US: First FDA nod for cultivated meat

Cultivated meat maker Upside Foods received approval from the FDA for its chicken grown from animal cells. This is the first regulatory approval for any cultivated meat in the US.

The “no questions” letter from the FDA indicates regulators have found nothing unsafe about the cultured chicken the company makes. Upside Foods now awaits approval from the USDA in order to serve its chicken products to consumers.

Several cultivated meat startups have been working since 2018 with the FDA and the USDA — which are jointly regulating the space — in hopes of gaining approval. Eat Just has the only other regulatory approval for cultured meat, which it has sold in Singapore since 2020.

Upside Foods and the US have both reached a milestone with this approval, reports Not only is Upside Foods a step closer to selling cultivated chicken, but the US could soon have a new kind of meat available for consumers to choose.

Uma Valeti, CEO and founder, UPSIDE Foods

“This is a watershed moment in the history of food,” said Uma Valeti, CEO and founder of Upside Foods. “We started UPSIDE amid a world full of skeptics, and today, we’ve made history again. … This milestone marks a major step towards a new era in meat production”

Upside Foods, founded in 2016 as Memphis Meats, was one of the first companies in the cultivated meat space. 

It also is the one that’s closest to being able to produce meat at scale. Just over a year ago, Upside opened a 53,000-square-foot facility in the San Francisco Bay Area that will be able to make 400,000 pounds of meat a year — enough to serve some restaurant customers.

A statement from FDA Commissioner Robert Califf and Center for Food Safety and Applied Nutrition Director Susan Mayne said the world is experiencing a “food revolution.” 

Through this approval, the FDA is showing its commitment to supporting innovation in the food supply. The statement stressed that the FDA’s first priority is safety.

Food made with cultured animal cells, the agency wrote, must meet the same stringent requirements as other food regulated by the FDA.

“We have no questions at this time about UPSIDE’s conclusion that foods comprised of or containing cultured chicken cell material resulting from the production process … are as safe as comparable foods produced by other methods,” the no questions letter states.

Amy Chen, Upside Foods’ COO, said this is a tremendous moment for the company and the cultivated meat industry. It’s also cementing the United States’ leadership in the food tech space by showing the rigorous vetting of a new technology. 

“I think everything feels so much more real and tangible now than it did yesterday. What will be wonderful is that consumers now who may have heard about this and may have dismissed this as science fiction, will see this news and realize that this is coming maybe much sooner than they think.”Amy Chen, Upside Foods’ COO

There are still steps that must happen before Upside Foods’ cultivated chicken can be served. Under a formal agreement issued in 2019, the FDA and the USDA jointly regulate the space. 

For meat and poultry products, the FDA ensures products are produced in a safe manner. After the meat is harvested from the bioreactor, it enters the USDA’s jurisdiction — just like any animal meat product.

Chen said Upside Foods has worked with the USDA toward getting a regulatory green light, but there are some actions that could not take place until the FDA approval. Facility inspections and registration need to occur, as well as work on product labelling.

Chen could not say how long it could take to get this work done.

This announcement comes after a series of milestones as UPSIDE Foods approaches commercialidation, including a $400M Series C placing their valuation at over $1 billion, the acquisition of cultivated seafood company Cultured Decadence, a partnership with three-Michelin starred chef Dominique Crenn, and the opening of its Engineering, Production, and Innovation Center (EPIC), one of the world’s most advanced cultivated meat production facilities….. Read the full story