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FDA, CDC and Other Federal Agencies Discuss Marijuana Research Barriers at National Academies Meeting, State Legalization models, CBD Regulations

September 15, 2023 by Kyle Jaeger

On Friday, representatives of several federal agencies attended a meeting of the National Academies of Sciences, Engineering and Medicine. Experts shared their perspectives on cannabis policy, including marijuana research barriers during prohibition, efforts to establish a regulated path for CBD, and state initiatives that promote social equity.

The NASEM Committee on Public Health Consequences Changes in Cannabis Policy Landscape Meeting saw a number of agencies present a series presentations on the policy areas they prioritize, and ongoing questions they are working to answer regarding the impact of legalization.

The following agencies participated in both the virtual and physical event: Food and Drug Administration, National Institute on Drug Abuse, Centers for Disease Control and Prevention (CDC), National Cancer Institute and National Center for Complementary and Integrative Health.

Scientists who wish to conduct research on marijuana are faced with significant obstacles due to its Schedule I classification under the Controlled Substances Act.

Brooke Hoots is a cannabis adviser at CDC. She noted that many of the questions raised in a 2017 report by the academies regarding the health effects associated with cannabis “still remain unanswered”, due to the complexity of requirements placed on scientists who are interested in researching Schedule I substances such as marijuana.

As other federal health officials explained in recent years there are also questions about the quality the federally-authorized studies have been conducted. Researchers are unable access to the actual cannabis products sold by state-licensed marijuana dispensaries, which are usually more potent and varied than those grown for study.

NIDA’s Susan Weiss stated that NIDA is particularly interested in neuroscience research on the endocannabinoid to “understand the neurobiological implications–both adverse consequences as well as the potential to develop medications to treat different illnesses”.

She said, “We’re also interested in certain medical uses.” “We are interested in possible medical uses for HIV, substance abuse disorders, pain and HIV treatment. We also have a portfolio for the treatment of cannabis addiction disorder.”

Weiss added that there are “a few barriers to research” and “we’re all aware of them.” Some of these barriers are administrative, such as the lengthy registration process required by the Drug Enforcement Administration (DEA) for researchers who want access to marijuana. Others are technical, like ensuring standardization of cannabis studies.

The NIDA official also spoke about the agency’s wish to study state regulatory model as well as the products available commercially at their licensed business.

Weiss stated that “we should learn from what’s happening in the States and in other countries.” “We should study products that people use.”

This is a very sensitive topic to discuss. She said that there are many people who feel strongly about the positive or negative effects of marijuana. It’s easy to cherry-pick findings and cherry-pick information to support your point. “We have to be able to understand the landscape of products.”

Many states are moving toward the legalization of #cannabis. However, the public health implications have not been fully examined.

Learn about our new study on the impacts of recent changes to cannabis policy on September 15: https://t.co/vhcUCXkb6X pic.twitter.com/A2M7s2V6IC

National Academies (@theNASEM 12 September 2023

She said that NIDA was also interested in research specific state policy questions like how cannabis is taxed, priced, packaged, labelled and tested. The agency also wants to examine how states address social equity within the industry.

She asked, “Have lessons been learned from the tobacco industry and alcohol industry to help us better understand this emerging cannabis industry?” How are states that have legal markets dealing with illicit markets?” she asked. What are the different approaches taken by states to criminal justice?

This is why people voted in favor of legalizing cannabis. She asked, “Are the changes happening attenuating negative impacts on the populations who are most adversely impacted by prohibition of cannabis?” How are the states addressing social equity within the cannabis industry?” What business models or investments in the community are successful? Are showing promise?”

Later, another attendee asked Weiss about NIDA’s interest and the specifics of the agency’s desire to learn more about social equity.

She admitted that “it may not be as directly related as what NIDA typically finances since most of our research is focused on health.”

She said, “But social determinants are a big focus for us right now. Social equity is a huge part of this.” NIDA “is moving towards understanding that these determinants can impact a variety of outcomes,” she said. “We need to understand whether there are ways we can improve some of those factors.”

