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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

Photo elements courtesy of carlosemmaskype and Apollo.

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.

Politics

Mitch McConnell Presses FDA Nominee On CBD And Hemp

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Senate Majority Leader Mitch McConnell (R-KY) met with the nominee to become the next Food and Drug Administration (FDA) commissioner on Wednesday and discussed the need for a regulatory framework for CBD products.

While there are few specific details available about their conversation, McConnell said he emphasized the importance of hemp legalization for Kentucky farmers and pointed out that those producers are also facing challenges given the lack of FDA regulations concerning CBD.

“I look forward to working closely with Dr. Hahn on several important issues for Kentucky,” McConnell said in a press release. “Like many Kentuckians who are taking advantage of hemp’s legalization, I am eager for FDA’s plans to create certainty for CBD products.”

The majority leader has previously pressed FDA to issue enforcement discretion guidance that prioritizes action against only CBD companies making especially unfounded medical claims about their products while allowing responsible businesses to continue to market their products as the agency continues to develop rules.

McConnell similarly raised his concerns about the importance of expediting CBD regulations during a separate meeting with Acting FDA Commissioner Ned Sharpless in June.

Stephen Hahn, the FDA nominee, was also pressed on CBD issues during a confirmation hearing on Wednesday. Sens. Jacky Rosen (D-NV) and Pat Roberts (R-KS) noted that there’s wide consumer interest in the cannabis products but stressed that more research is needed, barriers to research should be lifted and public health interests should be balanced with policies that support the industry.

Hahn replied that he believed there’s untapped therapeutic potential in the cannabis compound, but he also agreed that there are “unanswered questions that need to be filled in by data and science and research.”

In related developments, several consumer groups have recently expressed concerns about the current status of the CBD market.

Three groups—National Consumers League, Consumer Federation of America and Community Anti-Drug Coalitions of America—announced on Tuesday that they are launching an initiative called “Consumers for Safe CBD” that is designed to “warn the public of the potential risks related to CBD products.”

According to a press release, the coalition will also encourage FDA “to use its existing authority to protect consumers, provide guidance to manufacturers, and encourage further research for FDA-approved CBD treatments.”

Another group, the Consumer Healthcare Products Association (CHPA), launched a citizen petition to FDA last week that implores the agency to quickly develop rules for CBD so that the products can be lawfully marketed as dietary supplements.

“Intense consumer demand and commercial interest has resulted in a flood of CBD products of uncertain quality and unapproved claims already in the marketplace, and this scenario has created an urgent need for FDA action,” CHPA President Scott Melville said in a press release.

“The request in our petition seeks to have FDA utilize the authority it already has to establish a lawful regulatory pathway for manufacturers to bring dietary supplements containing CBD to market,” he said. “Only then will consumers be able to purchase CBD-containing dietary supplements in a manner that ensures product quality, safety, and a level-playing field for enforcement.”

Senators Push USDA To Adopt Five Changes To Proposed Hemp Regulations

Photo courtesy of Twitter/Senate Majority Leader.

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Senators Push USDA To Adopt Five Changes To Proposed Hemp Regulations

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Sens. Ron Wyden (D-OR) and Jeff Merkley (D-OR) sent a letter to the head of the U.S. Department of Agriculture (USDA) on Wednesday, requesting a series of changes to draft rules for hemp that the department released last month.

The senators said they appreciate that USDA issued the proposed regulations, which is a “necessary step to establish a domestic federal hemp production program.” However, they wanted to highlight “several concerns about the unintended and potentially harmful effects this interim final rule would have on hemp production in Oregon and across the country.”

In the letter to Agriculture Sec. Sonny Perdue, they listed five issues with the regulations and suggested potential fixes. Many of the concerns echoed those that stakeholders have submitted to USDA as part of a public comment period the department launched on October 31. Here’s what the senators highlighted:

—As written, the draft rules call for hemp to be tested within 15 days before harvest. Farmers have argued that’s far too little time, and the senators said it presents an “impossible obstacle for growers to overcome.” Oregon regulations require testing within 28 days, so they said USDA should adopt a similar timeline.

—USDA said that testing must be completed at a laboratory registered with the Drug Enforcement Administration. The senators said that will produce a bottleneck and delays for hemp producers, and that independent laboratories such as those operating in Oregon should be allowed to conduct the tests.

