Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA or we) is extending the compliance dates by approximately 1.5 years for the final rules providing updated nutrition information on the label of food, including dietary supplements; defining a single-serving container; requiring dual-column labeling for certain containers; updating, modifying, and establishing certain reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. The final rules appeared in the Federal Register of May 27, 2016. We are taking this action because, after careful consideration, we have determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.
A. Purpose of the Final Rule
The final rule extends the compliance dates for two rules. In the Federal Register of May 27, 2016 (81 FR 33742 and 81 FR 34000), we published two final rules entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labels" (the Nutrition Facts Label
Final Rule) and "Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and
Technical Amendments" (the Serving Size Final Rule). In those final rules the compliance date for manufacturers with $10 million or more in annual food sales was established as July 26, 2018; for manufacturers with less than $10 million in annual food sales, the compliance date was set as July 26, 2019.
This final rule extends the compliance date for manufacturers with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020; for manufacturers with less than $10 million in annual food sales, the final rule extends the compliance date from July 26, 2019, to January 1, 2021.
B. Summary of the Final Rule
The final rule extends the compliance date for manufacturers with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020; for manufacturers with less than $10 million in annual food sales, the final rule extends the compliance date from July 26, 2019, to January 1, 2021. We are extending the compliance dates for the Nutrition Facts Label Final Rule and the Serving Size Final Rule, which were issued consistent with our authority in
sections 403(q), 403(a)(1), 201(n), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q), 343(a)(1), 321(n), and 371(a), respectively) and section 2(b)(1) of the Nutrition Labeling and Education Act (NLEA) (Pub. L. 101-535).
