For many Americans, October is synonymous with Halloween: local grocers line store shelves with sugary products and houses across the country are decorated with cobwebs and jack-o-laterns. However, the Food and Drug Administration (“FDA”)—in an act that is antithetical to the sugar-induced holiday we anxiously await at the end of the month—recently began a public process to redefine the term “healthy” on food labeling.
As of September 28, 2016, the FDA is considering how to redefine the term “healthy” as a “nutrient content claim” as part of its “plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage the development of healthier foods by the industry.” See FDA announcement. To receive information on the use of the term “healthy” in the labeling of human food products, the FDA has established a docket to receive comments from consumers, food manufacturers and the public health community. At the end of May 2016, the FDA issued final rules updating the Nutrition Facts label and serving size information for packaged foods to reflect “new scientific information”. See 81 FR 33742. Accordingly, the recent initiative to redefine the term “healthy” is—in large part—an effort to align regulations for nutrient content claims with the regulations governing the updated Nutrition Facts labeling.
Currently, 21 CFR 101.65(d) establishes the parameters for manufacturers using the “implied nutrient content claim” for the word “healthy” or related terms on the labeling of a food. The “implied nutrient content claim” means that the labeling suggests to consumers that because of its nutrient content, the food “may help consumers maintain healthy dietary practices” and the claim is made with “explicit or implicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams of fat.” See 21 CFR 101.65(d). In the litigation context, the changing definition of the term “healthy” and related words could follow the same pattern of consumer fraud and false labeling cases that have enveloped manufacturers that label products as “all natural.” For example, last week the Center for Science in the Public Interest filed a lawsuit against PepsiCo (parent company of Naked Juice) alleging that the company has duped consumers into buying its products by suggesting that “high-value ingredients” constitute the main drink ingredients when really they are mostly apple and orange juice.
The public comment period for the FDA’s effort to redefine “healthy” and related terms will remain open through January 2017. Not surprisingly, companies that either missed out on the ability to label their products “healthy” or face potential litigation for labeling a product healthy that falls outside the definition have taken an active role in submitting specific recommendations about how they believe the FDA should approach the update. See e.g., Docket Number FDA-2015-P-4564 (“Kind LLC Citizen Petition”) submitted December 1, 2015. Last year, the maker of Kind bars had used the phrase “healthy and tasty” on its products, which allegedly contained too much fat to meet the FDA’s existing low-fat definition of the term.
Similar to the way that technology is challenging our understanding of legal liability (see article), modernizing science will also likely impact future litigation in the context of food labeling claims. Food makers should take an active role in helping to define workable regulations as a prophylactic measure against claims alleging deceptive or false advertising.