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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

California Governor Says Marijuana Legalization Is A ‘Civil Rights’ Matter Amid Mass Protests Over Racial Injustice

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The governor of California discussed systemic racism and injustice that is inspiring mass protests across the country in a Friday speech, and he touted the state’s legalization of marijuana as an example of how it has addressed racial disparities in the criminal justice system.

Gov. Gavin Newsom (D) said at a press conference that he’s “very proud of this state” for going beyond issues such as implicit bias in policing and the “deadly use of force.” California’s leadership helped advance “a conversation about broader criminal justice reform to address the issues of the war on drugs” and “race-based sentencing,” he said.

“That’s why the state was one of the early adopters of a new approach as it relates to cannabis reform. Legalization around adult-use of marijuana,” he said. “It was a civil rights call from our perspective.”

“I was proud to be out in front in those efforts,” he added. “It was about addressing the disparities. It was about addressing incarceration. It was about addressing the ills of this war on drugs.”

Newsom also discussed the racially discriminatory sentencing of crack versus powder cocaine and other mandatory minimum sentencing policies. While the federal disparity was reduced over time since Congress passed the sentencing provision—a policy presumptive Democratic presidential nominee Joe Biden helped enacted during his time in the Senate and later sought to undo—California eliminated the distinction in terms of state sentencing in 2014.

Even so, the governor recognized that the reforms the state has enacted to date are “not enough” and more work needs to be done. He’s also not alone in drawing a connection between drug policy reform and racial justice.

Earlier this week, the governor of Virginia said that the passage of marijuana decriminalization legislation this year represents an example of how his state has addressed racial inequities that are inspiring mass protests over recent police killings of black Americans such as George Floyd and Breonna Taylor.

Sen. Cory Booker (D-NJ) also recently said racial disparities in marijuana criminalization is an example of a systemic injustice that underlies the frustration of minority communities.

Last week, 12 House members introduced a resolution condemning police brutality and specifically noting the racial injustices of the war on drugs. It now has 160 cosponsors.

The measure came one week after 44 members of the House sent a letter to the Justice Department, calling for an independent investigation into a fatal police shooting of Taylor in a botched drug raid.

In New York, there’s a renewed push to pass a package of criminal justice reform legislation that includes a bill to legalize marijuana. Sen. Julia Salazar (D) told Marijuana Moment that “in this particular moment, I think what’s the important factor here is that [criminalization] disproportionately impacts black and brown New Yorkers.”

“Because of the criminalization of the use of marijuana, more black and brown New Yorkers have interactions with police than they need to,” she said. “More people end up in the criminal justice system in the first place than is necessary at all.”

New Jersey Lawmakers File Marijuana Decriminalization Bill Ahead Of Broader Legalization Referendum

Image element courtesy of Gage Skidmore.

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American Bar Association Says Firms Working ‘Indirectly’ With Marijuana Industry Should Get COVID Relief

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The American Bar Association (ABA) sent a letter to the heads of the Treasury Department and Small Business Administration (SBA) on Friday, urging them to end a current policy preventing law firms that service state-legal marijuana businesses from receiving federal coronavirus relief.

SBA has made clear that cannabis companies are ineligible for its Paycheck Protection Program (PPP) loans—but its policy also bars those that work with marijuana businesses indirectly from getting the aid. ABA, which has nearly 200,000 dues-paying members, said it wants clarification or a formal policy change to make it so indirect businesses are not impacted.

“The ABA supports amending federal law to ensure that lawyers do not face the threat of criminal charges when they represent clients in states that have legalized marijuana,” the organization said. “Even before those changes are made to federal law, lawyers should also not be penalized for providing legal services to cannabis-related businesses that comply with state laws.”

ABA also argued that the policy is excessively broad in that it stipulates that companies that derive any revenue from servicing a cannabis business cannot receive relief during the pandemic. “Thus, a law firm where a single lawyer provided advice to a single marijuana business client on legal issues for a nominal fee would arguably be ineligible under this language for the SBA PPP loan program,” the organization wrote.

ABA’s letter further notes that 78 percent of firms are located in states where marijuana is legal in some form.

“We urge SBA to provide further guidance that it will not treat otherwise eligible businesses, including law firms, as disqualified from the PPP program based solely on having provided legal, financial/accounting, policy, or regulatory advice to a Direct Marijuana Business,” Judy Perry Martinez, ABA’s president, wrote.

Steve Fox, strategic advisor at the Cannabis Trade Federation, told Marijuana Moment that it’s “wonderful to see an organization with the reputation and stature of the ABA engage on this issue.”

“As they note, the SBA guidance is overly broad and unjustly punishes companies and firms all across the country. In fact, in some states, the cannabis industry is so ingrained in the economy, you have many hundreds of companies providing goods or services to cannabis businesses,” he said. “According to the plain language of the SBA guidance, they are all, with very minor exceptions, ineligible for PPP loans.”

