Public Warning, Notification and Posting of Recalls and other Corrective Actions

March 20, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Filed electronically at regulations.gov Re:Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff; Draft Guidance (Docket No. FDA-2016-D-3548) Dear Sir or Madam: The American Frozen Food Institute (AFFI) appreciates the opportunity to submit comments regarding the Draft Guidance document Public Warning and Notification of Recalls Under 21 CFR Part 7 ("Draft Guidance"). AFFI is the national trade association representing the interests of U.S. frozen food processors and their suppliers. AFFI members manufacture and distribute frozen foods throughout the United States and globally. AFFI supports the release of the Draft Guidance and is providing these comments to make two points: (1) Public warnings of recalls not only must be timely, but also accurate; and (2) Recall classification is important because it defines the risk profile of a recall. Overall, AFFI appreciates the release of the Draft Guidance, which provides recommendations to industry and Food and Drug Administration (FDA) staff regarding the use, content, and circumstances for issuing public warnings and public notifications, and discusses the parties responsible for issuing public warnings. It is extremely important that the agency have clear policies and procedures in place to ensure firms or responsible parties initiate food recalls promptly and notify the public where and when appropriate. It's also extremely important for the agency to make clear its expectations for public warning and notifications of recalls in terms of content and distribution. Please find attached more detailed comments on this particular guidance. Best regards, Donna Garren Executive Vice President, Science & Policy