After pressure from the US Senate, the FDA signals movement on CBD regulations.

The US Food and Drug Administration (FDA) Principal Deputy Commissioner Amy Abernathy, MD, PhD, recently announced via Twitter that the FDA plans to accelerate the development of cannabidiol (CBD)-specific regulations, with an eye toward issuing a progress report by early autumn 2019. Principal Deputy Commissioner Abernathy’s announcement follows recent pressure from the US Senate, in particular by Senate Majority Leader Mitch McConnell (R-KY) and Senator Ron Wyden (D-OR), for the FDA to expeditiously develop regulations regarding the sale, distribution and use of CBD. The announcement is welcome news for hemp growers, hemp processors and companies engaged in the production of CBD and development of CBD products.
 
CBD, a non-psychoactive ingredient in cannabis, is widely believed to have wellness properties and the potential to treat a range of maladies, including chronic pain, inflammation and anxiety. The June 2018 approval by the FDA of GW Pharmaceuticals’ CBD-based Epidiolex for treatment of severe childhood epilepsy resulted in the FDA’s classification of CBD as a drug that is subject to a regulatory scheme requiring further research and clinical trials to determine the efficacy and safety of other products containing CBD. Nevertheless, the FDA has tolerated the sale of certain products containing CBD so long as related claims of therapeutic benefits are restrained.
 
Promulgation of appropriate regulations by the FDA is a critical first step. The CBD marketplace would benefit from thoughtful regulations that continue to encourage pharmaceutical companies to develop CBD-derived drugs while at the same time allowing the non-pharmaceutical CBD industry to continue to develop. Importantly, Lowell Schiller, the FDA’s Principal Associate Commissioner for Policy, will be the keynote speaker at the National Industrial Hemp Council’s 2019 Business Summit in Portland, Oregon, to be held August 12-13. It is widely expected that the FDA’s regulation of CBD will be the primary topic of that presentation, which may include a pathway to creating differing regulations around CBD isolate, full spectrum CBD and broad spectrum CBD. 

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