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FDA Releases Guidelines On Cannabis Research Following White House Review

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The Food and Drug Administration (FDA) published draft guidance on developing cannabis-based drugs on Tuesday.

This comes weeks after the White House completed its review of the document, clearing its path for public release.

FDA is still in the process of developing regulations that could allow for CBD to be marketed as a food item or dietary supplement, but in the meantime it has worked to create these new research guidelines for drug manufacturing.

Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.”

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”

The chief legislative change she referenced is the 2018 Farm Bill, which federally legalized hemp and its derivatives such as CBD.

For researchers, that reform means they are no longer bound to certain restrictions that exist for marijuana. For example, FDA noted in the new document that as long as a manufacturer produces hemp products that meet the federal definition of containing no more than 0.3 percent THC, scientists can use that for studies rather that rely on the nation’s only federally authorized marijuana manufacturer at the University of Mississippi.

“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” FDA wrote.

Because excess THC concentrations could render hemp illicit under federal law, FDA dedicated a section to testing standards for hemp-derived products.

“Sponsors and investigators proposing drug development activities involving controlled substances should consult with [Drug Enforcement Administration] about the applicable requirements,” it said. “Sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product.”

“Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing,” it continued.

Applicants for an investigational new drug should submit information to FDA that includes “quantitative data, such as a certificate of analysis from a laboratory” on THC content and “detailed descriptions of testing methods used to evaluate the level of delta-9 THC.” They should also provide “quantitative data regarding phytochemicals that are present in their proposed product, including but not limited to, cannabinoids, terpenes, and flavonoids.”

“Many sponsors initiating clinical research for drugs containing cannabis and cannabis-derived compounds may be unclear regarding, or unfamiliar with, applicable drug quality expectations,” FDA said.

The agency discussed how calculating dry weight for hemp is unique in that it should be based on “the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.” It’s not clear if that standard would prove burdensome for hemp producers, but it is the case that many farmers have already complained about existing stringent THC testing policies under U.S. Department of Agriculture guidance.

The new FDA guidance gives a step-by-step overview of how to test for THC on a dry weight basis in a way that meets their standards.

“We recommend that you consult DEA regarding the control status of cannabis or cannabis-derived materials or products that are under development,” the document states. “We note that intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even if the starting materials meet the definition of hemp, may no longer meet the definition of hemp and may be considered a Schedule I controlled substance.”

“We invite comment from the public on this recommended approach,” the agency said in a Federal Register notice accompanying the new draft guidance. “In addition, FDA invites public comment on the appropriate manufacturing controls over materials that cross under the 0.3 percent delta-9 THC by dry weight threshold during the production of a drug that contains cannabis or cannabis derived compounds.”

A 60 day public comment period will be opened for stakeholders to weigh in on the proposed research guidelines. At the same time, the agency has a separate comment period indefinitely open for information on the safety and efficacy of CBD.

FDA stressed that guidance documents such as this one “do not establish legally enforceable responsibilities.”

“Instead,” it said, “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

The agency said researchers should take other non-cannabis-specific past guidance on the development of botanical drugs into account as well and laid out several other considerations.

“Cannabis is held to the same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product,” the guidance states. To that end, researchers should be doing things like chemical fingerprinting to ensure consistency and testing for residual pesticides. FDA also noted that any drug products that require a device like an inhaler fall under their own category with its own set of requirements.

Further, researchers should “consider selection of a container closure system carefully.”

The agency also emphasized that “a naturally occurring compound isolated from a botanical source would be expected to have a different impurity profile from the corresponding synthetically produced cannabis related compound, and impurities for the naturally occurring compound should be controlled accordingly” as opposed to “synthetic single-chemical active pharmaceutical ingredients.”

Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before FDA last year at a historic public hearing to share their perspectives on how to best approach regulating CBD.

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” the agency’s Abernethy said. “The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”

“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes—and one key element of this support involves development of guidance, like this one,” she said.

