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Utah to seek curbs on delta-8 THC, other synthetics in medical marijuana market

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Utah regulators say they’re pushing for new rules governing the presence of delta-8 THC and other synthetic cannabinoids allowed in the state’s medical marijuana supply.

The regulators are reacting after patient advocates, product makers and researchers sounded the alarm over safety concerns in an MMJ market that Utah voters legalized in 2018.

The first medical cannabis pharmacies – as MMJ dispensaries are called in Utah – opened in 2020 after the state Legislature and then-Republican Gov. Gary Hebert made later tweaks.

Those tweaks make Utah an outlier among its more liberal neighbors such as Colorado and Nevada, according to patient advocates and researchers.

Unlike those two states, Utah law currently allows “THC analogs” into edibles, vaporizer cartridges and other products sold in state-licensed pharmacies.

Analogs are defined as “a substance that is structurally or pharmacologically similar to, or is represented as being similar to, delta-9-THC.”

State officials admit this has made it legal for MMJ pharmacies to sell products that contain delta-8 THC as well as other controversial synthetic derivatives with unknown safety profiles, including delta-6 and delta-10 THC.

Underscoring concerns from researchers and advocates, Utah patients have reported adverse effects such as blackouts after using products containing delta-8 THC, which other states have banned.

Largely unknown to the public before passage of the 2018 Farm Bill – which triggered a flood of hemp and hemp-derived products nationwide – delta-8 THC can be created from CBD isolate via a chemical process.

That process is almost entirely unregulated.

Experts have said that the chemical process might also taint the end product with contaminants that are unknown to science and not detected during laboratory analysis.

Authorities also blamed delta-8 THC for the May death of a Virginia toddler, whose mother was charged with homicide.

Although, to date, “no public health body has recognized a synthetic cannabinoid as a toxic or deleterious substance,” the Utah Department of Agriculture and Food (UDAF) is asking for changes to state law “that would allow us to restrict the presence of synthetic cannabinoids in products in Utah, even if they have not been demonstrated to be toxic,” said Brandon Forsyth, the director of the agency’s Cannabis and Hemp Division.

“This is being done out of an abundance of caution,” Forsyth told MJBizDaily via email.

Whether the changes would impose limits or an outright ban is “still being discussed,” he added.

“As I’m sure you can appreciate, there are a lot of details to consider.”

‘Hot-button deal’

The UDAF’s pivot to consider new rules follows a monthslong public-safety campaign led by marijuana manufacturers and patients, some of whom say that products containing delta-8 THC purchased at state-licensed MMJ pharmacies caused troubling complications.

Other critics have said that Utah’s allowances for delta-8 THC and other analogs allows so-called “hot hemp” into the state medical cannabis program, charges regulators have denied.

“This is a super-hot-button deal,” said Blake Smith, a trained biochemist and chief scientific officer at Zion Medicinal, a licensed manufacturer in Salt Lake City that makes oils and other products sold at MMJ pharmacies across the state.

Smith expressed familiar concerns over these understudied analogs’ unknown safety profiles.

He and other advocates have called for state authorities to more strictly regulate Utah MMJ products – and, if necessary, ban analogs outright.

“Here’s the deal: Lack of data does not equal safety,” he said. “If we don’t know anything about these things that we just discovered, we should probably not be giving them to cancer patients.

“I think that’s perfectly reasonable, and yet, nobody seems to be moving in that direction.”

Alex Iorg is the co-founder of Salt Lake City-based WholesomeCo Cannabis, which sells products such as vaporizer cartridges that contain delta-6 and delta-10 THC, according to the company’s website.

That disclosure is a recent development, an update made “to improve transparency of the presence of these cannabinoids,” Iorg said.

“In the end, we rely on and comply with the state’s guidance on testing requirements and patient safety,” he said, noting that “a lot is unknown about these cannabinoids.”

