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FDA Issues Draft Guidance on Reconditioning Fish

The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry, titled, “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance explains two potential approaches to separating non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The two approaches to reconditioning adulterated fish and fishery products, described in the draft guidance, are:

  1. Segregation based on a production-related rationale supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article along with sampling and testing to confirm that the segregation was successful; or

  2. Segregation based on the results of statistically significant sampling and testing.

These approaches can be used if they satisfy the requirements of the applicable statutes and regulations but do not apply when reconditioning is proposed by means other than segregation, such as be cooking or conversion to animal feed, according to FDA (84 Federal Register 48935). Although, the Agency cautions that anyone introducing, delivering, or receiving fish and fishery products in interstate commerce is ultimately responsible for ensuring that the food is safe and complies with all applicable laws and regulations.

FDA has requested feedback on the draft guidance. The comment period will be open for 60 days until November 18, 2019. Electronic comments can be submitted on https://protect-us.mimecast.com/s/VHGXCmZEzmSj03MjIQWIRD to docket FDA-2019-D-3324.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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