Last week, the National Cancer Institute held the Cannabis, Cannabinoids, and Cancer Research Symposium, a four-day event solely focused on the intersection of cancer and cannabis.
The panels covered a wide range of topics, from the state of the science with cannabinoids and cannabis to use in cancer patients.
In recent weeks, both the House and Senate have passed cannabis research bills, with discussion during hearings often returning to hurdles related to cannabis research. These hurdles were a recurring theme during the symposium, as panelists discussed barriers that investigators face when trying to study cannabis.
Cannabis researchers are also up against a lack of national-level guidance, testing of products, and standardization, said Steven Gust, who directs the National Institute on Drug Abuse International Program, which coordinates the Institute’s global research, training, and education efforts. Gust gave updates on the federal regulatory landscape, and on National Institute on Health research as it relates to cannabis and cannabinoids.
“The federal situation, in terms of the regulatory landscape,” Gust said, “remains a challenge. But … there are signs of optimism and certainty.”
Gust laid out the state-by-state patchwork approach to cannabis laws, and how fast it’s evolving, which “drives home the point of the need and the urgency for getting more research done, to help drive and direct these policies and practices.” Interestingly, Gust said, just four states have designated tax revenue to support research, and he prompted researchers attending the presentation to use their roles by “encouraging the dedication of some of the some of the tax income that’s coming in from the states to be directed back into the research enterprise.”
Adding to the rising national conversation around cannabis and research, the Drug Enforcement Administration announced last week that it could begin to issue federal licenses to entities hoping to cultivate cannabis for research, as the federal agency published its final rule for these licenses. Though, because the DEA announced its plans for these licenses four years ago, and then overhauled its approach after dozens of license applications came in, the status of those applicants remains up in the air.
“Despite the fact that they’ve published the final rule, that’s really not clear if or when the DEA will approve any of the current relatively long list of applicants,” Gust said.
Gust also spoke about the sea change that the recent House passage of the MORE Act would bring, if it was passed in the Senate and signed by the president. The MORE Act, which would remove cannabis from the Controlled Substances Act, where it is currently in the strictest category, Schedule I, would catalyze sweeping reforms from criminal justice to cannabis research. Gust spoke about the “momentum” and “action” in Congress when it comes to cannabis, and said, “I would not be a bit surprised myself as a long time observer of some of the some of the federal activities, that this does become law.”
“What a huge change this would bring,” Gust continued. There would be immediate access to dispensary marijuana products for research purposes, which are currently not not allowed,” Gust said, referencing the fact that state-legal products, because they are federally illegal, are off-limits to researchers.
Today, as has been the case for decades, researchers only have access to one federally-approved site for cultivating research grade cannabis, which is at the University of Mississippi.
“While NIDA’s supply has diversified, it’s costly and time-consuming to grow new products. And it definitely does not represent a wide diversity of products and formulations currently available,” Gust said.
Douglas Throckmorton, deputy director for the FDA’s Regulatory Programs, later spoke about the FDA’s role in the regulation of cannabis products. After the passage of the 2018 Farm Bill, which legalized cannabis plants with .3% THC or less, also known as hemp, which is abundant in cannabidiol (CBD), the FDA was tasked with crafting regulations for CBD products.
“From the FDA perspective, there are a number of things that are making it challenging as we think about how we regulate in a world where the DEA is no longer engaged in day to day regulation of the specific compounds. First and foremost, cannabidiol products are almost literally everywhere,” Throckmorton said. “Our surveillance network tries to keep track of all the various products, at least the kinds of products. But you can get CBD infused socks, if you feel that those are valuable to you.”
Throckmorton added that public health officials also don’t know enough about cannabis and cannabinoids, including CBD, exposure concerns related to vulnerable populations, like children, the elderly, and pregnant people, or how prescribed drugs might interact with cannabis products. Early data points to some areas of concern, though, including related to the potential for liver damage, and how cannabis might affect the male reproductive system, Throckmorton said.
“There is a lot we do not know about cannabidiol,” Throckmorton said. “There’s even less we know about the other species of cannabinoids, those other 80-odd things and the terpenes and the other things that are found in the cannabis plant. We know next to nothing about the cumulative and long term human exposure in the way that I would expect to understand it.”
Throckmorton outlined the variety of ways that the FDA is working on cannabis: groups within the agency meet with Throckmorton “every week to talk about it, to talk about cannabis, talk about cannabidiol. We exchange information,” he said.
“An extensive fraction of the agency is at work on cannabis at any given time. Going forward, we have a plan, because we understand that there is broad interest in the public in expanding the availability of safe, effective, and high quality products made from the cannabis plant,” Throckmorton said, to “engage” with “outside groups,” because the Agency understands “how important that is.”
Throckmorton said that the FDA has fielded proposals and suggested rules and approaches about CBD regulation.
“We also think it’s important from a policy perspective to think about how we might enable a broader availability of these safe, effective, and high quality cannabidiol products, whether that’s to continue our activities around enforcement, in addition to potentially allowing broader use of these products under appropriate circumstances, is something we’re in the process of working through,” Throckmorton said.
Throckmorton also added that the FDA continues to hear comments from a public hearing held in 2019. Since that hearing, the public comment window has been opened “indefinitely.”
“Our role has not changed based on the recent activities at the legislative level,” Throckmorton said. “We continue to support the scientific assessment of cannabis-derived products and cannabis-derived compounds. We think it needs to be robust and scientific. We understand the broad interest in expanding the availability of these products. We’re looking at various regulatory pathways to lawfully allow that that would be appropriate for the safety of the American public. And we are committed to protecting the public health with respect to these products wherever possible and to the extent we possibly can.”
