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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

Scientists Sue DEA Over Alleged ‘Secret’ Document That Delayed Marijuana Research Expansion

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The Drug Enforcement Administration (DEA) is finding itself in court over marijuana again after scientists filed a lawsuit against the agency, requesting “secret” documents that they allege DEA used to delay action on expanding cannabis research.

The Scottsdale Research Institute (SRI) is behind the suit. It’s one of more than 30 organizations that have submitted applications to DEA to become licensed cannabis manufacturers for research purposes.

Some background should be noted: In 2016, DEA announced it would expand marijuana research by approving additional growers beyond the sole source that has existed for half a century at the University of Mississippi. But after more than three years, applicants heard silence, and SRI filed an initial lawsuit alleging that the agency was deliberately holding up the process. A court mandated that it take steps to make good on its promise, and that case was dropped after DEA provided a status update.

This month, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party. A public comment period is now open, after which point the agency says it will finally approve an unspecified number of additional growers.

But what really accounted for the delay?

According to the plaintiffs in this new suit, after DEA said it would accept more cultivators, the Justice Department’s Office of Legal Counsel (OLC) secretly issued an opinion that interprets international treaty obligations as making it impossible to carry out the 2016 proposed rule while maintaining compliance.

The new revised rule aims to address the problem, in part by shifting jurisdiction over the cannabis to a single agency, DEA, which would purchase and technically own all of the cannabis grown by approved cultivators, and would then later sell the product directly to researchers.

That OLC document, which is not public, is the basis of SRI’s Freedom of Information Act (FOIA) complaint. The case was filed with the U.S. District Court for the District of Arizona on Wednesday and requests that the Justice Department be found guilty of unlawfully failing to make records available related to its interpretation of the Single Convention treaty, including the OLC opinion. It further states that DEA should release those documents and pay the plaintiff’s attorney fees.

Matt Zorn, an attorney working the case, told Marijuana Moment in a phone interview that it’s not clear what’s contained in the OLC opinion and that the uncertainty is “entirely the point” of the suit.

“I think we all know vaguely what it says—the subject matter of it—but we don’t know what it actually says,” he said. “That’s important because you need to know what that instruction was or what their interpretation of the law is to assess whether what they’re doing now is appropriate.”

The suit claims that SRI, “as a non-commercial company dedicated to advancing the state of medical care through clinical research, is directly harmed by this unlawful secrecy.”

“Because Defendants have failed to fully disclose their re-interpretation of federal law and treaty obligations as the law requires, Plaintiff lacks information necessary to protect its legal rights, including the right to have its application to manufacture marijuana for research processed in compliance with the Administrative Procedure Act and the [Controlled Substances Act],” the filing states.

SRI’s research objective for cannabis is to determine potential therapeutic benefits for veterans suffering from conditions such as post-traumatic stress disorder. “While DEA’s unlawful and dilatory conduct harms the public generally, the secrecy and delay have been especially harmful to our nations’ veterans,” the suit says.

“We deserve not only to know the scientific truth about medical marijuana use, but candor from our government, which includes disclosure of the ‘secret law’ the agency continues to rely on as a basis to delay and ultimately revamp the process for researching and manufacturing marijuana in this country,” the filing says. “Plaintiff brings this FOIA action so can understand the legal basis—if there is one—for the government’s conduct surrounding the Growers Program.”

While SRI acknowledged that DEA last week announced its revised rule change proposal, the suit states that the explanation about how it arrived at its determination “leaves Plaintiff and the public in the dark with respect to several critical considerations.” For example, it alleges, the notice doesn’t account for how the Justice Department advised the agency on the matter and which parts of the amended proposal would make the action compliant with international treaties.

“The answer to these questions and others presumably lies in the undisclosed OLC Opinion and related records that animated DOJ’s decision to sideline the Growers Program and prompted DEA to embark on this notice-and-comment rulemaking in the first place… In sum, using a secret OLC Opinion interpreting the CSA and a 1961 international treaty, DEA delayed processing applications to cultivate marijuana for research and now proposes to radically revamp federal law through rulemaking—rules which will loom large over the future of medical marijuana research, manufacture, and distribution going forward.”

The plaintiffs argue that DEA violated federal statute that prohibits the creation of a “secret law.” The statute says that federal agencies must make records—including final opinions and policy interpretations not published in the Federal Register—public.

