FDA Debars Food Importer as Tougher Food Safety Legislation Looms
Client Alert | 2 min read | 12.29.09
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.
Contacts
Insights
Client Alert | 5 min read | 12.12.25
Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality
On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument.
Client Alert | 8 min read | 12.11.25
Director Squires Revamps the Workings of the U.S. Patent Office
Client Alert | 8 min read | 12.10.25
Creativity You Can Use: CJEU Clarifies Copyright for Applied Art
Client Alert | 4 min read | 12.10.25
Federal Court Strikes Down Interior Order Suspending Wind Energy Development