FDA also recently submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.

Also this month, a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”

Read FDA’s draft guidance on cannabis research below: 

FDA cannabis research guide… by Marijuana Moment on Scribd

Justice Department Demands Marijuana Documents From California Officials In Federal Court Filing

Photo courtesy of Philip Steffan.

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.

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Canada Will Let Terminally Ill Patients Use Psychedelic Mushrooms For End-Of-Life Care

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Four cancer patients in end-of-life care will be become the first people in decades to legally possess and consume psilocybin mushrooms in Canada after a landmark decision Tuesday by the country’s minister of health.

The patients petitioned Health Minister Patty Hajdu back in April for exemptions from the country’s laws against psilocybin in order to use psychedelic mushrooms as part of psychotherapy treatment. On Tuesday afternoon, Hajdu officially granted the patients’ request, the nonprofit TheraPsil, which assisted with the application, announced.

The approvals mark the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act to access psychedelic therapy, Therapsil said, and the first medical patients to legally use psilocybin since the compound became illegal in Canada in 1974.

“This is the positive result that is possible when good people show genuine compassion. I’m so grateful that I can move forward with the next step of healing,” one of the patients, Thomas Hartle, said in a statement Tuesday.

The applicants, as well as various advocates for psychedelic therapy, had personally appealed to Hajdu via a concerted social media campaign during the months their applications were pending.

“Health Canada is committed to carefully and thoroughly reviewing each request for an exemption under the Controlled Drugs and Substances Act, on a case-by-case basis, taking into account all relevant considerations, including evidence of potential benefits and risks or harms to the health and safety of Canadians,” a government spokesperson told Marijuana Moment in an email. “These exemptions do not change the fact that the sale and possession of magic mushrooms remain illegal in Canada.”

In statements issued Tuesday, other patients thanked Hajdu and said they were optimistic that more patients will one day have safe, legal access to psilocybin for therapeutic use.

“I want to thank the Health Minister and Health Canada for approving my request for psilocybin use. The acknowledgement of the pain and anxiety that I have been suffering with means a lot to me, and I am feeling quite emotional today as a result,” said Laurie Brooks, an applicant from British Columbia. “I hope this is just the beginning and that soon all Canadians will be able to access psilocybin, for therapeutic use, to help with the pain they are experiencing, without having to petition the government for months to gain permission.”

TheraPsil said on Tuesday that it expects more people to petition the government for exemptions following the first four patients’ approval. A separate request by the nonprofit to allow therapists to use psychedelics themselves in preparation for treating patients with psilocybin was not addressed in Tuesday’s announcement, the group said.

The government, in its statement to Marijuana Moment, said that the use of “magic mushrooms also comes with risks, including increased heart rate and blood pressure, flashbacks and bad trips that may lead to risk-taking behaviour, traumatic injuries and even death.”

All of the four patients who received the new exemptions have been diagnosed with untreatable cancer. Therapists who use psychedelics in their practices say that psilocybin-aided therapy sessions can help patients deal with issues such as depression and anxiety, allowing them to better accept death as a natural part of existence.

“At this point psilocybin is a reasonable medical choice for these individuals,” TheraPsil’s executive director, Spencer Hawkswell, told Marijuana Moment in an interview last month. “This is about the minister being compassionate and using her ministerial abilities to help give patients access to something that’s going to help them.”

The therapeutic potential of psychedelics has attracted attention in recent years from a growing number of academics, policy makers and even the U.S. government. In September of last year, Johns Hopkins University announced the launch of the nation’s first-ever psychedelic research center, a $17-million project to study whether psychedelics can treat conditions such as opioid use disorder, Alzheimer’s disease, depression, anxiety and post-traumatic stress disorder.

In June, the University of North Carolina (UNC) announced a $27 million project funded by the U.S. Department of Defense to research and develop an entirely new class of psychedelics-inspired drugs. The program, UNC said, “aims to create new medications to effectively and rapidly treat depression, anxiety, and substance abuse without major side effects.”

