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Brian Sylvester Quoted Extensively on Proposed Joint USDA-FDA Oversight for Cell-Based Meats

Inside Health Policy’s FDA Week 
August 27, 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 an August 24 article concerning an August 23 letter to President Donald Trump asking the Administration to clarify the regulatory framework for cell-based meat and poultry products. The letter was co-signed by the North American Meat Institute (Meat Institute) and Memphis Meats.

In the letter, NAMI President and CEO Barry Carpenter and Memphis Meats Co-Founder and CEO Uma Valeti, MD, FACC, contend that FDA should exercise oversight of pre-market safety evaluations for cell-based meat and poultry products after which the U.S. Department of Agriculture (USDA) should regulate cell-based meat and poultry products in a manner similar to other meat and poultry products.

The “letter marks an exciting new step for cell-based technology,” Mr. Sylvester told FDA Week. “It makes the Trump Administration's job easier if both sides that have been opposed are coming together in this way,” added Mr. Sylvester, who proposed a similar joint jurisdiction between the USDA and the U.S. Food and Drug Administration (FDA) in a July article for Food Safety News. “This is a big step in bringing together those interests. It’s an exciting step in the right direction.”

With respect to the mechanics of how the USDA will develop rules for cell-based meats, Mr. Sylvester stated: “Given FDA’s familiarity with this technology, it is expected that FDA and USDA would work closely in developing appropriately tailored rules that ensure consumer safety and confidence, and at the same time are not onerous to producers.”

Notwithstanding all of the details that need to be worked out, Mr. Sylvester told FDA Week that this kind of compromise would go a long way towards helping set up a regulatory pathway to facilitate the commercialization of cell-based technology.

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