Earlier this week, the Food and Drug Administration (FDA) announced that it plans to redefine the criteria required to claim that a particular food is “healthy” on product labels. As a first step, the agency is soliciting public input on what “healthy” should mean and how consumers understand the term on food labels. FDA then plans to reevaluate the regulatory criteria for a “healthy” claim based on these comments, the latest nutrition science, and current dietary recommendations.
In the meantime, the criteria provided in the current regulations remain in effect. These require, among other things, that “healthy” products (i) be low in total fat and (ii) contain 10% or more of the Daily Value (DV) per reference amount customarily consumed (RACC) of certain beneficial nutrients—namely, vitamin A, vitamin C, calcium, iron, protein, or fiber.
That said, FDA simultaneously issued guidance for industry regarding these total fat and beneficial nutrient criteria for “healthy” claims. Specifically, FDA plans to “exercise enforcement discretion” with respect to foods that either (i) have a fat profile of predominantly mono and polyunsaturated fats; or (ii) contain at least 10% of the DV per RACC of potassium or vitamin D. In practice, this means that manufacturers could make a “healthy” claim on foods that meet one of these two new requirements (but not the current criteria), and FDA will refrain from sending a warning letter. So a food that is not low in total fat, but does incorporate predominantly mono and polyunsaturated fats, may bear a “healthy” claim without facing an FDA enforcement action. Similarly, a food that contains 10% or more of the DV per RACC of potassium or vitamin D, but not any of the other listed beneficial nutrients, could still be considered “healthy” without FDA enforcement. To qualify under these new criteria, the food label must declare either the amount of mono and polyunsaturated fats or the amount of potassium or vitamin D, as applicable.
TIP: Companies with an interest may wish to submit comments to FDA prior to the January 26, 2017 deadline. Manufacturers could also consider reviewing their food labels in light of the updated guidance from FDA.