NEWS: FDA Issues Final Guidance for Industry on Reconditioning Fish and Fishery Products by Segregation

The US Food and Drug Administration issued a final guidance titled “Reconditioning Fish and Fishery Products by Segregation: Guidance for Industry.”

The final guidance:

  • Clarifies the steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine) or decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.
  • Recommends information that industry should include in reconditioning by segregation proposals.
  • Provides uniform guidance and greater transparency to industry and stakeholders on how the FDA evaluates these proposals.

The final guidance does not apply to situations where reconditioning is proposed by means other than segregation, such as by cooking or conversion to animal feed. This guidance finalizes the agency’s draft guidance released in September 2019.

The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to using Docket ID: FDA-2019-D-3324. Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

Federal Register Notices:

Final Guidance Federal Register Notice April 2022

Draft Guidance Federal Register Notice September 2019

For Additional Information:

Seafood Guidance Documents & Regulatory Information

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