• Summaries of Final Rules on Revisions to Nutrition and Supplement Facts Labeling and Serving Sizes
  • June 30, 2016 | Authors: Melvin S. Drozen; Evangelia C. Pelonis; Natalie E. Rainer; Laura D. Venker
  • Law Firms: Keller and Heckman LLP - Washington Office; Keller and Heckman LLP - San Francisco Office; Keller and Heckman LLP - Washington Office
  • We have reviewed and analyzed FDA's recently-issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. The final rules were published in the Federal Register on May 27, 2016. See Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Final Rule, 81 Fed. Reg. 33741 (May 27, 2016), available at:https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11867.pdf; 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; Final Rule, 81 Fed. Reg. 34000 (May 27, 2016), available at: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11865.pdf.

    The final rule revising the Nutrition and Supplement Facts Labels (1) updates the list of nutrients that are required or permitted to be declared; (2) provides updated Daily Reference Values and Reference Daily Intakes; (3) amends requirements for foods represented or purported to be specifically for children under the age of 4 years, pregnant women, and lactating women and establishes nutrient reference values specifically for these population subgroups; and (4) revises the format and appearance of the Nutrition and Supplement Facts labels. In addition the rule now provides a new definition for "dietary fiber".

    The final rule revising serving sizes (1) changes Reference Amounts Customarily Consumed (RACCs) for certain foods; (2) creates new reference amount categories and reference amounts; (3) amends the definition of a single-serving container; and (4) requires dual column nutrition labeling for certain food containers.

    The final rules are effective July 26, 2016. Companies generally have 2 years from the effective date to comply with the final rule, i.e., July 26, 2018, except that manufacturers with less than $10 million in annual food sales have 3 years from the effective date to comply, i.e., July 26, 2019.