He also questioned whether other states might also have synthetic cannabinoids in their regulated medical cannabis products supplies.

“State regulators suggested this may not just be a Utah issue but, rather, a national cannabis issue,” he said.

“We are curious to find this out as well, as Utah’s cannabis production standards and practices did not originate in Utah.”

In a Nov. 3 news release, the UDAF acknowledged “recent increases in the availability of products that contain poorly characterized cannabinoids,” including “cannabinoids that are produced semi-synthetically/synthetically,” such as delta-8.

The department pulled some products from shelves over safety concerns, but those holds were lifted by the state Department of Health and Human Services (DHHS) – which directly oversees the Utah medical cannabis program – after the agency was “unable to find any evidence that these cannabinoids are harmful to human health at this time,” according to the UDAF.

OK, as long as it’s labeled

That release followed an Oct. 25 hearing in which Rich Oborn, director of the DHHS’ Center for Medical Cannabis, confirmed that Utah allows “synthetic and derivative cannabinoids,” provided they “are listed on cannabis product labels.”

Patients concerned about the safety of such products “should talk with their medical provider and/or a medical cannabis pharmacist to determine if they should use products with synthetic and derivative cannabinoids,” he added, according to meeting minutes and a recording.

The DHHS did not immediately respond to an MJBizDaily request for comment.

State lawmakers are expected to revisit medical marijuana regulations during the legislative session that begins in February.

That isn’t nearly enough for Zion Medicinal’s Smith and for outside observers such as Dr. Ethan Russo, a neurologist and acknowledged national expert.

In a letter he submitted to state authorities and shared with MJBizDaily, Russo pointed out that “it is possible to make a blanket assertion that all products with delta-8-THC content of significant concentrations are contaminated with delta-6-, delta-10-THC, possibly other isomers, and residual solvents, making them public health risks.”

Since “no formal studies” into these analogs’ toxicology and effects in humans have been conducted, these products should be pulled from shelves and not sold until they are studied, he said.

Blackouts, lack of trust

During that Oct. 25 meeting, several patients told state regulators that they suffered blackouts and other serious aftereffects after using state-licensed products that contained delta-8 THC and that the synthetics pose serious concerns.

Before making a recent purchase, “I had an hourlong conversation with a pharmacist, expressing I needed good, clean medicine,” medical marijuana patient Mitchell Butterfield said.

That pharmacist led him to purchase a vaporizer cartridge that indicated it contained delta-8 THC, he said.

“I asked him what was in it, and he said, ‘It’s still just THC. The state just makes it label it that way,’” Butterfield said.

He bought it and brought it home. He hit it and, “after five minutes, I started yawning uncontrollably and then I blacked out,” he said.

“In 50 years’ experience with this plant, I have never had an experience like that,” said Butterfield, who added that the MMJ pharmacy refused to give him a refund and instead offered him only half off a future purchase.

“I don’t trust the CBD products on the market because of all the synthetics. … The delta-9 and -6 and all of that garbage,” Emily Tucker, a patient who said she has a teenaged son who wants to treat anxiety with CBD but is fearful about product quality, said during the meeting with regulators.

“I want to keep him safe. I don’t want him to get high because people are trying to make a cheap high.”

Christine Stenquist, the founder and president of nonprofit advocacy group Together for Responsible Use and Cannabis Education (TRUCE), said the only acceptable level of THC analogs “is zero.”

“If you can’t create quality products, you should not have a license in this state,” she told MJBizDaily.

While she welcomes limits on synthetics, she faulted state regulators for trying to “minimize safety concerns from the beginning” and says she’s heard rumors that synthetic analogs will still be allowed under new legislation, though with age limits.

“We never wanted synthetics in the program,” she said. “They’re only acting out of abundance of caution because I am raising Cain everywhere.”

Source: https://mjbizdaily.com/utah-medical-marijuana-market-curbs-on-delta-8-thc-other-synthetics/

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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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