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FDA Proposes Extension Dates for Labels and Serving Size Final Rules


On Friday, September 29, the United States Food and Drug Administration (FDA) announced its proposal to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from 2018 to 2020. Earlier this year, in June, the FDA announced its intent to delay implementation of both final rules but did not announce future dates for compliance at that time. You can read more on that announcement here.

The Nutrition and Supplement Facts Label final rule, finalized in May 2016, amended the FDA's labeling regulations for conventional foods and dietary supplements by updating the list of nutrients that are required or permitted to be declared, changing the designation in units used to declare certain nutrients, providing updated Daily Reference Values and Reference Daily Intake values, and revising the format and appearance of the Nutrition Facts and Supplement Facts labels.

The companion Serving Size final rule, also finalized in May 2016, was issued to define a single-serving container, require dual-column labeling for certain containers, update and establish several reference amounts customarily consumed, and to make other technical amendments to various aspects of the serving size regulations.

The FDA's recent announcement to extend compliance from June 26, 2018 to January 1, 2020 for manufactures with more than $10 million in annual food sales – and to January 1, 2021 for manufactures with less than $10 million in annual food sales – was lauded by industry who had expressed concern about their ability to update product labeling by the original 2018 compliance dates. The FDA also recognized the extension was necessary for industry to obtain clarification from the agency on a number of technical issues relating to the final rules. The proposed extension now provides all manufacturers of conventional foods and dietary supplements with an additional 18 months to implement the labeling changes required by the final rules. 

For more information about the required labeling changes and final rules, or how this issue may affect your business, please contact the author of this alert, Kyle Diamantas, or any member of the Firm's FDA Group.

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