February 5, 2023

Volume XIII, Number 36

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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].


  1. https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology 

  2. https://www.fda.gov/media/163262/download 

  3. https://www.fda.gov/media/163261/download 

  4. https://www.fda.gov/media/163260/download 

  5. https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=AnimalCellCultureFoods

  6. https://www.fda.gov/food/human-food-made-cultured-animal-cells/inventory-completed-pre-market-consultations-human-food-made-cultured-animal-cells

© 2023 Keller and Heckman LLPNational Law Review, Volume XII, Number 332
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About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China
Partner

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

86 21-6335-1000
Evangelia C. Pelonis, food and drug regulatory lawyer, Keller Heckman law firm
Partner

Evangelia C. Pelonis joined Keller and Heckman in 2003 as a Food and Drug Associate. Ms. Pelonis' practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements. Ms. Pelonis' works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food...

202-434-4106
Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
Legal Consultant

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

86-21-6335-1000
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