[co-author: Carmen Tracy, Summer Associate]
Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had seized the food products held by Professional Warehouse and Distribution, Inc., at a food warehouse facility in St. Paul, Minnesota. The related complaint filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the District of Minnesota alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act in reliance on 21 U.S.C. §342(a)(4). The seized products are worth approximately $73,000 and include barley flour, spices, pasta, dried beans, tea and cookies.
The facility had previously been inspected by FDA twice in 2015 and again in 2017. During the first of the FDA inspections, in February 2015, FDA reportedly found unsanitary conditions that could cause the foods to become adulterated. Based on this inspection, FDA issued an untitled letter to the warehouse in April 2015 that identified deficiencies with respect to Current Good Manufacturing Practices for food. FDA requested that the company provide information about corrections that they would make to remedy the violations, which the company provided also in April 2015. Upon the second inspection in October 2015, FDA reportedly found that the warehouse had not implemented the corrective actions necessary to bring the facility into compliance. In response, the company sent a letter in October 2015 to the FDA promising further corrective actions. FDA conducted a third inspection on May 26, 2017, and again found that the corrective actions had not been implemented, and that the unsanitary conditions apparently had become more severe, reportedly including widespread vermin activity in the food warehouse. FDA detained the products at the facility.
On June 14, the U.S. Attorney’s office in Minneapolis filed a complaint for forfeiture in rem of the food products held in the facility. The complaint requested that the federal district court issue a warrant of arrest for the food products subject to the action (Defendant Articles), give notice to the affected parties, and enter a judgment declaring the Defendant Articles to be condemned and disposed of according to law. On June 15, the court issued the warrant for arrest and notice in rem, having determined that there is probable cause that the food held in the warehouse is adulterated and therefore subject to seizure, condemnation, and forfeiture to the United States under 21 U.S.C. §334. The warrant authorized the U.S. Marshal’s Service of the Department of Justice to arrest and seize the food products held in the warehouse facility, and use whatever means appropriate to protect and maintain the products and detain them, including through seizure in place or in the custody of another authorized agency, until further order of the court. The products were subsequently seized by the U.S. Marshals or embargoed by the state of Minnesota, an illustrative example of FDA and state coordination with respect to food safety enforcement matters.
Under its administrative detention authority, the FDA can detain food for up to 20 days if the agency has reason to believe the product is adulterated or misbranded. This allows the agency to keep detained food products out of the marketplace while it determines whether to take further enforcement action, such as seizure.
Summer Associate Carmen Tracy contributed to this post. Ms. Tracy is not a practicing attorney and is practicing under the supervision of principals of the firm who are members of the D.C. Bar.
