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GUIDANCE DOCUMENT

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 November 2018

Final
Docket Number:
FDA-2016-D-4414
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4414.