The U.S. Food and Drug Administration in the Nov. 5 Federal Register issued guidance on final rules for Nutrition and Supplement Facts Labels and for Food Labeling of Serving Sizes for conventional food and dietary supplement manufacturers, finalizing guidance issued in January 2017.

Concerning the Nutrition and Supplemental Facts label final rule, the Nov. 5 guidance provides questions and answers related to compliance, including the labeling of added sugars, and formatting of labels.


The Nov. 5 guidance provides questions and answers primarily on two final rules for Serving Sizes and Food Labeling, and discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling and additional issues dealing with compliance.  

In the May 27, 2016, Federal Register, the F.D.A. issued two final rules titled, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” 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.”

In addition to amending regulations for nutrition labeling of conventional foods and dietary supplements, the Nutrition Facts Label final rule also revised the Nutrition Facts Label to replace “sugars” with “total sugars” and to include the declaration of added sugars. The Serving Size final rule amended the definition of a single-serving container, required dual-column labeling of certain packages and amended several reference amounts used to determine serving size. The two final rules set compliance dates of July 26, 2018, for manufacturers with $10 million or more in annual food sales and July 26, 2019, for manufacturers with less than $10 million in annual sales.

The Jan. 5, 2017, guidance made changes to the original guidance, including compliance dates, noting that although the Nutrition Facts Label and Serving Size final rules became effective on July 26, 2016, compliance dates had not been realized. On Oct. 2, 2017, the F.D.A. proposed compliance dates of Jan. 1, 2020, for food manufacturers with $10 million or more in sales and of Jan. 1, 2021, for those with less than $10 million in annual sales.

The Nov. 5 guidance finalizes the January 2017 draft guidance, the F.D.A. said.

Interested parties can file comments on the final rules. Comments must include docket number FDA-2016-D-4414.