Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels


How to Comment

The comment period opens July 5, 2016.

Submit electronic comments on to docket number FDA-2015-D-1839.

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-2015-D-1839.

Contains Nonbinding Recommendations

July 2016  

This guidance addresses how conventional food and dietary supplement manufacturers should declare small amounts of nutrients and dietary ingredients on nutrition labels. 

It specifically explains how FDA intends to consider exercising enforcement discretion when a conflict occurs between compliance with Title 21 of the Code of Federal Regulations (21 CFR), section 101.9(c), and compliance with 21 CFR 101.9(g) such that compliance with both sections is not possible

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. 

Download Guidance for Industry:
FDA's Policy on Declaring Small Amounts
of Nutrients and Dietary Ingredients on Nutrition Labels
(PDF 80KB)

This guidance represents 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 as listed on the title page.

This guidance has been prepared by the Office of Nutrition and Food Labeling, Food Labeling and Standards Staff in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

Page Last Updated: 12/07/2016
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