U.S. Marshals Seize Detained Food under Authority of FSMA
An illustration of FDA’s increased powers, a recent seizure was the first directed by the FDA under the authorization of the Food Safety Modernization Act (FSMA). Specifically, on October 11, 2011, the U.S. Food and Drug Administration (FDA) announced that U.S. Marshals seized food products at the FDA’s request. The food, which was being held at a storage and processing facility in Washington, was originally detained due to an infestation found during a FDA inspection. After having ordered the detention of the food products on September 2, 2011, FDA sought a warrant for the arrest of the products in federal court, ultimately resulting in the seizure.
As we previously reported, the FSMA expanded FDA’s powers in a number of areas, including those dealing with the administrative detention of goods. While FDA formerly had the authority to order the detention of goods, the Agency had to possess “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” 21 C.F.R. § 1.378 (2011). Today, pursuant to the FSMA, the FDA may detain foods where there is “reason to believe” that the food is adulterated or misbranded.
On May 5, 2011, the FDA issued its interim final rule, relaxing the “credible evidence” standard to require only a “reasonable basis” to believe that food is either adulterated or misbranded, and thus marking an increased burden on industry as well as the Agency. First, because the FDA must only have a reasonable basis for believing that a food is adulterated or misbranded, industry must be increasingly-vigilant in ensuring that its products are at all times compliant with FDA regulations, including the minute particularities concerning the labeling of products. Additionally, this increased power “ if fully enforced “ could strain the FDA’s overburdened resources.
Fuerst Ittleman will continue to monitor the FDA’s measures under the FSMA. For more information regarding the FSMA or FDA regulations, please contact us at email@example.com or (305) 350-5690.