WASHINGTON — The Department of Health and Human Services has recommended a ban on the chemicals in kratom that would make the popular herbal supplement as illegal as heroin or LSD, according to documents obtained by STAT.
HHS asserted in a letter to the Drug Enforcement Administration that two chemicals in kratom should be classified as Schedule I substances, meaning that the chemicals have “a high potential for abuse” and that there is “no currently accepted medical use” for them. The letter was accompanied by a supporting analysis.
Should the DEA make such a ruling, anyone who buys, sells, or uses the substances might face steep punishments, like prison sentences, and anyone who wants to do research with the chemicals would need to obtain special permission from the the DEA. Specific penalties would depend on state and federal laws that are often related to the DEA’s scheduling decisions — so possession of kratom might be treated differently than LSD, for example.
In interviews with STAT, several scientists expressed concerns that such a ban would stifle research on chemicals that could be developed into alternatives to the addictive prescription opioids that kill tens of thousands of Americans each year. They said banning kratom would harm people who are currently using the substance.
People have been using kratom, a plant from Southeast Asia, to treat pain and other conditions, and to wean off opioids. It is not approved by the Food and Drug Administration, and that agency has led an aggressive crackdown on the plant, halting some imports and reprimanding companies for claiming that the substance has medical benefits.
The recommendation in the documents is in keeping with past public statements from leading federal officials, including FDA Commissioner Scott Gottlieb, but it is the first indication of the agency’s position on scheduling the chemicals in kratom. Gottlieb has said that kratom is “an opioid” and has been “associated” with dozens of deaths.
“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids,” Gottlieb said in a statement in February. He added, “There is no evidence to indicate that kratom is safe or effective for any medical use.”
Now, it’s up to the DEA to decide whether or not the chemicals should be placed on Schedule 1. DEA spokesperson Katherine Pfaff declined to say when this might happen, and said the process can take “months to years.” Members of the public would have some time to appeal the decision, or make comments, before the decision is finalized.
“The medical and scientific evaluation that HHS provides to DEA is a crucial document in the process,” Pfaff said.
DEA spokesperson Rusty Payne declined to say whether the agency typically follows HHS recommendations like the one in the documents STAT obtained. He said it would take days to pull those statistics. But Payne said that HHS does have the power to prevent a substance from being scheduled. “If they say no, we’re bound by that,” Payne said.
Scientists and kratom advocates warn that banning kratom outright will only harm people, especially people who are using kratom instead of stronger painkillers.
“I have major concerns about just pulling the rug out from under tens of thousands of people who are using this to support their health, especially in the case of people who are using it to stay off of more dangerous opioids,” said Andrew Kruegel, a Columbia University associate research scientist in chemistry, who has studied kratom. A Washington-based group that opposes a kratom ban, the Drug Policy Alliance, paid to fly Kruegel to D.C. twice this year to discuss this issue with Congress, he said.
Some states have already banned kratom, but it’s currently legal at the federal level. It’s sold in different forms, including dry powder and capsules. According to the American Kratom Association, millions of Americans use the substance. Pete Candland, executive director of the association, said this is the organization’s “best estimate,” but did not provide a specific source.
The federal government has been contemplating tougher regulation for years. In 2016, the DEA tried to ban the chemicals in kratom, but reversed course after severe backlash from kratom users and members of Congress. DEA then solicited the advice of the FDA on how to proceed.
STAT obtained the document through a Freedom of Information Act request sent in March to the DEA. The DEA routed the request to HHS. HHS provided a document that appears to be missing some pages but included the department’s recommendation.
An HHS spokesperson declined to provide the complete document and said the original document was provided to STAT in error.
“This document was inadvertently disclosed and should have been withheld as it is part of a pre-decisional, deliberative process rightfully protected by the Freedom of Information Act and implementing regulations,” said HHS spokesperson Caitlin Oakley. “That deliberative process is still ongoing, and therefore we have nothing further to add.”
In the letter letter dated Oct. 17, 2017, HHS sent a recommendation, which, according to the letter, is supported by the FDA as well as the National Institute on Drug Abuse at the National Institutes of Health. The recommendation: put the chemicals in kratom on Schedule 1.
Not only would the move make it illegal to buy, sell, or use the substances, but it would also make it more difficult for researchers to study kratom, because they would need to obtain permission from the DEA to work with the substance, scientists said.
“Me and my colleagues and other collaborators who are already working on it would probably find a way to continue, but anyone new who was looking at that would probably say, ‘forget it,’” Kruegel said.
