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Brian Sylvester Quoted by Three Media Outlets on FDA-USDA Agreement to Jointly Oversee Cell-Based Meat

IEG Policy, Food Navigator-USA, Inside Health Policy
March 12, 2019

Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug and Medical Device Law and Consumer Product Regulation practices, was quoted by IEG Policy, Food Navigator-USA, and Inside Health Policy regarding a Memorandum of Understanding between the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) to jointly oversee foods made from cell-based meat.

The agreement codifies a regulatory approach announced by the two agencies in November 2018, IEG Policy reported in a March 7 article. Cell-based meat, also known as cell-cultured meat, is an emerging technology in which meat is grown in vitro from the cells of livestock and poultry.

Mr. Sylvester, a former USDA regulatory lawyer, told IEG Policy the agreement is an important step forward and “builds on existing regulatory precedents, leveraging appropriate expertise from the FDA and USDA respectively.” But he noted that a “number of critical questions core to developing a functioning regulatory review process” must still be addressed.

He said these questions include application processes for cell-meat developers, the time frame for obtaining premarket approval, the specifics of the respective inspection regimes, and whether standards of identity will be required.

Mr. Sylvester told Inside Health Policy he was encouraged that throughout the agreement, the FDA and USDA commit to working together and with industry to answer those questions.

“The time is now for stakeholders to engage so that FDA and USDA can develop appropriate guidance and/or regulations to help ensure oversight is not unduly onerous, but at the same time ensures consumers are confident in the safety of the products,” Mr. Sylvester said. 

To read the IEG Policy article, please click here (subscription required).

To read the Food Navigator-USA article, please click here.

To read the Inside Health Policy article, please click here (subscription required).