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Cultured chicken cell material received FDA's "No Questions" response letter: a milestone for the future of lab-grown meat

In November 2022, the U.S. Food and Drug Administration (“FDA”) issued a “No Questions” response letter (“Response”) to Upside Foods’ cultured chicken cell material submission (“Submission”).

The California-based cultivated meat company seeks to produce and sell cell-cultured poultry products that look, cook, and taste just like traditional poultry without having to slaughter chickens. The FDA’s “No Questions” Response marked a milestone for the U.S. cultivated meat industry as it was the first in the U.S.

Upside’s Submission includes descriptions of the production process, identity verification, composition, and impurities, as well as additional safety information such as risk assessment frameworks for gene amendments and cultured media. (See Submission Table of Contents at 2). Specifically, the production process involves two stages: preparation of master cell banks (cell line isolation, generation, and banking) and cultured poultry meat production (cultured media and food contact articles, cell seed train, and integral meat tissue maturation and harvest). Process controls include contamination controls, growth environment controls, harvested product controls, and batch history controls (See Submission at 10-29).

The FDA’s scientific memorandum accompanying its Response (“Memo”) states that the FDA had evaluated Upside’s cell material at harvest comprised of cultured Gallus gallus cells originally isolated from adult chickens or mid-stage fertilized chicken eggs. (See Memo at 1-2). After evaluating information about the cell lines, production process, and substances used in the production process, the FDA concluded in its Response that it had no questions about Upside’s conclusion that the foods are as safe as comparable foods produced via other methods. (See Memo at 1-2). Further, the FDA did not identify any information showing that the production process would result in food bearing substance or microorganisms that would adulterate the food (See Memo at 18). While the FDA noted moderately elevated levels of nutritional components such as iron, potassium, phosphorus, and cholesterol relative to conventional chicken meat, it stated that these components serve to support primary metabolism in cell culture rather than for inappropriate or indiscriminate food fortification. (See Memo at 18).

At the end of its Response, the FDA advised Upside to continue ensuring that foods are safe, wholesome, and compliant with legal and regulatory requirements, and to consult with the FDA again if Upside introduces new production procedures, cell lines, or substances during production. (See Response at 2). This is to ensure that food resulting from any modified production process will still comply with all applicable laws and regulations. (See Response at 2).


Key Takeways:

  1. The FDA’s Response and Memo indicate that food safety, especially compared to that in traditional animal meat products, was key to the FDA’s greenlighting for Upside’s proposed cultivated chicken product. 
  2. It is crucial for other cultivated meat companies seeking FDA approval to indicate specific steps and precautionary measures at each stage of the production process and preemptively identify areas of potential food contamination or other safety issues. These should be included and elaborated in depth in FDA submissions.