• The U.S. District Court for the Southern District of California on August 14, 2019 dismissed a proposed class action alleging the term “healthy” is deceptive when used to market coconut milk containing high levels of saturated fat. At issue in Andrade-Heymsfield v. Danone US, Inc. were marketing claims that So Delicious coconut milk contains “good fats” and can help promote bone strength through calcium and vitamin D. U.S. District Judge Cathy Ann Bencivengo found the advertised benefits are permitted under the Food and Drug Administration (FDA) guidelines, that the labeling made accurate admissions about the saturated fat content, and “plaintiffs cannot claim deception on label statements modelled on FDA guidance.” The judge also rejected the plaintiffs breach of an express or implied warranty claim about treating osteoporosis, finding statements about the coconut milk’s nutrients and their effects are structure and function claims permitted by FDA.
  • Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food is misbranded if it bears claims that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA. FDA’s regulation at 21 CFR 101.65(d) provides such regulatory definition for use of the term “healthy” as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.
  • As previously reported on this blog, FDA is considering updating its nutrient content claim regulations to be consistent with current federal dietary guidance. In the interim, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition (21 CFR 101.65(d)). FDA has also issued a guidance document, stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. It is the second provision of FDA’s enforcement policy that the U.S. District Court found applicable to the “healthy” claim on Danone’s coconut milk.