This week, the Food and Drug Law Institute hosted a panel titled “Federal Cannabis Regulation: A New Way Forward” during its 2023 Annual Conference.
Patrick Cournoyer, the lead for the U.S. Food and Drug Administration’s Cannabis Product Committee, a group that coordinates cannabis-related work within the agency, mostly covered familiar terrain. But given this moment in time — as Farm Bill negotiations take root in Congress, and as the federal Department of Health and Human Services conducts its review on cannabis scheduling — the kernels of new information were illuminating.
Cournoyer started with an overview of how the 2018 Farm Bill legalized low-THC cannabis, which is known as hemp, and the hemp and hemp-derived cannabinoid market that’s since taken root in the United States. Added together, the market for cannabidiol (CBD), the most prevalent hemp-derived cannabinoid, is valued at more than $5 billion, Cournoyer said, and that includes everything from CBD vapes to pet products, much of which is “self-medication.”
“That’s the market that we’re confronted with,” Cournoyer said.
While these products are not regulated by the FDA, the FDA has spent the years since 2018 collecting public comments for potential rule making, calling for more data, and issuing warning letters against the most egregious false health claims. Cournoyer said that the FDA is aware that unregulated, untested cannabinoid products are being sold everywhere from gas stations to smoke shops.
“This is a relatively new thing. It’s a pretty big deal in terms of the impact on public health and it’s an important factor in this whole equation here,” Cournoyer said.
Complicating matters is the FDA’s approval in 2018 of Epidiolex, a CBD medicine that’s prescribed most often for severe seizures in children. This created a statutory barrier for CBD products because it’s not lawful under the Food, Drug, and Cosmetic Act to sell foods or dietary supplements that contain a drug approved for a medical indication, in this case, CBD.
That hasn’t stopped many, even in Cournoyer’s family.
“Aside from probably Epidiolex, I have people in my family that use all of them. So it’s very obvious what the impact of what we work on here is,” Cournoyer said.
Following the passage of the 2018 Farm Bill, the FDA embarked on a “fact-finding” mission to determine, essentially, if CBD could be one of the ingredients added to food.
“Over time, we’ve discovered that CBD raises really important safety concerns. Not nit picky ones, but big ones, real important toxicological red flags that are not typical for food ingredients. Let’s say these are not things that you see happening at these levels in, let’s say, a normal emulsifier or sweetener or or preservative,” Cournoyer said.
Existing scientific literature has shown that CBD could potentially harm the liver, could interact with other medications, and could have negative effects on the male reproductive system.
Cournoyer specifically called out research involving CBD dosed to monkeys that appeared to shrink their testicles, and in rodents CBD had long-term effects on the reproductive potential of male subjects.
“As soon as this became clear to us, we started communicating about that. And these safety concerns are really what were one of the big reasons behind our FDA statement in January of this year that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol, and that is based on, as I mentioned, the inherent risk profile of CBD,” Cournoyer said.
For context, in January, the FDA announced that a “new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.”
Cournoyer said that stakeholders have asked the FDA what kind of research could be done to “show that CBD is safe enough.” But that’s not how things at the FDA work, Cournoyer said.
“It’s not like you do research to show something is safe. You do research to show what the actual risk profile of something is. It reveals the truth. It doesn’t lead to a predetermined outcome. And what was becoming apparent was that CBD is just not safe enough and you can do more and more research. You’ll be characterizing that risk profile, but you won’t be removing that risk profile,” Cournoyer said.
Ultimately, with its “risk profile,” CBD could not meet the “highly protective” safety standards for foods and dietary supplements, Cournoyer said. This became the foundation for the conclusion in January that CBD is “not right” for the food and dietary supplement pathways.
With the future of CBD rules likely in the hands of Congress, Cournoyer addressed what the FDA hopes to see.
“What’s envisioned here is really a harm reduction framework. The existing pathways that we have for foods and supplements don’t really allow for risk or harm. If it’s shown to be harmful or we can’t really show that it won’t be harmful, then it’s not allowed to be there,” Cournoyer said. “What we’re proposing here is a more permissive category where it is acknowledged that there’s a risk here. We can’t eliminate it, but we would view that people can make an informed choice. People can make a choice, take a risk, and if it works for them, then that can be okay.”
That legislation from Congress would ideally cover things like testing and accurate labeling, Cournoyer said.
“What we’re doing here in this January announcement is trying to be proactive and pragmatic to try to provide the type of oversight that people are expecting of us, in spite of the fact that our [FD&C] Act doesn’t really provide us the tools to do so,” Cournoyer said.
While many in the cannabis industry expressed deep disappointment that the FDA would not be releasing those CBD rules, Cournoyer said there was a “misconception” that the FDA has “said for years it was working towards regulation for CBD.” That, Cournoyer said, appears to be a case of “rumors that get repeated and you repeat them often enough and people think they’re true.”
The FDA said in its 2018 announcement that it would “only consider doing that rulemaking if it were evident that CBD could meet the other requirements of the Act,” Cournoyer said. “That’s all I can say. People just keep saying that we were working on regulations and that we’ve never said that.”
Cournoyer didn’t provide details about the federal scheduling review, except to say that that the FDA’s Center for Drug Evaluation and Research (CDER) is “leading the process of putting together and evaluating data,” and that President Joe Biden asked for the review to be done in an “expedient way.”