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Federal Health Agencies Acknowledge Therapeutic Potential Of Psychedelics

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The heads of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) coauthored a new letter describing that status of research into psychedelic drugs such as psilocybin, LSD and ibogaine.

The letter, dated last week, also contains surprising admissions about the therapeutic potential of these federally prohibited controlled substances.

It comes in response to an inquiry from Sen. Brian Schatz (D-HI), who requested information about the government’s research agenda on investigating the medical value of psychedelics as well as any plans the agencies have to recommend rescheduling them under the Controlled Substances Act.

Psychedelics present an “opportunity to provide treatment to patients while expanding psychotherapy treatment options,” the senator wrote. “Studies have found the benefits of the controlled use of psychedelics in psychotherapy programs, including the benefits of lysergic acid diethylamide (LSD) to reduce anxiety for patients with life-threatening diseases, and the safety and efficacy of ketamine, MDMA, psilocybin, LSD, and ibogaine in clinical trials.”

While the agencies said they do not have plans to recommend reclassifying any psychedelics that are currently placed in the restrictive category of Schedule I, they acknowledged throughout their response that psilocybin, LSD, MDMA, ketamine and ibogaine hold therapeutic promise and can help uncover “mechanisms of illness and possible interventions, ultimately leading to novel treatments with fewer side effects and lower abuse potential.”

Ketamine is already an FDA-approved drug for treatment-resistant depression and is accordingly classified under Schedule III.

Federally funded research into LSD has also proved valuable, as scientists were able to observe its molecular structure bind to receptors in the brain, providing the “first structure-informed insights into the molecular mechanisms of a hallucinogen,” the FDA and NIH leaders said.

“In addition, these findings may hold clues to the roots of psychopathology and consciousness and may accelerate the discovery of new treatments for serious mental illnesses such as schizophrenia and depression,” they wrote.

There are ongoing clinical trials into MDMA, which may be able to treat symptoms of post-traumatic stress disorder and anxiety. Researchers are working to understand the mechanisms through which MDMA produces its psychoactive effects, and that information could be used to develop compounds “with improved safety or efficacy profiles and reduced abuse liability.”

Ibogaine is a bit trickier, the officials wrote. Earlier research has demonstrated that the naturally occurring compound can help treat opioid addiction and reduce cravings generally, but scientists have also identified significant health risks, including toxicity to nerves in the brain and muscles in the heart, they said. Because there’s a risk of fatality associated with using ibogaine, the agencies determined that it does not have therapeutic potential.

FDA and NIH also responded to a question from Schatz about gaps in scientific understanding that currently exist as it relates to psychedelics.

“Further research is needed to examine the efficacy and long-term safety of psychedelic drugs, including with repeated exposure and potential interactions with existing treatments,” they wrote. “It is also important to understand their mechanisms of action in order to identify new targets that preserve the therapeutic effect and minimize negative side effects.”

The letter goes on to describe the various benefits and risks of each psychedelic substance.

Ketamine can cause sedation and disassociation that is useful in some clinical settings, but it’s also proved addictive and can produce frightening hallucinations; LSD and psilocybin cause “intensified feelings and sensory experiences, and changes in the perception of time” but their long-term effects are unknown; MDMA shows promise in treating symptoms of certain mental conditions but withdrawal effects include irritability and sleep problems; ibogaine seems to “reduce craving and relapse in patients with substance use disorder,” yet it can also cause various health problems.

The letter concludes that FDA is “not currently recommending a transfer of any Schedule I psychedelic drugs to any of the schedules applicable for drugs having a currently accepted medical use in the United States,” but it stressed that research opportunities will continue to be made available and if studies demonstrate that any given psychedelic possesses proven medical benefits, it retains the authority to make a rescheduling recommendation.

The response from FDA and NIH comes amid a growing conversation around the country and in Congress about laws governing psychedelic substances. After Denver became the first city to decriminalize psilocybin in May, Oakland’s City Council followed suit and decriminalized multiple psychedelics including psilocybin, ayahuasca, mescaline and ibogaine.

This month, Rep. Alexandria Ocasio-Cortez (D-NY) introduced an amendment to remove a rider from a spending bill that inhibits research into controlled substances, and she pointed specifically to psilocybin and MDMA as examples of drugs that ought to be further investigated. Her amendment was soundly defeated on the House floor last week, however.

