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MARIJUANA MOMENT

Key takeaways from FDA’s historic CBD regulations meeting

Muscle Joint & Relief Cream is displayed at the Cannabis World Congress & Business Exposition trade show on Thursday in New York.
Muscle Joint & Relief Cream is displayed at the Cannabis World Congress & Business Exposition trade show on Thursday in New York.Mark Lennihan/Associated Press/Associated Press

Marijuana Moment is a wire service assembled by Tom Angell, a marijuana legalization activist and journalist covering marijuana reform nationwide. The views expressed by Angell or Marijuana Moment are neither endorsed by the Globe nor do they reflect the Globe’s views on any subject area.

Advocates, industry representatives, regulators, health professionals, and marijuana legalization opponents stood up before the Food and Drug Administration Friday to share their perspectives about how to best approach regulating the cannabis compound, CBD.

The first-of-its-kind public meeting is meant to inform the FDA’s approach as it considers developing alternative pathways to regulate cannabidiol, which is not currently permitted in food or as a dietary supplement.

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Here’s a look at the discussions that took place at the event:

Advocates and opponents

Jonathan Miller, general counsel at US Hemp Roundtable, said there is “an urgent need for an efficient regulatory framework for CBD” and noted that it was the intent of Congress to provide for the marketing of hemp-derived CBD products when it passed the 2018 Farm Bill, federally legalizing the crop and its derivatives.

Interestingly, Miller said his organization has been working with lawmakers in recent weeks to draft standalone legislation to regulate CBD if the FDA determines that the task is too complicated for the agency to complete on its own. Senate Majority Leader Mitch McConnell, who led the charge on hemp legalization, previously suggested that further legislative action may be necessary to unlock the full potential of the hemp economy.

The National Cannabis Industry Association, which represents a wide range of industry stakeholders, made a similar argument in its testimony.

Andrew Kline, the group’s director of public policy, said “we strongly recommend FDA act quickly to clarify the regulatory environment.”

“Because there are significant confusions in the market, businesses don’t know what is legally permissible and some are making health claims in the absence of clear regulatory guidance,” he said. “Most significantly, banks and payment processors don’t understand and as a result many CBD companies are at risk of losing financial services.”

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NCIA also provided the panel with extensive written testimony it compiled from more than 100 industry representatives, scientists, and attorneys in support of establishing clear regulatory guidelines for CBD.

“The bottom line is this: an overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal safety concerns,” Kline said. He added that the FDA should create universal testing and labeling requirements to “help protect the public from health and safety risks.”

On the opposing side, members of the anti-legalization group Smart Approaches to Marijuana (SAM) Canada and the Marijuana Victims Alliance offered testimony that touched on CBD regulations but mostly served to express opposition to marijuana reform more broadly.

“The public is up against a narrative that is at war with science,” SAM Canada’s Pamela McColl said. She claimed that marijuana is addictive, leads people to harm themselves, and damages DNA.

“The subversion of truth and science and what is going on in North America great concern and reason to pause and do risk assessments on these drugs and analyze the influence of the billionaires and in the industry that have influenced public sentiment and dictated a very deceitful campaign,” she said.

Sally Schindel, the representative from Marijuana Victims Alliance, said that her son committed suicide, which she attributed in large part to his cannabis use.

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“What we need is our federal government enforcing federal laws,” she said. “We need FDA to be more involved and take a leading role in marijuana research and policy formation.”

Regulators

Representatives from state regulatory agencies in Virginia, Florida, North Carolina, and Pennsylvania also addressed the uncertainty that’s prevalent throughout the industry without updated FDA guidelines.

“Currently, states are struggling with the lack of sound scientific research available in CBD and long-term health impacts, including those to children,” Pam Miles of the Virginia Department of Agriculture, said. She added that her department “is hopeful that FDA will begin to supply significant leadership as it related to CBD, including research related to its health impacts.”

Brenda Morris, representing the Florida Department of Agriculture and Consumer Services, talked about the “patchwork of laws” surrounding CBD and how that has fostered an environment where “anything is allowed.”

“Without the FDA’s guidance and leadership, individual states may carve out their own regulatory exceptions for CBD,” said Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services, noting that his state’s hemp industry has greatly expanded in recent years. “We urge the FDA to resolve the statutory issues and properly establish a legal pathway for CBD products to enter the market place.”

Health and consumer advocates

The Alzheimer’s Association argued that existing research is insufficient to substantiate claims about the therapeutic potential of cannabis for Alzheimer’s and dementia. The group said the “lack of evidence creates a substantial risk for individuals and their families.”

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The American Epilepsy Society expressed similar concerns, despite CBD being an FDA-approved drug in the treatment of seizures in the form of Epidiolex.

“We support reducing regulatory barriers to research of cannabis-derived compounds,” a representative for the group said. “We strongly urge the FDA to classify the compounds and drugs under the complete jurisdiction of the FDA. We also advocate for ongoing studies on the efficacy of cannabis drugs.”

Ashley Morgan, of the American Veterinary Medical Association, told the FDA panel that “we believe there is therapeutic potential in the development of cannabis-derived and cannabis-related compounds, and we would like to see the potential realized.”

“We believe FDA must seriously consider the need for efficacy and safety data when therapeutic claims are made” about CBD products, she said. “To facilitate the development of such products for veterinary use is imperative provide pathways to ensure the regulatory clarity and predictability and economic viability of the industry. The agency must make enforcement priorities known and consistently and intentionally act on the priorities.”

Another testimony came from Larry Walker at the University of Mississippi, which is currently the site of the nation’s only federally authorized marijuana manufacturer for research purposes. He raised some concerns about potential adverse effects of CBD but made a series of recommendations to the FDA about how to minimize risks.

“A possible path forward, it seems to us, is prudent to have a multitrack approach with these products that are cannabis-related,” Walker said.

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“It would be outstanding if the FDA could conduct some basic studies in this realm. It is a national need,” he said. “We need a national testing program for cannabinoid quality and standardization, a national adverse reporting program for whatever products are out there and a rapid response program for products where there are serious incidents. We need analytical backup on many of these things where the serious incidents have occurred. Finally, if possible, together research outcomes in the state medical programs.”

FDA reaction

Amy Abernethy, the FDA principal deputy commissioner who helped organize the public meeting, identified several themes that emerged during the talks.

In general, there is a need to “further clarify the regulatory framework to reduce confusion in the market,” to provide that clarification in timely manner, to collect data on CBD to ensure that the products are safe, and to create labeling standards so consumers know what they’re getting.

Another theme that seemed to develop is the lack of information about dosing guidelines. Several experts who testified were unable to give clear answers to the FDA panel when asked what the proper doses are in different contexts, and what their effects on consumers are.

Read this story on Marijuana Moment.