FDA Emphasizes Enforcement for Imports

At an FDLI conference in April, FDA Commissioner Margaret Hamburg, M.D., made clear her agency’s focus: Enforcement. She told the conference that, as a response to the rising globalization of the food supply, FDA needed to step up the regulation and policing of imported food products. Increased enforcement comes as no surprise to the industry—this year has already seen a record number of Warning Letters sent out by the agency, with no sign of slowing.

Additionally, as part of a renewed effort to refine and accelerate the importation of food, drugs and supplements, Dr. Hamburg signaled FDA’s intention to augment regulation strategy by “extending the FDAs’ global reach.” The primary player in the improved system will be PREDICT, a soon-to-be implemented regulating system that will allow the agency to more easily identify high-risk imports, as well as to expedite the shipment of low-risk imports. Inspections at borders could even be less likely if an importer meets all predetermined guidelines.

FDA hopes the new compliance measures will ensure a more sophisticated yet manageable set of enforcement guidelines for importers.