UNPA / FDA's Gottlieb sheds light on agency's go-forward thinking on CBD

Dear Colleagues,

At a Q&A session this afternoon at the Brookings Institute in Washington, outgoing FDA Commissioner Scott Gottlieb, M.D., relayed some important information about the agency’s thinking on cannabidiol (CBD). He also said that he will be leaving the agency on April 5 after providing congressional testimony on the budget, April 3.

On CBD, Gottlieb stated:

• He did not think the agency’s work would be done before he left, or even before his successor leaves!
• He indicated that it takes 2-3 years for an “average” rule to be finalized and suggested it would be much longer for CBD, since it would be a “highly novel rulemaking to do a complex rule like this.”
• He will announce within the week a working group on CBD. It will be led by Lowell Schiller, senior counselor to the commissioner, and Amy Abernathy, principal deputy commissioner.
• He believes that the most efficient way for a regulatory pathway for CBD would be through legislation, which would probably focus on CBD only. He said FDA is getting started “now” on this and has been briefing staff on Capitol Hill around its thinking.
• He expected that the agency will make recommendations on potential legislation this summer.

Gottlieb also noted that he didn’t believe that the Drug Enforcement Agency (DEA) had yet officially rescheduled hemp, which would need to be done. He also raised a separate question of how to distinguish CBD sourced from non-psychoactive hemp from CBD sourced from marijuana containing tetrahydrocannabinol (THC).

With warm regards,
Trish