Kratom consumers oppose ban in comments to FDAKratom consumers oppose ban in comments to FDA
An expert committee of the World Health Organization will meet next month in Geneva to conduct a pre-review of kratom and its constituents. The pre-review is the first step in a process that could lead to the plant being scheduled as a drug internationally.
September 22, 2021
Many of their stories are similar. Homeless and hooked on heroin. Suffering from chronic pain and addicted to opioids. Unemployed with a grim outlook for the future.
Until these consumers started using a botanical native to Southeast Asia: kratom.
In response to a Federal Register notice related to an upcoming meeting of the World Health Organization (WHO), one man named Abe Stewart wrote to FDA that he suffered from “chronic pain” and turned to opioids.
“I became addicted, I lost my home and my job, and I was homeless for years dealing with an opioid addiction,” he shared. “Kratom not only [helped] me get over that addiction, but it also helps me deal with the pain so I can be a functioning member of society. Without this plant in my life, the pain would be so horrific that it would not be worth living.”
Stewart is among scores of consumers seeking to preserve access to kratom in the U.S. amid concerns over an international ban of the plant.
WHO pre-review of kratom
In October, the WHO’s 44th Expert Committee on Drug Dependence (ECDD) will meet in Geneva to review the potential of certain substances to cause abuse, dependence and harm to health, as well as any therapeutic applications. Among other items on the agenda during the Oct. 11-15 meeting, the ECDD will conduct a pre-review of kratom and its constituents, mitragynine and 7-hydroxymitragynine, to determine whether current information justifies a critical review.
“The pre-review process determines basically whether sufficient evidence exists to bring the substance before the [Expert] Committee on Drug Dependence for a formal review,” explained Robert Hoban, a Denver-based member with the law firm Clark Hill PLLC.
Kratom advocates fear a worst-case scenario: That the U.N. Commission on Narcotic Drugs (CND) will “schedule” (as a drug) kratom internationally, requiring dozens of countries—including the U.S.—who are parties to the 1971 Convention on Psychotropic Substances to ban the substance.
An international ban on kratom isn’t expected to occur anytime soon. The entire process could take two to five years, Hoban said, with the U.S. eventually modifying the Controlled Substances Act (CSA).
Either DEA or FDA, or both agencies, “would create a temporary scheduling, which would then go through a scheduling process, but it would not require congressional action,” the lawyer added during an interview.
The secretariat of WHO’s ECDD explained the implications if CND ultimately votes to add kratom to the list of substances under international control.
“Scheduling a substance would place reporting requirements on countries in order to regulate the manufacturing, distribution and trade of a psychoactive substance,” the secretariat told Natural Products Insider via email. “The exact reporting requirements would depend on how the substance is scheduled, for example, as a psychotropic substance or as a narcotic drug, and also the degree of scheduling, which balances the harms to health presented by the drug as well as its need for therapeutic use.”
The secretariat added, “While the recommendations for international control from WHO are based on the health effects of a substance in relation to its risks to public health and therapeutic uses, the CND may also consider social, economic, administrative and other matters when deciding whether to place a drug under international control.”
Life before kratom
In comments submitted in response to FDA’s July Federal Register notice, Cecelia Lore said kratom saved her from a “lifetime” of opioid addiction. She added she was “unemployable” at the age of 45 and on her “way to prison or death.”
She said she has been using kratom for three years, has held a job at a hospital and is attending college full time.
“I [physically] or mentally would never have been able to do this without the stability kratom gave me,” Lore wrote.
FDA has received many first-person accounts regarding kratom’s purported benefits. The American Kratom Association (AKA) has submitted nearly 52,000 comments to FDA, Mac Haddow, AKA’s senior fellow on public policy, said in a Sept. 2 email.
According to regulations.gov, FDA has received more than 70,000 comments in response to its Federal Register notice. In addition to kratom, the notice also announced other substances that will be subject to “critical” or pre-reviews by WHO during the October meeting.
AKA isn’t trusting FDA will forward all the public comments to WHO.
