Business
Marijuana companies find increasing acceptance for therapeutic MJ research
Long restricted by the federal government and stigmatized by the medical and scientific communities, cannabis has been involved in only a handful of studies carried out in the United States over the past several decades.
The overwhelming majority of cannabis studies undertaken by universities, pharmaceutical companies and other entities – and frequently funded by the canna-skeptical National Institute on Drug Abuse and the National Institutes of Health – have focused on addiction and impairment, impact on teens and other potentially negative consequences of cannabis.
But federal agencies such as the Drug Enforcement Administration and the Food and Drug Administration – while not exactly smoking blunts with NORML on the frontlines of legalization – are not the anti-marijuana zealots they were only a decade ago.
DEA expands licenses
The DEA, for example, has in the past year increased the number of entities licensed to cultivate cannabis for federally approved research from one to six. The agency also has awarded cannabis research licenses, including some for companies with state-issued marijuana business licenses, such as Colorado-based MedPharm Holdings.
There has been a modest increase in federal funding opportunities for cannabis research, and at least one state-licensed marijuana company, CT Pharma in Connecticut, has federal approval to provide cannabis for a study in partnership with Yale University. Such research funding likely will increase, thanks to a provision in the $1 trillion federal infrastructure bill passed last year allowing researchers to use cannabis from state-licensed businesses.
Additionally, many federally approved cannabis growers and researchers say the DEA and FDA have been supportive partners.
“The DEA has actually been very good to work with. They’re slow, I’ll say that. But for the most part, they’re very responsive,” MedPharm CEO Albert Gutierrez told MJBizDaily earlier this year.
“The DEA has been an extremely collaborative supporter … ever since I started working with them 15 years ago,” said Dr. Sue Sisley, executive director of the Scottsdale Research Institute, one of the six entities to receive federal cannabis cultivation approval. “We have had an excellent rapport with the DEA.”
Growing partnerships
At the same time, U.S. medical, scientific and pharmaceutical circles have been slow to accept the therapeutic benefits of cannabis – though that, too, is changing.
Indeed, a few universities are studying cannabis’ potential therapeutic effects, such as one study into pain management coordinated by the Albert Einstein College of Medicine in New York in partnership with Minnesota-based multistate operator Vireo Health, a subsidiary of Goodness Growth Holdings.
“There has been a marked change in terms of buy-in from physicians and providers,” said Dr. Stephen Dahmer, chief medical officer at Vireo. “I’ve seen a tremendous shift in bias.”
Despite this progress, marijuana’s status as a Schedule 1 drug still makes it very difficult to get research approval. Many research institutions find the amount of time, effort and money needed to get federal approval to study cannabis remains too much squeeze for the juice in return.
Other cannabis executives eschew the federal framework by surveying their own consumer database for information about product efficacy, as California-based infused products maker Papa & Barkley has done with its so-called in-home-use tests.
Dedicated consumers
While research into the harms of cannabis still make up the bulk of studies on the plant, there are an increasing number of studies into marijuana’s impact on specific ailments, such as pain management, opiate replacement, brain inflammation and sleep problems, among others.
This is critical at a time when the cannabis industry is maturing to a point where consumers who once were content to jump from product to product will increasingly select items that provide consistent relief, Dahmer said.
“There is a very marked amount of attrition for new patients that come into any market,” Dahmer said. “One way to combat attrition is to find a therapy that truly works for patients.”
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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