Weiss stated that “I believe that is important because we can try to influence policies to the extent we are able to show data.” “For us, it’s an important way to understand whether social equity initiatives work and how they work and if they improve people’s abilities to live a reasonable life without being homeless or lacking access to health care.”

The NIDA official stated that the agency seeks guidance from the National Academies regarding “our future direction.”

She said that NIDA had “recently begun to support a medical cannabis registry.”

Patrick Cournoyer is the FDA’s senior science advisor. He discussed the agency’s priorities and work, with a focus on hemp-based cannabinoids such as CBD, and enforcement actions against companies selling intoxicating goods like delta-8 THC, without proper safeguards.

He said that since hemp was made legal under the 2018 Farm Bill he has seen “a market grow really quickly for cannabinoid products, including CBD”.

In January, FDA refused to implement regulations allowing the marketing of CBD in dietary supplements and food. This decision was based on two factors: “One, the inherent risk profile associated with CBD.” The other reason is that we had to combine that with the extremely protective safety standards for food ingredients and dietary supplements.

“However we do recognize that there are these products out there.” Cournoyer stated that it is a big market, and some kind of oversight was needed. “The solution we have suggested is that, with Congress, we are prepared to find a new path forward that takes a more harm reduction approach and could allow consumers access while maintaining the regulatory oversight they desire.

He said that CBD products, which are cannabinoids in hemp, could help people make better decisions about their health and manage their risks.

Bipartisan Congressmen have Introduced Different Bills to Create a Regulatory Pathway for CBD Marketing . However, they have yet to be enacted. The 2023 Farm Bill is also being considered by industry stakeholders as a potential vehicle to reform regulations for hemp-based cannabis.

He said the FDA is also “very concerned” about “the relatively recent proliferation of intoxicating hemp products including but not only delta-8 THC.” The FDA official said people who buy hemp products with unregulated cannabinoids don’t know what they are using.

Joseph Ciccolo, NCI’s Joseph Ciccolo, also commented on the NCI’s approach to marijuana. He acknowledged that many cancer patients use cannabis, primarily as a pain reliever, and a survey revealed 80 percent of oncologists had discussed marijuana with their patients.

He said that only 30% of oncologists consider themselves “sufficiently informed” about cannabis.

Ciccolo stated that it is difficult to understand the assessment of cannabis depending on the mode, dosage, frequency and knowing whether the product the individual uses is what they believe they are using. “Sometimes, those are not matched.” “We are concerned with the potential benefits and harms of cannabis for cancer patients.”

NCI also wants to know about polydrug use, such as whether there is a substitution effect between marijuana, alcohol, and tobacco. The institute also wants to know if there is a correlation between the price and tax rate of cannabis and the prevalence on the illicit market.

David Shurtleff noted that NCCIH is encouraging research into “minor terpenes and cannabinoids to determine their potential analgesic effect,” as well “as possible benefits for other symptoms including sleep disruption and certain mental health conditions.”

NCCIH “is very interested in understanding reported positive health outcomes but is also concerned about adverse events associated with medical usage,” he stated. “If we begin to understand the predominant ingredients in these mixtures, or if individuals are using cannabinoids to treat a specific condition, this is a good first step to identifying new research opportunities on those constituents.”

FDA’s Cournoyer said, in a related statement, that the agency was committed to exploring medical product pathways. We support rigorous scientific tests and the submissions of new drug application for drugs derived cannabis, so that, like any other substance the drug development path is open.

The NASEM Cannabis Ad Hoc Committee is expected to provide recommendations to strengthen a harm-reduction approach that would minimize harms of various regulatory models including, but not limited, to social, education, employment and health impacts, as well as recommendations on “policy and research for the next five years”.


A Senate source confirms that the Senate committee will vote on marijuana banking bill in the last week of September.


Photo by Mike Latimer.

The post FDA and CDC Discuss Marijuana Research Barriers at National Academies Meeting, State Legalization Models, CBD Regulations and CBD Regulations appeared first on Marijuana Moment.

Kyle Jaeger
Author: Kyle Jaeger

About Kyle Jaeger

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