Business
New Zealand Approves Domestic Medical Cannabis Products
New Zealand health authorities have given approval for domestically produced cannabis products, freeing patients from regulations that allowed only imported cannabis medications.
New Zealand health regulators last week began allowing the use of domestically produced medicinal cannabis products, ending patients’ reliance on imported medical marijuana products. The Ministry of Health allowed access to local medicines beginning on September 9, opening a new opportunity for New Zealand cannabis growers and manufacturers.
Under New Zealand’s medicinal cannabis legalization laws, any licensed general physician can prescribe cannabis medications to any patient to treat any health condition. But since 2017, only imported cannabis medicines have been approved for use by patients, notes Tim Aldridge, managing director of cannabis grower Puro New Zealand.
“Up until now, New Zealand patients could only be prescribed medicinal cannabis grown overseas, with the vast majority being imported from Australia and Canada,” Aldridge said in a statement.
Puro New Zealand grows organically produced cannabis at its outdoor facility on the nation’s South Island. Earlier this year, the company signed a multi-million dollar, five-year deal to provide cannabis to Helius Therapeutics, a firm that manufactures cannabinoid medications at its facility in East Auckland. Carmen Doran, chief executive of Helius, noted that a change in the law now allows New Zealand patients access to the company’s products.
“In 2018, Parliament’s legislative intent around improving access and affordability was clear,” said Doran. “The subsequent Medicinal Cannabis Scheme has also strived for both locally grown and made cannabis medicines. That national ambition to better serve long-suffering Kiwi patients is finally a reality and that’s exciting.”
“This is great news for many patients who have long sought legal access to both New Zealand-grown and made medicinal cannabis products,” Doran added.
Medications Approved for Local Market
On Tuesday, Helius was notified by the Ministry of Health that two of its medications had passed quality standards tests, a requirement that must be met before cannabis products can enter the local market under regulations adopted in 2019. New Zealand already has 35 cannabis companies across the country, with Helius Therapeutics being the largest in the nation.
Helius was New Zealand’s first medicinal cannabis business to achieve a GMP Licence for Manufacturing Medicines in July 2021, bringing the first products to market three months later. The new products will first be launched in New Zealand before being rolled out internationally, with Europe and South America already identified as priority foreign markets for the company.
“Gaining approval of medicinal cannabis products that are truly New Zealand-grown and made is a significant milestone for our industry,” Doran said. “Local patients and their advocates have fought long and hard for truly Kiwi products which are both high quality and cost-effective.”
Aldridge said that his company has spent four years bringing its operations up to government standards.
“It hasn’t always been plain sailing,” Aldridge said. “Navigating this new industry, coming to grips with the regulatory regime, and growing a new crop at scale has been a massive undertaking.”
Although the work to develop a local cannabis production infrastructure has not been easy, he says that patients will soon reap the rewards. Locally produced cannabis medications are expected to cost patients half as much as imported medicines.
Doran of Helius said that a local source of CBD and other cannabis products will help ensure that patients in New Zealand have access to their medicines, noting that global logistical challenges over the past two years have affected imports of cannabis products from producers abroad.
“We have seen significant delays and disruptions in the availability of imported products as COVID continues to impact supply chains,” said Doran. “It is disconcerting for patients and prescribers when products that are making a difference in people’s lives are not available. Fully New Zealand-grown and made products will help alleviate such issues.”
Source: https://hightimes.com/news/new-zealand-approves-domestic-medical-cannabis-products/
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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