Food

Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics

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How to Comment

The comment period opens November 5, 2018.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), submit either electronic or written comments on the draft guidance by January 4, 2019 to ensure that FDA considers your comment on the draft guidance before work begins on the final version of the guidance.

Submit electronic comments to https://www.regulations.gov to docket number FDA-2018-D-1459.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2018-D-1459.

Contains Nonbinding Recommendations
Draft - Not for Implementation

November 2018

This guidance is being distributed for comment purposes only.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 primarily to two final rules: (1) “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”; and (2) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” This guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.

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. 

Download the Draft Guidance for Industry

Page Last Updated: 11/05/2018
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