Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

Hazardous foods or potentially contaminated products can expose Americans to foodborne illness that can sometimes be life threatening. Our nation depends on the U.S. Food and Drug Administration to ensure that the foods they buy are safe. Therefore, when issues arise that would put consumers at risk, we won’t hesitate to mandate the removal of a product from the market using the full extent of our authorities. It’s our responsibility. And it’s critical to our mission to ensure the safety of Americans.

Over the course of this year I’ve announced several new policy changes that are aimed at improving our food recalls processes. Our goal is to make sure we take action more swiftly and provide timely, actionable information to consumers. We’ve taken steps to communicate food recalls earlier so consumers have timely information to protect themselves from unsafe food products. To continue to advance these goals, we must also work with industry to further improve and modernize our recall processes. This includes the use of the FDA’s mandatory recall authority when appropriate.

Fortunately, most companies collaborate with the FDA to rapidly initiate voluntary recalls of hazardous food products. On average, a recall occurs within four calendar days of the problem being discovered. Most recalls are conducted in close coordination with the FDA’s food program staff.

However, we’ve seen cases where companies don’t voluntarily agree to issue a recall of food products that are violative, even if the food products are reasonably likely to cause serious illnesses or death.

To me, this is unacceptable. And it’s why today we’re taking additional steps to further outline in a final guidance information about the implementation of FDA’s mandatory recall authority.

The guidance issued today is part of our efforts to be as robust and transparent as possible and provide answers to questions that many have asked about the FDA’s mandatory recall processes.

Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products.

The guidance further outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food product a serious health risk. Providing this additional clarity can enable the FDA to make more robust use of this recall authority.

The FDA first gained authority under the 2011 Food Safety Modernization Act (FSMA) to mandate recalls when certain unsafe food products are identified, and the manufacturer does not voluntarily remove the product from market. Prior to the enactment of the FSMA, the FDA could generally only rely on manufacturers to voluntarily recall certain potentially harmful food products.

Since gaining this authority under FSMA, the FDA has only had to issue one mandatory recall order of a food product in order to protect public health. In April 2018, the 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.

While the FDA’s mandatory recall authority plays an important role in ensuring that potentially dangerous food products are removed from the marketplace, the agency remains committed to working with companies to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply. That’s why we make FDA Recall Coordinators available to assist firms during the recall process and continue to issue guidance on when and how food recalls should occur.

This final guidance is another of a series of meaningful step we’re taking this year to make our recall processes more efficient and transparent. A few weeks ago, we issued new draft guidance that describes situations when disclosing retail information for recalled products. We also took an important step in January when we released a draft guidance on public warnings for consumers that outlined situations where the FDA and companies would publicize public warnings to help carry out a recall.

We’ve already acted on these draft guidances.

For example, the FDA issued a public warning earlier this year on imported crab meat from Venezuela as soon as we knew there were Vibrio illnesses in several states associated with that product. More recently, we issued a public warning on recalled vegetable products as soon as we knew the scale of the recall. We’ll continue to improve our policies related to food safety and recalls, and advance our authorities to make sure that that we arm consumers with information to protect themselves and their families.

More actions to improve our recall policies will be forthcoming. We are committed to ensuring that recalls by companies – voluntary or involuntary – are initiated, overseen, and completed promptly and effectively.

Our goal is protecting consumers. Most of our regulated industry partners share our commitment. But when they don’t, Americans should know that the FDA won’t hesitate to take steps to protect their health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.