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5 Canadian cannabis producers face May deadline in ‘extracts/edibles’ conflict

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Health Canada has asked five companies to stop distribution and sale of noncompliant cannabis edibles products by the end of May and provincial wholesalers have been notified of the ongoing crackdown after months of confusion, MJBizDaily has learned.

Canada’s cannabis industry and the federal government have been on a collision course over the products since January, when Health Canada started asking some licensed companies to stop selling certain ingestible marijuana products.

The industry says the products are appropriately classified as cannabis “extracts” because the ingredients used are not food and, thus, are compliant with federal marijuana regulations.

However, Health Canada, the nation’s federal cannabis regulator, has said the affected products are improperly classified as “extracts” and should actually be categorized as “edibles.”

The distinction is important because any cannabis product classified as an extract has 100 times more allowable THC per package than a product classified as an edible.

For instance, certain packages of Ottawa, Ontario-based Indiva Limited’s Wild Cherry Lozenges and Life Lemon Lozenges contain 100 milligrams, 250 milligrams and 500 milligrams of THC per package.

However, if those were classified as edibles, they would be limited to no more than 10 milligrams of THC per package.

Indiva was one of the five companies hit with a notice of noncompliance letter by the federal regulator.

Toronto-headquartered Organigram Holdings also said it received a notification from Health Canada claiming some of its products were incorrectly classified as “extract” rather than “edible.”

Both Indiva and Organigram paused production of the affected product formats.

Health Canada released a long-awaited compliance statement in early March intended to help identify products improperly classified as extracts.

Deadline looms

Health Canada said federal license holders with noncompliant products are expected to “stop further distribution and sale” of those products in question by May 31.

To date, five noncompliance letters have been issued regarding affected product formats, but that number might grow “while we (Health Canada) gather information from them on their products,” a spokesperson told MJBizDaily via email.

Asked what consequences license holders could face if they fail to comply, the spokesperson said Health Canada’s preference is for regulated parties to voluntarily undertake actions to regain compliance.

“However, Health Canada may take enforcement measures to address non-compliance or mitigate risks to public health or public safety as outlined in the Compliance and enforcement policy for the Cannabis Act,” the email noted.

Those measures could range from calls and letters – which are intended to educate and prevent noncompliance – to inspections to measures intended to correct noncompliance or address a public health or safety risk.

Those could include the suspension or cancellation of a federal license or the issuance of administrative monetary penalties up to 1 million Canadian dollars ($730,000).

Health Canada also told MJBizDaily it recently informed provincial wholesalers of the situation.

The Ontario Cannabis Store, the largest marijuana wholesaler in Canada, subsequently sent letters to suppliers on March 15.

In one such letter viewed by MJBizDaily, the wholesaler reminds the recipients they must ensure products they sell to the OCS are compliant with applicable laws and regulations.

“If you currently sell or have proposed to sell products to the OCS that may be affected by the Compliance Statement, you must provide the names and brands of the affected product(s) by the end of day, March 24, 2023,” the letter reads.

The letter, sent by OCS Chief Operating Officer Denny Palarchio, says the agency “will continue to replenish and accept deliveries” for the affected products until May 31, 2023.

Industry reacts

Industry sources say the crackdown will cost the struggling industry tens of millions of dollars.

They also say Health Canada’s crackdown is a gift for the underground market, since legal cannabis edibles containing no more than 10 milligrams of THC per package can’t compete with illegal products that don’t face such restrictions.

Another source of frustration is the fact that the products Health Canada is trying to pull from the market already underwent the government’s so-called Notice of New Cannabis Product (NNCP) process, which requires licensed producers to notify the regulator months in advance of new products.

While that process doesn’t mean those products were necessarily “approved” by Health Canada, the agency would have signed off on and been aware of the respective products, including the amount of THC contained in each package.

Shane Morris, founder of Ottawa-based Morris & Associates Consulting, said serious questions need to be asked about why Health Canada reviewed several NNCPs for these products and then allowed them to exist in the market for years.

“For example, the Organigram Jolts were launched in August 2021 and subsequently had multimillion-dollar sales. How does this happen?” Morris asked.

“Regulatory certainty is a key element of good regulatory policy. Having the regulator change their minds overnight after months or years of allowing reviewed products in market speaks to either incompetence and/or gross inconsistency on the part of Health Canada.”

Morris wants the industry to ask for an independent review of this situation.

Source: https://mjbizdaily.com/5-canadian-cannabis-producers-face-may-deadline-in-extracts-edibles-conflict/

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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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