Meanwhile, activists in the United States have advocated for state- and local-level reforms to research, decriminalize and in some cases even legalize psychedelics.

In May 2019, Denver became the first U.S. city to enact such a reform, with voters approving a measure that effectively decriminalized psilocybin possession. Soon after, officials in Oakland, California, decriminalized possession of all plant- and fungi-based psychedelics. In January of this year, the City Council in Santa Cruz, California, voted to make the enforcement of laws against psychedelics among the city’s lowest enforcement priorities.

Reformers are pushing for similar changes in other jurisdictions. A proposal in Washington, D.C. would allow voters to decide this fall whether to decriminalize plant- and fungi-based psychedelic drugs, including psilocybin, ayahuasca and ibogaine. A decision on whether that initiative will make the ballot is expected later this week. In Oregon, voters in November will consider a measure that would decriminalize all drugs and expand access to treatment. A separate Oregon proposal would legalize psilocybin therapy—the same therapy sought by the Canadian cancer patients.

Lawmakers in Hawaii earlier this year approved a plan to study psilocybin mushrooms’ medical applications with the goal of eventually legalizing access.

This story was updated with comment from Health Canada.

Psychedelic Therapists Petition Government For Permission To Dose Themselves In Order To Better Treat Patients

Photo courtesy of Wikimedia/Mushroom Observer.

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Arizona Governor Slams Marijuana Legalization Ballot Measure In Voter Pamphlet Argument

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Ahead of what’s shaping up to be a contentious campaign season around marijuana in Arizona, Gov. Doug Ducey (R) and other opponents are claiming that legalization would unleash a host of public health hazards on the state.

In an official voter guide argument published on Monday against a proposed initiative that’s likely to be on the November ballot, the governor called legalizing cannabis “a bad idea based on false promises.”

“We know from states that have fully legalized marijuana that it has real consequences: more deaths on highways caused by high drivers, dramatic increases in teen drug use, and more newborns exposed to marijuana,” Ducey claimed in his comments.

It’s not yet certain whether the legalization proposal, from Smart and Safe Arizona, will make it to the ballot. County officials have until August 7 to validate hundreds of thousands of signatures submitted by activists last month. But on Monday afternoon, the Arizona secretary of state’s office published arguments submitted both for and against the measure, including a handful from elected officials.

The arguments, which will be printed and mailed to registered voters, give a taste of what’s to come during the mounting fight over legalization in the weeks leading up to Election Day.

As with politics in general in 2020, expect considerable disagreement over basic facts. For instance, Ducey’s argument that cannabis legalization has led to “dramatic increases in teen drug use” seems at odds with available evidence. Even according to legalization opponents, such as the federal government’s High Intensity Drug Trafficking Area (HIDTA) program, teen use rates have actually gone down since the end of prohibition for adults.

In a presentation last month to North Dakota lawmakers, who themselves are considering whether to legalize marijuana, the Colorado-based deputy coordinator of the federal National Marijuana Initiative acknowledged that data from government drug use surveys show that Colorado saw a general decline in the number of teens using marijuana after the state enacted legalization.

Another of Ducey’s claims, that Colorado has a particularly high rate of teen cannabis use compared to other states, is true. But his submission fails to mention that was also true during the years before legalization.

Ducey wasn’t the only official to argue that legalization would increase teen consumption in the new official ballot arguments pamphlet. State Sen. Sine Kerr (R) wrote that she was “deeply saddened by the prospect of how this initiative would harm children.”

“Kids would become easy prey for an industry hungry to create a new generation of users,” Kerr argued, noting that legal products would include vape pens and edible products such as gummies, cookies and candy, which she implied would appeal to children. (Gummy bears would be banned due to a provision forbidding animal-shaped products.)

“The industry will succeed in hooking too many of our kids and stealing their potential early,” she wrote.

