The U.S. Food and Drug Administration (FDA) on Monday 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, according to an update published by FDA. “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,” the agency explained it 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, which will be published to the Federal Register on Tuesday, the agency notes that it received a number of comments from stakeholders asking that the agency clarify exactly what “reason to believe” that food is adulterated or misbranded means. “[D]ecisions 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. Because such decisions are fact specific, FDA has not, therefore, amended the regulation to provide additional explanation of the criteria for ordering administrative detention.” The FDA adds notes that it is aware the new criteria provides “more flexibility” in its use of administrative detention and “intends to use this tool as appropriate.” The agency says it will continue to utilize warning letters and other actions to try to achieve voluntary corrective actions.
