 million. See Press Release, Cal. Office of the Att'y Gen., Brown Announces $3 Million Settlement over Misleading Claims that Multivitamins Can Reduce Cancer Risk (Oct. 26, 2010), http://oag.ca.gov/news/press-releases/brown-announces-3-million-settlement-over-misleading-claims-multivitamins-can [].
177
See, e.g., Assurance of Voluntary Compliance, In re Warner Lambert Company LLC (May 11, 2004), http://apps.americanbar.org/antitrust/at-committees/at-state/pdf/settlements/cp/warner-lambert.pdf [] (describing a settlement with fifty states regarding promotional and marketing practices for off-label uses of a prescription drug).
178
See C
179
Id. at 5.
180
See id.
181
See id.
182
Id. at 5–6.
183
Coca-Cola marketed the drink as a weight loss product, claiming that it had “negative calories” and labeling it as “the calorie burner” on its cans. Watchdog Group Sues Coke, Nestlé, for Bogus “Enviga” Claims, C]. CSPI scientists reviewed the studies relied on by Coke and determined that Enviga was simply “a highly caffeinated and overpriced diet soda.” Id. In 2007, CSPI filed suit alleging that the claims “were made without prior substantiation and no evidence that most consumers would realize any calorie-burning benefit.” N
184
CSPI sued Bayer in 2009 alleging that the claims were deceptive and lacked scientific evidence. Litigation Project-Closed Cases, C] (“That lawsuit was dismissed on procedural grounds. CSPI was preparing to refile when the Attorneys General of Oregon, California, and Illinois announced a broad settlement with Bayer on the same issues.”).
185
See id. (describing cases against Airborne for deceptive claims regarding its cold remedy, against Aurora Dairy for selling its non-organic dairy products as “organic”, against Dr. Pepper Snapple Group for misleading antioxidant claims on its labels, and General Mills for misleading claims about “the nutritional and health qualities of its ‘fruit’ snacks”).
186
See id. (listing agreements with Pfizer Consumer HealthCare for health claims made about Centrum Dietary Supplements, Pepsico for claims that its IZZE sparkling juices are “natural and fortified,” Quaker Oats for claims that its oatmeal lowered cholesterol, and Smart Balance for claims that its Blended Butter Sticks help block cholesterol).
187
N
188
The majority of cases (over 100) have alleged that food products have inappropriately used the label “natural” and that use of the term is misleading. See id. at 11.
189
Id. at 10.
190
Id. at 1 (finding this to be true as of June 2014).
191
See Amended Stipulation of Settlement at 8, Gemelas v. The Dannon Company, Inc., 2010 WL 377068, at *11-15 (N.D. Ohio Jan. 20, 2010) (No. 1:08-cv-00236). The complaint alleged violations of two Ohio consumer protection statutes and breach of express warranty. Class Action Complaint, Gemelas v. The Dannon Company, Inc., 2008 WL 824363 (N.D. Ohio Jan. 29, 2008) (No. 1:08-cv-00236).
192
Class Action Complaint, Gemelas v. The Dannon Company, Inc, 2008 WL 824363, at *4. As part of the settlement, the company agreed to make changes to the labeling and advertising of Activia and DanActive. Stipulation of Settlement, Gemelas v. The Dannon Company, Inc., 2009 WL 3197886, at *12-*15 (N.D. Ohio Sept. 18, 2009) (No. 1:08-cv-00236). DanActive labels that said the yogurt has “a positive effect on your digestive tract's immune system” were reworded to say the yogurt will “interact with your digestive tract's immune system.” Id.
193
N
194
Id. at 3.
195
See id. at 4 (citing 21 U.S.C. §§ 333(f)(2)(a), 334 (a)(1), 336) (“The FDA may enforce compliance with a recall order or impose civil monetary fines when adulteration or misbranding of food ‘will cause serious adverse health consequences [or] death,’ such as when a label is missing allergen information. The FDA may condemn and seize misbranded foods only after the company receives proper notice and the opportunity to respond and the FDA has ‘probable cause to believe … that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer.’ Injunctions or criminal prosecutions are rarely used for food misbranding because the FDCA expressly provides that these enforcement actions should not be initiated for ‘minor violations’ when the ‘public interest’ may be adequately served by a written warning.”).
196
Id.
197
S
198
Id. at 6.
199
Id. at 5; see also U.S. G].