Other common arguments against the proposal centered on the increased risk of impaired driving, fears of unbridled advertising by the commercial cannabis industry and economic impacts resulting from unmotivated employees or worker impairment.

“In Arizona, positive marijuana workplace tests have nearly tripled over the past eight years since legalization of medical marijuana,” wrote Yavapai County Attorney Sheila Polk, an outspoken cannabis opponent. “Workplaces with higher rates of drug use have employees that are less productive, suffer higher absenteeism, and have more accidents.”

Polk, whose office prosecutes cannabis cases, also downplayed the impact that legalization would have on the criminal justice system.

“As for their argument that legalizing recreational pot will empty our prisons? Not a single state has seen a reduction in prison population because of legalization,” she argued. “This is because, contrary to the myth, our prisons are not filled with people serving time for marijuana possession.”

Legalization supporters, however, point to Polk’s own office as a reason to reform marijuana laws. In recent years, Polk famously filed felony charges against a black medical cannabis patient for possessing a small amount of marijuana concentrate purchased legally from a dispensary. Critics accused Polk’s office of exhibiting racial bias in the case.

Advocates for the proposed legalization measure, meanwhile, said in ballot arguments that the initiative takes a relatively measured, sensible approach by taxing and regulating marijuana rather than handling it as a criminal matter.

“The war on drugs failed,” wrote Chad Campbell, chair of Smart and Safe Arizona, the organization behind the proposed ballot measure. “Marijuana is safest when it’s sold in a taxed, tested and regulated environment—not on a street corner.”

The campaign says legalization will also bring in at least $300 million in tax revenue that can be used to support things like education, public health, infrastructure and safety. Penalties for driving under the influence of marijuana would go up under the proposal, and millions of dollars in funding would be funneled toward drug treatment and mental health programs.

As for youth use, organizers argue, “we know a well-regulated, licensed, legal environment is the best way to keep marijuana out of the hands of children—period. We set the legal age at 21, limited potency, required childproofed packaging, required products to be unattractive to kids and forbade advertising to youth.”

The state’s voters narrowly defeated a legalization measure in 2016, but a poll released last month indicates the current initiative is on the path to being approved. The survey found that more than 6 in 10 Arizona voters saying they support legalizing marijuana.

Another supporter, former Gov. Fife Symington (R), who served from 1991 to 1997, wrote in his argument that voters “must constantly re-evaluate our policies in the face of new evidence.”

“Today the evidence is overwhelmingly clear: criminalizing law-abiding citizens who choose to responsibly consume marijuana is an outdated policy that wastes precious government resources and unnecessarily restricts individual liberty,” he said. “A far more logical approach would be to respect the rights of adults to choose to consume marijuana while taxing and regulating its production and sale.”

The proposal imposes significant penalties for selling marijuana products to minors, Symington wrote, allows law enforcement to target drivers who demonstrate impairment and allows employers to maintain a drug-free workplace.

“Finally, and perhaps more importantly,” he wrote, “it frees up law enforcement to deal with more serious issues that actually jeopardize public safety.”

Perhaps the most balanced ballot argument submitted over the measure came from Will Humble, executive director of the Arizona Public Health Association, who said the proposition “poses public health risks and benefits.” Humble‘s statement, which identifies what he said are both risks and benefits of legalization, is printed twice—once alongside ballot arguments against legalization, and again next to arguments in support of it.

One one hand, Humble argued, ending felony charges for cannabis possession would reduce mental, physical and economic impacts for individuals and families. “Incarceration and felony convictions for marijuana offenses have multigenerational social, economic, and health impacts that have been disproportionately thrust on communities of color,” Humble wrote, “because they are more likely to be arrested for and convicted of marijuana offenses.”

Humble noted the measure also includes provisions to regulate and test cannabis products, support evidence-based public health programs and prevent sales to minors—although he acknowledged those efforts won’t eliminate all risks, which he said include “impaired neurological development from use in adolescence, increased visits to emergency rooms from marijuana intoxication or accidental ingestion by children, adverse birth outcomes from maternal use, and injuries caused by impaired driving or workplace use.”

