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FDA Issues First Approval for Cell-Cultured Chicken

Last week, California-based Upside Foods received regulatory approval from the Food & Drug Administration for its cell-cultured chicken product, making it the first company to reach this milestone in the U.S. While not a green light for the cultivated meat industry at large, the decision opens the door to more approvals.

In the U.S., cultivated meat is regulated by both the FDA and the USDA. UPSIDE Foods will now work with the USDA’s Food Safety and Inspection Service (FSIS) to secure the remaining approvals the company needs to sell its cultivated chicken to consumers.

Investments in plant-based meats have cooled off in the last year with many venture capitalists turning their attention to cell-cultured meat, which has fueled the growth of numerous companies working in the space.

“This is a watershed moment not just for American cultivated meat companies but also for the hundreds which exist globally,” Maya Benami, PhD microbiologist and alternative protein consultant told The Food Institute. “These companies and venture capitalists can now fortify their assertions that there is a path for cultivated meat to become a viable investment.”

Steps to Approval

As part of the regulatory framework for cultivated meat and poultry products, FDA conducts premarket consultations to evaluate production materials, processes and manufacturing controls, including tissue collection, cell lines and banks, and all components and inputs.

According to an UPSIDE spokesperson, the company filed a submission with the FDA in October 2021, but it was working with the agencies well before that.

“There are parts of the USDA’s evaluation that can be done independent from FDA’s safety determination, and therefore were already underway, and parts that are dependent upon the safety determination and can now begin,” the spokesperson said. “The NQL is a foundational step in the regulatory process.”

Market Outlook

With the FDA evaluation finalized, UPSIDE can now complete the remaining work of obtaining its grant of inspection and label, “though we cannot speculate on exact timing,” the spokesperson said.

While the company’s go-to-market strategy remains in development, it is targeting food service for its initial rollout. Following completion of the USDA premarket process, UPSIDE’s cultivated chicken will be on the menu at Atelier Crenn in San Francisco.

“After that, we plan to partner with additional chefs and restaurants in the U.S. and eventually sell our products in grocery stores and markets worldwide,” said the spokesperson. “Ultimately, we want them to be available everywhere meat is sold, including retail and food service channels.”