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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels February 2020

Final
Docket Number:
FDA-2012-N-1210
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

In the Federal Register of May 27, 2016 (81 FR 33742), FDA (we) published a final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (“the final rule”). The final rule amends the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices and set a compliance date of July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales. We subsequently extended the compliance dates to January 1, 2020, and January 1, 2021, respectively (83 FR 19619). 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 revisions made in the final rule and is intended to help small entities comply with the requirements established in 21 CFR 101.9, 101.30, and 101.36.

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.

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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-2012-N-1210.