—The senators said that USDA should allow for forms of THC concentration testing that do not involve post-decarboxylation and also argued that the congressional intent of hemp legalization was not to require testing of all THC compounds but rather just delta-9 THC in particular.

—USDA requires that testing samples come from the top one-third of the flower portion of the plant. Instead, the senators said, samples should follow established protocol in states like Oregon, which stipulates that samples should be taken from the flowering tops when they’re present and be eight inches long.

—While the Farm Bill defines hemp as cannabis containing no more than 0.3 percent THC on a dry weight basis, USDA gave slight margin of error and considers any plants with more than 0.5 percent THC to be in violation of the regulations. Farmers have called that limitation arbitrary and the senators said it would be more reasonable to set the negligence threshold at 1 percent, if there must be a THC restriction at all.

“Farmers in Oregon and across the country are on the precipice of an agricultural boom that, with the right regulatory framework, stands to boost rural economies in every corner of the country,” they wrote.

Wyden and Merkley have been some of the most vocal proponents of developing USDA regulations that bolster the hemp industry since the passage of the Farm Bill, through which they worked to legalize the crop in the first place. As early as February, Wyden and Senate Majority Leader Mitch McConnell (R-KY) were knocking at USDA’s door, urging the department to expedite the rulemaking process.

Read the full senators’ letter to USDA on hemp regulations below: 

Wyden Merkley USDA Hemp Rul… by Marijuana Moment on Scribd

GOP Senator Says He Tried CBD And Jokes About Its Hair Regrowth Potential

Photo courtesy of Brendan Cleak.

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Virginia Attorney General Hosts ‘Cannabis Summit’ To Advance Reform In New Democratic Legislature

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Virginia’s attorney general is inviting state lawmakers to a “Cannabis Summit” next month as talk about advancing marijuana decriminalization and other reforms during the 2020 legislative session picks up.

Officials from other states that have legalized or decriminalized cannabis will speak at the event, as will academics who study the issue.

“This upcoming General Assembly Session policymakers will be considering legislation related to cannabis use in the Commonwealth,” an invitation states. “This summit is designed to better inform those discussions and offer perspectives from states that have implemented similar changes at the state level.”

“The summit will consist of 4 panels of experts from around the country to speak on the following topics related to cannabis policy: decriminalization of marijuana, social equity, regulating CBD & Hemp products, pathways towards legalization through legislative efforts and other topics that will better inform the upcoming legislative work,” reads the invitation sent out by the attorney general’s office, which was first reported by The Virginia Mercury.

Attorney General Mark Herring (D) said last month that the legislature will first move to pass a cannabis decriminalization bill—something that Gov. Ralph Northam (D) had campaigned on and talked about in his State of the State address.

Lawmakers will then “get to work on a larger study about how and when we could move toward legal and regulated adult use,” Herring said.

“Criminalizing marijuana possession is not working. It is needlessly creating criminals, saddling people with convictions and costing taxpayers millions each year,” the attorney general wrote in an op-ed for the Virginian-Pilot this week. “The social and human costs are tremendous, and the weight of the system falls disproportionately on African Americans and people of color. There are smarter, better ways we can handle cannabis and that begins with decriminalizing simple possession of small amounts, addressing past convictions and moving towards legal, regulated adult use.”

The chances of getting cannabis reform policies through the General Assembly significantly increased after this month’s election, which saw Democrats reclaim control of both chambers for the first time in decades.

Accordingly, a lawmaker prefiled a cannabis decriminalization bill this week that would make possession of up to one ounce of marijuana punishable by a maximum $50 civil penalty.

The announcement of the Cannabis Summit, which will take place in Richmond on December 11, is another signal that political support for reforming Virginia’s marijuana laws is strong. And while Northam has not endorsed adult-use legalization, the inclusion of that issue in panel discussions indicates that decriminalization is just the beginning of the conversation. Advocates are also pushing the state to expand its limited medical cannabis program.

“The attorney general’s public support for advancing evidence-based cannabis policy, coupled with the recent formation of the Virginia Cannabis Caucus, set the stage for a robust and unprecedented exploration of real-world experiences with decriminalization, legalization and regulation in other states,” Jenn Michelle Pedini, executive director of Virginia NORML, told The Virginia Mercury.

NORML honored Herring with its “Vanguard Award” as part of its national conference in September.

Rhode Island Governor Will Pursue Legal Marijuana In 2020

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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