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Jonathan Havens Presents During the Food & Drug Law Institute Conference: Legal and Practical Issues in the Evolving World of Cannabis Regulation

Event Dates: December 3, 2021
Industries: Cannabis Law | Food, Beverage and Agribusiness

FDA's Search for Data to Inform Cannabidiol Regulation as a Food and Dietary Ingredient

Jonathan Havens, co-chair of both the Firm's Cannabis Law Practice and its Food, Beverage, and Agribusiness Practice, will participate in a panel discussion during the FDLI Conference: Legal and Practical Issues in the Evolving World of Cannabis Regulation. The panel is entitled, FDA's Search for Data to Inform Cannabidiol Regulation as a Food and Dietary Ingredient. Since the 2018 Farm Act legalized hemp, FDA has not authorized any CBD-containing substances for non-prescription drug use. The agency has repeatedly cited the need for data to better inform regulation of the CBD marketplace. The agency has also recently objected to several CBD-based new dietary ingredient notifications due to the provision in 21 U.S.C. § 321(ff) that excludes “articles” from the dietary supplement category if they were previously approved as drugs. Yet, CBD is widely available online and in brick-and-mortar stores, but the cloud of regulatory uncertainty is affecting the marketplace. Where is FDA in its search for more data? Is that data sufficient or will federal legislation be required? This panel will also discuss the potential state role in regulating hemp-derived products, and how the CBD industry can navigate the current landscape.