On Feb. 4, the U.S. Food and Drug Administration (FDA) adopted a final rule to strengthen the agency’s authority to use administrative detention to prevent potentially unsafe food from reaching the marketplace. This action makes the criteria for administrative detention consistent with the changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act (FSMA), which was signed by President Barack Obama in January 2011.
This final rule adopts, without change, the interim final rule (IFR) entitled “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption” that published in the Federal Register on May 5, 2011. This final rule affirms the IFR’s change to the criteria for ordering administrative detention of human or animal food as required by the FSMA. Under the new criteria, FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
“Before the passage of the FSMA, the FDA was able to detain a food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans or animals,” the agency explained in its update. “Under the final rule, the FDA can detain food if it believes that the food is adulterated or misbranded. The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether to take further enforcement action, such as seizure.”
Federal Register notice