U.S. Government Accountability Office (GAO) recently issued a report that reviewed the steps FDA takes when removing seafood products from import alert. Although FDA intends to conduct a certain amount of sampling or inspections as part of their decision to remove a product from import alert, GAO found that they repeatedly failed to meet their own sampling and inspection goals.
The U.S. imports most of the seafood we consume, and the import alert program is a key enforcement tool for FDA to meet their food compliance mandate. When FDA places a product or company on import alert (see previous blog about seafood import alerts), they require certain steps before considering removal. This may include FDA sampling or inspecting shipments, as well as reviewing evidence provided by firms or private labs. It can be a very time-consuming process to remove a product from import alert.
Enforcement Implications
In the report, FDA “stated that it plans to develop goals for its auditing process to ensure audit sampling targets products of higher public health concern.” We anticipate that the import alert removal process may become more exacting, with FDA asking more questions and focusing more precisely on the particulars of the specific product and import alert.
Attorney John Johnson, who regularly represents companies on import alert, commented that “making the removal process more precise could extend beyond seafood industry to other food products subject to import alert,” as FDA continues to explore ways to ensure the safety of the nation’s food supply.
Our regulatory specialists and affiliated attorneys routinely assist seafood manufacturers and importers with HACCP planning, import alert violations, detentions, and facility inspections. Contact us today with your concerns.