200
S
201
This was confirmed by the OIG in a 2012 report describing its analysis of structure/function claims and related substantiation documents “on a purposive sample of 127 dietary supplements marketed for weight loss or immune system support in retail stores and on the Internet.” Id. at 7. The OIG found that “[i]n contrast to FDA guidance, most substantiation was not derived from human studies,” and “10 percent of the documents appeared to have no significance in supporting structure/function claims.” Id. at 11–12. Furthermore, only 2% of the human studies that the OIG reviewed examined the products in the sample; 4% had results that contradicted the claims made; 85% were not randomized clinical trials; 49% “were not based on populations similar to those that will be consuming the supplements”; and 34% focused on a disease, rather than a structure/function endpoint, and of these, 20% “had prohibited disease claims” including treating diseases “such as influenza, the common cold, herpes, and HIV.” Id. at 12–16. Ten percent of the documents submitted did not qualify as substantiation—for example, one was a “30-year-old handwritten college term paper.” Id. at 15.
202
Id. at 4-5; see also U.S. G
203
See Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999); see also Alliance for Natural Health v. Sebelius, 786 F. Supp. 2d 1, 13-14 (D.D.C. 2011); Alliance for Natural Health v. Sebelius, 714 F. Supp. 2d 48, 61–62 (D.D.C. 2010).
204
While the agency conducts internet surveillance to find supplements making such claims, it has not expanded its surveillance to retail stores. S
205
Singer, supra note 28.
206
Taylor, supra note 2.
207
Id.
208
Id.
209
I.
210
E-mail from Michael Jacobson, Exec. Dir., Ctr. for Science in the Pub. Interest, supra note 38; see also Taylor, supra note 2 (quoting a CSPI press release which stated that “establishing ‘a systematic regulatory framework to prohibit misleading health-related claims’ … is a noble goal and one we can readily embrace conceptually. But it's a tall order, especially considering the other high-priority nutrition and food safety initiatives that compete for FDA's finite resources.”).
211
Alexandra Ledyard, Snake Oil in Your Pomegranate Juice: Food Health Claims and the FTC, 47 U.S.F. L. REV. 783, 794 (2013).
212
Id. at 794 & n.95; see also Carol Brophy, An Agency “Warning Letter” Does Not a Lawsuit Make: Sometimes a “Warning Letter” is Really Just a Warning, S] (“If the FTC believes that a person or company has violated the law …, the agency may attempt to obtain voluntary compliance by entering into a consent order with the company. A company that signs a consent order need not admit that it violated the law, but it must agree to stop the disputed practices outlined in an accompanying complaint ….”).
213
214
See Young, supra note 58 and accompanying text.
215
Fringe operators, unconcerned about long-term reputational damage, are also unlikely to be deterred by a self-regulatory regime operated by the National Advertising Division (NAD), a project of the Council of Better Business Bureaus. The NAD is responsible for receiving, investigating, and resolving complaints “involving the truth or accuracy of national advertising.” A].
216
See, e.g., Michael R. Ward & Michael J. Lee, Internet Shopping, Consumer Search and Product Branding, 9 J. P
217
Carter, supra note 171, at 3; see also N].
218
Bronson v. Johnson & Johnson, Inc., No. C 12-04184 CRB, 2013 WL 1629191, at *8 (N.D. Cal. Apr. 16, 2013); see also, e.g., Scheuerman v. Nestlé Healthcare Nutrition, Inc., Nos. 10-3684(FSH)(PS), 10-5628(FSH)(PS), 2012 WL 2916827, at *6 (D.N.J. July 17, 2012).
219
See, e.g., In re GNC Corp. 789 F.3d 505, 513–16 (4th Cir. 2015) (holding that a claim cannot be literally false (as distinct from misleading) if even one reasonable expert agrees with it). But see also Fed. Trade Comm'n v. Pantron I Corp., 33 F.3d 1088, 1100 (9th Cir. 1994) (holding that the FTC “is not required to prove that a product is ‘wholly ineffective’ in order to carry its burden of showing that the seller's representations of product efficacy are ‘false’”).
220
See Dale J. Giali, Are State-Law Claims for Violating Federal Food Labeling Law Preempted?, C].
221
Many of the cases have been dismissed on preemption grounds or because the plaintiff fails to have standing. Others have been settled and some are going through the steps of class certification. See U.S. C].
222
See Roller & Pippins, supra note 132, at 447.
223
See Brophy, supra note 212 (asserting that plaintiffs' attorneys often bring these suits based on FDA or FTC “press releases, warning letters and complaints” which do not establish the law).
224
Robert Pitofsky, Beyond Nader: Consumer Protection and the Regulation of Advertising, 90 H
225
J. Maria Glover, The Structural Role of Private Enforcement Mechanisms in Public Law, 53 W
226
15 U.S.C. § 2073(b)(1) (2012).
227
15 U.S.C. § 6103 (2012).
228
15 U.S.C. § 6504 (2012).
229
15 U.S.C. § 8405 (2012).
230
Olatunde C.A. Johnson, Beyond the Private Attorney General: Equality Directives in American Law 1, 9 (Columbia Law Sch. Pub. Law & Legal Theory, Working Paper No. 9204, 2012), http://lsr.nellco.org/columbia_pllt/9204/ []. Versions of this argument have likewise been presented in support of unsuccessful claims for judicial recognition of an implied private right of action under the FTC Act. See, e.g., Carlson v. Coca-Cola Co., 483 F.2d 279, 281 (9th Cir. 1973) (Solomon, J., dissenting). It is well established that there is no private right of action under the FTC Act. See, e.g., Holloway v. Bristol-Myers Corporation, 485 F.2d 986 (D.C. Cir. 1973).
