Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals


How to Comment

The comment period opens January 5,2017.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017.

Submit electronic comments on to docket number FDA-2016-D-4414.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-4414. 


For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2373.

Contains Nonbinding Recommendations
Draft - Not for Implementation

January 2017 

This guidance is being distributed for comment purposes only. 

This guidance is intended for conventional food and dietary supplement manufacturers.

It will provide questions and answers on topics related to compliance with our final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742 (May 27, 2016)) (to be codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)).

This guidance also discusses labeling of added sugars and formatting for lines (e.g. thickness of lines) and leading (e.g. space between lines) 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. 

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page.

Download the
Draft Guidance for Industry
(PDF: 173KB)

This guidance has been prepared by the Nutrition Programs Staff in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.


Page Last Updated: 11/05/2017
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