Now kratom proponents are suggesting that Washington stands behind WHO’s interests – an attempt to end the federal regulatory process by taking the international route to end what it could not achieve domestically.
The WHO Drug Addiction Committee will conduct a “pre-screening” of kratom. The analysis could set the stage for the drug to undergo further review by global health authorities and potentially move on to planning as a controlled substance.
The drug’s planning by the US or the WHO, its proponents say, would create even more obstacles to its research – much like complaints from local cannabis researchers who were only allowed to study “research-quality” marijuana, provided by a government, for more than 50 years Approved plant was grown facility.
“Making this a banned substance will actually encourage people to use more dangerous drugs,” said Albert Perez Garcia-Romeu, a professor at Johns Hopkins University School of Medicine who studies kratom.
An FDA spokesman said the agency would seek public comment to inform the US position if the WHO recommends international controls of kratom or any other drug under consideration next week.
“It is therefore premature to speculate what, if any, action will be needed before this point,” she said.
While the FDA and HHS aren’t asking WHO to plan for kratom, they have theirs public comment signals that her view of the botanical is still cloudy.
“Kratom is an increasingly popular drug of abuse and is readily available in the recreational drug market in the United States,” said the FDA.
The FDA has long been critical of kratom, warning consumers to avoid it, and seizing imported supplements containing the substance. The agency has announced several kratom distributors marketing it as a treatment for opioid addiction or pain, claims that are not backed by science.
Both the Obama and Trump administrations attempted to ban kratom, only to protest because of the widespread support for the drug from its supporters in the public and from members of Congress, including Sen. Cory Booker (DN.J.) and former Utah GOP Senator Orrin Hatch.
Scott Gottlieb, who served as FDA commissioner during the Trump administration, has claimed that kratom is just as dangerous as opioids. Twitter in May that he “believes it is fueling the opioid addiction crisis”.
Gottlieb’s claim prompted a quick reprimand 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 List 1 controlled substance “because of embarrassingly poor evidence and data and failure to consider general public health.” Giroir, in a 2018 memo, overturned 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 noted that listing kratom as a List I drug is hindering research and potentially leading users to more deadly options like heroin and more Fentanyl would lead.
Gottlieb did not respond to requests for comments.
Kratom grew in popularity in the 2000s along with 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 laws in place to regulate it.
Two compounds in kratom interact with the brain’s opioid receptors, raising concerns about whether people might become dependent on its use.
However, scientists like Garcia-Romeu say kratom’s effects are different from opioids, noting that the drug doesn’t slow breathing as much as traditional opioids do.
“It’s a double-edged sword with abuse potential, but also medicinal potential,” he said.
A Garcia-Romeu survey carried out in 2017 of approximately 2,800 self-reported kratom users in the US showed that they are typically middle-aged, white and use the substance to treat symptoms of anxiety, depression, pain, and opioid withdrawal. And 41 percent said they used kratom to wean themselves off opioids, with more than a third of that group saying they stopped taking these drugs for more than a year.
“When you see something like this, it is a signal that you may have an effective treatment for opioid addiction here,” said Garcia-Romeu.
Mac Haddow of the American Kratom Association says his group would like the substance to be regulated as a food so that the raw materials can be tested for contaminants like salmonella and heavy metals. FDA regulation would also require good manufacturing processes and labeling requirements, he said.
The FDA recently awarded a $ 2.3 million contract to Altasciences in Overland Park, Kan. to study the dosage of kratom to determine its potential for abuse. But under that Conditions of the solicitation, the FDA has the rights to all data and documents created by the contractor that are subject to a confidentiality agreement.
That could allow the FDA to keep the results of the study under wraps, Haddow said.
“We believe science should dictate these policies,” he said.