FDA Commissioner Suggests There is No Reason For a DEA Delay in Rescheduling

On April 11, the U.S. Food and Drug Administration Commissioner Robert Califf testified to the House of Representatives Committee on Oversight and Accountability, causing many in the industry to speculate when and if the Drug and Enforcement Administration (DEA) will change the scheduling for cannabis. The most critical statement in his testimony came when being questioned by Congresswoman Nancy Mace. She wanted to know when the DEA would act and Califf responded that he didn’t know.

However, when she pushed for an answer and asked whether it would be this year, Califf responded, “There is no reason for the DEA to delay.”

Still, he cautioned that the DEA needed to take into account all of the regulations in play. Califf doesn’t speak for the DEA and pointed out the differences between medical marijuana and adult-use (recreational) cannabis. He also seemed to stress that it should be Congress making changes concerning cannabis and that the FDA should be in referee mode.

Med vs. rec

Zuanic and Associates analyst Pablo Zuuanic wrote in a report published today, “He distinguished between medical and recreational cannabis (note: recall the conventional wisdom narrative says that cannabis is not bifurcated in Schedule I, so it will not be bifurcated in Schedule III; we disagree with that view). He said, ‘Medical cannabis is one thing when used for proven medical pathways, but then if it is used for recreational purposes there are no medical benefits in that case, and it does not fall into the typical FDA purview of regulations.’ In our interpretation, this would mean then that only medical cannabis can be rescheduled and not rec.”

Ultimately, based on the Califf testimony, Zuanic believes that the DEA will reschedule medical marijuana at the Federal level and leave adult-use regulations to the state. He thinks that the FDA prefers Congress to address adult-use cannabis rescheduling at a future date.

That would give a 280E tax break to the medical-only companies, while leaving the adult-use companies still on the hook.

CBD

Califf testified that the FDA’s position regarding CBD is that it does not meet the definition of dietary supplement (DS) due to “elevated liver enzymes.” Even though there is pressure on the FDA to make a decision on CBD products, the agency prefers to let Congress take the wheel. The FDA would rather be in a harm reduction role, versus a legislative role. While the proposed House Bill H.R. 1629 (Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023) would allow the use of hemp, cannabidiol derived from hemp, or any other ingredient derived from hemp as a dietary supplement, the FDA is steadfast in its opinion that CBD is not a dietary supplement.