FDA Completes First Consultation for an Animal Cell-Cultured Food

November 17, 2022By Ricardo Carvajal

FDA announced that it has completed the first pre-market consultation for an animal cell-cultured food, based on a safety assessment submitted by UPSIDE Foods. In an indication of the significance of this development, FDA Commissioner Robert Califf and CFSAN Director Susan Mayne issued a statement marking the occasion, and reiterating the agency’s commitment to supporting innovation while ensuring the safety of the food supply.

FDA’s response letter to UPSIDE Foods indicates that the safety standard applied by the company was one of comparable safety (i.e., “foods comprised of or containing the cultured cellular material resulting from the production process defined [in the submission] are as safe as comparable foods produced by other methods”). In addition, FDA “did not identify a basis for concluding that the production process as described in [the submission] would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food.” FDA posted a longer and more detailed scientific memo that summarizes FDA’s evaluation.

In keeping with FDA’s agreement with USDA-FSIS regarding the agencies’ joint oversight of this product category, FDA’s response letter notes that submitters must still ensure that they comply with all regulatory requirements administered by FSIS. That includes labeling requirements, for which FSIS has initiated rulemaking (see our prior post here).