Now, kratom advocates suggest Washington is behind the WHO interest – an attempt to end the federal regulatory process by going the international route to complete what it failed to accomplish domestically.
The WHO Committee on Drug Addiction will do a “pre-examination” of kratom. The analysis could set the stage for the drug to come under further scrutiny by global health regulators, potentially putting it on track for scheduling as a controlled substance.
The US or WHO is programming the drug, its supporters say, would create even more obstacles to its study – such as complaints from domestic cannabis researchers who, for more than 50 years, were only allowed to study “research” marijuana cultivated by a federally approved body. establishment.
“Making it a banned substance is actually going to encourage people to use more dangerous drugs,” said Albert Perez Garcia-Romeu, a Johns Hopkins University medical school professor who studies kratom.
An FDA spokesperson said the agency would seek public comment to inform the U.S. position if the WHO recommends international controls on kratom or any other drug under consideration next week.
“Therefore, it is premature to speculate on what actions, if any, would be needed before then,” she said.
As the FDA and HHS wait to urge WHO to schedule kratom, their public comment notice reported that their botany view continues to be weak.
“Kratom is an increasingly popular drug of abuse and readily available in the recreational drug market in the United States,” the FDA said.
The FDA has long criticized kratom, warning consumers to avoid it and seizing imported supplements containing the substance. The agency has warned several distributors of kratom to market it as a treatment for opioid addiction or pain, claims that are not supported by science.
Both the Obama and Trump administrations have tried to ban kratom for withdrawal due to the drug’s broad support from its adherents in the public and members of Congress, including Sen. Cory booker (DN.J.) and former GOP Senator Orrin Hatch of Utah.
Scott Gottlieb, who served as FDA commissioner during the Trump administration, has claimed that kratom is just as dangerous as opioids, tweet in May that he is “convinced that this is fueling the crisis of opioid addiction.”
Gottlieb’s request prompted a quick rebuke by Brett Giroir, former Assistant Secretary of Health and Acting FDA commissioner during the Trump administration. Giroir rejected the FDA’s recommendation to classify kratom as a Schedule 1 controlled substance due to “embarrassing evidence and data and a failure to consider overall public health.” Giroir, in a 2018 memo, quashed the HHS recommendation to ban kratom and called for more studies and public comment.
After spending “hundreds of hours” reviewing the data, Giroir told POLITICO on Friday that he determined that listing kratom as a Schedule I drug would hamper research and potentially steer users towards options. more deadly like heroin and fentanyl.
Gottlieb did not respond to requests for comment.
Kratom gained popularity throughout the 2000s alongside the opioid crisis, Garcia-Romeu said, leading the DEA to label it a “drug of concern.” The drug is illegal in Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin, while some states like Arizona and Utah have passed laws to regulate it.
Two compounds in kratom interact with opioid receptors in the brain, which has raised concerns about whether people can become addicted to its use.
But scientists like Garcia-Romeu say that the effects of kratom are different from those of opioids, noting that the drug does not slow breathing to the extent that traditional opioids do.
“It’s a double-edged sword that has potential for abuse, but it also has medical potential,” he said.
A Garcia-Romeu survey carried out in 2017 about 2,800 self-proclaimed kratom users in the United States have been shown to be generally middle-aged and white, and use the substance to treat symptoms of anxiety, depression, pain, and withdrawal opioids. And 41% said they used kratom to wean themselves off opioids, with more than a third of that group saying they had gone without these drugs for more than a year.
“When you see something like that, the signal is, hey, you might have effective treatment here for opioid addiction,” Garcia-Romeu said.
Mac Haddow of the American Kratom Association said his group wanted the substance to be regulated as a food product so that the raw materials were tested for contaminants such as salmonella and heavy metals. FDA regulations would also require good manufacturing processes and labeling requirements, he said.
The FDA recently awarded a $ 2.3 million contract at Altasciences in Overland Park, Kan., to study the dosage of kratom to determine its potential for abuse. But under the terms of solicitation, the FDA holds the rights to all data and documentation produced by the contractor, which is subject to a confidentiality agreement.
This could allow the FDA to keep the study results a secret, Haddow said.
“We believe that science should dictate this policy,” he said.