January 23, 2001

The Food and Drug Administration will prevent the distribution of unsafe imported food by requiring that shipments from "bad actor" importers be held in a secure storage facility at the importers' expense until released by the agency. FDA also established procedures to enhance interagency coordination and efficiently use Customs' civil monetary penalties procedures against importers who attempt to enter food into the United States by means of a material false statement, act or omission. Penalties can be issued in amounts up to the domestic value of merchandise so imported.

FDA developed the procedures in response to former President Clinton's directive on July 3, 1999, to the Secretaries of Health and Human Services and Treasury to work together to address six specific issues targeting unscrupulous importers who violate the rules and subvert the system by moving unsafe food into U.S. markets. FDA and U.S. Customs Service presented their joint plan in an Oct. 27, 1999, report to the President, posted it for public comment, and held a series of public meetings to discuss the plan. FDA and Customs then worked together to develop procedures and new rules to initiate the plan.

In addition, FDA has published for comment a proposed rule that will require marking food shipments refused for safety reasons to indicate that the product was denied entry into the United. States. This is designed to help eliminate the practice of "port shopping" in which importers whose cargo is denied entry at one port try to reintroduce it at another port without bringing the food into compliance with U.S. laws and regulations.

FDA also is developing a proposed rule that will establish standards for importers and other persons who use sample collection services and/or private laboratories to demonstrate compliance with FDA law, including standards for the collection and analysis of samples.