231
15 U.S.C. § 2072(a) (2012) (“Any person who shall sustain injury by reason of any knowing (including willful) violation of a consumer product safety rule, or any other rule or order issued by the [Consumer Product Safety] Commission may sue any person who knowingly (including willfully) violated any such rule or order ….”). The statute provides for attorneys' and expert witnesses' fees. Id.
232
“Any consumer” with respect to whom certain willful violations of the Fair Credit Reporting Act (FCRA) occurred may be awarded actual damages (within statutory limits), punitive damages, and costs including attorneys' fees. 15 U.S.C. § 1681n (2012). Not all provisions of the FCRA, however, are encompassed by this private right of action. See Longman v. Wachovia Bank, N.A., 702 F.3d 148, 151–52 (2d Cir. 2012).
233
A creditor that violates statutory or regulatory requirements is liable to “an aggrieved applicant” for actual damages, punitive damages (within statutory limits), and costs including attorneys' fees. 15 U.S.C. § 1691e (2012).
234
This statute contains three private causes of action: (1) Anyone who violates certain notice requirements is liable to “the borrower” for actual damages, additional damages in cases of a pattern or practice of noncompliance (within statutory limits), and costs including attorneys' fees. 12 U.S.C. § 2605(f) (2012); (2) Anyone who gives or receives kickbacks or unearned fees in connection with settlement services is liable to “the person or persons charged for the settlement service” for treble damages and costs including attorneys' fees. 12 U.S.C. § 2607(d)(2), (5) (2012); (3) Any seller who requires the purchase of title insurance from a particular title company is liable to “the buyer” for treble damages. 12 U.S.C. § 2608(b) (2010).
235
The statute specifies certain requirements for “imitation political item[s]” and “imitation numismatic item[s]” and provides that violations of these requirements are violations of the Federal Trade Commission Act. 15 U.S.C. § 2101(a), (b) (2012). The statute authorizes “any interested person” to seek injunctive relief and damages for violations and provides for costs and attorneys' fees. 15 U.S.C. § 2102 (2012).
236
“Customer[s],” as well as competitors, of precious metal manufacturers or dealers who violate certain requirements related to markings and tolerance from stated quality may sue for injunctive relief and damages and may be awarded costs and attorneys' fees. 15 U.S.C. § 298(b) (2012).
237
Violations of the Truth in Lending Act or its implementing regulation (adopted by the Federal Reserve Board) are deemed to be violations of the Federal Trade Commission Act. 15 U.S.C. § 1607(c) (2012). Individual and class actions are authorized against creditors who fail to comply with the Act; actual damages, statutory damages under certain circumstances, and costs and attorneys' fees may be awarded. 15 U.S.C. § 1640(a) (2012).
238
F].
239
See supra notes 214-15 and accompanying text regarding “fringe” manufacturers.
240
Margaret H. Lemos, State Enforcement of Federal Law, 86 N.Y.U. L. R
241
See Henry N. Butler & Joshua D. Wright, Are State Consumer Protection Acts Really Little-FTC Acts?, 63 F
242
See, e.g., Richard F. Conklin, Why “Or” Really Means “Or”: In Defense of the Plain Meaning of the Private Securities Reform Act's Safe Harbor Provision, 51 B.C. L. R
243
CSPI's litigation docket includes several cases alleging false or misleading claims in the marketing of foods and beverages. Litigation Project – Current Docket, C].
244
Nutrition is one of the Federation's areas of focus. Nutrition, C].
245
We assume that suits authorized under the proposed statute would ordinarily meet the criteria for associational standing. See, e.g., United Food & Commercial Workers Local 751 v. Brown Group Inc., 517 U.S. 544, 553 (1996) (citing the finding in Hunt v. Wash. St. Apple Advert. Com'n, 432 U.S. 333, 342 (1977) that there are three criteria: (1) the members would have standing to sue in their own right; (2) “the interests it seeks to protect are germane to the organization's purpose”; and (3) “neither the claim asserted nor the relief requested requires the participation of individual members”).
246
David Freeman Engstrom, Harnessing the Private Attorney General: Evidence from Qui Tam Litigation, 112 C
247
This provision is adapted from a provision in the Consumer Financial Protection Act of 2010. 12 U.S.C. § 5301 (2010). It is based on the assumption that in these cases state Attorneys General would be advocating theories of liability that are different from those embraced by the FTC.
N utritional P roducts C onsumer P rotection A ct
15 U.S.C. §______.