FDA, CDC And Other Federal Agencies Discuss Marijuana Research Barriers, State Legalization Models And CBD Regulations At National Academies Meeting

Representatives of multiple federal agencies participated in a National Academies of Sciences, Engineering and Medicine (NASEM) meeting on Friday for a wide-ranging discussion about cannabis policy, with experts sharing their perspective on issues such as marijuana research barriers under prohibition, efforts to create a regulated pathway for CBD, state initiatives to promote social equity and more.

At the NASEM Committee on Public Health Consequences of Changes in the Cannabis Policy Landscape meeting, agencies made a series of presentations to share the policy areas that they’re prioritizing, as well as ongoing questions that they’re working to answer about the impacts of legalization and the use of cannabis.

Agencies that participated in the virtual and in-person event were: the Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), Centers for Diseases Control and Prevention (CDC), National Cancer Institute (NCI) and National Center for Complementary and Integrative Health (NCCIH).

One theme that quickly emerged is how scientists who want to research marijuana face significant challenges due to its Schedule I status under the Controlled Substances Act (CSA).

Brooke Hoots, a cannabis advisor at CDC, noted that “many of the questions on the health effects of cannabis use” that were raised as part of a collaborate report from the academies in 2017 “still remain unanswered” because of the complex requirements imposed on scientists interested in studying Schedule I substances like marijuana.

What’s more, as other federal health officials have explained in recent years, there are additionally questions about the quality of the federally authorized studies that have been conducted, as researchers are unable to access the actual cannabis products from state-licensed dispensaries that legal consumers use, which are typically more potent and diverse than the government-grown products that are available for study purposes.

NIDA’s Susan Weiss said that the institute is especially interested in neuroscience research into the endocannabinoid system to “understand what the neurobiological consequences are—both the adverse consequences and also the potential for development of medications to treat various illnesses.”

“We are also interested in some medical uses,” she said. “We’re interested in potential medical uses for pain, for substance use disorders and for HIV treatment, and we also have a portfolio on the treatment of cannabis use disorder.”

But, again, there are “a number of barriers to research [and] we’re all very aware of those,” Weiss said, adding that “some of these are administrative” such as the onerous Drug Enforcement Administration (DEA) registration process researchers must go for access marijuana, while other are more technical like ensuring standardization in cannabis studies.

The NIDA official also talked about the agency’s desire to study state regulatory models and the products that are commercially available at their licensed businesses.

“We should be learning from what is already happening in the states and what is happening in other countries,” Weiss said. “We should be studying products that people are using.”

“You know, this is such a fraught area to talk about. There are people that feel so strongly about either the positive or the negative effects of cannabis, and it’s very easy to cherry pick findings and to cherry pick information when you’re trying to make points that you want,” she said. “We need to have a really good understanding of what of what the product landscape looks like.”

Notably, she said NIDA is also interested in researching specific state policy issues like how cannabis is priced, taxed, packaged, labeled and tested. Also, the agency wants to look at how states are addressing social equity in the industry.

“Have we learned lessons from the tobacco and alcohol industry that can help us understand how to deal with this new emerging cannabis industry?” she asked. “And again, how are the states with the legal markets countering the illicit markets? How are different states tackling criminal justice issues?”

“I mean, this is one of the most compelling reasons that people have voted to legalize cannabis in the states. Are the changes that are happening actually attenuating the negative impact on these populations that who are most adversely affected by cannabis [prohibition]?” she said. “And finally, how are states approaching social equity in the cannabis industry? What if any business models or community investments are working? Are showing promise?”

Another attendee later asked Weiss to expand on NIDA’s interest in social equity and what specifically the agency would like to learn about the issue.

She acknowledged that it “may not be as directly related to what NIDA typically funds since most of our work is on health.”

“But we’re very interested right now overall in social determinants of health, and social equity is obviously a very big part of that,” she said. NIDA is “moving towards understanding that those determinants can have massive impacts on a whole variety of outcomes,” and “we need to understand if there are ways that we can actually improve some of those those factors.”

