Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:
Just a few weeks ago, FDA investigators ordered an administrative detention of a Maine company’s cold-smoked salmon product, a ready-to-eat food, during an inspection. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision, after inspectors found Listeria monocytogenes within the company’s facility and on its processing equipment.
Similarly, in October 2011, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., where the seized products had first been subject to a detention order issued by FDA, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility’s warehouse and processing area.
These administrative food detentions are becoming more and more widespread and this trend is not accidental. The January 2011 amendment to the FDA Food Safety Modernization Act (FSMA) granted the FDA a far broader authority than in years past to administratively detain foods suspected of adulteration or misbranding. According to Dara Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs:
The FDA will not hesitate to take immediate steps to protect the public’s health. We will aggressively use our enforcement tools to prevent potentially adulterated food from reaching the public.
Appealing an administrative detention is an option for claimants who act fast! After receiving the administrative detention order, an owner of perishable foods must file an appeal within two (2) calendar days and the owner of non-perishable foods has four days to file a notice of intent to file an appeal and to request a hearing with the actual appeal due within ten (10) calendar days of the receipt of the administrative detention order. A timely appeal filed correctly can result in a quicker termination of the administrative detention and thus, the return of the food article. Furthermore, it grants the owner of the food articles the opportunity to present evidence supporting the legitimacy of the detained food rather than to simply be at the mercy of the inspectors.
For more information, visit the recently published guide entitled “What You Need to Know About Administrative Detention of Foods, available at http://www.fda.gov/Food/guidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm276871.htm.
As always, if you are unsure, consult with a professional. Failure to appeal an administrative detention of food can result in seizure. Moreover, not only may you lose the food you intended to sell, but also get fined by the U.S. Government.