April 12, 2024 – The US Food and Drug Administration (FDA) will reopen the comment period for 60 days for the draft guidance “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention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,” announced in the Federal Register on February 12, 2024. The Federal Register Notice is forthcoming. We are taking this action in response to a request from stakeholders for additional time to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-5303.
February 9, 2024 – The US Food and Drug Administration (FDA) issued draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products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 The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import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The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to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The intent of this draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation.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Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register.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Federal Register Notice for the Draft Guidance
