FDA’s Suspected Push for Global Kratom Ban Rattles Advocates

Despite Thailand’s recent legalization of kratom—swiftly following the country’s decriminalization earlier this year—international kratom advocacy’s momentum is facing stern resistance from the United States Food and Drug Administration.

The FDA has made no secret of its attitude to the plant, following numerous attempts to schedule it as a federally illegal substance in recent years. Dr. Scott Gottlieb, the agency’s former commissioner, even groundlessly blamed kratom for “fueling the opioid addiction crisis” this past spring. While the failures of attempts at federal scheduling have represented victories for kratom advocacy, it doesn’t mean the FDA is slowing down.

In late July, the FDA publicly announced that it will be gathering feedback from the US public as part of an effort to compile data on kratom.

Continue at Filter.

Kratom Activists Send Tens Of Thousands Of Comments Telling FDA To Oppose Possible International Ban

Kratom advocates have rallied tens of thousands of people to submit comments to the Food and Drug Administration (FDA) that will help inform the U.S. position on how the substance should be classified under international law.

In October, the World Health Organization’s (WHO) Expert Committee on Drug Dependence will discuss whether to recommend that kratom be globally scheduled. While FDA opened a public comment period for input that was set to end on August 9, the American Kratom Association (AKA) successfully sued for an extension that ended this week.

With those extra weeks for input, AKA’s online activist portal managed to get more than 63,000 people to share their experiences, scientific literature and recommendations encouraging the U.S. to oppose an international ban. FDA itself has logged about 26,000 comments that were directly sent in through the federal government’s own submission site.

Read more at Marijuana Moment.

FDA Should Regulate Kratom, Not Ban It; Trauma And Its Physical Effect On The Body

Opinion writers weigh in on kratom, trauma, prescription drug costs and price transparency.

Stat: Proposed Kratom Ban Would Harm The Public, Damage FDA’s CredibilityTrust in the U.S. Food and Drug Administration (FDA) declined after its approval of the controversial Alzheimer’s drug aducanumab. Three experts resigned amid allegations that the FDA had caved to industry pressure. Some argue that its credibility has reached a new low. These events should have prompted the FDA to pause, reflect, and work to repair its reputation. Instead, the agency is forging ahead with actions that may further erode its credibility. A timely example is its position on Mitragyna speciosa, commonly called kratom, a tree related to coffee plants. (Mason Marks, 8/23)

Talking the Future of Magic Mushrooms and Their Therapeutic Uses

Marijuana was legalized in Canada just a few years back and we are certain there are not too many who are truly upset with this. Psilocybin, however, the chemical compound found in “magic mushrooms”, is still illegal. It has been since 1974. This needs to change.

Enter Spencer Hawkswell. He’s the CEO of a new Victoria based non-profit called TheraPsil. He helped co-found this venture with his friend and mentor Dr. Bruce Tobin, a psychotherapist. Together they’ve helped a small group of Canadians in their time of need, specifically end of life treatment.

In doing so they’ve given those individuals at this time a new medicine with which to work with, one that isn’t addictive and completely natural. The results have been life changing. They want to help all Canadians, but until Health Canada changes the law regarding the manufacture, production and use of psilocybin, their hands are largely tied.

Read more at Scout Magazine.

The FDA Shouldn’t Support a Ban on Kratom

In ordinary times, there would be no question about whether a drug with opioidlike effects should be proven safe and effective and approved by the Food and Drug Administration (FDA) before it is widely marketed. But these aren’t ordinary times and the herbal supplement kratom is not a typical drug.

In fact, the issue of whether or not to ban kratom is an excellent litmus test of whether the Biden administration will actually use the philosophy of harm reduction to guide drug policy—or just spout the trendy catchphrase as window dressing to hide ongoing engagement in the war on drugs.

An estimated 10–16 million Americans currently use kratom as an alternative to opioids, most commonly to treat pain or as a substitute for street drugs. The herb, formally known as Mitrogyna speciosa, has a centuries-long history of use in herbal medicine in Southeast Asia—notably as a substitute for opium.

Read the full article at Scientific American.

