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FDA Issues Draft Guidance on Public Warning and Notification of Recalls and Announces Move to Expedite Release of Recall Information

Tuesday, February 6, 2018

(North American Meat Institute)

The Food and Drug Administration (FDA) issued draft guidance regarding public warning and notification of recalls, and announced steps to release recall information more quickly. The draft guidance provides recommendations to industry and FDA staff about the use, content and circumstances for issuing public warnings and public notifications, and discusses the parties responsible for issuing public warnings. The document's recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers food, dietary supplements, cosmetics and other FDA-regulated products. The guidance also details the release of retail consignee information as a component of public warnings of recalls. Meanwhile, FDA issued a blog post announcing its adoption of a new policy to release recall information in its weekly Enforcement Report, even when the recall has not yet been classified. The law firm Hogan Lovells issued a memo explaining the draft guidance and the new policy for Enforcement Reports.

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