U.S – The U.S Food and Drug Administration (FDA) has granted Upside Foods the first “No Questions” letter it has ever issued for cultivated meat, poultry, or shellfish, confirming the safety of its cultivated chicken for consumption.

Upside Foods grows meat, poultry, and seafood directly from animal cells. These products are not considered vegan or vegetarian but meat made without the need to raise and slaughter animals.

Cultivated meat has been gathering pace for several years, with many developments globally. Seen as the solution to the world’s ballooning population, alternative proteins without the need for animals, and as a way to mitigate increasing climate pressures, companies are attracting billions in investments and the R&D race is well and truly on.

“After a rigorous evaluation, FDA accepts our safety conclusion. Upside Foods is ushering in a new era in meat production with this “No Questions” letter, and this historic step paves the way for our path to market in the US. Cultivated meat has never been closer to the US market than it is today,” an Upside spokesperson told FoodIngredientsFirst.

Although much R&D continues to gather pace in the burgeoning cultivated meat industry, Singapore has been the only country to permit the commercialization of products, proving to be a hub for the cell-based movement.

Approval in a significant market has been absent, including the EU, where it is expected in 2025/2026.

“It’s a hugely legitimizing moment for the cultivated meat industry and will set the stage for the industry in the U.S and around the world. Our technology platform is capable of producing full cuts of meat, not just a ground or minced product.

“This enables our products to have amazing texture and allows for greater versatility of culinary applications. Our first product to market will be our delicious cultivated chicken filet,” the spokesperson explained further.

To have an official “greenlight” in the US regulatory process is a huge step forward for this major market.

“This is a watershed moment in the history of food. We started Upside amid a world full of skeptics, and 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 toward a new era in meat production, and I’m thrilled that U.S consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells,” said Dr. Uma Valeti, CEO and Upside Foods founder.

Regulation of cultivated meat in the U.S

The FDA and USDA oversee the regulation of cultivated meat in the United States.

Following receipt of the FDA letter, Upside Foods will cooperate with the USDA’s Food Safety and Inspection Service (FSIS) to get the last set of authorizations required for the sale of the chicken.

“We’ve found that the more people learn about cultivated meat and the potential benefits it can provide to the world, the more excited they become about it. Those who have tasted our products have been blown away by how good and familiar they taste, so ultimately it will come down to consumer education and having people taste cultivated meat for themselves.

“The real magical moment happens when someone sees the meat, hears it sizzling, and tastes it. The more these moments happen, the greater consumer enthusiasm will be,” the spokesperson continued.

This endorsement of Upside Foods’ cultivated chicken, according to the U.S government agency, shows the nation’s dedication to encouraging innovation in the food supply.

The next round of evaluation involves inspecting the company’s facility to make sure it complies with USDA and FDA regulations before this item can hit the market.

The manufacturing establishment needs a grant of inspection from the USDA-Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions, in addition to the FDA’s requirements, which include facility registration for the cell culture portion, and the product itself needs a USDA mark of inspection.

“The FDA’s approach to regulating products derived from cultured animal cells involves a thorough pre-market consultation process.

“While this is not considered an approval process, it concludes when all questions relevant to the consultation are resolved. A transition from the FDA to USDA-FSIS oversight will occur during the cell harvest stage,” explained the FDA.

USDA-FSIS will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry. 

“This closely coordinated regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry meet federal regulations and are accurately labeled.

“Both agencies are working with manufacturers to ensure these products meet all applicable requirements,” said FDA.

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