What’s the significance of Believer Meats’ FDA approval?
- First foreign firm approved: Believer Meats is the first non-US company to receive FDA clearance for cultivated meat
- Trump-era milestone: The approval comes under the Trump administration, despite broader efforts to reduce FDA oversight
- Massive production capacity: Believer Meat’s North Carolina facility can produce 12,000 tonnes of cultivated chicken per year
- Cost-competitive tech: The company claims it can produce cultivated chicken at $6.20/lb using proprietary bioreactor and media tech
- Next step: Believer Meats still needs USDA inspection and label approval before going to market
Israeli startup Believer Meats is the fifth cultivated meat business to gain US regulatory clearance with an FDA “no questions letter.” It’s also the first non-US cultivated meat startup to gain FDA approval.
The reveal comes as US beef prices rocket to $9.26/lb, with ground beef reaching record highs.
Earlier this year, egg prices in the US quadrupled, and chicken meat prices doubled. A pack of chicken breast tenderloins currently costs $4.12/lb on Walmart.com. Believer claims it can produce cultivated chicken at around $6.20/lb.
CEO Gustavo Burger dropped the approval news on LinkedIn last night (July 24), saying: “I’m thrilled to share a transformative moment for Believer Meats and the cultivated meat industry as a whole.
“We’ve received the FDA’s ‘no questions’ letter, confirming the agency’s acceptance of our safety conclusion.”
Believer Meats received an NQL
The FDA’s no questions letter (or NQL) shows the agency has reviewed submitted information in line with a product’s Generally Recognized as Safe (GRAS) status and has no additional safety questions or concerns.
In short, it means the FDA agrees the ingredient or product is safe for human consumption. However, Believer Meats still requires USDA inspection and label approval before going to market.
“This is more than just progress, it’s a defining moment, a bold leap forward in our vision to lead food innovation that cares for the planet,” continued Burger.
Moving forward, Believer would focus on bolstering its product execution and its mission to advance cultivated meat from “promise to product” as part of a wider vision to create a more resilient and sustainable food system.
Burger also revealed Believer Meats’ $123m, 200,000 sq ft manufacturing facility in Wilson County, NC, was built.
The largest cultivated meat production site
“We’ve completed construction of our facility … the first and only large-scale cultivated meat production site in the world,” he said.
The facility, built by German engineering firm GEA, was announced in 2022 and has been designed to lower cultivated meat production costs and emissions.
About 12,000 tonnes of cultivated chicken can be produced at the site each year.
“Commissioning of the factory is underway now and we are working with the USDA on the final steps for our facility’s grant of inspection,“ Believer Meats wrote in a LinkedIn post.
“With our regulatory progress on track, production facility complete and clear path to market, we are closer than ever to delivering cultivated meat at scale, strengthening global food security and helping shape a more sustainable food system.”
The FDA’s NQL and scientific memo, however, were not published on its website at the time this story was made live.
