FDA Issues Two Guidances on Nutrition Facts Label Issues

FDA Issues Two Guidances on Nutrition Facts Label Issues

November 2, 2018

The U.S. Food and Drug Administration today issued one draft and one final guidance on various topics related to the two final rules updating the Nutrition Facts label.

The first guidance, which is draft, “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics: Guidance for Industry,” includes sections relating to:

• the definition of a single-serving container,
• reference amounts customarily consumed, which are used by companies to determine serving size,
• dual-column labeling, and
• miscellaneous issues, such as requirements relating to chewing gum and to multi-unit retail food packages.

The second guidance, which is final, is “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry.” The majority of the guidance consists of questions and answers to help manufacturers determine how to calculate “added sugars” in their products under certain circumstances. Other topics include compliance, label formats, and the declaration of quantitative amounts of vitamins and minerals.

The guidances are meant to provide clarity to food manufacturers to help them comply with the FDA’s updated labeling regulations, which is required by January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will have an additional year to comply.

To ensure that comments on the draft guidance are reviewed before work begins on the final guidance, please submit them either electronically or in writing within 60 days of the date of the draft guidance’s publication in the Federal Register. Submit electronic comments to the Federal eRulemaking Portal: https://www.regulations.gov. Written comments can be submitted to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For Additional Information:

• Federal Register Notice for Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics
• Federal Register Notice for Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals