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Federal Settlement Will Allow Arizona Church To Import, Process And Use Ayahuasca As Religious Sacrament

April 24, 2024

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A new settlement between the federal government and an Arizona-based nonprofit will permit the group to import and use ayahuasca as a religious sacrament—an agreement leaders are calling a historic milestone for spiritual freedom.

Under the settlement announced by the Church of the the Eagle and the Condor (CEC), the group will be permitted “to import, receive, manufacture, distribute, transport, securely store, and dispose of ayahuasca solely for CEC’s religious purposes.”

Specifically, the agreement says the church will import ayahuasca, which contains the psychedelic substance DMT, “in concentrated paste or in liquid form” and then “combine the ayahuasca paste with water to manufacture ayahuasca tea for sacramental uses” at a location in Phoenix.

CEC says it’s “the first non-Christian church to receive protection for its spiritual practices regarding Ayahusca,” adding that the development under the federal Religious Freedom Restoration Action marks “the first time in history a church’s right to import and share its sacrament has been secured without going to trial.”

On the other side of the dispute was the Department of Justice (DOJ), the Department of Homeland Security (DHS), Customs and Border Protection (CBP) and the Drug Enforcement Administration (DEA).

CEC sued in 2022 over DHS’s seizures of shipments of ayahuasca intended for ceremonial use as well as the government’s threats that the group and its members could face federal prosecution.

The settlement document shared by CEC on Monday establishes that the group can now import, process and use ayahuasca, though DEA reserves the right to take spot samples of the imports “for the purpose of confirming that the consignment is in fact ayahuasca which contains no controlled substance other than DMT.”

Joseph Tafur, a doctor and ayahuasquero for CEC, said in a statement that the “Ayahuasca ceremony is an essential sacrament for our church.”

“Our ceremony is rooted in the Shipibo Amazonian tradition which has been passed down by countless generations. Now, in fulfillment of the ancient Prophecy of the Eagle and the Condor, this tradition has come to North America,” Tafur said. “Our ancestral practice will continue to support the community and nourish our holistic well-being.”

The group’s general counsel called the agreement “a watershed moment in the United States.”

“The resolution of this case represents the government’s recognition of this community’s right to exercise their religious beliefs without interference,” Martha Hartney said in a CEC release about the settlement. “Indigenous ways are returning to a place of honor, respect, and care in American culture–a culture made more beautiful because of Indigenous ritual, art, and cosmology in which all of creation is family.”

While some U.S. jurisdictions have recently loosened psychedelics laws, none has included provisions around importing psychedelic substances internationally.

Separately, DEA argued late last week in a U.S. appeals court case that the federal Right to Try Act—intended give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use—“does not provide anyone with a right to dispense or receive controlled substances.” The agency’s claim came in a new brief in a lawsuit filed by a Washington State doctor seeking to legally use psilocybin to treat cancer patients in end-of-life care.

Meanwhile, earlier this year DEA called for the production of even more DMT—along with psilocybin and THC—for research purposes than it had initially proposed for 2024, raising quotas for those drugs while maintaining already high production goals for marijuana and psychedelics.

DEA has touted its Schedule I drug production quotas as evidence that is supports rigorous research into the substances, but it’s faced criticism from advocates and scientists over actions that are viewed as antithetical to promoting studies.

For example, DEA in December announced that it would take another shot at banning two psychedelics after abandoning its original scheduling proposal in 2022, teeing up a fight with researchers and advocates who say the compounds hold therapeutic potential and who more recently argued that the agency’s administrative approach to the proposed scheduling is unconstitutional.

The agency separately backed down from a proposal to ban five different tryptamine psychedelics in 2022 amid pushback from researchers and advocates.

Read the full settlement agreement below:

Study Finds Natural Psychedelic Mushrooms Produce ‘Enhanced Effects’ Compared To Synthesized Psilocybin, Suggesting Entourage Effect

Photo courtesy of Apollo/Flickr.

The post Federal Settlement Will Allow Arizona Church To Import, Process And Use Ayahuasca As Religious Sacrament appeared first on Marijuana Moment.

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‘Don’t flood the market:’ Fault lines emerge among New York cannabis stakeholders over licensing

April 23, 2024

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Since New York marijuana regulators last met earlier this month, a small firestorm has cropped up among the Empire State’s cannabis trade organizations and business license applicants, after one of the leading trade associations appeared to call for a slow-down in the marijuana permitting process or a cap on the number of businesses allowed.

The episode erupted quickly into anger on social media, with critics of the trade group asserting that it was undermining its own membership in order to protect the relatively small number of companies that have landed state marijuana business permits to date.

Internal divide or miscommunication?

The conflict arose when the Cannabis Association of New York penned a letter to marijuana regulators, asking for a “stakeholder meeting” if the agency planned to “dramatically” increase the number of business permits. The letter asserted that “flooding” the New York market with new operators could have “disastrous consequences” for existing companies.

