The FDA has completed its second pre-market consultation for human food Good Meat, Inc is proposing to make from cultured animal cells. The agency evaluated information the company submitted about using animal cell culture technology to take living cells from chickens and grow them in a controlled environment to make the cultured animal cell food. The agency has announced it has no further questions at this time about Good Meat’s safety conclusions.
The FDA’s pre-market consultation with the firm included an evaluation of the its production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs.
Any human food Good Meat produces from cultured animal cells must meet the same FDA requirements, including facility registration and applicable safety requirements, as other food. The company also will need a grant of inspection from the United States Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. In addition, the food will require a mark of inspection from USDA-FSIS before it can enter the U.S. market.
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The FDA is ready to work with additional companies developing cultured animal cell food and production processes to ensure their food is considered safe and lawful under the Federal Food, Drug, and Cosmetic Act. The agency also will issue guidance to assist companies intending to produce human food made from cultured animal cells prepare for pre-market consultations. The published draft of this guidance will represent a formal opportunity for public comment and discussion.