Humble argued that if voters choose to pass the measure, regulators should be prepared to take the new legal sector seriously.

“If the Act passes,” he wrote, “we urge the state to use its full regulatory authority to enforce purchasing age-limits, packaging and potency standards, regulate advertising and place of use restrictions, enact workplace use policy requirements, and solidify motor vehicle operation restrictions and penalties. Arizona officials should also partner with state universities to analyze and publish data on its public health impacts.”

Read the arguments for and against the Arizona legal marijuana measure below:

Arizona Marijuana Legalizat… by Marijuana Moment on Scribd

Louisiana Law Allowing Medical Marijuana For Any Debilitating Condition To Take Effect

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McConnell Slams Pelosi Over Claim Marijuana Is A ‘Proven’ Therapy Amid Coronavirus Debate

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Senate Majority Leader Mitch McConnell (R-KY) took a shot at House Speaker Nancy Pelosi (D-CA) on Tuesday, criticizing recent comments she made defending marijuana provisions that were included in her chamber’s latest coronavirus relief legislation.

The majority leader, who has consistently railed against the inclusion of cannabis banking protections in the House COVID-19 bill, said on the Senate floor that Pelosi is “still agitating for strange, new special interest carve-outs for the marijuana industry and even claiming they are COVID-related.”

“She said that, with respect to this virus, marijuana is ‘a therapy that has proven successful.’ You can’t make this up,” he said.

“I hope she shares her breakthrough with Dr. Fauci,” McConnell wryly added, referring to National Institute of Allergy and Infectious Diseases Director Anthony Fauci, who has been helping to lead the White House Coronavirus Task Force.

McConnell is referring to remarks Pelosi made last week after she was asked about components of the House Democrats’ bill that Republicans have criticized as not germane, including specifically the marijuana language.

The speaker said she took issue with the suggestion that cannabis banking reform was not relevant amid the pandemic and said marijuana “is a therapy that has proven successful.” Prohibitionists have seized on that comment, interpreting it to mean that Pelosi believes cannabis can treat COVID-19.

That said, it wasn’t clear from the brief comment whether that was the case or if Pelosi was broadly referring to the therapeutic benefits of marijuana.

The Food and Drug Administration has made clear that there’s currently no solid evidence that cannabinoids can treat COVID-19 and it’s warned companies that make that claim.

Marijuana Moment previously exclusively reported that Pelosi—who said in 2018 that doctors should prescribe medical cannabis and yoga more often instead of prescription opioids—supported attaching the banking language to the House’s coronavirus package prior to the legislation’s introduction.

Senate leadership unveiled their latest round of coronavirus relief legislation last week, and it does not include the cannabis provisions. And given McConnell’s particular focus on those components, it seems likely that any attempt to get the language inserted in a bicameral conference will be met with resistance on the Senate side.

House Minority Leader Kevin McCarthy (R-CA) also recently slammed Pelosi’s latest cannabis comments on Twitter, saying “let’s focus on the pandemic. Not pot.”

Meanwhile, the standalone Secure and Fair Enforcement (SAFE) Banking Act has continued to sit in the Senate Banking Committee without action in the months since the House initially approved it.

Last month, a bipartisan coalition of state treasurers sent a letter to congressional leaders, asking that they include marijuana banking protections in the next piece of coronavirus relief legislation.

In May, a bipartisan coalition of 34 state attorneys general similarly wrote to Congress to urge the passage of COVD-19 legislation containing cannabis banking provisions.

McConnell’s latest comments also come a week after the House approved an amendment to protect state, territory and tribal marijuana laws from federal interference.

Top House Democrat Talks Marijuana Reform With Major Cannabis Company

Photo courtesy of Senate Majority Leader Mitch McConnell.

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