FDA Issues Draft Guidance Sampling Recommendations for Seafood Subject to DWPE

WASHINGTON, D.C. — On Feb. 9, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry to provide recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine) and/or decomposition.

The draft guidance, once finalized, is designed to help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE.

This guidance addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE. The intent of the draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register. Submit electronic comments to www.regulations.gov to docket number FDA-2023-D-5303. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2023-D-5303.