“We stand with the ABA in urging the Treasury and Small Business Administration to issue further guidance, clarifying that ‘indirect marijuana businesses’ are eligible for PPP loans. If they fail to do so, Congress should remedy this situation at the earliest possible opportunity,” he added.

In February, ABA’s House of Delegates voted in favor of proposals endorsing pending federal legislation to protect banks that service cannabis businesses and calling for a clarification of rules to ensure that lawyers will not be penalized for representing clients in cases concerning state-legal marijuana activity.

Rep. Earl Blumenauer (D-OR) introduced a bill last month that would fix the COVID-19 relief access problem, calling for SBA eligibility for cannabis businesses and ancillary companies. That came after he led a letter with 34 bipartisan members of the House urging leadership to include the policy change in future coronavirus-related bills.

Sens. Jacky Rosen (D-NV) and Ron Wyden (D-OR) made a similar request to Senate leaders in a separate letter.

Separately, the ABA-supported Secure and Fair Enforcement (SAFE) Banking Act was included in a House-passed COVID-19 relief package last month.

A bipartisan coalition of 34 state and territory attorneys general asked Congress to pass the bill with that language, which would protect banks that service marijuana businesses from being penalized by federal regulators.

The head of the Federal Deposit Insurance Corporation said this week that marijuana business banking represents one of the most “challenging issues that I have encountered” at the agency.

Read ABA’s letter to the Treasury and SBA below: 

ABA letter to SBA on PPP by Marijuana Moment on Scribd

Federal Financial Regulatory Agency Head Says Marijuana Banking Among Most Challenging Issues

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Bermuda Government Releases Marijuana Legalization Bill For Public Feedback

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The government of Bermuda released a draft bill on Wednesday to establish a legal marijuana market in the self-governing British overseas territory.

“Surprising for some, public attitudes have evolved apace with global legislative reforms and in recognition that opening up pathways for new economic opportunities and activity is needed,” Attorney General Kathy Simmons said in a video on the proposal.

Under the proposed legislation, adults 21 and older would be able to possess and purchase up to seven grams of cannabis from licensed retailers.

A regulatory body called the Cannabis Advisory Authority would be responsible for issuing licenses and regulating the market. There would be seven types of licenses available: cultivation, retail, research, import, export, transportation and manufacturing.

Individuals with prior marijuana convictions would not be barred from participating in the industry.

Fees for the licenses would be set in a way designed to both stimulate the territory’s economy while also ensuring that they are not prohibitively expensive for “underserved and marginalized communities,” a summary of the bill states.

People with convictions for possessing seven grams or less would be eligible for expungement.

Last year, Bermudan lawmakers unveiled draft legislation to create a medical cannabis program. Public feedback signaled that people felt the bill imposed excessive regulations and that the territory should more broadly legalize marijuana altogether for adult use.

Now that this new draft legislation has been released, the government is again asking for public input up until July 3. On its site, individuals are prompted with seven specific questions that feedback is being sought on. That includes queries about licensing requirements and penalties.

Premier David Burt, who pledged last year to introduce marijuana legalization legislation, also encouraged individuals to weigh in on the proposed regulations.

“The Government has made a commitment to progressively liberalize cannabis laws in Bermuda and to create economic opportunities for citizens wishing to participate in a regulated cannabis scheme,” the site states. “The Government again wishes to ‘take it to the people’ by commencing a one month public consultation exercise on the proposed scheme.”

The attorney general said in her video that the government plans to “move ahead with a more simplified, regulated cannabis scheme, which builds on the strength of the original medicinal cannabis policy and which embraces the public feedback.”

“The revised proposal with provide for a regulated cannabis program which has been hybridized to meet Bermuda’s requirements while modeling the best available legal provisions in Canada, both provincial and federal, and to a lesser degree, examples from the Caribbean,” she said.

Several Caribbean nations have started exploring marijuana reform in recent years. Importantly, in 2018, the heads of 19 Caribbean nations agreed to “review marijuana’s current status with a view to reclassification,” emphasizing “human and religious rights” issues stemming from criminalization as well as “the economic benefits to be derived” from legalization.

Since then, lawmakers in the dual-island nation of St. Kitts and Nevis said they would be introducing legalization legislation. The government of Trinidad and Tobago brought two cannabis reform bills before Parliament last year—one to decriminalize low-level possession and another to legalize cannabis for medical and religious purposes.

Meanwhile, the governor of the U.S. Virgin Islands has been stressing the need to legalize marijuana in order to generate tax revenue for the U.S. territory’s fiscal recovery from the coronavirus pandemic.

The Jamaican government also recently announced that it will be allowing medical cannabis patients to make marijuana purchases online for pickup at “herb houses” as a means to combat the coronavirus pandemic.

Read the draft bill to legalize marijuana in Bermuda below:

Bermuda marijuana legalizat… by Marijuana Moment on Scribd

U.S. Virgin Islands Governor Touts Legal Marijuana’s Economic Potential At Revenue Meeting

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