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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

Photo by Kimzy Nanney on Unsplash.

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

Idaho Senator Files Bill To Decriminalize Drug Possession

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A new bill filed by an Idaho senator would decriminalize possession of currently illegal drugs in the state, though it also contains a provision that advocates consider troubling, allowing the government to involuntarily commit people convicted of certain offenses to treatment.

Sen. Grant Burgoyne (D) introduced the legislation, which would remove criminal penalties for drug use and possession by “requiring intention to deliver for criminal trafficking.”

Burgoyne told Marijuana Moment the bill has been referred to the Judiciary and Rules Committee, where Chairman Todd Lakey (R) has agreed to hold a hearing on it.

“We have too much of a focus on prosecution and punishment and not enough on treatment,” Burgoyne said in a separate interview with KTVB. “We don’t have a functioning mental health treatment and substance abuse treatment capability for the needs of our people. We need new strategies, how we draw the lines between what is criminal conduct and what is not criminal conduct when it comes to drug possession and usage.”

The bill sets different possession thresholds for different drugs. Having just two grams of heroin could be considered trafficking, while for cocaine and methamphetamine, the amount is set at 28 grams. One pound of marijuana, or 25 plants, could be treated as a trafficking offense.

Any amount of LSD could be considered a trafficking offense, as could any amount of a “simulated controlled substance,” possibly referring to synthetic opioids like fentanyl. Using drugs with friends would also be harshly penalized, as “sharing or providing a controlled substance for use by another person shall constitute intent to deliver.”

“This will reduce arrests, but how much is very hard to predict,” Burgoyne told Marijuana Moment. “Unfortunately, illegal drug use, even in private, is too often accompanied by the commission of other crimes, which my bill does not excuse and which could lead to arrest.”

Burgoyne’s bill would also allow people using drugs to be “placed in protective custody” or “admitted for community-assisted behavioral health treatment.” This would apply to people under the influence and in various circumstances, such as being pregnant, posing a risk to themselves or others or in withdrawal.

But existing research on mandatory drug treatment suggests it is not helpful for people with substance use disorder. A 2016 study published in the British Medical Journal, for example, found that when people are ordered to undergo drug treatment without their informed consent, the practice does more harm than good and does not reduce their drug use. The researchers explained that harm reduction efforts like syringe exchanges and drug education were more effective.

“Although there is some theoretical danger of adverse consequences to mandated drug treatment, we already mandate it for prisoners with drug issues,” Burgoyne said. “I’d like to shift treatment out of our jails and prisons to a more appropriate place. Furthermore, a civil commitment is not an easy thing to obtain, and I think our courts will be conservative in how they handle them.”

If the senator’s legislation passes, it remains to be seen what effect it would have on drug arrest rates in Idaho. According to the FBI, in 2017 Idaho had 8,432 arrests for “drug abuse violations,” which is a little over 16 percent of all arrests that year.

Burgoyne’s reform proposal comes amid a growing national debate about the value of decriminalizing drug use over more arrests. Last year in May, Denver became the first city in the U.S. to decriminalize personal use and possession of psilocybin mushrooms. Oakland’s City Council followed the next month by decriminalizing a wide range of psychedelics.

Advocates are also raising the issue on the national stage. Rep. Alexandria Ocasio-Cortez (D-NY) proposed decriminalizing drug consumption in November. Former South Bend, Indiana Mayor Pete Buttigieg, a 2020 Democratic presidential candidate, has proposed decriminalizing drug possession and reducing sentences. His primary opponent, Rep. Tulsi Gabbard (D-HI), recently called for legalizing and regulating drugs in order to treat substance misuse as a public health issue.

Tulsi Gabbard Endorses Legalizing Drugs

Photo coutersy of Markus Spiske.

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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U.S. Virgin Islands Governor Pushes For Marijuana Legalization In Annual Speech

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The governor of the U.S. Virgin Islands (USVI) repeated his call for marijuana legalization in his annual State of the Territory address.

Gov. Albert Bryan Jr. (D), who called the legislature into a special session last month to begin taking up cannabis reform legislation, stressed that establishing a commercial marijuana market would bring in needed tax revenue to support a variety of government programs.

The proposed amendment to the territory’s existing medical cannabis law, which Bryan signed last year, would allow adults 21 and older to obtain a license from the government in order to purchase and cultivate marijuana. It would also promote participation in the industry by small farmers and local businesses, as well as providing for automatic expungements of prior cannabis convictions.

“Most importantly, it creates a taxing regime for the local industry that will generate higher revenues than the current law allows,” he said in the speech last Monday, noting that tax revenue will be distributed between the Government Employees Retirement System (GERS) fund (75 percent), implementation of regulations (20 percent) and services for senior citizens (5 percent).

“The revenues generated from this industry can benefit the system as a direct contribution,” the governor said. “However, the goal is to create a funding stream that is reliable enough to ultimately support a revenue bond that can provide a needed cash infusion to the system.”

Watch Bryan’s marijuana comments, first reported by Vibe High, about 36:24 into the video below:

“This is by no means the panacea or final solution for the GERS crisis, but a small part of a larger solution,” he continued. “It begins the process of generating the new revenues required to stave off the insolvency of the System. It takes existing policy, approved by this body, and leverages it to support this critical area of need.”

“We must acknowledge the opportunities that regulated expansion of this industry can bring to the territory and the potential benefits to the GERS,” he said. “I urge this body to take the necessary action to approve the amending legislation we have proposed.”

Bryan’s proposal calls for a 30 percent tax on marijuana sales, with revenue expected to be upwards of $20 million annually. His administration is also expecting the policy change to stimulate tourism, and visitors interested in participating in the market would be charged a $10 per day fee to access legal cannabis.

If approved, that would make USVI the third U.S. territory to legalize cannabis for adult use—after Guam and the Commonwealth of the Northern Mariana Islands.

This year has seen several governors voice support for marijuana reform during their high-profile annual addresses and in legislative agendas. New York Gov. Andrew Cuomo (D) reaffirmed his commitment to legalization in his State of the State speech and Virginia Gov. Ralph Northam (D) pledged to pursue decriminalization, for example.

In New Mexico, the governor included legalization in her 2020 agenda, and lawmakers followed suit by filing a cannabis reform bill on Thursday. Rhode Island Gov. Gina Raimondo (D) proposed legalizing marijuana through a state-run model in a budget proposal released on Thursday.

Rhode Island Governor’s Budget Includes Legal Marijuana Sales In State-Run Stores

Photo courtesy of Nicholas C. Morton.

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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Tulsi Gabbard Endorses Legalizing Drugs

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Rep. Tulsi Gabbard (D-HI) is calling for the U.S. to legalize currently illicit drugs.

“If we take that step to legalize and regulate, then we’re no longer treating people who are struggling with substance addiction and abuse as criminals and instead getting them the help that they need,” the 2020 presidential candidate said at a campaign stop in Merrimack, New Hampshire on Friday.

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

Photo element courtesy of Lorie Shaull.

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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