FDA Green-lights Upside Foods’ Cultivated Chicken

The U.S. Food and Drug Administration (FDA) has deemed cultivated proteins safe for consumption, according to an announcement from cellular agriculture company Upside Foods today.

The California-based company received a “No Questions” letter from the FDA, the equivalent to earning Generally Recognized As Safe (GRAS) status, indicating the administration accepts Upside’s case for the consumption of its cultivated chicken product. Upside will now move to secure remaining approval from the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) before it can begin selling products to consumers.

“This is a watershed moment in the history of food,” said Dr. Uma Valeti, CEO and founder of Upside Foods, in a press release. “We started Upside amid a world full of skeptics, and today, we’ve made history again as the first company to receive a ‘No Questions’ letter from the FDA for cultivated meat. This milestone marks a major step towards a new era in meat production.”

The announcement comes after Upside has spent nearly four years advocating for the development of a regulatory framework for cultivated meat, including co-founding the cultivated meat trade coalition, the Alliance of Meat, Poultry and Seafood Innovation (AMPS Innovation). The news also comes on the heels of the company’s acquisition of cultivated seafood company Cultured Decadence to accelerate its innovations in another category of protein.

Upside Foods has raised a total of $608 million to-date from investors including Bill Gates, Cargill, John Mackey, Kimbal and Christiana Musk, Richard Branson and Tyson Foods, among others. Upside began its venture in food tech in 2015, originally under the name Memphis Meats, with a goal of creating cellular animal proteins that could have a lower impact on the environment. The company chose to initially focus on chicken due to its popularity among consumers. According to documents released by the FDA, all growth factors used in the process of making Upside’s cultivated chicken are present in commercially available chicken products.

While the FDA letter received by Upside indicates that the administration accepts that the brand’s cultivated chicken is safe to eat, it is unclear whether this status will apply to future cultivated innovations including meat, seafood and other types of poultry. This announcement solely applies to Upside’s chicken filets.

“Don’t expect ubiquitous cultivated meat products immediately,” said Nate Crosser, an investor at Venture Capital firm Blue Horizon Corporation, in a LinkedIn post. “The industry has a massive amount of scale up ahead and regulatory hurdles for additional products and labeling (USDA in particular). However, it does signal that the U.S. federal government may be ready to support this innovation and now lucky consumers will be able to try the products soon.”

In 2019, as the plant-based movement was gaining momentum and colliding with food tech, the FDA and USDA announced they would have joint oversight of the emerging “cell-cultured food products” market for livestock and poultry, a partnership Upside had lobbied for. Traditionally, the FDA oversees food system safety, novel ingredients and new food innovations while the USDA ensures agriculture-derived products like meat, poultry, and egg are safe to consume.

Regulatory hurdles have been a major challenge to the growth trajectory of the emerging alternative protein market, which was valued at $163.6 million in 2021, and set to grow over 11% between 2022 to 2028. Meanwhile, Upside isn’t the only alt-meat product to face lengthy regulatory approval processes. In the plant-based meat space, disputes regarding product labeling have hindered the efforts of brands.

Impossible Foods was selling products via restaurant partnerships in 2015 when the FDA questioned portions of its GRAS submission, putting its retail efforts on hold until it was able to address the concerns. The company eventually secured GRAS status in 2019 for the soy-based heme protein that makes its products “bleed-like-meat,” however, competitors like Boston-based Motif Foodworks have since received approval for similar proteins which has now led to an intellectual property dispute between the two corporations.

Over the past two weeks, both plant-based proteins and cultivated proteins have been presented as solutions to the climate crisis at the UN’s COP27 Climate Change summit. Today’s announcement may indicate that cultivated proteins will become a part of international roadmaps to mitigating the food system’s impact on the environment.

“FDA sets the standard for global acceptance of new food innovations, and we are incredibly grateful for the agency’s rigorous and thoughtful process to ensure the safety of our food supply,” said Eric Schulze, VP of regulatory and public policy at Upside Foods, in a press release. “We’re also extremely proud to have played a leading role in helping to champion the framework for how cultivated meat, poultry and seafood are regulated in the U.S.”