“I think that’s important because, to the extent that we can show data, we could try to influence policy,” Weiss said. “For us, I think it’s a way of helping us understand whether or not social equity initiatives are working and how they’re working and are they improving people’s ability to have a reasonable life and not be homeless and not have access to proper health care.”

The NIDA official said the agency is looking for guidance from the National Academies “in terms of our future directions.”

“Again, we’re interested in different regulatory models that are already in place, the many of the impacts of the different models of legalization and and non-legalization,” she said, noting that NIDA “recently started to support a registry on medical cannabis uses.”

FDA senior science advisor Patrick Cournoyer, meanwhile, discussed his agency’s work and priorities, focusing on regulations for hemp-based cannabinoids like CBD and enforcement against companies that are selling intoxicating products such as delta-8 THC without proper guardrails.

“We’ve seen a market that has grown really rapidly for cannabinoid hemp products, including CBD” since hemp was legalized under the 2018 Farm Bill, he said.

He recognized that, in January, FDA declined to implement regulations to allow for the marketing of CBD as dietary supplements or in the food supply. There were two main reasons for that decision: “One is the inherent risk profile of CBD. And the other is that we have to bring that to bear on the highly protective safety standards that exist for food ingredients and for dietary supplements, so it’s the combination of those two things that led us to our conclusion.”

“However, we recognize that these products are out there. It’s a large market and there’s a need for some type of oversight,” Cournoyer said. “So the solution that we’ve suggested is that we’re prepared to work with Congress on a new way forward—on a new pathway that would take more of a harm reduction approach that could enable consumer access with the regulatory oversight that is desired that we hear about, that people want.”

“It could give people options to manage and reduce their risk and help them make informed decisions about their health if they take cannabinoid hemp products like CBD,” he said.

Bipartisan congressional lawmakers have introduced different bills to create a regulatory pathway for CBD marketing, but so far they have not been enacted. Industry stakeholders are also eyeing the 2023 Farm Bill as a possible vehicle for reforms to enact regulations for hemp-based cannabinoids.

The FDA official also said that the agency is “very concerned about the relatively recent proliferation of intoxicating cannabinoid hemp products, including but not limited to delta-8 THC.” People who are buying hemp products with different unregulated cannabinoids “don’t necessarily know what they’re using,” he said.

NCI’s Joseph Ciccolo also weighed in on how the cancer institute is approaching marijuana, acknowledging that many cancer patients are using cannabis, primarily for pain, and one survey found 80 percent of oncologists have discussed marijuana use with their patients.

However, he said, only 30 percent of oncologists describe themselves as “sufficiently knowledgeable” about cannabis.

“Understanding the assessment of cannabis is difficult depending on the mode, the dosage, the frequency, knowing whether or not the product that the individual is using is actually what they think they’re using,” Ciccolo said. “Oftentimes those are mismatched. We are concerned about the benefits and any harms that cannabis might be providing cancer patients.”

He also said NCI wants to know more about the poly-drug use—for example, whether there’s a substitution effect with respect to marijuana, tobacco and alcohol. And the institute would further like to know whether there’s a relationship between the cost and tax rate for cannabis and the prevalence of the illicit market.

David Shurtleff, deputy director of NCCIH, noted that his agency is promoting research into “minor cannabinoids and terpenes for their potential analgesic effects,” as well as “for possible benefit for other symptoms, including sleep disturbance and some mental health conditions.”

NCCIH is “very much interested in understanding reported beneficial health outcomes, but also equally concerned with adverse events that are associated with medical use,” he said. “If we start to understand what is predominantly in these mixtures or if people are using single cannabinoids for a particular condition, that is a first step for us to really think about new opportunities for further research on those particular constituents.”

FDA’s Cournoyer relatedly said that the agency is committed to exploring “medical product pathways, and we support rigorous scientific testing and the submission of new drug applications for drugs derived from cannabis so that, just like any other substance, the drug development pathway is open.”

Ultimately, the ad hoc NASEM cannabis committee is expected to “provide recommendations for strengthening a harm reduction approach, which would minimize harms, of various regulatory models, including but not limited to social, employment, education, and health impacts” and also issues recommendations on “policy research for the next 5 years.”

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Photo courtesy of Mike Latimer.

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