Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls


How to Comment

Submit either electronic or written comments on the guidance starting November 6, 2018.

Submit Comments Online
Submit electronic comments on to docket folder FDA-2015-D-0138 starting on November 6, 2018.

Submit Written Comments
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2015-D-0138.

November 2018 

Contains Nonbinding Recommendations

The purpose of this document is to provide guidance to industry and FDA staff on the implementation of the mandatory food recall provisions of section 423 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 350l] , which was added by section 206 of the FDA Food Safety Modernization Act of 2011 (FSMA). The guidance in this document is in the form of Questions and Answers and provides answers to common questions that might arise about these mandatory recall provisions and FDA’s current thinking regarding their implementation.

The FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's 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 Agency guidances means that something is suggested or recommended, but not required. 

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Page Last Updated: 11/05/2018
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