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Non-profit Organization Marches on Canadian Capital To Fight for Therapeutic Mushrooms

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Due to the current limitations on psilocybin and psilocin, TheraPsil is in the Canadian capital of Ottawa petitioning for improved access to mushrooms.

Over the course of the past two years, TheraPsil has assisted over 130 patients, but it calls the country’s current limitations a “cruel approach” on the part of Health Canada. The organization has attempted to set up a formal meeting with parliament members, but so far has been denied, so it’s taking the conversation straight to the capital to protest between Nov. 28-30.

According to TheraPsil CEO Spencer Hawkswell, there needs to be a proper channel for patients to be able to legally access psilocybin and psilocin. “There is ample evidence of both the safety and efficacy of psilocybin in the treatment of various mental health conditions,” said Hawkswell in a press release. “The previous Minister recognized this and started approving exemptions. Unfortunately, this Minister has stopped and refused to consider reasonable regulations to ensure vulnerable Canadians don’t have to go to Court to access treatment that can improve their quality of life and death.”

Currently, psilocybin and psilocin are listed as a Schedule III substance under the Controlled Drugs and Substances Act. However, some patients gain legal access with an improved exemption called the Special Access Program

TheraPsil uses the example of Thomas Hartle, who was diagnosed with cancer in 2016, to demonstrate the problems that patients are encountering. Hartle was one of the first to receive approval from former Health Minister Patty Hajdu to use psilocybin to treat “end-of-life anxiety” in 2020, which was valid for one year. His treatments were successful, and he reapplied for continued access in October 2021, but was denied by current Health Minister Jean-Yves Duclos.

“We hope to meet with the Minister to find out why he and his officials are being so cruel to us,” said Hartle in a press statement. “Instead of a compassionate response, Health Canada is referring dying and vulnerable patients to a special access program that results in lots of red tape but no access for most. Many, like me have gone over a year without a response to their urgent requests.”

TheraPsil will be arranging media interviews over the next few days to raise awareness both for the medical benefits that psilocybin offers, as well as the need for improved access. “Mental health is a non-partisan issue,” said palliative care physician Dr. Valorie Masuda. “Reasonable treatment options should be available to Canadians who have the right to MAiD [Medical Assistance in Dying]. It is cruel to withhold medicine from vulnerable patients, especially when those medicines have worked for them.”

TheraPsil also sent a joint letter earlier this month signed by medical practitioners and social workers calling for the need for psilocybin regulations. “We believe that our patients have a right to Medical Psilocybin and this open letter is to demand this right on their behalf. We need a compassionate and immediate response and solution to the Section 56 applications for psilocybin access and seek your response to our proposed request for ‘Access to Psilocybin for Medical Purposes Regulations,’” the letter stated.

Meanwhile in Canada, Apex Labs received a “no objection” letter from Health Canada, which effectively greenlit the first North American study on psilocybin as a treatment for military veterans who suffer from conditions such as depression and post-traumatic stress disorder. “Veterans are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming,” said Apex Labs CEO Tyler Powell. “Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need.”

A new study published in The New England Journal of Medicine on Nov. 3 also provided evidence of the benefits of psilocybin in a double-blind trial. “In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects,” the researchers wrote. Those adverse effects included headaches, nausea, dizziness, and suicidal ideation.

Source: https://hightimes.com/news/non-profit-organization-marches-on-canadian-capital-to-fight-for-therapeutic-mushrooms/

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New Mexico cannabis operator fined, loses license for alleged BioTrack fraud

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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:

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/

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Marijuana companies suing US attorney general in federal prohibition challenge

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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.”

Source: https://mjbizdaily.com/marijuana-companies-suing-us-attorney-general-to-overturn-federal-prohibition/

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Alabama to make another attempt Dec. 1 to award medical cannabis licenses

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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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