FDA Regulation of Human Food Made from Cultured Animal Cells and Updates on FDA’s Imported Seafood Program


FDA completed its second pre-market consultation for human food made from cultured animal cells, and advised it had no further questions about the firm’s safety conclusions. The FDA’s premarket consultation with the submitter, GOOD Meat, Inc., involved an examination of the Company’s production process and the cultured cell material made by the production process. This also included the establishment of cell lines and cell banks, manufacturing controls and all components and inputs.

Human food produced from cultured animal cells are required to meet the same FDA requirements including facility registration and product safety as other food products. The food also requires U.S. Department of Agriculture inspection (USDA-FSIS) prior to entering the US market. Under a formal agreement with USDA-FSIS established in March 2019, the FDA oversees cell collection, cell banks and cell growth and differentiation, while USDA-FSIS has oversight during the harvesting stage of the cell culture process. FDA is encouraging firms to engage with the agency early in the product and process development to address safety and compliance of cultured animal cell food and production processes. The FDA will issue further guidance to assist such companies in preparing for pre-market consultations.

Separately, FDA released a new report this week called “Activities for the Safety of Imported Seafood” which outlines FDA’s comprehensive approach to ensuring the safety of imported seafood no matter where in the world the food is produced. As approximately 94% of seafood sold in the U.S. is imported, the FDA is committed to ensuring that imported foods meet the same safety standards produced by domestic farms and facilities. The FDA does so via inspections of foreign processing facilities, sampling of seafood offered for import, domestic surveillance sampling of imported products, inspections of seafood importers and assessments of foreign country food safety programs.

FDA’s import strategy for imported seafood comprises of four main goals as outlined in FDA’s 2019 strategy:

  1. Food Offered for Import Meets US Safety Standards: FDA aims to ensure compliance with inspections, food safety audits, fish and fishery regulatory requirements, and facilitating training and awareness of the FDA’s seafood safety requirements.
  2. Strengthen the FDA’s border surveillance to prevent entry of unsafe food: FDA seeks to use predictive analytics for import screening, which includes a pilot program using artificial intelligence, specifically machine learning, to improve the targeting of unsafe seafood at the border.
  3. Rapid and effective response to Unsafe Imported Seafood: FDA aims to maximize FDA’s responses to events relating to imported seafood including recalls, prevention strategies, and the Interstate Shellfish Sanitation Program.
  4. Improving effectiveness and efficiency of seafood import program: FDA seeks to develop a global inventory of seafood facilities and aquaculture farms and to develop new metrics to measure success.

FDA has commented that the wide range of known and emerging microbiological and chemical hazards, typically introduced at the source, including in growing areas, aquaculture farms and on fishing vessels, presents challenges and opportunities for seafood contamination. In addition, potential hazards are unique as aquaculture is vulnerable to changing environmental conditions and stress factors that make fish more susceptible to diseases. The FDA advised that it is committed to supporting improvement and innovation in the food program while ensuring consumer safety.

For more information on these matters or other food regulatory questions, please email us at

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