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Earlier in 2021, the U.S. Food and Drug Administration issued a notice that it would conduct preliminary consumer research into the use of a voluntary code that could be used to depict nutritional content claims as “healthy” on packaged foods. Congress also introduced the Food Label Update Act of 2021 that would, among other things, require labels on the front of packaging to include health symbols related to nutrients in food. All of this comes at a time when consumer demand for healthy food is driving manufacturers and other industry participants to innovate and share their brand developments. However, given the regulatory landscape (and plaintiffs bar willing to take advantage of any change in the law to try to open new fronts of often unfounded claims) associated with health claims, food companies are understandably wary of making claims about health or nutrition benefits. . the content of their products.
This white paper discusses how industry participants can strive to achieve a “healthy balance” when labeling their products, to provide consumers with the information they are looking for and to enhance the qualities and benefits of food, while mitigating potential litigation and regulatory risks
Consumers are increasingly interested in tasty and healthy food. This demand for healthy food is driving manufacturers and other industry participants to innovate and share their brand developments, including nutritional information that consumers seek to make healthier choices. However, given the regulatory landscape (and plaintiffs bar willing to take advantage of any change in the law to try to open new fronts of often unfounded claims) associated with health claims, food companies are understandably wary of making claims about health or nutrition benefits. . the content of their products. As detailed below, industry participants should strive to reach a “healthy balance” when labeling their products, to provide consumers with the information they are looking for and to enhance the qualities and benefits of food, while mitigating potential litigation and regulatory risks.
Consumer product manufacturers are no strangers to consumer class actions. These lawsuits target a wide variety of products, and allege (often without basis) state violations of consumer fraud and false advertising laws, common law fraud, and violations of express and implied warranties for alleged false, misleading, or deceptive claims regarding labels or packaging. The food and beverage industry has experienced a boom in these cases, particularly in the last decade. For example, the food industry has been the target of several class action lawsuits related to “all natural” claims.1
More recently, plaintiffs have focused on supposed explicit or implied health claims on food product labels and packaging. In these cases, consumers claim that they have been misled into believing that the food product is “healthier” or “healthier,” only to discover after their purchase that the food has no additional health benefits or, in some cases, was actually harmful to the consumer’s health. These claims include theories that the inclusion of certain ingredients, such as sugar or certain fats, or the function of an ingredient, such as citric acid as a preservative, detrimentally affects a person’s health.2
At the same time that consumers increased their interest in purported health claims, so did regulatory agencies. The Food and Drug Administration (“FDA”) has increased its focus on continuing to ensure that product labels provide accurate and non-misleading nutritional information to consumers. This initiative is part of the Food and Drug Administration’s Nutrition Innovation Strategy, which “empowers consumers with information and facilitates industrial innovation toward healthy foods that consumers want.”3 Companies that do not comply with the FDA’s labeling regulations, as well as potential class actions, may face FDA regulatory enforcement. When the Food and Drug Administration issues a warning letter or engages in other enforcement activity, whether or not such action is warranted, consumers and plaintiffs in consumer class actions take notice, and file additional litigation claims, claiming that they have been misled by allegedly incompatible labels.
Congress also pays attention to food labels and nutritional content claims. On August 3, 2021, Congress introduced the Food Label Update Act of 2021, which would amend the Food, Drug, and Cosmetic Act and change requirements regarding nutrient information on food labels.4 Among the proposed changes, the legislation would require that labels on the front of the package include health symbols related to nutrients in food. The legislation would also require food manufacturers and importers to submit all label information to the FDA, including the main display panel image, nutrient content claims, and health-related claims, a major shift in food label policy. Failure to provide, update or complete this information may result in civil penalties.
Despite a bar of enthusiastic plaintiffs and an increasingly active Food and Drug Administration, food manufacturers can continue to serve consumers by sharing their product innovations. The key is to maintain a proper balance between sharing information and understanding and mitigating potential legal and regulatory risks.
Food and Drug Administration policy and rules on “healthy” claims and nutritional contents
The US Food and Drug Administration announced its Nutritional Innovation Strategy (“NIS”) on March 29, 2018, as part of its efforts to “reduce preventable malnutrition-related deaths and diseases.”5 Through the NIS, the FDA aims to advance its public health mission by enabling consumers to “make better and more informed decisions about their diets and health,” as well as foster innovation and the development of healthy food choices.6 The national intelligence system focuses on six main components: (1) health claims update; (ii) update identity standards; (3) update ingredient information to make it more convenient for consumers; (iv) Implementation of Nutrition Facts Labeling and List Labeling; (5) reduce sodium in food supply; and (6) improve nutrition education.7
1 See, for example, Campbell v. Whole Foods Mkt. Grp., Inc., No. 1:20-CV-01291 (SDNY) (the label claimed that the honey graham crackers were misleading because the word “honey” implied that the crackers were sweetened only with natural honey, rather than other sweeteners); Mason v. Reed’s, Inc., No. 18-cv-10826 (SDNY); Brazil v. Dole Food Co., Inc., No. 12-CV-01831 (ND Cal.) (Allegedly Dole misled customers by labeling fruit products as “All Natural Fruit” when they contain citric acid).
2 See, for example, Francioni v. Kraft Heinz Company, 1:21-cv-10928 (D., but did not inform consumers that the packaging contained traces of the chemical ortho-phthalate); Franklin v. General Mills 2: 21-cv-01781 (EDNY) (same).
3 FDA Nutrition Innovation Strategy, FDA.
4 HR 4917.
5 FDA, note 3 above.
6 same reference.
7 same reference.
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