Product Seizures Pave Way for New Recall Management Environment

By Mike Rozembajgier

The FDA recently signaled that it is ready to pursue a more proactive approach in ensuring the safety of the food supply by conducting its first seizure of food products subject to a detention order at a food warehouse and processing plant in Zillah, WA. With the FDA likely to continue targeting and detaining food products it finds unfit for the marketplace, food manufacturers and distributors need to be aware of the seriousness with which regulatory agencies are now pursuing their oversight responsibilities. This means maintaining high standards of product safety and having comprehensive recall management plans in place, just in case.

The seizure of the adulterated food in Zillah is the first such regulatory action undertaken by the FDA since the agency was given expanded oversight authority under the Food Safety Modernization Act (FSMA).  FSMA gives the FDA the authority to put a hold on food products that it has reason to believe are adulterated or misbranded. It gives the FDA 30 days to take appropriate action, including seizure and forfeiture  of the goods.  This seizure was ordered after a complaint was filed alleging that rodent droppings and urine stains were found on and around products stored in the warehouse.

As the FDA continues to build its capacity to regulate food products, new laws like FSMA give the agency additional tools with which to mitigate the risks of an expanding and increasingly complex global marketplace. This creates a new regulatory environment that will forces changes in the way companies manage recalls. While a company can choose to voluntarily recall a product when safety is compromised, a product seizure transfers control and recall management from the manufacturer to the regulatory agency. This transfer of power could create real risks for manufacturers trying to maintain relationships with their customers and protect their brands.

In a recent news release, Dara A. Corrigan, FDA associate commissioner for regulatory affairs, said, “FDA will not hesitate to take immediate steps to protect the public’s health.” Corrigan went on to note that the agency “will aggressively use our enforcement tools to prevent adulterated food from reaching the public.”

While this is the first FDA detention order that has resulted in a product seizure, it surely will not be its last. Food manufacturers, distributors and retailers must all do their part to make sure that their supply chains and facilities meet the highest standards of public safety in order to avoid increasingly severe regulatory action This case should also be a reminder of the important role that recall services will play as the FDA steps up its oversight and enforcement efforts against companies that do not meet appropriate standards of safety and compliance.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.