The top U.S. Food and Drug Administration official was grilled on everything from lead in baby food and Covid 19 vaccines to hemp and hemp-derived intoxicating products during an hourslong hearing of the House Oversight and Accountability Committee on Thursday.
But another topic also repeatedly came up in the exchange between FDA commissioner Robert Califf and elected officials: the rescheduling of cannabis.
Chair Rep. James Comer of Kentucky opened the hearing by saying that the committee “examined the FDA’s refusal to regulate hemp derived products such as CBD.”
Comer was referencing the FDA’s announcement last January that its existing regulatory pathways wouldn’t work for CBD, and that it sought to work with Congress to establish a new one. The 2018 Farm Bill legalized hemp, which led to an unexpected proliferation of unregulated hemp-derived cannabinoid products. Some, like CBD, don’t cause a high, while others do.
“The FDA refusal to regulate hemp products is creating a significant confusion in the market, and resulting in products with intoxicants that can be dangerous to Americans who use these products. It has also halted business trying in good faith to enter the market, while bad actors continue to thrive,” Comer said.
Califf was the only witness and much of his written testimony covered the same territory as previous statements on CBD that have come out of the FDA.
“FDA has concluded that a new regulatory regime is needed, which could encourage better information to inform consumers about their choices. In the meantime, FDA continues to assess the evolving information base and build awareness for Americans,” Califf wrote in his submitted testimony.
Rep. Nancy Mace, a Republican from South Carolina who is a strong proponent of states’ rights-focused cannabis reforms, asked Califf for an update on the ongoing review of how the federal government classifies cannabis.
While the Department of Health and Human Services, within which the FDA sits, has recommended that cannabis be moved from Schedule I of the Controlled Substances Act to Schedule III, the decision now rests with the Drug Enforcement Administration, within the Department of Justice. While Schedule III would be an acknowledgement of the medical use of cannabis, it would not legalize it, which would require full descheduling.
“I don’t even know, but if I did, I couldn’t tell you anyway. So the timing of a regulatory decision is something that would be up to the DEA, not up to me,” Califf said.
Mace asked if the decision would come “this year.”
“There’s no reason for DEA to delay. I think they just have to take into account all the regulations that are in play,” Califf responded.
Mace asked if Califf’s role will change, or if he expects to take on more responsibilities after the DEA decision, assuming their determination matches the HHS’.
“This is a very complicated topic,” Califf said, referencing the many different cannabinoids in the cannabis plant. “It falls in this area where state regulation has been dominant. This is an area where I believe we would be better off if we got guidance from Congress about how to proceed, because we’re not.”
Califf then separated medical cannabis from non-medical cannabis.
“Medical marijuana is one thing where there’s a medical purpose and it’s proven through traditional medical pathways. But when it’s used for recreational purposes, there is no medical benefit in that case. So it doesn’t fall under our typical regulation,” Califf said.
One topic that came up several times with regard to the topic of both tobacco and cannabis products is “harm” and how it can be reduced.
“The question is: how do we reduce harm that’s done when it’s used inappropriately or at a dose which is dangerous, or when it’s packaged in a way marketed specifically to children?” Califf asked. “We’re going to need help, and a regulatory pathway.”
Mace highlighted research that suggests cannabis reduces the need for opioids, and she mentioned that cannabis has been beneficial in her life. She also mentioned concerns related to her kids, who now require conversations about cannabis products that appeal to children, because while South Carolina doesn’t allow adult use cannabis, the products are still popping up in schools.
“Without revealing too much about my age, I’m a child of the 60s, so it’d be nice if in my lifetime we came up with a regulatory scheme where,” Califf said, “whatever your belief is about use of the product, where these safety issues you referred to are written into law so that we have a scheme whereby we can regulate it.” Califf added, “We’re referees who write the rules. We need the right rulebook in order to play the referee role.”
Rep. Pete Sessions, a longtime opponent of cannabis law reform, emphasized his concerns about cannabis.
Califf initially responded by pointing out how divergent Sessions’ opinion was from Mace’s, and represented the lack of “agreement in Congress about what should be done” with cannabis.
“Congress has not spoken because we believe that’s a dangerous product,” Sessions said.
“Let me remind you that Schedule III does not put marijuana on the market in the United States,” Califf said.
