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Key Takeaways From FDA’s Historic CBD Regulations Meeting

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Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before the Food and Drug Administration (FDA) on Friday to share their perspectives on 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 the food supply or as a dietary supplement.

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

Advocates and opponents

Jonathan Miller, general counsel at U.S. 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 (R-KY), 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 (NCIA), 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 [that] 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 [the regulatory rules] and as a result many CBD companies are at risk of losing financial services.”

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 [is a source of] 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.

“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.”

Shawn Hauser, a hemp and cannabinoid attorney with the law firm Vicente Sederberg LLP, represented the Cannabis Trade Federation at the hearing. “The appropriate regulation of products containing lawful cannabinoids already exists, and that data arising out of the state-regulated regime supports such regulation,” she said.

But “whether right or wrong, the current situation has created a vacuum. It opens the door to bad actors,” which ought to inform the FDA’s next steps.

“Cannabis products can be safely regulated under the existing dietary supplement framework and where products are intended for non-medicinal purposes, it is appropriate to regulate them as such,” she said. “The years of data from these state regulatory regimes are an important source of data for the agency to consider in determining the regulatory pathway. We stand ready to advance to the next level as a partner with FDA in effective federal regulation of cannabinoid products.”

Regulators

Represents 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,” Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services, said, 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.”

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 [for the FDA to] 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 interesting 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.

“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.”

Sue Sisley, an internal medicine physician at the Scottsdale Research Institute, expressed frustration over the fact that the DEA “has not processed” applications to increase the number of authorized manufacturers for research-grade cannabis “despite members of Congress repeatedly urging” the agency to do so.

“Sadly, because of the limitations with the current drug supply, we are forced to import study drugs from a Canadian manufacturer and that is disappointing to us,” she said. “We would like to see our own domestic variety of domestic manufacturers. The point is that researchers need access to options. Scientists need options when it is to embolden scientific freedom.”

James Beck, representing the Parkinson’s Foundation, noted that while traditional pharmaceuticals can treat some of the symptoms Parkinson’s patients experience, many remain unaddressed, leaving the community “seeking alternative ways in which to control the symptoms.”

He said that marijuana doesn’t seem to treat tremors, but “it may be helpful on a targeted level for nonmotor symptoms, sleep, anxiety.”

“Bottom line, we really need more research to understand the utility of cannabis for Parkinson’s disease,” Beck said. “I don’t know that there’s very other circumstances we have a drug that is life-saving.”

Jacqueline French of the Epilepsy Foundation said that the group wants the FDA to “preserve access to CBD for those who need it as a life-saving medication.” However, she emphasized the need to create “manufacturing standards” to avoid contamination from mold and other contaminants.

Americans for Safe Access’s Heather Despres talked about standards that her organization has developed, recommending that the FDA consider integrating some of their best practices on “cultivation, manufacturing, distribution and laboratory operations.”

“There are many challenges facing the cannabis industry. There are solutions available,” she said. “We have worked with state regulators to develop and implement a standard, [and] we look forward to working with you, together, to help implement those standards.”

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 about what the proper doses are in different contexts, and what their affects on consumers are.

Interested parties can submit public comments to FDA’s docket on CBD issues through July 2.

This story was updated to include testimony delivered later in the day. 

Federal Court Orders DEA To ‘Promptly’ Consider Marijuana Rescheduling…Or Else

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Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

New York And Connecticut Governors Talk Marijuana Legalization On Fishing Trip

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The governors of New York and Connecticut went fishing and talked about marijuana legalization on Tuesday.

The conversation comes after lawmakers in both states were unable to pass legalization legislation before their respective sessions’ ends this year, despite having the support of New York Gov. Andrew Cuomo (D) and Connecticut Gov. Ned Lamont (D).

“We talked about policy issues like the marijuana issue, which is obviously also relevant to contiguous states,” Cuomo said at a press conference following the fishing trip. “What Connecticut does on marijuana is relevant to New York, what New York does is relevant to Connecticut so we talked about that and a lot of issues. So we had fun.”

Watch Cuomo’s marijuana comments at about 5:00 into the video below:

Cuomo had described legalization as a top legislative priority for 2019 and included it in his state budget proposal. But after months of negotiations with lawmakers, the plan fell through, due in part to disagreements about how to allocate tax revenue and whether to allow individual jurisdictions to opt out of allowing cannabis businesses.

The governor did sign legislation in July that expands the state’s marijuana decriminalization policy and provides a pathway for expungements of past marijuana convictions.

Over in Connecticut, Lamont campaigned on legalization during his election bid last year and described it as one of his administration’s “priorities” after he took office. But as with neighboring New York, the legislature failed to advance a legalization bill beside multiple successful committee votes and hearings throughout the year.

The specifics of what the governors talked about during their fishing expedition on Lake Ontario aren’t clear, but both are presumably gearing up for another round of legislative efforts marijuana over the coming year and could take lessons from each other as reform talks continue.

Another East Coast state, New Jersey, has also struggled to move legalization legislation forward, with lawmakers saying that the issue should be taken up by voters in 2020 rather than pushed through the legislature, though there has been discussion lately about another try at moving a bill before year’s end. Gov. Phil Murphy (D) did sign a decriminalization and expungements bill in May, however.

Federal Data Shows Youth Marijuana Use Isn’t Increasing Under Legalization

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GOP Congressman Will Meet Attorney General To Discuss Expanding Marijuana Research

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Rep. Matt Gaetz (R-FL) said on Monday that he will soon be speaking with the U.S. attorney general about expanding marijuana research.

The congressman, a close ally of President Trump, is a vocal proponent of medical cannabis and has argued that the federal drug scheduling system is hampering research into the plant’s therapeutic potential.