“To block the Growers Program, DOJ formulated—through the OLC Opinion and related records—and DEA adopted to an undisclosed interpretation of the Single Convention and federal law contrary to the view espoused and published by DEA in the August 2016 Policy Statement, and contrary to the view of the State Department,” it continues, apparently referencing a letter the State Department sent to a senator in response to questions about the role of international treaties as it concerns expanding cannabis cultivation facilities.

In that letter, the department said nothing about the Single Convention prevents member nations from increasing the number of such facilities. “If a party to the Single Convention issued multiple licenses for the cultivation of cannabis for medical and scientific purposes, that fact alone would not be a sufficient basis to conclude that the party was acting in contravention of the Convention,” it read.

Read the State Department’s responses on international treaties and marijuana below:

State Dept Response on Single Convention by Marijuana Moment on Scribd

If the new lawsuit’s allegations prove accurate, it could help explain the role of former Attorney General Jeff Sessions, the anti-marijuana official who was reportedly involved in blocking research expansion.

The suit, which was first reported by Politico, goes on to say:

“For more than three years, Defendants relied on this undisclosed interpretation, contained in the OLC Opinion and related records, to make an end-run around the Administrative Procedure Act by unlawfully withholding and unreasonably delaying agency action on marijuana cultivation applications. The OLC Opinion has guided DEA’s actions—and its inaction… The government’s unlawful conduct under FOIA prevents Plaintiff and those similarly situated from timely and effectively vindicating legal rights under the Administrative Procedure Act, effectively rendering its protections and judicial review provisions meaningless.”

To resolve the issue, SRI said it wants DEA to be held accountable for violating federal law, release the documents and compensate them for the legal action. While this is a FOIA-related suit, the institute didn’t first seek the documents through a standard document request but instead filed the case under the law’s “Reading Room provision” that allows courts to force federal agencies to put records online, according to a Ninth Circuit ruling last year.

Sue Sisley, a researcher with SRI, told Marijuana Moment that the institute has generally had a good relationship with DEA over the years and doesn’t expect that it would unduly deny their application in retaliation for the institute’s repeated legal actions against the agency.

“I couldn’t fathom that that would happen, but I hope that the merits of our application are so clear that it would carry us forward,” she said. However, these licensing agreements are “not always a merit-based process so it is possible that if politics get deeply involved here that there could be a situation where licenses are awarded to friends of the government. We’re still praying that there is some merit-based system.”

Researchers and lawmakers have made clear that the current availability of federally authorized cannabis for research raises questions about the accuracy of tests that rely on it, as the quality is insufficient. As of now, there’s only one facility at the University of Mississippi that’s authorized to grow cannabis for researchers. The products developed at the university have been widely criticized by scientists and lawmakers. A study indicated that the facility’s cannabis is chemically more similar to hemp than marijuana available in state-legal markets.

“If adopted, these proposed rules would radically overhaul how medical marijuana manufacture and research will proceed in this country,” the plaintiffs wrote. “Better supply is needed for better research, and better research is needed not only because millions use medical marijuana every day, but also to facilitate informed policymaking at the federal and state levels, including legislation and drug scheduling decisions.”

Read the full lawsuit against DEA below:

SRI FOIA Complaint by Marijuana Moment on Scribd

Federal Agency Touts Hemp Progress While Refusing To Serve Marijuana Businesses

Photo courtesy of Mike Latimer.

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First Legal Marijuana Home Deliveries Begin In Colorado

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For the first time, people in Colorado will be able to legally have marijuana products delivered directly to their homes starting on Friday.

The launch of the limited program focused on medical cannabis patients comes one week after the dispensary chain Native Roots announced that its Boulder location The Dandelion had received the state’s first marijuana delivery license. And while the license wasn’t related to the coronavirus outbreak, the timing is opportune, as officials have increasingly cautioned against leaving home to avoid catching or spreading the virus.

The delivery service will be limited to patients living in either Boulder or Superior. They must also be registered with the dispensary, and those who are not already signed up must do so in-person for the time being—though Native Roots said it is “looking into a compliant, remote solution for patient registration.”

Native Roots said there is a $100 minimum purchase, and they’re encouraging patients to pay with a debit card rather than cash, presumably because drivers could be targets of burglaries if they’re transporting large amounts of cash or because of concerns that money changing hands could further the spread of COVID-19.

Cannabis delivery services are a new feature of Colorado’s legal marijuana program. Gov. Jared Polis (D) signed legislation last year allowing the option, though individuals jurisdictions must proactively opt-in, so as of now that number of cities permitting deliveries is limited. Native Roots said it’s been engaging with local governments about the issue for months.

