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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.

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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.

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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.

  • Marketing on these health related sites is extremely lucrative. Not one media outlet anywhere looked at how trolls, are doing the same thing they did before the 2016 election. There was a reason that advertising health related products was illegal here in the US until 1996. Internet trolling and marketing is having a serious effect on the health of Americans. Physicians need to be educated on deceptive marketing practices, and how people like LInda DiPrimo troll sites like this to promote their business with misinformation and lies. The industry trolls are a lot more sophisticated, these kind of anecdotal “ads” are the same tactic the Russian trolls used to undermine our democracy.

  • Hahaha! I found you, Linda DiPrimio! The woman is using her real name! She’s director of operations for a drug treatment center called Center City Recovery. What’s wrong, Linda? Afraid kratom is going to cut into your lucrative opiate treatment business? Girl, have the sense not to use your real name. I see you!

  • Wow! I am confident that every negative comment was left here by pharma shills and I’m sick of it. All of this blowing kratom completely out of the water business cracks me up. It’s like watching “Reefer Madness” and I would just laugh it off if I didn’t know their objective is to make it illegal. I use kratom daily with no negative side effects except I have to pee a little more often, like I do with coffee. Out of the two substances, I find coffee more mind-altering and more addictive. When I get up in the morning, I crave coffee, not kratom. Quit lying about kratom! It’s like you’re attacking cod liver oil as “dangerous” and “addictive.” 😂
    It’s so obvious too. Every damn day there’s an alarming news story on a fake news site about kratom. First it’s full of salmonella (never proven), then some guy claims a 15,000 py habit 😂 I just bought two entire kilos for a hundred bucks, foo! It will last me at least 6mo, regular use. Either you’re lying or I’d like to sell you my extra-special bag of salt for 20K. Betty Davis once owned this bag of salt. Y’all are so transparent it’s embarrassing.

    • I’ve got news for you. While it may seem like a cure all , I doubt you’ve tried to quit using it! I’ve been through a 6 day detox where they weren’t equipped to help me withdrawal from it , followed by 8 weeks of post acute withdrawal . I wanted to kill myself during that time because it stripped my brain of Serotonin and dopamine and left my family terrified for me. I will go to my grave working to ban this shit. It’s dangerous . You need to read more on the people who have been devastated by this product before you bash people leaving negative comments. The side affects are crippling .

  • Wow! I am confident that every negative comment was left here by pharma shills and I’m sick of it. All of this blowing kratom completely out of the water business cracks me up. It’s like watching “Reefer Madness” and I would just laugh it off if I didn’t know their objective is to make it illegal. I use kratom daily with no negative side effects except I have to pee a little more often, like I do with coffee. Out of the two substances, I find coffee more mind-altering and more addictive. Quit lying about kratom! It’s like you’re attacking cod liver oil as “dangerous” and “addictive.” 😂

  • I recently had been in Alcoholics anonymous For 21 years sober and drug-free. I moved to Florida, and one day went into a shop, and was introduced to Kratom . I believe it should be a scheduled one drug. After a year of using Kratom, and only Kratom , The thought of suicide was in my mind. I could not stop using it I would stop for four days and then buy more. I literally had to go to rehab to stop using it Kratom is just as bad as opioids.Sober again . I want it banned

    • If you already know you are easily addicted why did you start kratom?
      Do you also eat too much, smoke cigarettes, and are tupe 2 diabetic?

      So we should all lose kratom because you cant control yourself?

      What if I decided it would be better if we reduced your cslorie consumption, and made it illegal to be fat? Its for your own good!

    • If you already know you are easily addicted why did you start kratom?
      Do you also eat too much, smoke cigarettes, and are type 2 diabetic?

      So we should all lose kratom because you can’t control yourself?

      What if I decided it would be better if we reduced your calorie consumption, and made it illegal to be fat? Its for your own good!

    • Linda, would you also like all prescriptions you might get addicted to put to a schedule 1 substance?

      The logic with your story doesn’t really make sense. Just because something is addictive, doesn’t mean it should be banned. Alcohol, cigarettes, coffee = great examples.

