The Food and Drug Administration (FDA) has released draft guidance for the industry regarding the collection of representative samples for food testing. 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 guidance aims to assist foreign manufacturers and processors in submitting evidence to the FDA to support the removal of their products from DWPE.
The draft guidance addresses concerns about the challenges faced by the industry in supporting arguments about the safety of seafood products subject to DWPE. It provides recommendations for collecting statistically strong representative samples, identifying sample units within affected articles, and utilizing analytical methods for testing. Additionally, it outlines evidence requirements for requests to release articles from DWPE and for requesting removal of products or manufacturers from DWPE.
Stakeholders have 60 days after publication in the Federal Register to submit comments on the draft guidance. Comments can be submitted electronically to the docket number FDA-2023-D-5303 at www.regulations.gov, or in writing to the Dockets Management Staff at the FDA’s address in Rockville, MD.
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For more information or to submit comments on the draft guidance, visit the FDA’s website.
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