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UPSIDE Foods’ Cultured Chicken: What the FDA’s 2022 Consultation Means

FDA completed its first pre-market consultation for cultured animal-cell food in 2022, reviewing UPSIDE Foods’ chicken. The result was not itself USDA inspection or authorization to sell.
From TheFinanceBase Team2 min to read

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On November 16, 2022, the U.S. Food and Drug Administration completed its first pre-market consultation for human food made using cultured animal cells, reviewing information from UPSIDE Foods about its cultured chicken. FDA said it had “no further questions at this time” about the company’s safety conclusion. That was a significant regulatory milestone, but not, by itself, USDA inspection or authorization to sell.

What did the FDA conclude about UPSIDE’s cultured chicken?

FDA evaluated information UPSIDE submitted about the cultured chicken and its production process. The agency’s notice says: “We evaluated the information UPSIDE Foods submitted to the agency and have no further questions at this time about the firm’s safety conclusion.” The qualification matters: this was the outcome of a pre-market consultation about the defined material and process, not a blanket approval of every cultured-meat product or future production method.

FDA’s inventory describes the food as cultured chicken cell material, including myocytes (muscle cells) and fibroblast (connective tissue) cells in sheets. The consultation addressed whether foods made using the described process were as safe as comparable foods produced by other methods. FDA’s November 16, 2022 notice and consultation detail describe the agency’s response.

Was this an FDA approval to sell the chicken?

No. “FDA blessing” is shorthand for the consultation result, not a stand-alone authorization to sell. FDA explained that the company still needed to meet applicable FDA requirements, including facility registration for the cell-culture portion, and obtain a USDA Food Safety and Inspection Service (USDA-FSIS) grant of inspection for the establishment. The product also needed a USDA mark of inspection.

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The agencies’ roles are part of a joint oversight framework: FDA oversees cell-culture stages, while USDA-FSIS inspects relevant harvest and post-harvest operations and the product. The Congressional Research Service’s overview of cell-cultivated meat describes that federal framework.

What happened after the FDA consultation?

UPSIDE later announced that USDA had approved it to produce and sell its cultivated chicken in the United States. That was a later regulatory step, distinct from FDA’s 2022 consultation. The announcement is UPSIDE’s account of its USDA approval; it does not change what the earlier FDA consultation did or did not establish. The company’s explanation is available in its USDA approval announcement. FDA’s April 13, 2023 additional response letter restated the scope of its no-further-questions response concerning the company’s safety conclusion.

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Can consumers buy UPSIDE’s cultured chicken now?

The regulatory milestones establish that UPSIDE reported USDA approval to produce and sell cultivated chicken in the United States. They do not establish present-day broad retail availability or identify a restaurant where consumers can buy it. These sources therefore are not enough to confirm a current purchase location.

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