Guidance for Industry: 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; Small Entity Compliance Guide


How to Comment

You may submit electronic or written comments regarding this guidance at any time starting on March 2, 2018.

Submit electronic comments to to docket number FDA-2004-N-0258.

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-2004-N-0258.

Contains Nonbinding Recommendations

February 2018

In the Federal Register of May 27, 2016 (81 FR 34000), we published a final rule pertaining to serving sizes for food. The final rule amends the definition of a single-serving container, requires dual-column labeling for certain containers, updates the tables of Reference Amounts Customarily Consumed (reference amounts, or RACCs), and amends the serving size for breath mints. The rule became effective on July 26, 2016. We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule, and is intended to help small entities comply with the rule established in 21 CFR 101.9 and 101.12.

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 our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” and “I” refer to food manufacturers that are subject to the rule. Many answers in this guidance are followed by citations to show where a specific requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 of the Code of Federal Regulations. 

Download the Guidance for Industry

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