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GUIDANCE DOCUMENT

Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels July 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-1839
Issued by:
Guidance Issuing Office
Human Foods Program

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 the Guidance 

Related Information

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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-2015-D-1839.

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