FSMA Update: FDA Publishes Interim Final Rules to Amend its Administrative Detention and Prior Notice Regulations

By Ricardo Carvajal –

As directed by the Food Safety Modernization Act (“FSMA”), FDA published interim final rules amending its administrative detention and prior notice regulations.  Both rules (here and here) take effect July 3, 2011.

Under the administrative detention regulations as amended, an FDA officer or qualified employee will have authority to administratively detain food that the officer or qualified employee has “reason to believe” is adulterated or misbranded – a standard that is much easier for FDA to meet than the current standard of “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.”  The relative difficulty of meeting the current standard, coupled with the fact that foods meeting this standard are typically the subject of Class I voluntary recalls or are embargoed by the states, helps explain why FDA has never used its administrative detention authority. 

Not surprisingly, FDA declined to provide an interpretation of the “reason to believe” standard: “Decisions regarding whether FDA has a ‘reason to believe’ a food is adulterated or misbranded would be made on a case by case basis because such decisions are fact specific.”  However, FDA indicated that the exercise of administrative detention is more likely under the new standard, particularly in Class II recall situations (i.e., those in which “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”). 

Under the prior notice regulations as amended, submitters of prior notice of imported food (whether for humans or animals) will be required to report any country to which the food has been refused entry.  FDA expects submitters to “gather and verify” information about whether a food was previously refused entry.

Senior FDA officials have signaled that implementation of the new and enhanced enforcement authorities granted by the FSMA is a high priority.  Their first use can’t be far behind.