The U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to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.” This guidance aims to assist foreign manufacturers and other processors of seafood products in providing evidence to remove their products from DWPE.

DWPE is implemented for seafood products suspected of adulteration due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The draft guidance outlines methods for collecting representative samples to demonstrate the safety of these products.

The FDA encourages industry feedback on the guidance within 60 days of its publication in the Federal Register, through electronic comments to www.regulations.gov (docket number FDA-2023-D-5303) or written comments to the FDA’s Dockets Management Staff in Rockville, MD.

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Constituent Updates

Center for Food Safety and Applied Nutrition 

The U.S. Food and Drug Administration (FDA) today issued draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products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 The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import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The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to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The intent of this draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation.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Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register.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

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SUMMARY

• The FDA released draft guidance for sampling seafood products subject to Detention Without Physical Examination (DWPE) due to potential adulteration concerns.
• Aimed at assisting foreign manufacturers and processors to provide evidence for safely importing their seafood products.
• Addresses adulteration issues related to pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition.
• Encourages industry to submit comments on the draft within 60 days via www.regulations.gov (docket number FDA-2023-D-5303) or in written form to the FDA’s Dockets Management Staff.

We understand the importance of ensuring that your products meet FDA standards and the potential challenges this new guidance may present to your business. Our goal is to help you navigate these regulatory waters smoothly and efficiently.

We offer our legal expertise and support in response to the recent draft guidance issued by the U.S. Food and Drug Administration (FDA) regarding the sampling of seafood products subject to Detention Without Physical Examination (DWPE). On the key points of the FDA’s draft guidance:

• Providing methods for collecting representative samples of seafood products.
• Aiding foreign manufacturers and processors in demonstrating product safety to remove their goods from DWPE.
• Addressing concerns related to adulteration from pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition.

Our team of FDA attorneys is well-versed in regulatory compliance and can offer comprehensive assistance in the following areas:

• Interpreting the new guidelines and assessing their impact on your operations.
• Developing strategies to efficiently collect and present the required evidence for FDA compliance.
• Assisting in drafting and submitting comments on the draft guidance within the 60-day feedback window.
• Providing ongoing legal advice to ensure continuous compliance with FDA regulations.