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GUIDANCE DOCUMENT

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 December 2019

Final
Docket Number:
FDA-2018-D-1459
Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition

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.

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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-2018-D-1459.