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

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

by Universalwellnesssystems

On Friday, representatives from multiple federal agencies attended a National Academies of Sciences, Engineering, and Medicine (NASEM) meeting for a wide-ranging discussion of cannabis policy, with experts highlighting barriers to cannabis research under prohibition, They shared their views on issues such as barriers to marijuana research and efforts to create scientific evidence. Regulated pathways for CBD, national efforts to promote social equity, and more.

At the NASEM Committee on Public Health Implications of Changes in the Cannabis Policy Landscape, each agency gave a series of presentations on the policy areas they are prioritizing and the ongoing efforts they are making to answer questions about the impact of cannabis. shared questions. Cannabis legalization and use.

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

One theme that quickly emerged was how scientists seeking to study marijuana face significant challenges due to its Schedule I status under the Controlled Substances Act (CSA).

Brooke Fouts, a cannabis advisor at the CDC, said “many questions about the health effects of cannabis use” raised as part of a joint report from the academy in 2017 are due to the complex requirements placed on cannabis. Therefore, the matter “remains unresolved,” he said. He is a scientist interested in studying substances such as marijuana.

Furthermore, as other federal health officials have explained in recent years, research conducted with federal authorization is not possible because researchers do not have access to actual cannabis products from state-licensed dispensaries used by legal consumers. There are also questions about the quality of These are typically more powerful and diverse than government products available for research purposes.

Susan Weiss of NIDA Said The institute has a particular interest in neuroscience research on the endocannabinoid system in order to “understand both its neurobiological effects, or negative effects, and the potential for drug development to treat a variety of diseases.” That’s what it means.

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

However, “there are many barriers to research.” [and] “We’re all very familiar with them,” Weiss said, adding that “some of them are administrative, some of them are complicated,” such as the cumbersome Drug Enforcement Administration (DEA) registration process required for researchers to obtain marijuana. “Some are more technical, such as ensuring standardization of marijuana,” he added. Cannabis research.

NIDA officials also spoke about the agency’s desire to study state regulatory models and products marketed by licensed companies.

“We should learn from what’s already happening in our states and what’s happening in other countries,” Weiss said. “We need to study the products that people are using.”

“You know, this is a very difficult area to talk about. There are people who feel very strongly about the positive and negative effects of cannabis, but when they try to make their point, , it’s very easy to just pick on the findings and information,” she said. “We need to have a good understanding of what the product landscape is.”

Notably, she said NIDA is also interested in studying specific national policy issues, such as how cannabis is priced, taxed, packaged, labeled, and tested. The agency also wants to look at how each state is addressing social equity in the industry.

“Have we learned lessons from the tobacco and alcohol industry that will help us understand how to deal with this newly emerging cannabis industry?” she asked. “And again, how do states with legal markets compete with illegal markets? How do different states approach criminal justice issues?”

“So this is one of the most compelling reasons why people voted to legalize cannabis in their states. Does it actually reduce it? [prohibition]? ” she said. “And finally, how is the state addressing social equity in the cannabis industry? What if the business model and community investments are working? Are they showing promise?

Later, another attendee asked Mr. Weiss more about NIDA’s interest in social equity and what specifically the organization wanted to know about this issue.

She acknowledged that “most of our work is related to health, so it may not be directly related to the amount that NIDA typically funds.”

“But we’re all very interested in the social determinants of health right now, and it’s clear that social equity is a very big part of that,” she said. Stated. NIDA is “moving toward understanding that these determinants can have a profound impact on a variety of outcomes,” and “is investigating whether there are ways that we can actually improve some of those factors.” It needs to be understood.”

“I think this is important because as long as you can show data, you can try to influence policy,” Weiss said. “For us, this is about whether and how social equity efforts are working, and how people who are homeless or without adequate health care are able to live a reasonable life. I think it’s a useful way to understand if you’re improving your abilities.”

NIDA officials said the agency is seeking guidance from the National Academies “on future direction.”

