BERKELEY, CALIF. — Cultivated meat is one step closer to becoming a commercial reality in America. Upside Foods on Nov. 16 received a greenlight in the form of a “No Questions” letter from the US Food and Drug Administration (FDA), indicating the agency accepts the company’s conclusion that its cultivated chicken product is safe to eat.

The Berkeley, Calif.-based startup still needs approval from the US Department of Agriculture(USDA) before it begins selling the product to consumers.

Cultured meat in the United States is co-regulated by the FDA and the USDA, except for seafood, which falls solely under the FDA’s jurisdiction. Under the joint regulatory framework, the FDA oversees cell collecting and cell culturing and conducts premarket consultation on production processes. The USDA oversees the processing, packaging and labelling of food products created from harvested cells.

Upside Foods is working with the USDA’s Food Safety and Inspection Service to secure the remaining approvals. It did not say when its first product will be commercially available.  

The company launched under the moniker Memphis Meats in 2015 “amid a world of skeptics,” said Uma Valeti, founder and chief executive officer. It has achieved several milestones since then, including becoming the first company to produce multiple species of cultivated meat and opening a 53,000-square-foot production and innovation center in California.

Now, it is the first company to receive a “No Questions” letter from the FDA.

“This is a watershed moment in the history of food,” Valeti said. “This milestone marks a major step towards a new era in meat production, and I’m thrilled that US consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells.”

Upside Foods this spring raised $400 million in a Series C funding round, bringing its valuation to more than $1 billion. Its vision of providing protein to a growing population without raising and slaughtering animals has attracted more than $608 million in total funding from investors including Cargill, Tyson Foods and Givaudan.

With cultivated meat predicted to generate up to 96% fewer greenhouse gas emissions than conventionally produced meat, the environmental benefits are significant, said Rosie Wardle, co-founder and partner at Synthesis Capital, an investor in Upside’s $400 million fundraise.

“As changing regulation allows cultivated meats to enter mainstream global markets, this has the potential to dramatically decrease the environmental impact of the meat industry, which accounts for nearly 60% of all greenhouse gases from food production,” she said.  

Singapore became the first country to commercialize cultivated meat in 2020, and Israel is widely viewed as having a favorable regulatory landscape. Industry stakeholders have maintained those smaller markets won’t be enough for widespread adoption.

“The US will be seen as a trend-setter, as many countries will look to the US for guidance around regulation,” Wardle said. “We expect a domino effect as more countries will follow suit and initiate their own regulatory processes.”