June 26, 2018

FDA Approval of Epidiolex: No Legal Impact on Hemp-Derived CBD

U.S. Hemp Roundtable

Yesterday, as long anticipated, the Food and Drug Administration (FDA) approved GW Pharmaceutical’s Epidiolex, a cannabidiol (CBD) oral solution for the treatment of seizures associated with two forms of epilepsy. Please see the FDA’s press release here, and this statement from the FDA’s Commissioner. The US Hemp Roundtable has reviewed the release with its FDA counsel, Amin Talati Upadhye (ATU). Here are our preliminary conclusions:

  • Fundamentally, Epidiolex’s approval has no legal impact on the sale of hemp-derived CBD.
  • The FDA focuses its concern on the “proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.” The agency notes that its recent Warning Letters have been aimed at companies that make such “unproven medical claims.” The Roundtable applauds the FDA’s efforts to target bad actors in the industry who undermine legitimate hemp-derived products by making unproven claims. We look forward to working with federal and state agency officials through our continuing efforts to develop standards, best practices and a self-regulated organization (SRO) for the industry.
  • In ATU’s informed opinion, the arguments related to the marketing of hemp-derived CBD as a dietary supplement remain the same as before FDA’s approval of Epidiolex. ATU contends that hemp-derived CBD was marketed as a food or dietary supplement prior to the institution of substantial clinical investigation of Epidiolex that was made public by GW Pharmaceuticals, and even prior to the date on which FDA authorized the article for investigation as a drug. This would mean that dietary supplement versions of hemp-derived CBD would be permissible.
  • Given that the FDA’s approval of Epidiolex raises the visibility of hemp-derived CBD products, it is even more critical that Congress passes the Hemp Farming Act to permanently establish hemp and hemp-derived products as agricultural commodities, removing them from the purview of the Controlled Substances Act. We encourage supporters of hemp and hemp-derived CBD to use our web portal to contact their Congressmen today to urge them to support passage of the Hemp Farming Act.