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Brian Sylvester Quoted in Coverage of Ongoing FDA-USDA Turf Battle for Regulating Cell-Cultured Foods

Inside Health Policy’s FDA Week
July 23, 2018

Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug and Medical Device and Consumer Product Regulation practices, was quoted extensively by Inside Health Policy’s FDA Week in a July 19 article about the ongoing jurisdictional turf battle between the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) for regulating cell-cultured foods.

Over the past several weeks, both USDA and FDA have been on record stating that they think cultured meat falls within their regulatory purview. The FDA and the USDA are now working to determine each agency’s role in the oversight of emerging cultured meat technology – in which meat is grown from in vitro animal cell cultures.

At FDA’s July 12 public meeting on foods produced by way of cellular agriculture, cultured meat producers welcomed FDA oversight. Commenting on why cultured meat producers are pushing for FDA to take the lead, Mr. Sylvester explained, “I think companies in this space are primarily focused on FDA’s significant experience with fitting novel technologies into its existing regulatory framework.” Mr. Sylvester went on to state: “It is also important to note that FDA has extensive background in cell culture technology in the medical product space that could help inform FDA’s approach to evaluating the safety of these foods produced by way of cellular agriculture. So it makes sense for FDA to have a substantial role in regulating the safety of these products.”

Conventional agriculture interests are pushing for USDA to take the lead. Mr. Sylvester said it is not yet clear what role, if any, the USDA might play in the regulation of cultured meat. He noted, however, that at FDA’s July 12 public meeting, FDA Commissioner Scott Gottlieb indicated that the FDA and USDA are coordinating behind the scenes.

The FDA Week article also touched on the labeling and marketing of cultured meat products. Mr. Sylvester said a strong case can be made for labeling and advertising cultured meat as meat. “Unlike plant-based meat substitutes that mimic the appearance and taste of meat but are compositionally directly produced from plants, clean meat is actual animal meat and would be expected to be perceived by consumers as such,” he said. “Whether and to what extent any qualifying language will be required to provide transparency on the production method will be determined by whichever agency takes the lead on labeling and marketing oversight.”

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