Read Schatz’s letter on psychedelics below:

Final Letter to NIH, FDA Re… by on Scribd

Read the response from FDA and NIH below:

Response From FDA and NIH R… by on Scribd

How Democrats Helped Republicans Shut Down AOC’s Psychedelics Research Measure

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Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

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Minnesota Marijuana Legalization Bill Clears 12th And Final House Committee, Advancing To The Floor

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A bill to legalize marijuana in Minnesota has been approved by its final House committee and will now advance to the floor.

The road to get to this position has been long and winding, with 12 panels hearing and voting on the measure since it was introduced in February.

House Majority Leader Ryan Winkler (D), Speaker Melissa Hortman (D) and other lawmakers filed the proposal, which would allow adults 21 and older to purchase and possess up to 1.5 ounces of cannabis and cultivate up to eight plants, four of which could be mature.

Members of the House Ways & Means Committee approved the legislation in a 16-10 vote on Friday.

Winkler previously said that he expects a floor vote this month, though that has yet to be scheduled. The legislature is slated to adjourn on May 17.

The bill “helps to correct wrongs that have been done for too long in Minnesota to communities who’ve been over-policed who have been targeted for cannabis enforcement to further a prohibition of cannabis that does not work,” the majority leader said in opening remarks.

Winkler said that “legalizing and creating a safe marketplace by taxing cannabis and using the proceeds from those taxes to pay for cannabis regulation to help invest in a cannabis industry” would reflect “the values of Minnesotans and help to address the harm that is caused by cannabis prohibition on our black and brown communities.”

The panel adopted an amendment from Winkler that expands the definition of social equity applicants to include those from communities disproportionately impacted by prohibition and makes changes to how regulators would address rules violations by businesses. It would also revise the amount of funding for various state agencies, including a reduction in appropriations for the Department of Corrections.

A proposal to require that the label on marijuana products include information about the maximum dose that is considered safe within a 24-hour period was also approved.

An additional amendment that would have required marijuana products to be labeled with a warning that cannabis remains illegal under federal law was rejected.

Prior to taking up the legalization bill, members adopted an amendment to separate budget legislation that would provide funding for the implementation of the cannabis program for the first biennium, after which time marijuana tax revenue would more than cover costs.

It the measure does clear the full House chamber, it’s still expected to face a significant challenge in the Republican-controlled Senate, where lawmakers have signaled that they’re more interested in revising the state’s existing medical cannabis program than enacting legalization of adult use.

That said, a GOP member of the Taxes Committee, which approved the legalization bill on Wednesday, indicated that he felt an amendment he introduced and that was adopted could bolster Republican support.

That revision from Rep. Pat Garofolo (R) directs remaining cannabis revenue to a tax relief account after implementation costs are covered and substance misuse treatment and prevention programs are funded.

“The adoption of this amendment is a gamechanger,” Garofalo said in a press release. “The Democrat majority accepting this amendment means that if signed into law, this bill will result in lowering taxes Minnesotans are FORCED to pay, financed with the revenue generated from taxes that people are CHOOSING to pay.”

Before the Taxes Committee, the bill passed the Health Finance and Policy Committee, Public Safety and Criminal Justice Reform Finance and Policy Committee, Education Finance Committee, State Government Finance and Elections Committee, Judiciary Finance and Civil Law Committee, Environment and Natural Resources Finance and Policy Committee, Agriculture Finance and Policy Committee, Workforce and Business Development Finance and Policy Committee, Labor, Industry, Veterans and Military Affairs Finance and Policy Committee and Commerce Finance and Policy Committee.

“At the beginning of the year, a House committee had never passed a legalization bill. Now, we’re on the verge of passing a bill off the House floor,” Winkler said in an email to supporters on Friday. “We have the ability to change laws in a way that improves people’s lives, whether it’s expunging cannabis-related records, targeting economic opportunity for those impacted most by the war on drugs, providing relief for veterans suffering from PTSD and serious health conditions, and more.”


Marijuana Moment is already tracking more than 1,100 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

The litany of committees the bill has gone through makes it perhaps the most thoroughly vetted legalization measure to move through a state legislature—and it means that a solid portion of the House has already had the chance to review, propose amendments to and vote on the legislation it as it advances to the floor, presumably increasing its chances of passage in the chamber.

