Tablets & Capsules


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32B October 2020 Tablets & Capsules T Adapting to change is the name of the game Justin J. Prochnow Greenberg Traurig regulatory compliance Earlier this year, proposed changes to the Nutrition and Supple- ment Facts panels started coming into mandatory compliance. This article discusses these changes to regulations governing dietary supplements, their impact on nutritional information and claims, and the possible ramifications of non-compliance. his year has brought a number of changes to the food and supplement industries, with perhaps none greater than the changes to the regulations governing the label- ing of dietary supplements, food, and beverages. While changes to the look and feel of the Nutrition Facts labels for food and beverages, such as increased text size of "calories" and other information, have drawn the most attention, the revisions to the information displayed in the Supplement Facts panel have had great effect on the dietary supplement industry as well. Time for change The Food and Drug Administration (FDA) first pro- posed changes to the regulations mandating the display of information on the labels for dietary supplements, food, and beverages in 2014, announced revisions to those changes in 2015, and finalized the proposed changes in 2016 with two final rules, "Food Labeling: Revision of the Nutrition and Supplement Facts Labels" and "Food Label- ing: Serving Sizes of Foods That Can Reasonably Be Con- sumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments" [1]. Both final rules came into effect on July 26, 2016, meaning that companies could have implemented changes to product labeling based on those revisions starting on that day. The initial mandatory compliance dates were July 26, 2018, for companies with annual sales of $10 million or more and July 26, 2019, for com- panies with less than $10 million in annual sales. The agency, however, pushed the deadlines to January 1, 2020, and January 1, 2021, respectively. After numerous sectors of the food and supplement industries asserted that the FDA had not allowed enough time to implement the required changes, the agency further indicated that it would exercise enforcement discretion on those com-

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