Today the U.S. 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 This guidance finalizes the agency’s draft guidance released in September 2019.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 guidance can be downloaded by going to https://www.fda.gov/regulatory-information and then search FDA guidance documents.
The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to www.regulations.gov 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.