Deliveries for recreational cannabis consumers won’t begin until January 2021 under the law.

As more businesses shutter as a result of the pandemic, there’s growing demand for alternative means of obtaining marijuana products, and several states have taken steps to address that concern by encouraging deliveries and curbside pickup, for example.

For patients and reform advocates, that represents an ideal solution compared to closing dispensaries altogether. Numerous legal states have categorized cannabis shops as essential services that are exempt from mandates to close down. And according to a poll released this week, a majority of Americans agree with that decision.

But while the market remains largely operational in the midst of this health crisis, reform advocates across the U.S. are feeling the impact and struggling to continue campaign activities, including in-person signature gathering.

Campaigns to change state marijuana programs, legalize psilocybin mushrooms, legalize psilocybin for therapeutic purposes, legalize medical and recreational cannabis, decriminalize psychedelics and broadly decriminalize drug possession have all faced challenges amid the pandemic, and several have implored officials to allow electronic signature gathering to overcome the barrier.

An exception to this appears to be Arizona, where activists recently said they’ve collected more than enough signatures at this point to qualify for the state’s November ballot.

Arizona Marijuana Activists Have More Than Enough Signatures To Put Legalization On Ballot, They Say

Photo courtesy of Philip Steffan.

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Federal Agency Touts Hemp Progress While Refusing To Serve Marijuana Businesses

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The federal Small Business Administration (SBA) is celebrating the potential of hemp and is urging federal regulators to address concerns from farmers before rules for the crop are finalized. At the same time, however, it is maintaining that it cannot service marijuana businesses due to ongoing federal prohibition.

In a blog post published on Tuesday, SBA’s Office of Advocacy described the wide range of uses for hemp, including rope and CBD oil, and detailed the crop’s evolution from a federally controlled substance to an agricultural commodity that was legalized through the 2018 Farm Bill.

“From rope to clothing, biodiesel to hempcrete, plant-based ingestible protein to CBD balm, the uses of hemp are far-reaching.”

The U.S. Department of Agriculture (USDA) now has jurisdiction over the plant, and it released an interim final rule last year outlining guidelines for a domestic hemp program. In the time since the crop’s legalization, SBA says it has “embarked on an ambitious and lengthy outreach effort to hear from small businesses” and heard feedback from farmers about how USDA’s proposed rules could impact their operations.

“Advocacy staff were first introduced to the concerns that many other producers would later echo” during those outreach events, the post states. “Advocacy also learned about the concerns that educational institutions have with the program, and the wide reach the rule would have if left as-is without modification.”

During a trip to a Virginia hemp farm, for example, the agency “learned about the various non-CBD uses for hemp, and that the rule as written would stifle the ability of small producers to grow for purposes other than manufacturing CBD products.”

“The one commonality that all stakeholders expressed was the ‘chilling’ effect the rule would have on the hemp industry.”

SBA also hosted its own forum on hemp issues in Pennsylvania “where concerns were raised about the length of time between testing and harvest, especially for those growers that do not use technology, such as Amish communities,” the agency reported.

To address such issues, SBA was one of numerous organization to submit feedback on USDA’s interim final rule during a public comment period. In its letter, the agency identified several potentially problematic provisions of the proposed rule, including the THC testing window, maximum THC limit and restricted authorized testing methods.

USDA took much of that feedback and announced last month that it would temporarily suspend enforcement of certain policies, including the requirement that test be conducted by Drug Enforcement Administration-registered labs. However, it said it couldn’t make other changes such as raising the THC threshold because that it a statutory matter that must be resolved by Congress.

“At this stage, Advocacy and the regulated community are eagerly awaiting further action from the agency including additional guidance, and the publication of a final rule by fall of 2021,” SBA said in the new blog post. “The hemp community is hopeful that the agency will consider some key modifications to the rule so that hemp can blossom into a successful industry.”

While SBA evidently is standing strong with the legal hemp industry, cannabis reform advocates have expressed frustration that the agency’s services—particularly concerning disaster relief loans—are unavailable to marijuana businesses who might be in need of additional support amid the coronavirus outbreak.

SBA confirmed in tweet and a statement this week that it cannot provide those services so long as marijuana remains a federally controlled substance, unlike hemp.

Americans Want Medical Marijuana Dispensaries To Stay Open As ‘Essential Services,’ Poll Finds

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