AHPA urges careful FDA use of administrative detention under FSMA

The Food Safety Modernization Act (FSMA) was signed into law in January this year. Its development was prompted by a spate of contaminated food recalls in recent years, some of which were fatal, including a nationwide recall of salmonella-tainted peanut products that killed at least nine at the beginning of 2009.

AHPA notes that Section 207 of FSMA amended the Federal Food, Drug, and Cosmetic Act by changing the criteria under which FDA can detain a food – including dietary supplements – from 20 to 30 days.

This was amended to give FDA authority to order detention of a food if it has "reason to believe"​ that the food is "adulterated or misbranded".​ This was previously limited to instances in which the agency had "credible evidence or information"​ indicating that a food "presents a threat of serious adverse health consequences or death”.​

Comments filed in response to the new Act by AHPA urge FDA continue to use its administrative detention authority sparingly.

It is also noted by the trade association that Congress did not limit administrative detention to food that is in domestic commerce, such that "any detention of food that is made due to FDA's determination that is has a reason to believe that the food is adulterated or misbranded, including detentions at a point of importation or of domestic possession, should be considered to be an administrative detention."​

“If FDA agrees with this analysis, any adulteration – or misbranding-based adulteration – would be subject to certain rules, including that such detention could not exceed 30 days,”​ stated AHPA.

Initial reception​

When FSMA was first released, it was received well by stakeholders in the dietary supplements industry, and commended by the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA)​.

Among the other actions linked to the new legislation are the setting up of a food recall search site​, the release of a food safety guidance document​ for the seafood industry, and two public meetings with industry and consumer groups on the import and preventive control provisions of the law.