What to know about the booming psychedelics industry, where companies are racing to turn magic mushrooms and MDMA into approved medicines

The psychedelics space is booming.

Over the past year, startups focused on turning psychedelic compounds into approved medicines have raised hundreds of millions of dollars from private investors and dozens have gone public.

Research on compounds like psilocybin, the active compound found in magic mushrooms, and MDMA is resurfacing after years of neglect amid the war on drugs.

Here’s a look at the booming psychedelics industry:

VCs have deployed millions into psychedelics startups – here’s what they say will happen next

Venture-capital investors have been at the center of the psychedelics boom. In early 2020, startups in the space said they were beginning to see signs that investor appetite was growing.

Then, we saw a flurry of activity, which one industry exec called a “psychedelic renaissance.”

Soon, VC firms focused on psychedelics companies specifically began to emerge.

Read more at Business Insider via MSN.

FDA Gathers Public Comment on Looming Global Kratom Ban

Should kratom be banned on a global scale? Published in the Federal Register on July 23, the U.S. Food and Drug Administration (FDA) is now seeking public comment to inform the U.S. position on how the plant should be scheduled under international statute.

Public comment will help inform the FDA’s position on kratom regulation ahead of an October meeting of the World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD), where international officials will discuss whether to recommend the substance be globally scheduled.

Kratom and its two active compounds—mitragynine and 7-hydroxymitragynine—are in pre-review status, according to WHO. The pre-review process determines if there is sufficient evidence to bring the substance before the ECDD for a formal review; “findings at this stage should not determine whether the control status of a substance should be changed,” according to the WHO notification.

Read more at High Times.

Oregon Gov. Kate Brown plans to veto bills related to mental health oversight, kratom sales

Gov. Kate Brown intends to veto two bills approved during the recent Oregon Legislature session.

Brown’s office announced Sunday that she will reject Senate Bill 721. It changes the way members are selected for a consumer advisory council that helps the Oregon Health Authority deal with mental health and substance abuse. The bill would allow members of the advisory council to select future members and refines its advisory role in an attempt to ensure consumers have a voice in how mental health and substance abuse policies are crafted and enforced.

The governor’s office says the legislation is well intentioned, but contradicts federal law, which prohibits the Oregon Health Authority from delegating its responsibility over implementing Medicaid policies.

Sponsors plan to submit a revised bill.

Read more at OPB.org.

FDA Seeks Public Input On Possible Global Kratom Ban After Domestic Scheduling Effort Stalled

After failing to get kratom prohibited domestically, the Food and Drug Administration (FDA) is now seeking public comment to inform the U.S. position on how the substance should be scheduled under international statute.

In a notice published in the Federal Register last week, the agency is soliciting feedback on a number of substances. But advocates are especially concerned about where FDA and global drug officials come down on kratom, which has been touted as a natural painkiller that works as a safer alternative to prescription opioids.

The U.S. agency doesn’t quite see it that way, however.

“Kratom is abused for its ability to produce opioid-like effects,” FDA wrote in the notice. “Kratom is available in several different forms to include dried/crushed leaves, powder, capsules, tablets, liquids, and gum/ resin. Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States.”

Read more at marijuanamoment.net.

Why some Mass. communities are moving to decriminalize psychedelics

As evidence of the medicinal value of psychedelics grows, advocates and legislators are pushing to decriminalize and eventually legalize these long-used natural substances.

Since February, Cambridge, Somerville, and Northampton have passed resolutions decriminalizing entheogenic plants, a family of natural sources containing certain psychoactive compounds. Examples include peyote (a species of cacti), psychedelic mushrooms (which contain the hallucinogen psilocybin), and ayahuasca.

Oakland, California, did it first: in 2019, the City Council passed a resolution effectively decriminalizing entheogenic plants. In 2020, Oregon voters passed a ballot measure giving the state health authority two years to develop a program where adults can purchase and consume psilocybin products under supervision at a service center.

Though in the U.S., these substances famously grew in popularity in the 1960s and 70s, indigenous cultures across the Americas have used them for remedial and spiritual purposes for hundreds of years.