“FDA has maintained that they have no statutory obligation to do anything but collect comments, and then to ‘consider them,’ and I don’t think that means that they pay much attention to them at all,” Haddow said.
He added AKA plans to submit all its comments directly to WHO for its review, and he expects the final number of comments to total around 75,000.
Haddow in recent years has lobbied aggressively to promote access to safe, regulated kratom products. In a recent update of a 2018 article examining kratom’s abuse potential, Jack Henningfield, Ph.D., and his colleagues at PinneyAssociates, a regulatory consulting firm, refuted the idea that kratom presents a looming threat to public health.
PinneyAssociates developed the paper for AKA to inform policy makers and others about kratom’s safety and abuse potential.
“Evidence does not support the conclusion that kratom is an imminent public health threat or that it is fueling the opioid and drug overdose epidemic that led to more than 93,000 deaths in 2020,” PinneyAssociates wrote in the Aug. 6 update.
Since 2018, experts have led more than 100 new peer-reviewed published studies that add to the body of scientific evidence about kratom and its alkaloids, according to PinneyAssociates.
“These studies provide a much fuller characterization of how kratom works and how it provides the benefits that many people report as their reason for use, but without narcotic-like addiction and overdose risks,” PinneyAssociates concluded.
FDA has an entirely different perspective. In the Federal Register notice regarding the upcoming WHO meeting, FDA described kratom as a substance “abused for its ability to produce opioid-like effects.”
“In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms,” the Federal Register notice stated. “Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been reported to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.”
In 2017, FDA’s then-commissioner, physician Scott Gottlieb, reported “mounting concerns regarding risks associated with use of kratom," and he questioned whether use of kratom could “expand" the nation’s opioid epidemic.
The prior year, DEA had announced its intent to temporarily place kratom’s primary active ingredients mitragynine and 7-hydroxymitragynine on the Schedule I (high potential for abuse and no currently accepted medical use) list under the CSA. But the agency subsequently withdrew its notice in response to an outcry from Congress and the public.
Haddow maintains FDA harbors a bias against kratom not rooted in science.
“The FDA’s been wrong on the science from the get-go,” he proclaimed during a press conference this summer. “They just won’t acknowledge the error, and they continue to double down on their anti-kratom position.”
He added in a video, “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.”
Mitragynine ‘abuse liability’
When asked for this article about government bodies or private entities that conveyed to WHO concerns regarding kratom and its alkaloids, the ECDD secretariat responded, “Kratom has been under ECDD surveillance since 2020 due to country-level reports of the abuse liability of its main psychoactive ingredient, mitragynine, and from an international [organization] reporting fatalities.”
The secretariat added in an email, “A pre-review was initiated following a proposal with supporting information regarding fatalities due to kratom use provided by an international [organization].”
The secretariat’s email did not identify the specific international group reporting the fatalities associated with use of kratom.
AKA has maintained kratom itself is not to blame for many fatalities associated with the plant. For instance, the association points to kratom products that are adulterated with potentially harmful substances, highlighting the need for regulation.
Implications of international ban
Even though kratom isn’t currently scheduled as a controlled substance in the U.S., firms already face hurdles importing the plant into the U.S., observed Garrett Graff, an attorney with the law firm Moye White LLP. An FDA import alert has been in effect for years regarding supplements and bulk dietary ingredients containing kratom.
Graff conceded an international ban on kratom would present “additional complications,” but he doesn’t foresee it would entirely eliminate the industry. For instance, he pointed to WHO member countries that have not enforced against the international control of cannabis based on the 1961 Single Convention on Narcotic Drugs.
However, it’s clear kratom consumers don’t want to be subject to the whims of government in the U.S. or abroad. Terri Spink, a woman who described herself as a “bone cancer patient who also suffers from anxiety and depression,” is among those opposed to subjecting kratom to drug controls.
She said kratom has enabled her to be a “good wife, mother and grandmother.” A ban on the plant, she warned, would force her to return to using “medications that make me a walking zombie and not want to participate in my own life.”
“Please do not ban this amazing plant,” Spink wrote to FDA. “Regulate it but don’t ban it.”
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