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.

Please find our summary of the requirements and implications of the Nutrition and Supplement Facts Labeling Final Rule here and of the Serving Size Final Rule here.

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.

Please join us on June 21 for a webinar that will review the changes set forth by these new regulations and the impact these changes will have on your products. To register to attend the webinar, click here.

We will continue to monitor and report on FDA's activities to implement these rules and other food labeling-related activities.