FDA Announces Final Rule on Administrative Detention of Food | Regulatory Doctor
February 4, 2013
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. This action makes the criteria consistent with changes to the Federal Food, Drug, and Cosmetic Act under the Food Safety Modernization Act (FSMA). The final rule adopts the interim final rule “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change. The interim final rule amended the criteria for ordering administrative detention to permit FDA to administratively detain food it believes is adulterated or misbranded. The interim final rule became effective in July 2011.
Before the passage of FSMA, 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. 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.
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