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FDA Issues New Guidance on “Healthy” Claims

Tree_iStock_000004633733LargeBy Alexander M. Smith

In May 2016, the FDA announced that it intended to re-evaluate its regulations concerning implied nutrient content claims, including the use of the term “healthy,” in light of evolving nutrition science.   As part of that process, the FDA issued guidance this Tuesday, September 27, in which it clarified its position on two types of nutrient content claims.  The FDA first announced that it will decline to require foods labeled as “healthy” to comply with the requirements for total fat content in 21 C.F.R. § 101.65(d), so long as the amounts of monounsaturated and polyunsaturated fats are declared on the label and the amounts declared constitute the majority of the product’s fat content.  The FDA reasoned that this rule is consistent with recent developments in nutrition science, which has “shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats.”  The FDA also announced that it would no longer require foods labeled as “healthy” to contain at least ten percent of the daily value per reference amount customarily consumed of Vitamin A, Vitamin C, calcium, iron, protein, or fiber if the food instead contained at least ten percent of the daily value per reference amount of potassium and vitamin D, which the FDA characterized as “nutrients of public health concern.”  As Law360 notes, this guidance may have a significant impact on lawsuits arising out of food manufacturers’ use of the term “healthy.”