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On February 7, U.S. Food and Drug Administration (FDA) has released its statement in taking new steps to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls.
Most companies collaborate with the FDA to quickly introduce voluntary recalls and work with their supply chain partners to eliminate the product from shelves and prevent further distribution. Over the last year, a draft guidance document was released to address these circumstances along with another draft guidance that describes situations where FDA will disclose retail information for recalled food. In November 2018, a finalized mandatory recall guidance for food, intended to provide answers to common questions about the mandatory food recall provisions was also published.
At the present time, U.S. FDA takes a new step to ensure appropriate public warnings and notifications of recalls by beginning to implement the recommendations extracted from the issued final guidance. The guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may act to issue its own public warning should a company’s warning be deemed insufficient.
It also describes the agency’s policy for moving forward with posting recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA, in some cases before a final health hazard evaluation is completed.
The agency claims to be advancing on other new steps to modernize efforts and improve how information is being provided to consumers.