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Food Navigator Quotes Brian Sylvester on FDA-USDA Plan to Regulate Cell-Cultured Meat
Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug, and Medical Device Law and Consumer Product Regulation practices, was quoted by Food Navigator-USA in a November 19 article concerning a just-announced dual agency plan to regulate cell-cultured meat.
On Friday, November 16, 2018 the FDA and the USDA formally agreed to share oversight of meat grown from cell lines of livestock and poultry. FDA will oversee cell collection, cell banks, and cell growth and differentiation. Jurisdiction will then transfer to USDA at the cell harvest stage and USDA will oversee food production and labeling. The announcement is consistent with the regulatory pathway Mr. Sylvester outlined in a July 1 Food Safety News article suggesting that the agencies might undertake a joint FDA-USDA regulatory approach to cell-based meat, building on existing precedents.
Asked for his insights on the dual FDA-USDA regulatory pathway, Mr. Sylvester noted to Food Navigator-USA: “Now that the agencies have made clear that they will work together within the existing regulatory framework, a number of critical questions core to developing a functioning regulatory review process need to be addressed. For example, how will the FDA and USDA initiate their respective application processes, how long will it take to obtain premarket approval, and what will inspection of the production facilities look like? Further, how should the food products be labeled?
To read the article, click here.