Keep reading at Boston.com via MSN.

N.J. has dismissed 88K weed cases under new marijuana law

ew Jersey has vacated or dismissed tens of thousands of marijuana convictions as the state continues to work out the details of its new legal cannabis market.

The state Judiciary has dealt with 88,000 cases so far, it announced Monday evening. These are the first wave of an estimated 360,000 identified that qualify for expungement.

Cases that have been vacated or dismissed still need to be expunged. That’s the step that ultimately clears a person’s record. That phase will come in the next few months, according to the judiciary.

A state Supreme Court order issued earlier this month laid out a process for vacating, expunging and dismissing certain marijuana offenses from people’s records. These include selling less than one ounce of marijuana and possession, as well as related crimes like possession of drug paraphernalia, being under the influence, failing to turn over marijuana or being or possessing marijuana while in vehicle.

Read the full story at NJ.com.

MAGIC MUSHROOMS could work as antidepressant, study finds

A psychedelic drug found in mushrooms could work as an antidepressant, new research shows.

Psilocybin, a compound that naturally occurs in some mushrooms, may be able to increase the long-lasting connections between neurons in the brain by 10 percent.

A research team from Yale University believes these connections can reduce the effects of depression on a person.

The study, which will be published in the journal Neuron on Monday, also found that the strength of neuron connections increases as well.

‘We not only saw a 10 percent increase in the number of neuronal connections, but also they were on average about 10 percent larger, so the connections were stronger as well,’ Alex Kwan, senior author of the study and associate professor of psychiatry and of neuroscience at Yale.

Keep reading at The Daily Mail UK.

Kratom Controversy — What is kratom?

Kratom products are sold everywhere from smoke shops to gas stations, and even specialized stores.

Proponents of the herbal supplement claim it can help with a lack of energy, focus or even a natural alternative to pain medication and opioids but the Federal Drug Administration (FDA) doesn’t agree and is warning people not to buy it.

Grown mainly in southeast Asia, kratom looks like an average house plant. Mac Haddow, with the American Kratom Association says the plant can be used for a number of health reasons.

“It has been used there for centuries by mostly laborers who would pick the leaves from the trees which grow everywhere,” Haddow said. “They would chew on him for an energy boost and increase focus and some, because of the long hot days they were working, would use it in order to as an analgesic to relieve pain”.

Read more at CBS19.

Magic mushrooms, other psychedelics would be decriminalized in California under proposed legislation

California could become the second state to decriminalize magic mushrooms and other psychedelics.

SB 519, a bill that would decriminalize the possession and sharing of certain psychedelics by people 21 or older, is gaining momentum.

The measure has cleared the state Senate, and an Assembly hearing is set for Tuesday.

State Sen. Scott Wiener, D-San Francisco, who authored the bill, said research indicates that psychedelics help with mental health.

He also said it’s time to stop criminal-justice policies that target people of color.

“The racist war on drugs, which has fueled mass incarceration and torn apart communities — particularly communities of color — has not made us any safer,” Wiener said. “For 50 years, the war on drugs has not made us safer. We have incarcerated as many people as possible, and we have had no benefit.”

Read more at ABC7

Campaign for legal kratom use nears goal

After being listed as an illegal narcotic for many decades, Thais will finally be allowed to use and own Mitragyna speciosa, also known as kratom, as traditional medicine by August this year.

On May 28, an announcement was made in the Royal Gazette which effectively removed the plant from the list of narcotics. As new laws take effect 90 days after their publication in the Gazette, kratom use and possession will be effectively decriminalised on Aug 24.

Prior to its decriminalisation, kratom was categorised as a Class 5 Narcotic substance under the Narcotics Act, which made consuming, cultivating and possessing any part of the plant illegal.

Justice Minister, Somsak Thepsutin, said the move the regulate kratom does not end with its decriminalisation, as the parliament is now working on new laws to manage and control the cultivation and use of the plant.

Read more at the Bangkok Post.

Company contests FDA’s position in lawsuit that kratom is an NDI

A firm linked to a government seizure of $1.3 million in kratom products denied in federal court that the botanical is a new dietary ingredient (NDI).

