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FSIS Seeks to Expand Use of Term “Healthy”

Consistent with similar efforts by FDA, USDA’s Food Safety and Inspection Service (FSIS) is initiating rulemaking to update its regulations on the term “healthy” in line with FDA’s 2016 updates to its nutrition labeling rules.  The rulemaking seeks to amend both 9 CFR 317.363(b) and 381.463(b).

FDA, in response to a Citizen Petition filed in December 2015 by KIND LLC, issued guidance in 2016 stating that it will exercise enforcement discretion for foods labeled as “healthy,” even though they do not comply with the definition under 21 CFR 101.65, when such foods (1) have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or (2) that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Both FDA’s and USDA’s initiatives seek to make its enforcement of the “healthy” definition more consistent with FDA’s 2016 changes to its nutrition labeling regulations.  Those changes refocused attention from lowering fat in the American diet to lowering sugar in the American diet.  The same changes replaced vitamins A and C with potassium and vitamin D as mandatory nutrients to be declared on food labels.

USDA is accepting comments until May 18, 2020.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...