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FDA Publishes Draft Guidance on Mandatory Recall Authority

On Wednesday, the Food and Drug Administration (FDA) published draft guidance for industry on its mandatory food recall authority that has been in effect since the Food Safety Modernization Act (FSMA) was enacted in January 2011.

The recall authority was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by Section 206 of FSMA and gives FDA the ability to order a company to recall an article of food (other than infant formula) which the agency believes is adulterated or misbranded and that use of or exposure to it would cause serious adverse health consequences or death to humans or animals.

FDA inspectThe seven-page guidance document is formatted as a Q&A and “provides answers to common questions that might arise about these mandatory recall provisions and FDA’s current thinking regarding their implementation.”

After deciding a product meets the criteria for a mandatory recall, FDA must give the “responsible party” the opportunity to voluntarily recall it and cease distribution. If the company refuses, FDA can order them to stop distributing the food and allow them an informal hearing. After these steps are completed, FDA can order a recall from commerce.

The guidance document explains these steps, along with which foods are subjected to mandatory recall authority, what constitutes a “responsible party,” the criteria for a mandatory recall, what evidence FDA might consider when deciding whether to move forward with a recall, the role of fees, and other details.

Since gaining mandatory recall authority for food, FDA has used the power twice – in the 2013 recall of Salmonella-tainted pet treats produced by Kasel Associates Industries and in the 2014 recall of OxyElite Pro Dietary Supplements.

The public now has 60 days to comment on the guidance before FDA begins work on the final version.

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