The U.S. Food and Drug Administration (FDA) has released a draft guidance for industry on collecting samples for testing seafood products subject to Detention Without Physical Examination (DWPE).

Seafood products may be placed under DWPE under an import alert by FDA due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. The recently issued guidance is intended to help foreign manufacturers and other processors of seafood products subject to DWPE collect representative samples for testing and submit evidence to FDA to support a request to have their products removed from DWPE. The draft guidance clarifies FDA’s thinking on when the appearance of adulteration may be removed while giving industry the tools it needs to help support importation, addressing industry concerns about challenges in supporting arguments for the safety of seafood products subject to DWPE.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register.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