Payne said that 692 scientists currently have permission to do research on Schedule 1 substances, and that about three-quarters of them are working with marijuana or related substances.
“I understand that people would rather not have to deal with bureaucracy, but it’s our job to keep the public safe, and you can’t just have controlled substances running around, especially Schedule 1, being handled by non-registrants with no oversight,” Payne said.
Dr. Alicia Lydecker, an emergency physician at Albany Medical Center, said that it’s important to keep researching kratom because the substance might be able to provide pain relief in a safer way than prescription opioids.
“Limiting research on this could be kind of limiting or restricting a potential useful therapy for a huge problem that’s going on right now,” Lydecker said.
Some research conducted on rats, which was published after HHS sent its memo to DEA, provides evidence that some of the chemicals in kratom carry little risk for addiction. Two studies published this summer showed that one of the chemicals in kratom that HHS recommended scheduling, mitragynine, was not abused by the rats. Both of the studies were funded in part by the NIH.
While the FDA has been clear about its opposition to kratom for some time, it has not previously publicly supported a scheduling decision.
In February, the FDA warned that kratom might kill people. They released information about some of the 44 “reported deaths” that were “associated with the use of kratom,” in Gottlieb’s words.
But many of those individuals were also using other drugs, according to the FDA’s own data. One person fell out of a window. Another was shot, The Huffington Post reported.
“It’s really hard to create a consistent picture of what are the causes of death,” said Oliver Grundmann, a professor at the University of Florida’s College of Pharmacy. He said that “kratom is not a harmless supplement” and that there are risks to using it, but that scheduling two of the chemicals in it is “not warranted, in my opinion.”
Kratom advocates say that FDA is cherry-picking the science, and that evidence exists to support the idea that kratom can help patients.
“[FDA] treated essentially a lot of anecdotal evidence of harm as fact, but is not willing to consider anecdotal evidence of benefit in the same way,” said Grant Smith, deputy director of national affairs at the Drug Policy Alliance, which opposes criminalizing kratom.
The scheduling of substances by DEA doesn’t always match up with how users are treated by law enforcement.
For example, marijuana is also on Schedule I, but many state have passed laws decriminalizing the use or possession of small amounts.
The American Kratom Association supports regulations for kratom, and potentially a ban on a type of kratom that is modified so it becomes more potent, Candland, the executive director, said.
I’ve been on methadone for 5years it saved my life but if kratum is alleviate ing pain for some the under supervision I say go for it if it was so dangerous they would have stopped the sale of it immediately just like they did the Vapes
Methadone was the hadestvdrug to get off of for me. I was crushed by a large object when a shelf collapsed. For 10 years I was prescribed a daily regimen of 160mg Oxycontin, Fentanyl patches, Fentanyl popsicles and .5mg of methadone. My life consisted of just laying around and going to the pain clinic. I could not drive. I could not travel because meds run out and you have to go back to the exact same pain clinic.
I kicked all the drugs on my own because my doctors said the pain would cause suicide. But the semi dream world of opiates was not a life anyway.
The minute they found out I was reducing my meds, the pain clinic threw me out.
First I stopped Fentanyl. That took a couple months to taper off. Then I started cutting back on Oxy, but it was super hard to cut back. Then I discovered Kratom and added it to my daily meds. After just a month I managed to stop Oxycontin when using Kratom.
Then the last prescription drug was methadone. I only took .5mg once a day, so that should be easy, right? I cut it in half (.25mg) and did that for a month. So far so good. I was in extreme pain, but the kratom made it tolerable. Kratom did not dull my senses or put me in a dream state. Jazzed that I was doing so well on .25mg of methadone, I tried to go cold turkey, just using Kratom. The withdrawal was horrible. But I could not get any pain meds at all since the pain clinic disapproved of my effort to quit.
I cut my remaining 10 pills of .5mg into quarters and took .125mg every day until I ran out. That day I was sticking my tongue in the bottle trying to lick any residue from inside the bottle. I was so addicted to methadone I was going crazy. I went thru my medicine cabinet and found some old vicodin and some muscle relaxers. Between the Kratom and those other meds I kicked methadone in 40 days.
No drugs of any sort. Just Kratom. After that I began reducing Kratom and the first thing I noticed is there was no withdrawal. Today (5 years later) I take 4 Kratom capsules before bed and one capsule at noon. I vary strains to keep them working.
I am limited to about an hour a day of activity. Beyond that the pain is excruciating and puts me out of comission for a couple days. I can add an hour of light driving to that without too much pain. But at least 5 days a week I have to rest or it’s just too much.
