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FDA Debars Food Importer as Tougher Food Safety Legislation Looms

December 29, 2009

While food safety legislation with a strong emphasis on imports continues to work its way through Congress, the Food and Drug Administration ("FDA"), in an unprecedented exercise of its current authority, recently debarred a food importer for the first time. As the result of the debarment, the importer is prohibited from importing food into the United States for the next twenty years. The debarment flows from the importer's conviction for mislabeling food for importation into the United States, a violation of the federal Food, Drug and Cosmetic Act ("FDCA").

The United States District Court for the Central District of California recently sentenced Peter Xuong Lam, president of the Virginia Star Seafood Corporation, to five years in prison and ordered him to forfeit more than $12 million for his role in a conspiracy to import mislabeled food into the United States from Vietnam. Lam is one of twelve individuals who has been criminally convicted to date in connection with a scheme to avoid paying federal import tariffs by falsely labeling more than 10 million pounds of frozen catfish fillets as other species of fish. The frozen fillets were then sold in the United States at below-market prices.

The FDA's decision to employ for the first time its statutory power to debar a person convicted of a felony relating to the importation of mislabeled food is consistent with the agency's aggressive enforcement approach, announced by FDA Commissioner Margaret Hamburg, in August. FDA also has the power to debar any person who has engaged in a pattern of importing, or offering for import, adulterated food that presents a threat to humans or animals of serious adverse health consequences or death, and given its renewed emphasis on enforcement, it is likely that FDA will begin to debar importers convicted of importing adulterated foods.

The debarment comes as legislation is being considered in the Senate that would fundamentally restructure and modernize the food safety system and greatly expand FDA's authority over food imports. The FDA Food Safety Modernization Act (S. 510) unanimously passed out of the Senate Health, Education, Labor, and Pensions Committee and is currently on the Senate Legislative Calendar, awaiting consideration by the full Senate. The House of Representatives passed a companion bill food safety bill, the Food Safety Enhancement Act of 2009 (H.R. 2749), on July 30, 2009.

Both the Senate and House bills include provisions authorizing increased safety certification requirements for imported food. In addition, the Senate version calls for the creation of voluntary qualified importer program that would allow for expedited entry of imported food where importers certify the of safety of their foreign suppliers.

For more information on food importation requirements or the pending federal food safety legislation, please feel free to contact the professionals listed below or your regular Crowell & Moring contact.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John B. Brew
Partner – Washington, D.C.
Phone: +1.202.624.2720