The Fight for Botanicals

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.

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 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.

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.

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.

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.

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.

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.

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.