The letter was sent in the days following the April 11 meeting of the state’s Cannabis Control Board and was signed by CANY President Damien Cornwell, the owner and operator of Just Breathe, a licensed dispensary in Binghamton.

When the New York Post ran a story the following Sunday, proclaiming that CANY had asked the state to slow down license expansion, it was quickly applauded by some social equity advocates online. That included Shaleen Title, a former Massachusetts cannabis regulator and founder of the Parabola Center for Law and Policy, who wrote on X, “Don’t flood the market.”

But that New York Post story was also the first that many of CANY’s roughly 700 members had heard about the policy suggestion of slow-walking licensing in order to avoid market saturation – and a lot of them didn’t like it.

“I had to reread that letter like four times. I just couldn’t believe that they were speaking out against something I was fighting for. I’m one of the applicants that’s paying rent and just in limbo, not knowing what’s going on,” said Pete Longo, a dues-paying CANY member and one of thousands of business license applicants waiting to hear if he’ll receive a permit or not.

Longo applied in November for a microbusiness license and locked down a retail site in Westchester that’s been costing him $9,000 per month in rent, which was supposed to give him priority consideration in the pool.

Now, Longo said he’s considering leaving CANY, because its position is in direct contrast to his own business success.

“This was something that just came out of nowhere. And I think it only benefits the people who already have their licenses,” Longo said of the CANY letter. “And that’s a very small amount compared to the entire (pool of) applicants.”

Christian Talgo, the CEO of microbusiness applicant Pure Cannabis, wrote in an email to Green Market Report that his “immediate reaction was downright bewilderment” after he read the New York Post story.

“After reading the Post article a few times, I became angry as it was clear the intent was to stall licensing,” Talgo said.

Another dues-paying CANY member from Buffalo also waiting on a state license, Roaring 420s Lounge owner John Averill, said the letter made him feel like “I am paying for the right to be part of my own firing squad.”

“Everyone I speak to at CANY who doesn’t currently hold a cannabis license is up in arms,” Averill said, who also called it “self-serving” by Cornwell, since he owns an already-operational dispensary in Binghamton.

Other members who have won permits downplayed the letter from CANY, which Averill said translates to little empathy for those in his and Longo’s situation.

“The response we’re getting from these other people is basically, ‘You’re making a mountain out of a molehill.’ … It’s like, you don’t understand. We’re all going bankrupt here, and you’re telling them to take more time,” Averill said.

CANY’s government relations director, Jesse Campoamor, said the blame for the situation lies with the New York Post and its mischaracterization of CANY’s position.

“The suggestion that CANY is asking for a full stop in the market is categorically not our position,” Campoamor said.

“If the (governor) and the control board are considering adding more licenses than what’s already been allotted – meaning, they’ve told us they’re going to award 200 or some in the November queue and another 450 in the December queue – if they’re thinking of going beyond what they’ve already announced, all we’re asking for is a public conversation, some type of public engagement, to talk about how to do that,” Campoamor said.

“If I can be clear to anyone, CANY supports expanding licensing, especially with market participants,” he said.

CANY also wrote on Instagram that its board of directors fully supports the issuance of 1,500 business permits this year by New York regulators, an estimate that the agency provided last fall. That includes 500-1,000 dispensaries and another 220 microbusinesses in 2024. The OCM also disclosed in court filings last year that it envisions a statewide market of about 2,000 retailers to meet demand.

“Internal discussion in the industry is circulating about the expansion of the licensing pool beyond that number,” CANY wrote on Instagram. “Based on the current pace of licensing to date, we are suggesting that any new expansion should be based on data driven research and at a minimum, should have input from our members, industry operators and stakeholders.”

CANY members were not the only ones in the New York marijuana trade upset by the suggested slowdown in the pace of licensing.

Last week, the Cannabis Farmers Alliance issued its own open letter to CANY to express its “strong disagreement.”

“Your suggestion to slow down the issuance of retail licenses, presumably to prevent market flooding, does not align with the needs of the industry,” CFA President Joseph Calderone wrote. “This stance inadvertently supports the proliferation of the illicit market – a direct competitor that undermines our regulated system.”

Estimates of unlicensed marijuana sellers in New York range from 2,000 to 8,000, depending on the source.

CFA_Open_Letter_to_CANY_Retail_04_16_24_Proofread_1 2

Yet another parallel letter with a similar take was sent to Gov. Kathy Hochul, legislative leaders, and the Office of Cannabis Management and CCB by the New York Cannabis Retailers Association, the Association of New York Cannabis Processors, and the Black Cannabis Industry Association. The letter opposed CANY’s original missive “in the strongest possible terms,” and said more retail permits should be issued “without restrictions or further delay.”

“As long as the flow of new licenses remains at a trickle, the illegal industry will keep expanding because consumers don’t have a legal option,” the letter states. “Consumers need many more legal retail options if illegal operators are to be eliminated.”

Cannabis industry licensing memo 4-18-24

The numbers

As of Friday, only 112 legal adult-use cannabis shops have opened for business in New York, according to an OCM press release. Those establishments are likely part of the conditional adult use retail dispensary cohort of 463 “justice-involved” entrepreneurs granted retail permits last year.