The majority leader’s bill as introduced was identical to a proposal he filed last year, with some minor technical changes. Winkler, who led a statewide listening to gather public input ahead of the measure’s introduction, called it the “best legalization bill in the country” at the time. It did not advance in that session, however.

Under the legislation, social equity would be prioritized, in part by ensuring diverse licensing and preventing the market from being monopolized by corporate players. Prior marijuana records would also be automatically expunged.

On-site consumption and cannabis delivery services would be permitted under the bill. And unlike in many legal states, local municipalities would be banned from prohibiting marijuana businesses from operating in their areas.

Retail cannabis sales would be taxed at 10 percent. Part of that revenue would fund a grant program designed to promote economic development and community stability.

The bill calls for the establishment of a seven-person Cannabis Management Board, which would be responsible for regulating the market and issuing cannabis business licenses. It was amended in committee month to add members to that board who have a social justice background.

People living in low-income neighborhoods and military veterans who lost honorable status due to a cannabis-related offense would be considered social equity applicants eligible for priority licensing.

Cannabis retails sales would launch on December 31, 2022.

Gov. Tim Walz (D) is also in favor of ending marijuana prohibition, and in January he called on lawmakers to pursue the reform as a means to boost the economy and promote racial justice. He did not include a request to legalize through his budget proposal, however.

Walz did say in 2019 that he was directing state agencies to prepare to implement reform in anticipation of legalization passing.

Winkler, meanwhile, said in December that if Senate Republicans don’t go along with the policy change legislatively, he said he hopes they will at least let voters decide on cannabis as a 2022 ballot measure.

Heading into the 2020 election, Democrats believed they had a shot of taking control of the Senate, but that didn’t happen. The result appears to be partly due to the fact that candidates from marijuana-focused parties in the state earned a sizable share of votes that may have otherwise gone to Democrats, perhaps inadvertently hurting the chances of reform passing.

In December, the Minnesota House Select Committee On Racial Justice adopted a report that broadly details race-based disparities in criminal enforcement and recommends a series of policy changes, including marijuana decriminalization and expungements.

Wisconsin Governor’s Marijuana Legalization Proposal Stripped From Budget By GOP-Led Committee

Photo courtesy of Mike Latimer.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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Feds Announce New Standard THC Dose To Be Used In Marijuana Research, Effective Immediately

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A top federal health agency announced on Friday that it has determined the standard dose of THC that should be used for marijuana studies moving forward.

The National Institute on Drug Abuse (NIDA) said in a notice to researchers that there is a “new requirement to measure and report results using a standard THC unit in all applicable human subjects’ research,” which is effective immediately. That standard unit is five milligrams of THC.

NIDA said that inconsistencies in measuring and reporting THC exposure “has been a major limitation in studies of cannabis use, making it difficult to compare findings among studies.” Therefore, a “standardized measure of THC in cannabis products is necessary to advance research by providing greater comparability across studies of both its adverse effects and potential medical uses.”

The agency recognized, however, that “the same quantity of THC may have different effects based on route of administration, other product constituents, an individual’s genetic make-up and metabolic factors, prior exposure to cannabis, and other factors.”

But by creating a standard THC dose, it will nonetheless be easier to compare studies that involve THC exposure, which is a “high priority” of NIDA and the National Advisory Council on Drug Abuse.

“It is not the intent of this Notice to prescribe the quantity of THC that is permissible for use in research projects. Indeed, investigators are free to use more or less than 5mg of THC as appropriate for their study,” the notice states. “However, for applicable studies, investigators will be required to report the quantity of THC using the standard unit. Investigators may also report the quantity of THC in other units (e.g., milligrams) as appropriate.”

This comes one year after NIDA, which is part of the National Institutes of Health, first solicited feedback on a proposal to standardize THC content in cannabis research.

The agency said that it carried out “extensive stakeholder input,” along with “consultation with experts in the field,” to arrive at the decision to set the standard unit at 5 mg.

“This guidance will apply to applications where THC is a focus of the research,” the new notice continues. “Applicants are responsible for determining whether use of this standard unit is applicable to their research and for determining best approach to applying it in their research applications. A justification should be provided for research that does not propose to use the standard unit.”

NIDA Director Nora Volkow discussed the importance of establishing a standard THC unit in commentary published in the journal Addiction last year.

