FDA issues final guidance on mandatory recall authority

FDA issues final guidance on mandatory recall authority


When the Food and Drug Administration tells a food company to issue a recall “or else,” a new document describes exactly what that means.

The Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act.

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, according to a news release.

However, the law says FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, according to the release.

Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

Providing clarity to draft guidance issued in 2015, the FDA said the final guidance includes modifications based on comments received.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,” the agency said.

In its guidance, the FDA said it would go through a series of steps if a company does not cooperate.

“If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to 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 2 days after the issuance of the order,” the guidance said.

After those steps are completed, the FDA said it may order a recall under section 423(d) of the FD&C Act 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 under section 423(d), the agency said.

Rarely used authority

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 began the process of using its mandatory recall authority under FSMA until the companies ultimately chose to voluntarily recall their product, according to the agency.

The agency said it “remains committed” to working with firms on food recalls.

In comments to the FDA on its draft guidance, the Produce Marketing Association said that the agency must be sure that a food under mandatory recall is “indeed the food vehicle” that is causing or is reasonably likely to cause severe adverse health consequences or death.

“While swift identification and recall of a food that is likely to cause severe adverse health consequences or death is an absolute necessity, so is assuring to the greatest extent possible that the food vehicle has been correctly identified,” PMA said in its 2015 comment.

The FDA’s final guidance holds no surprises, said Jennifer McEntire, vice president of food safety and technology for the United Fresh Produce Association. She said the FDA was given mandatory recall authority with the 2011 Food Safety Modernization Act.

“It is helpful to see the sort of parameters under which they will use that (authority),” she said.

“Obviously, they’re giving the first opportunity (for a food company) to do the right thing and recall a product,” she said. The FDA will move, she said if a firm procrastinates and public health is at risk.

“ I would expect (mandatory recall) will be very rarely used because I think that companies do recognize that they need to act,” she said. “I think (the guidance) just fits right along with what the FDA has been saying or quite some time.”