FDA Finalizes Rule Of Greater Discretion in Ordering Administrative Detention of Human or Animal Food

The FDA has adopted as final, without change, a May 2011 interim final rule amending the criteria for ordering an administrative detention to prevent potentially unsafe food from reaching the marketplace.

Before the passage of the Food Safety Modernization Act (FSMA) the FDA was able to detain a food product only when it had credible evidence indicating that an article of food presented a threat of serious adverse health consequences or death to humans or animals. Under the revised criteria, the FDA can order an administrative detention if it has reason to believe that the food is adulterated or misbranded.

This rule permits the FDA to keep products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as a seizure.

To address industry worries that this rule provides unfettered authority, the FDA states that it is committed to evaluating the individual facts in each case to inform its “reason to believe” that a food is adulterated or misbranded. The FDA has also indicated that it will continue to use its advisory action tools, such as warning letters and untitled letters, to achieve voluntary compliance and voluntary corrective action.

The final rule adopts the procedures for administrative detention, including the process for appealing and requesting an informal hearing on the matter, as outlined in the Code of Federal Regulations.

The FDA notes that it will issue a notice of termination of administrative detention on the same day the decision is made whenever practicable. If the FDA fails to issue a detention termination notice and the detention period expires, the detention is deemed terminated. However, it is important to note that the FDA will not be liable for the costs associated with an administrative detention (e.g., storage or moving costs) or with the disposal of the detained products (e.g., reconditioning, re-export or destruction), which must be resolved by the private parties involved.

For more information, click HERE.