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.
Advocates have been skeptical about FDA’s intent with the upcoming committee meeting, with some suspecting that it initially limited the comment period window to minimize activists’ ability to push back against a ban.
“The FDA is attacking the right of every American to make their own decisions about their health and well-being, and we have to send a strong message to the WHO to stand up against the unfair treatment of the FDA for any natural product, including kratom,” Mac Haddow, senior fellow on public policy at the AKA, said in a press release.
Kratom has been touted as a natural painkiller that works as a safer alternative to prescription opioids, but the U.S. agency doesn’t quite see it that way.
“Kratom is abused for its ability to produce opioid-like effects,” FDA wrote in a notice on the comment period last month. “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.”
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.
FDA doesn’t technically need to send the comments to the WHO committee for consideration, so AKA plans to take feedback its received and circumvent the U.S. agency by providing it to the international body.
Haddow told Marijuana Moment in a phone interview on Thursday that the group has heard from WHO representatives who’ve said the deadline for member nations to comment is September 24, so AKA is still inviting people to use its online portal to weigh in regardless of the fact that FDA closed its extended comment period on Tuesday.
“It’s clear that, even though we got the extended [comment] period, there’s no good faith here by the FDA,” Haddow said. “There’s no question where the FDA is. We could have a million comments and it won’t change them. They’re going to continue to recommend that kratom should be scheduled and banned, not only here in the United States, but globally.”
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.
Meanwhile, Thailand’s government recently ended that nation’s criminalization of kratom.
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.
Photo courtesy of Wikimedia/ThorPorre.