Citing research that calls for a five milligram THC standard, Volkow said she agreed with the study’s conclusion despite complicating factors. Those factors include potential issues related to the effect of having cannabis products with the same THC level but different concentrations of other cannabinoids such as CBD.

The complexities in research beyond having a standardized measure of THC “hardly negate the value” of setting one, Volkow said in her commentary. “In fact, having and using such a standard is a prerequisite for comparing the effects of various cannabis products on THC bioavailability, pharmacokinetics and pharmacological effects, which is knowledge fundamental to studies pertaining to medical use of cannabis.”

“Although cannabis remains an illicit substance in the United States, the expanded legalization by states requires us to develop the knowledge base that can help states develop policies to minimize risk from cannabis exposures, such as limits on the THC content of cannabis products,” she said.

Volkow has been vocal about the importance of streamlining and improving research into cannabis, and she’s laid partial blame for the the lack of studies on marijuana’s restrictive federal classification.

Kansas Senate Running Out Of Time To Pass Medical Marijuana Legalization Bill That Cleared House

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Kansas Senate Running Out Of Time To Pass Medical Marijuana Legalization Bill That Cleared House

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As advocates applaud the passage of a medical marijuana legalization bill in the Kansas House of Representatives, anxieties remain high over its prospects in the GOP-controlled Senate.

The chamber has days left being the end of the legislative veto session, and Senate leadership has signaled that they do not view the reform legislation as a priority.

“The Senate is not real high on the issue at this point” Senate President Ty Masterson (R) told an Associated Press reporter in a pun-filled text message on Thursday, adding that “we may roll it into a joint committee and see if we can weed out the issues.”

Whether he was serious about the joint committee or simply making an attempt at cannabis-related humor is unclear. A spokesperson for his office separately said that the chamber is focused on passing a budget bill and a school funding measure in the final days of the session.

“I can’t imagine we’d take the subject matter up this year,” Masterson said earlier this week ahead of the House vote.

If the Senate doesn’t take up the medical marijuana bill by May 11, it would still be alive for the second half of the legislative biennium that starts early in 2022 and could be acted upon then.

But even if senators do make time to establish a bicameral conference committee to consider the proposal, there are still serious doubts about whether the body would approve the resulting negotiated legislation. And defeat in the Senate this year would mean lawmakers would have to start the process all over again if they wanted to pursue the reform again next year.

Getting the bill to this stage alone has proved challenging.

It moved through the House Federal and State Affairs Committee after a series of hearings and onto the floor in March, but then it was rereferred to the panel for further consideration. Members then adopted several additional amendments before sending it back on the floor.

The legislation would establish a medical marijuana program for qualified patients. It lists about two dozen conditions that make a person eligible for cannabis, including Alzheimer’s disease, cancer, Crohn’s disease, glaucoma, multiple sclerosis, post-traumatic stress disorder and traumatic brain injury.


Marijuana Moment is already tracking more than 1,100 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

Smoking and vaping products would be prohibited. The bill would also not provide for home growing.

The state would license medical cannabis growers, testing labs, processors distributors and retailers, and counties would be able to opt out of allowing marijuana businesses to operate in their jurisdiction.

Patients would be able to purchase up to a 90 day supply of cannabis from licensed dispensaries, which would be regulated by the state Department of Alcoholic Beverage Control (ABC). That department would also be renamed the Division of Alcohol and Cannabis Control.

The secretary of the Department of Health and Environment would have to develop regulations to administer the medical cannabis program by July 1, 2023.

Gov. Laura Kelly (D), for her part, supports medical cannabis and would be expected to sign a bill if it arrived on her desk.

She pushed a separate proposal that would legalize medical cannabis and use the resulting revenue to support Medicaid expansion, with Rep. Brandon Woodard (D) filing the measure on the governor’s behalf.

Kelly has she said she wants voters to put pressure on their representatives to get the reform passed. And with the small timeline before the session’s end, the time to apply that pressure would be now.

While both pieces of legislation would make it so Kansas would join the vast majority of states that have legal medical marijuana markets, advocates view them as restrictive, particularly as it concerns the limited methods of consumption that would be permitted.

A separate medical cannabis legalization bill was introduced by the Senate Commerce Commerce in February, though it has not seen action beyond being referred to another panel.

Alabama Governor Will Give Medical Marijuana Bill A ‘Thorough’ Review, Spokesperson Says

Photo courtesy of Philip Steffan.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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