The U.S. Food and Drug Administration (FDA) last week announced a final rule strengthening 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 Obama in January 2011. Now, instead of needing hard evidence that food could present a health threat, the agency can detain food if it believes the product is adulterated or misbranded.
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.
“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,” 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.”
In the final rule, the agency notes that it received a number of comments from stakeholders asking the agency to clarify exactly what “reason to believe” that food is adulterated or misbranded means. “Decisions regarding whether FDA has ‘reason to believe’ that food is adulterated or misbranded will be made on a case-by-case basis because such decisions are fact-specific,” reads the rule. “The Agency will consider the individual facts in each particular situation to inform its reason to believe that an article of food is adulterated or misbranded. FDA has not, therefore, amended the regulation to provide additional explanation of the criteria for ordering administrative detention.”