The U.S. Food and Drug Administration (FDA) today announced a final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace.

Evidence vs. Belief

Under the new criteria, FDA can order an administrative detention if the agency has reason to believe that an article of food is adulterated or misbranded.

Before the passage of Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act (FSMA), FDA was able to detain a food product only when it had credible evidence or information that a food product presented a threat of serious adverse health consequences or death to humans or animals. Under the final rule, the FDA can detain food if it believes that the food is adulterated or misbranded.

Reasonable Probability

Decisions regarding whether FDA “reasonably believes” food is adulterated or misbranded and present a threat of serious adverse health consequences or death to humans or animals or to pose a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals will be made on a case-by-case basis because such decisions are fact-specific.

Q&A

Does the FSMA risk categorization approach apply to both human food and animal feed facilities?

No, it doesn’t. Not yet anyway. To date, FDA has only categorized facilities manufacturing food for human consumption as high-risk and non-high-risk under the framework established by FSMA. FDA already has risk models that are used within the Center for Veterinary Medicine (CVM). The Agency is currently working to update the CVM models based on the framework established by FSMA.

Would a voluntary recall preclude a FDA mandated recall?

Under the law, FDA is required to first give a responsible party the opportunity to cease distribution and conduct a voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease distribution or recall the food within the time and in the manner prescribed by FDA, FDA may proceed with a mandatory recall.

For more information:
Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
Inspection & Compliance under the FDA Food Safety Modernization Act