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Ohio State University Gets DEA License To Grow Psilocybin
Ohio State University and research partner Inner State have received the DEA’s first license to cultivate whole psilocybin mushrooms.
The U.S. Drug Enforcement Administration has issued a license to Ohio State University that allows researchers to cultivate psilocybin mushrooms for use in scientific studies. The license, which was awarded to Ohio State and partner Inner State Inc., a mental health and wellness research and development company, is the first license issued by the DEA for the cultivation of whole psilocybin mushrooms for research.
“This license is a major milestone not only for Inner State and Ohio State, but for the entire field of psychedelic research,” Inner State CEO Ashley Walsh said on Wednesday in a statement quoted by the Columbus Dispatch.
Multiple studies have shown that psilocybin, the primary psychoactive compound in magic mushrooms, may have extraordinary potential as a treatment for several serious mental health conditions. But studies of psilocybin normally use forms of the drug that have been synthesized in a laboratory. The new license issued by the DEA allows Ohio State and Inner State to grow whole psilocybin mushrooms to produce the compound naturally. Under the terms of the license, all cultivation of psilocybin mushrooms will take place in a federally registered facility in accordance with strict DEA regulations.
“By combining cutting-edge techniques in genomics and metabolomics, we have the opportunity to obtain a high-resolution picture of the chemical diversity of mushrooms that have remained difficult to study for several decades,” said Ohio State researchers Dr. Jason Slot and Dr. Kou-San Ju.
Researchers believe that using whole mushrooms in mental health studies could give participants the advantage of other compounds besides psilocybin, potentially offering additional therapeutic benefits. Walsh said that it is possible that psilocybin mushrooms “have multi-dimensional healing properties” that could more effectively improve the quality of life for people with severe mental illness.
Continuing research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. A study published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. Separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.
In 2017, the U.S. Food and Drug Administration designated MDMA as a breakthrough therapy for PTSD, a move that streamlined clinical trials to test the effectiveness of the drug. The following year, the FDA granted the same status to psilocybin as a breakthrough therapy for treatment-resistant depression.
Alan Davis serves as the director of the Center for Psychedelic Drug Research and Education in the College of Social Work at Ohio State University, which he launched last year with the assistance of a private donation of $1.5 million. The center has developed a 25-hour continuing education program and an undergraduate minor in psychedelic studies. In January, the center launched its first clinical trial to explore the use of psilocybin as a treatment for military veterans diagnosed with PTSD.
“Currently, there have been clinical trials completed for people with addiction, depression, PTSD, obsessive-compulsive disorder, social anxiety [and] end-of-life distress in patients who are terminally ill,” Davis told Columbus Monthly earlier this year. “All of those studies so far have shown really promising effects.”
The ongoing research suggests that treatment with psychedelics such as psilocybin, when combined with psychotherapy, can “reduce and, for some, ameliorate, the mental health problems that they are dealing with,” Davis said. “With some studies, they’ve seen that those positive effects can last six to 12 months.”
Other universities are also studying the therapeutic value of psilocybin and other psychedelics, but Davis says Ohio State is the first to create such a center in a social work setting. He added that educating professionals with social work degrees is essential because they are the biggest part of the workforce dealing directly with patients in a clinical setting.
“Usually, the only message that’s been out there is, ‘drugs are bad, drugs are dangerous, don’t do drugs,’” Davis said. “This is meant to provide that foundational knowledge for people so that they can understand all the interdisciplinary work that’s been done about psychedelics.”
Slot believes that we can learn a lot from mushrooms, noting that government prohibition has hindered study and set back researchers decades during an era of significant advancement in the biological sciences, especially genetics. He hopes that recent efforts to destigmatize psychedelics are successful so that the research can continue to advance.
“I don’t think psychedelics are going away. They get at the nature of consciousness, of the relationship between the mind and the body,” said Slot. “These are questions fundamental to our nature.”
Source: https://hightimes.com/news/ohio-state-university-gets-dea-license-to-grow-psilocybin/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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