FDA Published Draft Guidance on Mandatory Food Recalls

The U.S. Food and Drug Administration (FDA) has published a notice in the Federal Register that a draft guidance for industry on mandatory food recalls is available for public comment. FDA has the authority to order a responsible party to recall a food if there is reasonable probability that the food (other than infant formula, for which FDA has separate recall authority) is adulterated or misbranded under certain provisions of the Federal Food, Drug, and Cosmetic Act, and that the use of or exposure to that food will cause serious adverse health consequences or death.

This authority for mandatory food recalls was provided by the FDA Food Safety Modernization Act (FSMA) to better protect public health by strengthening food safety measures and providing more effective enforcement tools. Before the enactment of FSMA in January 2011, the FDA had to rely on manufacturers to voluntarily recall food products.

In February 2015, the FDA reported to Congress that it has used this new authority twice. In both cases, the FDA issued letters to the responsible party warning that if the firm did not voluntarily cease distribution and conduct a recall, FDA may, by order, require the firm to cease distribution and give notice to other parties.

The draft guidance is in the form of questions and answers that focus on common questions that might arise about how FDA will use this mandatory recall authority. They include:

• What foods are subject to FDA’s mandatory food recall authority?
• What are the criteria for a mandatory recall? 
• What is the process FDA must follow for a mandatory recall?

The draft guidance will be available for public comment for 60 days starting May 7, 2015. The FDA will consider all comments before completing a final version.

For More Information:

• Federal Register Notice
• Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
• Annual Report to Congress on the Use of Mandatory Recall Authority