Kratom saved my life, and mind.
That’s mind blowing. Kratom is the only reason I’m not on heroin and I’m working for the first time in years and trying to be a functional member of society like I was before getting hooked on pain meds from a surgery. If it’s banned, I would still take it. I’d much rather risk being arrested than risking a relapse and possibly overdosing. There were around 5-10 times in the last year that I would have relapsed if I didn’t have kratom tea to minimize my opiate cravings. A ban would only cause a black market situation with drug dealers selling it on the street. The little regulation we do have would become nonexistent. Anyone who has actually taken kratom understands how silly it would be to make it a schedule 1 narcotic. Comparing kratom to opiates like heroin and pain medication would be like comparing coffee to methamphetamine. People who try kratom for recreational purposes are usually disappointed.
Now that the DEA messed it up for everybody that has legitimate pain that’s the only thing we have to turn the DEA or just money hungry idiots if they’re not making money they don’t care about anybody else there are a lot more drugs they prescribe that mess people up but they’re making their money off of it so it’s okay
HHS might want to direct the FDA and FTC to regulate false advertising and misleading health information online. The failure to regulate and enforce laws on pharmaceutical advertising has done a lot more damage, damaged public health and led to healthcare based on anecdotes, content marketing and industry propaganda.
HHS should also consider how the scheduling of other drugs like marijuana has had more native effects than the drug itself. HHS should base it’s policy recommendations on facts and science, not anecdotes and nonsense. HHS has not adequately addressed the damage and consequences of the “Drug War” and it’s effect on public health, or the true costs to HHS.
HHS should be protecting public health, instead of criminalizing herbal remedies, and demanding fact based scientific study of these possibly beneficial compounds. We did not see HHS look at at any of the adverse events associated with their bad decisions over the years, or at any caused by the DEA, the CDC or the FTC. These same agencies forced people with chronic pain or opioid addiction to turn to these remedies in the first place. All of these agencies were silent as Americas Epidemic of Despair, and so called addiction crisis were turned into a marketing gimmick.
All we are seeing here is the effect of the For Profit Market driven healthcare system. The FDA refused to ensure that these products were safe or effective, just like they refused to evaluate any other herbal products or supplements. Too bad sick people in America had to turn to untried and unsafe substances sold on the internet to treat themselves, due to lack of health accountability and the profitable and criminal behavior in our healthcare system.
Oh. IKE,…..
The scheduling of substances by the DEA, never seems to match public sentiment. They are supposed to protect the public, but all these agencies have become so corrupted, their views are slanted by cash. Missouri passed HB1115 making Kratom legal for public use. They are many other states doing the same thing. Why not report on the positive side of Kratom? Research ?
Words have been changed from the original text to protect the guilty.
“””Ike revealed that FDA claims about its claims that Kratom deaths were wildly inflated and overblown. Including deaths in Gottlieb reports from dangerous drugs like heroin and fentanyl. Mitragynine is safe for human consumption in the raw form, just like it’s been used for centuries by natives in that area. Doctors around the world complained that the product was safe and millions of American favor Kratom over heroin preferences. Nearly a year later, we revealed that FDA knew about that Kratom was safer than aspirin, but then if there is no regulating, there is no money for the government to keep.
Come on Ike, you want to be known world wide, get on the right side.
I can go outside and pick a weed or flower that is more dangerous than Kratom. Lame report. No real research, and slanted to fit his biased view.
Leave kratom alone it easily SUCCESSFUL helps as many people as most HHS officES.
This ongoing ban on kratom and kratom bashing is BS. All the people including myself that have chronic pain issues and other extreme health problems are being robbed of our God given rights. Free will and our American right of freedom of choice. It’s all about the money for big pharma and anyone of high stature, power and control to keep something beneficial away from all of those who need it just to function on a daily basis. Sure, just ban kratom and let millions who benefit from it seek out the black market instead to help control their pain, anxiety and all that comes along with it, Like that’s such a better option like turning to alcohol for support. I was on those stronger opiods and benzos and they are more harmful synthetics than anything they can scrape up about kratom and we all know that alcohol can kill too but it’s still legal. Kratoms helped me a great deal with my disability and without side effects or a risk of pending death. No one on Capital hill, the DEA or FDA will ever get it until they or one of their own has to suffer and live in sheer misery because others have stopped what you did benefit from without regard and “say no, you can’t have that anymore sorry about your luck.” I’m so sick of my government telling me what I can and can’t have and I really wanna know where that’s NOT a clear invasion of my free will and choice.