“Again, we are interested in the many implications of the different regulatory models that are already in place, the different models of legalization and decriminalization,” she said, adding that NIDA We recently started supporting medical registries.” Cannabis use. ”

Meanwhile, FDA Senior Scientific Advisor Patrick Cournoyer will focus on regulation of hemp-based cannabinoids such as CBD and enforcement against companies selling addictive products such as delta-8 THC without proper guardrails. , spoke about FDA’s work and priorities.

Since hemp was legalized under the 2018 Farm Bill, “we’ve seen the market for cannabinoid hemp products, including CBD, grow very rapidly,” he said.

He acknowledged that in January, the FDA refused to introduce regulations that would allow the sale of CBD in dietary supplements or the food supply. He had two main reasons for that decision. “One is the risk profile that is unique to CBD. And the other is that we have to apply the highly protected safety standards that exist in food ingredients and dietary supplements, so these two things The combination of these led to our conclusion.”

“But we recognize that these products are out there. This is a big market and there needs to be some oversight,” Cournoyer said. “So our proposed solution is that we are willing to work with Congress in a new direction: a new path that takes a more harm-reducing approach, with the desired regulatory oversight. It’s about giving consumers access to what we’re hearing and what people want. ”

“Cannabinoid hemp products like CBD could give people who consume hemp products options to manage and reduce their risks and help them make informed decisions about their health,” he said.

A bipartisan group of members of Congress has introduced various bills to establish a regulatory pathway for CBD marketing, but so far no legislation has passed. Industry players are also eyeing the 2023 Farm Bill as a reform vehicle to enact regulations for hemp-based cannabinoids.

FDA officials also said the agency is “very concerned about the relatively recent proliferation of intoxicating cannabinoid hemp products, including but not limited to delta-8 THC.” People purchasing hemp products containing various unregulated cannabinoids “don’t necessarily know what they’re using,” he says.

NCI’s Joseph Chicolo also weighed in on how cancer institutes are approaching marijuana, acknowledging that many cancer patients use cannabis primarily for pain, and The survey found that 80 percent of oncologists have discussed marijuana use with patients.

However, only 30 percent of oncologists say they are “well-informed” about cannabis, he said.

“Understanding the valuation of cannabis can be difficult depending on method, dose, and frequency, making it difficult for individuals to know whether the product they are using is actually what they think they are using. ” said Ciccolo. “Often they don’t match up. We are concerned about the benefits and harms that cannabis may have for cancer patients.”

He also said the NCI would like to know more about polydrug use, such as whether there are substitution effects when it comes to marijuana, tobacco, and alcohol. The institute also wants to know whether there is a relationship between the cost and tax rate of cannabis and the prevalence of the illicit market.

David Shurtleff, deputy director of NCCIH, said the agency is promoting research into “trace cannabinoids and terpenes for potential analgesic effects” and “for sleep disorders and some mental health conditions.” “We are promoting research with the aim of potentially having an effect on other symptoms as well,” he said.

NCCIH is “very interested in understanding the beneficial health outcomes that have been reported, but we are equally interested in the adverse events associated with medical use,” he said. “Once we start to understand what’s primarily in these mixtures, or whether people are using a single cannabinoid for a specific condition, that opens the door for further research into those specific components. This is the first step to thinking seriously about new opportunities for

In this regard, the FDA’s Mr. Cournoyer said that the FDA is “committed to exploring drug pathways and will conduct rigorous scientific testing for cannabis-derived drugs to ensure drug development pathways are open to the same conditions as for other substances.” “We support the submission of new drug applications.” ”

Ultimately, the Special NASEM Cannabis Committee made recommendations to strengthen harm reduction approaches that minimize harm in various regulatory models, including but not limited to social, employment, education, and health impacts. It is expected that the government will provide the best possible results and will also issue recommendations. Regarding “Policy research for the next five years”.

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Photo by Mike Latimer.

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