“I will be meeting with Attorney General Bill Barr in the coming weeks to discuss the Department of Justice’s approach to unlocking more research grants so that we can have American innovation applied to our health care in a way that can get people off of some of these devastating opioids and painkillers, and on to a more natural product,” he said following a radio town hall event.

Even under the framework of prohibition, the Justice Department is able to promote research by, for example, approving additional marijuana manufacturers—something the Drug Enforcement Administration (DEA) said it would do three years ago.

Barr has voiced support for expanding the number of federally authorized cannabis manufacturers.

“I think we’re going to move forward on it,” the attorney general said in April. “I think it’s very important to get those additional suppliers.”

Earlier this year, Gaetz joined congressional colleagues in leading a letter addressed to Barr and the head of DEA expressing frustration that the Justice Department has declined to take action despite its pledges. The lawmakers implored DEA to “do whatever you can to speed up and improve the research application process.

Gaetz also introduced legislation that would force DEA to approve additional facilities to produce research-grade cannabis. A version filed last year cleared the Judiciary Committee in a voice vote, and he reintroduced the bill in January but it has not yet been acted upon.

Listen to Gaetz’s new cannabis comments, about 1:20 into the audio below:

DEA is facing two lawsuits regarding its approach to marijuana, including one that concerns the lack of diversity of research-grade cannabis since only one manufacture is currently authorized. The agency was ordered to respond to the suit by August 28.

Separately, a group of patients and advocates sued DEA over marijuana’s Schedule I status under the Controlled Substances Act, with a federal court directing the agency to “promptly” consider reclassifying cannabis.

Gaetz also spoke about the need to more broadly reform cannabis laws during the Monday remarks.

“The federal government listing marijuana as a Schedule I drug impairs financial transactions, it impairs research and it stops us from being able to unlock cures for some of America’s most vulnerable people,” the congressman said, adding that he’s a cosponsor of legislation that would deschedule marijuana that was introduced by Judiciary Chairman Jerry Nadler (D-NY).

Gaetz, who is also a member of the Judiciary Committee, said he is requesting that the panel hold a hearing on cannabis legislation. That’d mark the second such meeting after a Judiciary subcommittee convened last month to discuss paths to ending federal prohibition.

The congressman’s staff wasn’t able to provide Marijuana Moment with additional details regarding the meeting with Barr.

Congressman Says Marijuana Could Be Legal Sooner If Trump Stops Tweeting

Photo courtesy of Meredith Geddings.

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Elizabeth Warren’s Criminal Justice Plan Involves Legalizing Marijuana And Safe Injection Sites

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Legalizing marijuana, granting clemency to people convicted of drug offenses and investing in harm reduction programs such as safe injection sites are part of a criminal justice reform plan that Sen. Elizabeth Warren (D-MA) released on Tuesday.

The 2020 Democratic presidential candidate stressed that the war on drugs has been carried out in a racially discriminatory manner, writing that it’s unfair that “a kid with an ounce of pot can get thrown in jail, while a bank executive who launders money for a drug cartel can get a bonus. It’s long past time for us to reform our system.”

“This failure [of the drug war] has been particularly harmful for communities of color, and we need a new approach,” she said. “It starts with legalizing marijuana and erasing past convictions, and then eliminating the remaining disparity between crack and powder cocaine sentencing.”

What’s more, the drug war “has criminalized addiction, ripped apart families—and largely failed to curb drug use” when a more effective system would treat addiction as a public health issue.

That includes diverting people who’ve been convicted of non-violent drug offenses to treatment programs and providing evidence-based resources for people suffering from addiction. For example, Warren’s plan calls for safe injection sites where people can use illicit drugs under the supervision of medical professionals who can help prevent fatal overdoses and get people into treatment. She also said needle exchange programs and expanding access to buprenorphine would reduce the opioid crisis.

“Instead of locking up people for nonviolent marijuana crimes, I’ve proposed putting pharmaceutical executives on the hook to report suspicious orders for controlled substances that damage the lives of millions.”

She also called for the abolition of certain mandatory minimum sentences and said that “people who struggle with addiction should not be incarcerated because of their disease.”

“Mass incarceration has not reduced addiction rates or overdose deaths, because substance abuse disorder is a public health problem — and it’s long past time to treat it that way,” the plan says. “We know that diversion programs are both more humane and a better investment than incarceration — for every dollar we invest in treatment programs, we can save $12 in future crime and health care costs.”

“And rather than incarcerating individuals with substance abuse disorders, we should expand options that divert them into programs that provide real treatment.”

Like Sens. Bernie Sanders (I-VT), Cory Booker (D-NJ) and South Bend, Indiana Mayor Pete Buttigieg, Warren’s criminal justice reform proposal also mentions executive actions she could unilaterally take.

Specifically, she wrote that the Justice Department should not hold authority to make clemency recommendations and it should instead be left up to an independent clemency board so that those eligible for a pardons and commutations are more quickly identified.

“I’ll direct the board to identify broad classes of potentially-deserving individuals for review, including those who would have benefited from retroactivity under the First Step Act, individuals who are jailed under outdated or discriminatory drug laws, or those serving mandatory minimums that should be abolished,” she said.

The plan’s unveiling comes two days after Sanders released his criminal justice reform proposal, which also called for marijuana legalization and the implementation of harm reduction policies such as safe consumption facilities.

Buttigieg’s plan stands out from his fellow Democratic candidates in at least one regard: the mayor said drug possession should broadly be decriminalized.

Warren also released a separate plan for Indian tribes last week that involves protecting tribal cannabis programs from federal intervention.

Bernie Sanders Calls For Legalization Of Marijuana And Safe Injection Sites

Photo courtesy of Edward Kimmel.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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