BREAKING NEWS: U.S. FDA Completes First Pre-Market Consultation for Food Made by Cultured Animal Cells

On November 16, 2022, the U.S. Food and Drug Administration (FDA) announced[i] the completion of its first pre-market consultation for a human food product made from cultured animal cells.

The product is produced by UPSIDE Foods[ii], which uses animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to create the cultured animal cell food. FDA conducted a pre-market consultation on the product, including the evaluation of the cell lines, production process (including cell bank establishment), substances used in the production process, and properties of the harvested cell material, including information available in both the safety assessment as well as other supporting and corroborative information. FDA concluded[iii] that it has no further questions about UPSIDE Foods’ safety conclusion[iv].

We should note that while the company has successfully obtained FDA’s no-question letter, there are other requirements the company should follow before launching the product in the U.S., e.g., making sure the manufacturing facility is registered with FDA and passes the inspection from the United States Dept. of Agriculture Food and Safety Inspection Service (USDA FSIS) regarding the manufacturing establishment. 

The alternative protein industry has been closely watching the regulatory approvals around the world to implement their market-entry strategies. The clearance of the first cultured meat in the U.S. is a significant step moving forward and is a welcome follow-up to EAT JUST’s 2020 approval of its cultured meat product by the Singapore Food Agency.

It is worthwhile to note that FDA has also created a “Human Food Made with Cultured Animal Cells Inventory,”[v] which will include the products receiving the same type of no-question letter from FDA through the above pre-market consultations. Under such Inventory, FDA will make the following information accessible to the public: 

• Description of the food and species of origin;
• File number that FDA has assigned to the pre-market consultation;
• Sponsor’s final submission in the consultation explaining their basis for concluding that the cultured cell material is safe for use as human food;
• Letter that FDA sent in response to the sponsor at the completion of the pre-market consultation; and
• Scientific memo that documents FDA’s evaluation of the sponsor’s final submission[vi].

If you have any questions on the above U.S. pre-market consultation process or need any further information regarding the regulatory matters to clear cultured meat and any other alternative protein products, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Evangelia Pelonis (pelonis@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.

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Keller and Heckman represents the food industry on regulatory matters, including alternative protein companies around the world. Please sign up for our newsletters here.

[i] https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology 
[ii] https://www.fda.gov/media/163262/download 
[iii] https://www.fda.gov/media/163261/download 
[iv] https://www.fda.gov/media/163260/download 
[v] https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=AnimalCellCultureFoods
[vi] https://www.fda.gov/food/human-food-made-cultured-animal-cells/inventory-completed-pre-market-consultations-human-food-made-cultured-animal-cells