A policy commentary on the WHO pre-review of kratom

In this policy commentary, we first take a look at the developments in Southeast Asia, where the criminalization of kratom significantly increased after Prime Minister Thaksin declared a war on drugs in Thailand in 2003.

This intensified law enforcement in the region put kratom on the radar of UNODC’s SMART programme. Yet Thailand, where repressive enforcement of the kratom ban had reached dramatic proportions following Thaksin’s drug war, moved to lift the ban in August 2021.

We then look at how kratom became an issue of concern when it was labelled a ‘New Psychoactive Substance’ (NPS) and how procedures established to expedite the scheduling process for NPS, especially UNODC’s Early Warning Advisory, propelled kratom onto the ECDD agenda.

Read the full commentary at tni.org.

What is kratom the ‘legal heroin’, how dangerous is the drug and why is it now in WHO’s cross hairs?

The herbal substance kratom, or “legal heroin”, remained largely unnoticed in Hong Kong until it was banned in August. Weeks later, customs officers seized 2.5 tonnes of the psychotropic substance, with an estimated street value of HK$6.67 million (US$856,700), being shipped from Indonesia to Florida, in the United States.

The substance is not illegal at the federal level in the US and many parts of the world, but there has been a debate for years over the need to regulate its use. Indonesia and Thailand are believed to be the largest producers, and the US, the main market.

Between October 11 and 15, the World Health Organization’s Expert Committee on Drug Dependence will meet in Geneva for a “pre-review” of kratom, a first step in assessing whether it should be added to a list of internationally controlled drugs.

The Post gets the answers to common questions about the substance now under scrutiny.

Read the full story at South China Morning Post.

A global fight looms over Kratom, a possible opioid alternative

A World Health Organization meeting next week could determine the future of kratom, a widely available herbal supplement some tout as an alternative to opioid painkillers, in the U.S. and elsewhere.

A 2017 survey of about 2,800 self-described kratom users in the U.S. showed that they’re typically middle-aged and white, and use the substance to treat the symptoms of anxiety, depression, pain and opioid withdrawal.

Kratom, a plant indigenous to Southeast Asia, produces narcotic-like effects when smoked or taken in liquid or capsule form. Its advocates say the substance is a promising replacement for opioids that could help wean people addicted to those drugs, which killed nearly 70,000 people in the U.S. in 2020.

Those claims have yet to be fully vetted by scientists. The U.S. government has twice tried to restrict kratom’s use by classifying it as a controlled substance, arguing it has high potential for abuse and no known medical benefit.

The full Politico article has more.

Lee County residents pushing to ban recreational drug

TUPELO, Miss. (WTVA) – A group of parents in Lee County are trying to keep kratom out of reach of children.

Kratom is a recreational drug that anyone can find at convenience stores or smoke shops.

Chris Hussey spoke on behalf of the group during Monday morning’s Lee County Board of Supervisors meeting.

Hussey said his 15-year-old son wasn’t the same person after he started taking kratom. A few months ago, his son disappeared in the middle of the night. Hussey and his wife found him running on the side of the road.

Hussey said he had to stop using kratom for about a week.

Sheriff Jim Johnson said he asked supervisors to ban the drug over a year ago, but they decided not to.

Read more at WTVA.

Should we aim for harm reduction or absolute safety? Herbal supplement Kratom puts FDA risk calibration to the test

Kratom Powder

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.

Kratom does appear to be far safer than all illegal and most prescription opioids: a CDC study of some 27,000 overdoses that occurred between 2016 and 2017 found that it was implicated in less than 1 percent of deaths.

Read more at Genetic Literacy Project.

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)

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.

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.

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.

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.

Ex-FDA Head Falsely Claims Kratom Is “Fueling” the Overdose Crisis

Drug warriors have long deployed disinformation to justify panics and crackdowns. Kratom, an unregulated plant-based product used by many to manage opioid consumption and withdrawals, has not been spared.

On May 21, former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb spread a baseless claim on social media with a call to criminalize kratom consumers and obstruct access for people with opioid use disorder (OUD).

“I’m convinced [kratom is] fueling the opioid addiction crisis,” Gottlieb posted on Twitter, followed by a call for the Biden Administration to finish the Drug Enforcement Administration’s (DEA) 2016 scheduling effort that failed in the face of consumer advocacy and public opposition. 

Dr. Gottlieb’s statement came in response to a series of tweets by both the official FDA account and that of the agency’s current acting commissioner, Dr. Janet Woodcock.

Read the full article at Filter Mag

Kratom no longer on drugs list

The Kratom plant has been removed from a list of narcotics listed under the amended Narcotics Act.

Justice Minister Somsak Thepsutin said the Act has been modified and the new version was published in the Royal Gazette on Wednesday to annul the plant’s narcotics status.

The amendment will take effect on Aug 24, Mr Somsak said.

He thanked the organisations involved in pushing for the plant’s removal from the list, noting Kratom is a part of local people’s lifestyle.

However, cultivation of the plant will still be restricted until a new law to regulate kratom plantations is enacted, the justice minister said.

He said this legislation, also known as the Kratom Law, will detail how the plant is allowed to be used.

Keep reading at MSN

A Twitter Tiff Between Former Federal Health Officials Highlights the Weakness of the Case for Banning Kratom

Scott Gottlieb, former head of the Food and Drug Administration (FDA), says he is “convinced” that kratom, a pain-relieving leaf from Southeast Asia, is “fueling the opioid addiction crisis.” To the contrary, kratom enthusiasts argue, the plant is “the cure for the opioid epidemic.”

There is not much evidence to support either position. But as a recent Twitter tiff between Gottlieb and former Assistant Secretary for Health Brett Giroir shows, the argument about whether the federal government should ban kratom hinges on the question of where the burden of proof belongs.

Gottlieb seems to think any potentially dangerous psychoactive substance should be banned unless it meets the FDA’s strict criteria for approval as a medicine. If a drug is not explicitly permitted, in other words, it should be prohibited by default.

Continue reading at reason.com

U.S. Marshals seized more than 207,000 units of adulterated dietary supplements containing kratom

The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom. The dietary supplements are manufactured by Atofil, LLC, which is located in Fort Myers, Florida, and is a subsidiary of Premier Manufacturing Products. The dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo. The seized products are worth approximately $1.3 million.

There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse. The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”

Keep reading at news-medical.net