FDA Finalizes Rule Allowing Greater Discretion in Ordering Administrative Detention of Human or Animal Food
The U.S. Food and Drug Administration 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. This flexible tool provides the FDA with significantly wider discretion to detain food should the agency have reason to believe that an article of food is adulterated or misbranded.
Before the passage of the Food Safety Modernization Act 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, reexport or destruction), which must be resolved by the private parties involved.
What this means for you: While the enhanced authority helps the FDA prevent potentially harmful food from reaching U.S. consumers and thereby improves the safety of the U.S. food supply, manufacturers, processors, packagers, importers and distributors must take more preventative measures to ensure that food products are compliant with FDA standards and avoid possible administrative detention. This includes strict compliance with the Bioterrorism Act and FSMA, applicable current good manufacturing practice requirements, and label and nutrition facts requirements. This also includes reconsidering contractual agreements between manufacturers, distributors, warehousers and sellers to negotiate the terms of regulatory costs associated with administrative detentions.
If you have any questions regarding this rule or any other FDA or FSMA matters, please do not hesitate to contact an ST&R regulatory professional.