Another 118 retail permits and 79 microbusiness licenses have been awarded thus far this year, for a possible total of 660 legal retailers that could eventually open. And regulators are not done awarding permits.

Last year during the general application window between October and December, the state received 6,875 business license applications, of which 4,303 were retail applications with another 1,320 for microbusinesses.

Thus far, the CCB and OCM have proceeded cautiously, issuing only a handful of new permits each month. The state earlier this year said that it only expects to issue 250 retail permits and 110 microbusiness licenses from the applications submitted last year.

But the word through the grapevine was that Hochul – who has been infuriated by the achingly slow market rollout – has been pushing the OCM and CCB to ramp up their pace of licensing, possibly even by granting initial permits to everyone who put in a business license application last year.

Formally, the New York state law that legalized adult-use marijuana doesn’t cap the number of cannabis companies allowed; that’s up to regulators to decide.

That was the backdrop for CANY’s letter, according to sources. But even the possibility of actual market flooding in such a way hasn’t mitigated the discord.

Averill said he and many other CANY members simply disagreed with the trade organization’s leaders on a policy level, and said they’d prefer to be licensed and allowed to compete in an open market for their survival instead of being left out completely of a limited-license market structure.

“As one of those applicants, I think that CANY’s only stance on that should be, ‘Yes, please, absolutely do that, and do that as quickly as possible,’” Averill said when asked about the possible addition of thousands of new licenses.

“The idea that we would hear that they’re finally seriously contemplating the kind of sweeping change that could have a real impact on the industry, and then to immediately advise them to pump the brakes, is deeply offensive to me,” Averill said.

But to Campoamor, the real issue that CANY was trying to bring to the forefront was transparency and a say in the process for industry.

“This is a real opportunity to ask for more staff for the licensing unit, so that we can expedite these licenses getting out. … It’s an opportunity to ask for legal and technical funding support,” he said. “For the life of me, I can’t fathom why somebody in this market that wants New York state to be successful would oppose that.”

The OCM did not respond to a request for comment for this story.

The post ‘Don’t flood the market:’ Fault lines emerge among New York cannabis stakeholders over licensing appeared first on Green Market Report.

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Kentucky advances Medical Marijuana business application date for smoother rollout

April 23, 2024

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DEA resists permitting psilocybin for terminal patients under ‘Right to Try’

April 23, 2024

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A long-running showdown between a doctor and the U.S. Drug Enforcement Administration that could affect the legal status of psychedelics is heating up.

The agency last week urged the Ninth Circuit Court of Appeal to block the physician’s efforts to use psilocybin to treat depression in terminally ill cancer patients, Law360 reported. The case centers on the scope and application of federal and state “Right-to-Try” laws, which allows the use of unapproved, investigational drugs for therapeutic purposes.

Dr. Sunil Aggarwal, co-founder of Seattle-based psychedelics research and treatment clinic, Advanced Integrative Medical Science Institute (AIMS), has repeatedly argued that the Right to Try Act grants him the authority to administer psilocybin to his patients.

However, in a new filing, the DEA maintained that the Right to Try Act only amends the Federal Food, Drug, and Cosmetic Act and does not impact the restrictions imposed by the CSA. The agency asserted that doctors who wish to dispense controlled substances must comply with both sets of regulations.

“The CSA and the FDCA (which the Right to Try Act amends) are separate regulatory schemes with separate requirements and restrictions,” the DEA wrote. “Nothing in the Right to Try Act changes that.”

Aggarwal, who has been engaged in litigation over this for a few years now, says that psilocybin has shown promise in treating major depression in clinical trials and should be accessible to terminally ill patients. However, the DEA has repeatedly rejected his proposals, stating in a 2022 denied petition that offering psilocybin to terminally ill patients would not be consistent with public health and safety.

The doctor also claimed that the DEA wants him to register as a researcher to obtain the drug, which goes against the law.

That led him to appeal to the Ninth Circuit on the grounds that the agency’s decisions were arbitrary and contradict public health interests and established legal precedents. In February, he argued that the DEA must explain how their decision aligns with the CSA and the agency’s own precedent, since the DEA has granted waivers for therapeutic use of other drugs, like cannabis for children.

The DEA doubled down on its position, arguing that Aggarwal has not provided adequate evidence to support his claims. The agency also contended that it could not fully evaluate Aggarwal’s proposal because he failed to provide the text or scope of the waiver he was seeking.

Psilocybin is currently classified as a Schedule I drug, meaning it has no accepted medical use. However, the drug has received “breakthrough therapy status” from the FDA twice and is currently in stage III clinical trials.

It remains unclear when the appellate court may issue a ruling on this case.

In a separate case, the Ninth Circuit ordered the DEA to clarify why psilocybin should remain a Schedule I substance after the agency rejected Aggarwal’s petition to move it to Schedule II, which is for drugs with accepted medical use but severe restrictions.

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