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Brian Sylvester Discusses How Cultured Meat Could Be Regulated by FDA and/or USDA

Inside Health Policy’s FDA Week
July 10, 2018

Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug and Medical Device and Consumer Product Regulation practices, was quoted extensively in two FDA Week articles about the regulatory issues surrounding cultured meat, a newly developing technology in which meat is grown from in vitro animal cell cultures. According to the July 5 articles, two federal agencies have made conflicting claims as to which agency should have regulatory authority over this new type of food product, also known as “clean meat.”

FDA Week noted that while the U.S. Department of Agriculture (USDA) has stated on the record that it has jurisdiction over cultured meat, the U.S. Food and Drug Administration (FDA) appears to have taken the lead in this area by planning a July 12 meeting for stakeholders to discuss key issues surrounding government oversight of the new technology. Mr. Sylvester – a former USDA regulatory lawyer – said one ideal solution could be for the FDA to conduct an initial assessment of the technology, after which the USDA could execute regulatory oversight if the FDA determines that the technology is safe.

As the new cultured-meat technology emerges, questions have arisen about how it will compete with the conventional animal agriculture industry. But Mr. Sylvester said he believes cultured meat should simply be viewed as another protein option for consumers.

 “Consistent with statements made by the Good Food Institute and other clean-meat stakeholders” at a June 27 congressional briefing on clean-meat R&D, “the clean-meat industry is looking to partner with, rather than compete against, the conventional meat industry,” said Mr. Sylvester.

“No matter where you stand on cultured meat, I think folks are excited to see where the conversation leads,” he noted. “Clean-meat startups are poised to scale up production sooner rather than later, and so there is a lot of enthusiasm to work with regulators to chart a regulatory path that ensures consumer safety and confidence.”

“Obtaining regulatory certainty is key,” Mr. Sylvester told FDA Week. In announcing the July 12 meeting, “the FDA has underscored its ability to fit novel technologies into its existing authority, so we will likely hear from FDA officials regarding how they envision achieving this, and potentially also hear how they foresee partnering with USDA.”

 To read the articles, click here and here (subscription required).