On November 5, 2018, the U.S. Food and Drug Administration (FDA) published a draft guidance for Industry and FDA Staff on mandatory food recalls.

According to FDA, the document provides 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 in a question and answer format.

Some of the topics covered include, but are not limited to:

• The food subject to FDA’s mandatory recall authority;

• The definition of the responsible party;

• The criteria for a mandatory recall;

• The process for mandatory recalls.

FDA's guidance documents, “…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.”

The FDA press release may be found here:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm445428.htm

The FDA Guidance may be found here: