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

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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.”

Responses to the notice will help inform the federal government’s stance on kratom scheduling in advance of an October meeting of the World Health Organization’s (WHO) Expert Committee on Drug Dependence, where international officials will discuss whether to recommend the substance be globally scheduled.

“The FDA’s request for public comments on a matter of such importance involving the international scheduling of kratom is an extraordinary abuse of their authority,” Mac Haddow, senior fellow of public policy at the American Kratom Association (AKA), told Marijuana Moment.

He said the August 9 deadline for the responses allows “only three weeks for scientists, public policy makers and consumers to provide responses that are well researched and responsive to the complex requirements for data and information that will be considered by the WHO Expert Committee” and is therefore “unacceptable.”

As it stands, kratom is not scheduled under the federal Controlled Substances Act or under international drug treaties to which the U.S. is a party. But some advocates suspect that since FDA has been unable so far to impose a ban on kratom domestically, it may use the WHO convention as an opportunity to get prohibition enacted internationally, a move that the country would be compelled to comply with.

“If that happens, there are 37 countries that are part of that international treaty that will effectively ban kratom around the world,” Haddow said in a recent video update to supporters. “The FDA cannot get kratom scheduled here in the United States using the criteria that’s established by the Controlled Substances Act, so they’re circumventing that and going to the WHO.”

Haddow encouraged people to take advantage of the public comment period—but to remember that WHO is the target audience for those comment, not FDA.

“We want thousands of people to comment because every one of those comments will have to be packaged up and sent to the World Health Organization,” he said. “We don’t want people complaining about the FDA overreach because we can fight that battle on a separate battleground, but we want the WHO to know the powerful experiences that people have had” with kratom.

FDA, in its Federal Register notice, said the comments “will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs.”

Haddow told Marijuana Moment that the federal agency “is prosecuting a war on kratom to criminalize more than 15 million Americans, and they ignore the public health impacts of kratom consumers being forced to opioids with a high potential for addiction and that can be deadly.”

“More overdose deaths will occur if kratom is banned, and that is exactly what the FDA is trying to do,” he said.

On the domestic level, the House Appropriations Committee recently approved a report to spending legislation that says federal health agencies have “contributed to the continued understanding of the health impacts of kratom, including its constituent compounds, mitragynine and 7-hydroxymitragynine.”

“The Committee is aware of the potential promising results of kratom for acute and chronic pain patients who seek safer alternatives to sometimes dangerously addictive and potentially deadly prescription opioids and of research investigating the use of kratom’s constituent compounds for opioid use disorder,” it said.

It also directed the Health and Human Services secretary to continue to refrain from recommending that kratom be controlled in Schedule I.

Late last year, the Agency for Healthcare Research and Quality (AHRQ) asked the public to help identify research that specifically looks at the risks and benefits of cannabinoids and kratom.

The Centers for Disease Control and Prevention (CDC) last year separately received more than one thousand comments concerning kratom as part of another public solicitation.

FDA has on several occasions solicited public input to shape the government’s position on the international scheduling of marijuana and cannabinoids. The agency initially requested feedback on the proposal in March 2019 and then reopened that comment period five months later.

Last year, the United Nations approved a U.S.-backed WHO recommendation to remove marijuana from the most restrictive global scheduling category. However, the U.S. opposed several other cannabis reform proposals, including the one to clarify that CBD is not under international control.

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Photo courtesy of Wikimedia/ThorPorre.

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