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. Provided by the United States Food and Drug Administration. Updated Feb. 07, 2020 to reflect revisions by FDA.
Table of Contents
III. Questions & Answers on Compliance Issues
IV. Questions & Answers on Added Sugars
V. Question & Answer on Format Issues
VI. Question and Answer on the Declaration of Quantitative Amounts of Vitamins & Minerals
VIII. Downloads & Documents
This guidance is intended for conventional food and dietary supplement manufacturers. It provides questions and answers on topics related to compliance with our final rules issued on May 27, 2016, entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742; 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” (81 FR 34000; the “serving size final rule”) (codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)). This guidance also discusses labeling of added sugars, as well as formatting for lines (e.g. thickness of lines) and leading (e.g. space between lines) in the examples of graphics used by FDA on the Nutrition Facts label.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. In this guidance, “you” (or “I”) refers to a manufacturer of conventional food or dietary supplements.
On May 27, 2016, we published the Nutrition Facts label and the serving size final rules related to the Nutrition and Supplement Facts labels, which amended our labeling regulations for foods to provide updated nutrition information to assist consumers in maintaining healthy dietary practices. Below is a summary of the combined major provisions of the Nutrition Facts label final rule and serving size final rule. The final rules revise the Nutrition Facts and Supplement Facts labels by:
• Removing the declaration of “Calories from fat”;
• Requiring the declaration of the gram (g) amount of “added sugars” in a serving of a product, establishing a Daily Reference Value (DRV) for added sugars, and requiring the percent Daily Value (DV) declaration for added sugars;
• Changing “Sugars” to “Total Sugars” and requiring that “Includes ‘X’ g Added Sugars” be indented and declared directly below “Total Sugars”;
• Updating the list of vitamins and minerals of public health significance;
• Updating certain reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels;
• Revising the format of the Nutrition Facts labels to increase the prominence of the declaration of ‘‘Calories”;
• Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets;
• Requiring the maintenance of records to support the declarations of certain nutrients under specified circumstances;
• Amending the definition of a single-serving container;
• Requiring dual-column labeling for certain packages;