The “affirmative defense” raised by MT Brands LLC asserts the “articles” seized were marketed in the U.S. before Oct. 15, 1994.

Dietary ingredients marketed before the above date are not subject to a notification requirement in the law to demonstrate their safety to FDA.

For several years, FDA has raised concerns over kratom, a botanical from Southeast Asia which has long been the subject of an import alert. Although several companies aiming to lawfully market kratom in dietary supplements have submitted to FDA premarket NDI notifications, the agency has essentially rejected all of them, citing safety concerns and other considerations.

Read more at Natural Products Insider.

Thailand: Kratom officially removed from being Category V Narcotics and draft Kratom Act to be presented to Parliament

By way of background, kratom (Mitragyna speciosa (Korth.) Havil.) is a tropical tree with opioid properties and some stimulant-like effects, and was previously controlled under the Narcotics Act due to these properties and effects.

On 26 May 2021, the Amendment to the Narcotics Act (the “Amendment”) was published in the Government Gazette. The Amendment, once effective after 90 days from its publication, will remove kratom from being Category V Narcotics. The rationale behind this Amendment is to make the regulation of kratom in line with the position of the Single Convention on Narcotic Drugs of 1961, as amended, and the local customs in some areas where kratom is consumed.

Following the removal of kratom from the list of Category V Narcotics, on 1 June 2021, the Cabinet approved the amended draft of the Kratom Act to be considered for presentation to the Parliament.

Read the full story at lexology.com.

What if Seattle decriminalized magic mushrooms? City Council wants to explore that

The Seattle City Council is asking a drug overdose and recovery panel to explore the potential liberalization of local policies on psychedelics like magic mushrooms, citing their potential for treating addiction and mental health conditions.

Seven council members Monday signed a letter to the Overdose Emergency and Innovative Recovery Task Force, which will launch soon in King County.

The panel led by Black Lives Matter Seattle-King County and VOCAL Washington plans to reconsider how governments and communities can reduce overdoses, racial inequities in drug-user health and criminal-legal system challenges, representatives say.

The task force will delve into questions related to psychedelic medicines, also known as entheogens, among many other topics, said Malika Lamont, program director for VOCAL-WA, an advocacy organization that focuses on the war on drugs, homelessness, mass incarceration and HIV/AIDS. Entheogens include substances like psilocybin, ayahuasca and ibogaine.

Read more at Seattle Times.

House GOP Leader Says Pot Bill Is ‘Tainted,’ Vote Must Wait

With the Connecticut House of Representatives poised to take up a long-awaited bill that would legalize recreational marijuana for adults, the Republican leader on Tuesday called for an investigation into how language was tucked into the legislation that could have intentionally benefitted at least one individual.

House Minority Leader Vincent Candelora, R-North Branford, said the closed-door process that led to the massive, nearly 300-page bill is “tainted,” and the House should not proceed with a vote during the remaining hours of the regular General Assembly session, which adjourns at midnight on Wednesday. The bill narrowly passed the Senate early Tuesday after the contentious provision was stripped.

“It is so tarnished that the House of Representatives should not be taking up this bill,” Candelora said. “And frankly, there should be an investigation in the governor’s office and in the Democrats offices on how this provision came to be.”

Read the full story at usnews.com.

Why Is Ottawa Stalling Proven Magic Mushroom Therapy for the Dying?

For many, COVID-19 has made one day blur into the next and each month merge with another in a sameness that’s different from the pre-pandemic feeling of time passing.

But there are some who are never untethered from clocks and calendars as they confront something far more personally profound than even COVID-19.

They cope with terminal illness, and the existential grief and anxiety that comes with an end-of-life diagnosis.

Last year I wrote about what seemed to be enlightenment and compassion from the federal health minister. Patty Hajdu used her authority under Section 56 of Canada’s Controlled Drugs and Substances Act to grant legal access to psilocybin for terminal patients. In at least one case Hajdu gave the exemption to a woman with a crippling life-long mental illness.

Read the full story at thetyee.ca