This draft guidance aims to provide recommendations for collecting samples of seafood products that are under DWPE due to potential adulteration from pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The FDA guidance is designed to assist foreign manufacturers and processors in submitting evidence to the FDA to request removal of their products from DWPE.

It addresses industry challenges in proving the safety of their seafood products under DWPE and intends to clarify the FDA’s stance on the removal of the appearance of adulteration, while offering tools to support importation. Public comments on the draft guidance are invited within 60 days of its publication in the Federal Register, either electronically to www.regulations.gov under docket number FDA-2023-D-5303 or in writing to the Dockets Management Staff in Rockville, MD.

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The U.S. Food and Drug Administration (FDA) today issued draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import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The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to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The intent of this draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation.

To Submit Comments

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register.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

Additional Information:

• Federal Register Notice for the Draft Guidance
• Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE
• Seafood Guidance Documents & Regulatory Information
• More on Seafood from FDA