Now Hear This: FDA Issues Draft Guidance on Public Warning and Notification of Recalls

By Ricardo Carvajal — FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here).  Although the draft guidance extends to recalls of nearly all FDA-regulated products, it is of particular importance to the food sector because it follows on the heels of an HHS OIG report critical about the agency’s oversight of certain food recalls.  In response to that report, Commissioner Gottlieb issued a statement indicating that the agency intended to take “additional policy steps… as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.”  The issuance of the draft guidance appears to be the first of those additional policy steps. The draft guidance addresses both public warnings (meaning an alert to the public that a recalled product presents a serious…

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