Earlier in 2021, the FDA issued a notice that it will be conducting preliminary consumer research on the use of a voluntary symbol that could be used to depict the nutrient content claim "healthy" on packaged foods. Congress has also introduced the Food Labeling Modernization Act of 2021 that would, among several things, require front-of-pack labels to include health-oriented symbols related to the nutrients in the food. All this comes at a time when consumers' demand for healthy food is driving manufacturers and other industry participants to innovate and share their brand developments. However, given the regulatory landscape (and a plaintiffs' bar ready to leverage any change in the law to attempt to open new fronts of often unfounded claims) associated with health claims, food companies are understandably wary of making claims about the health benefits or nutritional content of their products.
This White Paper discusses how industry participants can strive to reach a "healthy balance" when labeling their products, so as to provide consumers the information they seek and to promote the food's qualities and benefits, while mitigating potential litigation and regulatory risks
Consumers are increasingly interested in food that is both tasty and healthy. This demand for healthy food is driving manufacturers and other industry participants to innovate and share their brand developments, including the nutritional information consumers seek to make healthy choices. However, given the regulatory landscape (and a plaintiffs' bar ready to leverage any change in the law to attempt to open new fronts of often unfounded claims) associated with health claims, food companies are understandably wary of making claims about the health benefits or nutritional content of their products. As detailed below, industry participants should strive to reach a "healthy balance" when labeling their products, so as to provide consumers the information they seek and promote the food's qualities and benefits, while mitigating potential litigation and regulatory risks.
Consumer product manufacturers are no strangers to consumer class actions. These lawsuits target a wide range of products, claiming (often without basis) violations of state consumer fraud and false-advertising statutes, common-law fraud, and breaches of express and implied warranties for allegedly false, misleading, or deceptive label or packaging claims. The food and beverage industry has endured a surge of these cases, particularly in the last decade. As an example, the food industry has been the target of numerous class-action lawsuits related to "all-natural" claims.1
Most recently, plaintiffs have focused on supposed express or implied health claims on the labels and packaging of food products. In these cases, consumers claim that they were misled to believe the food product was "healthy" or "healthier," only to discover after their purchase that the food had no added health benefits or, in some cases, was actually detrimental to consumer health. These claims include theories that including certain ingredients, such as sugar or certain fats, or the function of an ingredient, such as citric acid as a preservative, detrimentally affect a person's health.2
At the same time as consumers have increased their attention on alleged health claims, so too have regulatory agencies. The Food and Drug Administration ("FDA") has increased its focus on continuing to ensure that product labeling provides accurate and nonmisleading nutrition information to consumers. This initiative is part of FDA's Nutrition Innovation Strategy, which serves to "empower consumers with information and facilitate industry innovation toward healthier foods that consumers want."3 Companies that fail to comply with FDA labeling regulations may face, in addition to potential class action suits, FDA regulatory enforcement. When FDA issues a warning letter or engages in other enforcement activity, whether or not that action is warranted, consumers and the consumer class action plaintiffs' bar pay attention, filing addon litigation claims, claiming they were misled by allegedly noncompliant labels.
Congress also is paying attention to food labeling and nutrient content claims. On August 3, 2021, Congress introduced the Food Labeling Modernization Act of 2021, which would amend the Food, Drug, and Cosmetic Act and change requirements regarding the nutrient information found on food labels.4 Among the proposed changes, the legislation would require the front-of-pack labels to include health-oriented symbols related to the nutrients contained in the food. The legislation would also require manufacturers and importers of foods to submit to FDA all labeling information, including the image of the principal display panel, nutrient-content claims, and health-related claims, a major shift in food labeling policy. Failure to submit such information, or update or supplement it, could result in civil penalties.
Notwithstanding an eager plaintiffs' bar and an increasingly active FDA, food manufacturers can continue to serve their consumers by sharing their product innovations. The key is to maintain a healthy balance between sharing information and understanding and mitigating potential legal and regulatory risks.
FDA POLICY AND RULES REGARDING "HEALTHY" AND NUTRIENT CONTENT CLAIMS
FDA announced its Nutrition Innovation Strategy ("NIS") on March 29, 2018, as part of its efforts to "reduce preventable death and disease related to poor nutrition."5 Through the NIS, FDA aims to advance its public health mission by empowering consumers "to make better and more informed decisions about their diets and health," as well as foster innovation and the development of healthier food options.6 The NIS is focused on six key elements: (1) modernize health claims; (2) modernize standards of identity; (3) modernize ingredient information to make it more consumer friendly; (4) implement the nutrition facts label and menu labeling; (5) reduce sodium in food supply; and (6) improve nutrition education.7
1 See, e.g., Campbell v. Whole Foods Mkt. Grp., Inc., No. 1:20-CV-01291 (S.D.N.Y.) (alleging honey graham crackers label was misleading because the word "honey" implied the crackers were sweetened only with natural honey, rather than other sweeteners); Mason v. Reed's, Inc., No. 18-cv-10826 (S.D.N.Y.); Brazil v. Dole Food Co., Inc., No. 12-CV-01831 (N.D. Cal.) (alleging Dole misled customers by labeling its fruit products as "All Natural Fruit" when they contain citric acid).
2 See, e.g., Francione v. The Kraft Heinz Company, 1:21-cv-10928 (D. Mass.) (alleging that defendant-mac and cheese manufacturer misled consumers by marketing a product as healthy, with no artificial flavors or preservatives, but failed to inform consumers that the packaging contained traces of the chemical ortho-phthalate); Franklin v. General Mills, 2:21-cv-01781 (E.D.N.Y.) (same).
3 FDA Nutrition Innovation Strategy, FDA.
4 H.R. 4917.
5 FDA, supra note 3.
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