FDA Finalizes Guidance on Mandatory Recall Authority

FDA Finalizes Guidance on Mandatory Recall Authority

The guidance provides additional clarity including some modifications based on comments received.

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November 6, 2018
QA Staff Edited
Recalls Regulation

FDA has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

This final guidance follows a draft which was made available for public comment in 2015, and provides additional clarity including some modifications based on comments received. The guidance provides questions and answers on FDA’s mandatory recall process, explains what FDA considers when moving forward with a mandatory recall, and more.

For example, before FDA can use its mandatory recall authority, it must make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. FDA must also make a determination that there is a reasonable probability that the use of or exposure to such food will cause SAHCODHA.

Once FDA has determined that the criteria for a mandatory recall have been met, it must first notify the responsible party, in writing, that it has an opportunity to voluntarily cease distribution and recall the article of food. If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by FDA, the agency may order the responsible party to cease distributing the article of food and give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than two days after the issuance of the order.

After these steps are completed, FDA may order a recall if it is determined that the removal of the article from commerce is necessary. Only the FDA Commissioner has the authority to order a recall.

FDA has issued a mandatory recall order of a food product only once. In April 2018, FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several products were found to contain Salmonella. In two other instances, FDA started down the path of using its mandatory recall authority under FSMA until the companies ultimately chose to voluntarily recall their product.

While FDA’s mandatory recall authority plays an important role in ensuring that potentially dangerous food products are removed from the marketplace, the agency said it remains committed to working with firms to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply. FDA Recall Coordinators are available to assist firms during the recall process.

FSMA Recalls Regulation