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FDA Invites Input on Definition of “Healthy” in Food Labeling

Wednesday, September 28, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has launched a public process to redefine the “healthy” nutrient content claim for food labeling. The FDA has also declared its intent not to enforce certain requirements for use of that claim if specific conditions are met.

FDA regulations currently provide for use of the term “healthy” or related terms as an implied nutrient content claim on the label or in labeling of food. The food must meet specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, and sodium, as well as nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber. These criteria can vary for different food categories (e.g., fruits and vegetables, seafood and game meat, etc.).

FDA is now soliciting through Jan. 26, 2017, information and comments on the use of the term “healthy” in food labeling, including what it should mean from a nutrition perspective and how consumers understand and use “healthy” food claims.

In the meantime, FDA states in a new guidance document that it intends to exercise enforcement discretion with respect to the current requirement that any food bearing the “healthy” claim meet low fat requirements provided that (a) the amounts of mono- and polyunsaturated fats are declared on the label and (b) the amounts declared constitute the majority of the fat content. Similarly, the FDA intends to exercise enforcement discretion with respect to the requirement that such foods contain at least 10 percent of the daily value per reference amount customarily consumed of vitamin A, vitamin C, calcium, iron, protein, or fiber if the food instead contains at least 10 percent of the DV per RACC of potassium or vitamin D.

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