      Also, Chemically, Kratom is completely different than opium based opioids- Studies from North Carolina university and others have shown the herb to be much less addictive than opium based opioids and no respiratory depression (which is one of the key factors in fatalities of users who OD from opium based opioids).

      I believe you should do your research, instead of just using your own anecdotal evidence as a reason behind your position.

    • it is a good thing that you did not walk into a bar, where they offer alcohol. You probably would not have posted that on here. I guess 20 years in AA, did not teach you anything. That is one of the many limitations of AA. The hypocritical endorsement of a faith based group, and the implication that it relates to anything else is disturbing.
      AA is one of the reason we have any epidemic of Alcohol Deaths, drug Addiction, and deaths of despair. One would think at the very least 20 years at AA would have taught you something. No wonder so many American are dying from Alcohol Abuse and Drug Addiction, when AA or 12 Step groups are the only option. The CDC did not relate the true numbers of people who die from alcoholism in the US. Those findings would cut into profits for the alcohol industry. Promoting AA and 12 Step groups has led to a lot of deaths, and a lot of denial.

    • Hahaha! I found you, Linda DiPrimio! I spy a shill with my little eye. The woman is using her real name for some reason. She’s director of operations for a drug treatment center called Center City Recovery. What’s wrong, Linda? Afraid kratom is going to cut into your lucrative opiate treatment business? Girl, have the sense not to use your real name. I see you!

    • I too became dependent on Kratom and had to go to a detox center to stop the use of it followed by 8 weeks off work because it had crippled me. These people that think it’s a miracle haven’t tried to stop using it yet. They will be eating their snarky words. Kratom is dangerous in the long term and even more dangerous to market it as a alternative for opioid users. I agree it should be banned.

    • I literally stopped taking Kratom a week ago after taking it for over a year straight and have had ZERO withdrawal symptoms from it. ZERO.

    • I’m thankful more people are speaking out that have been addicted to it. It damn near ruined me too, financially, mentally, and physically. I was turned on to it by a client who owns a smoke shop and therefore, I got it either free or at a big discount. I was able to maintain use for about 2.5 years and I had a lot of problems from it. The withdrawals were horrible and lasted a long time. I am not big on govt having control over what we use and don’t use but I do believe this stuff needs to be regulated. It is absolutely dangerous. However, I do believe they need to provide some type of tapering program for those who are on it before they take it down.

  • Here is real science about Kratom.

    http://americankratom.org/index.php/component/sppagebuilder/42-follow-the-science

    5 million Americans have used this botanical for decades upon decades safely for their own well-being.

    If truly so dangerous, attention would have been drawn a long time ago with many deaths. Not a single death has been attributed to kratom alone. All FDA suspected deaths had significant other known causes including a gunshot wound, chronic illnesses and several other illicit and Rx drugs present.

    Instead, kratom is being demonized just like canabis was. The convenient timing makes kratom a wonderful scapegoat to draw attention away from the real threat of illicit opiods and Rx opiates that are truly killing Americans by the thousands annually.

    Yet, the FDA just approved another even more powerful opiate…

    • Fda ridiculous schedule it like a level 1 I get more of a buzz eating a jelley doughnut ..They are truly embarrassing this fda dea whoever …just cause dumbasses are mixing fentynal and heroin together ..just Darwin going to work ….we’re not stupid and all kratom does is even u out like coffee does a schedule one what a JOKE

  • There is no question in my mind that Scott Gottlieb and the FDA’s concern and opposition to Kratom is being driven by pressure from BIG PHARMA and their lobbyist. With several million people and growing daily that are using Kratom for relief from pain and anxiety, as well as, a substitute for Opioid addition, it has to be cutting into their profits. It is clearly all about money. Why isn’t Gottlieb and his cronies more focused on stopping the further legalization of marijuana? Because it is a battle that BIG PHARMA has already lost. The use and support for Kratom is far bigger than they can imagine and “at best” they can regulate and control it, but they cannot ban it. The backlash will be far too swift and widespread.

  • Greedy, greedy Big Pharma! Kratom is not dangerous, has not killed a single person and it isn’t mind-altering like every single Schedule 1 substance. But it is highly effective for pain and mood. It can curb diarrhea, it can completely stop a cough it helps people suffering from pain. The side effects are minimal and it doesn’t cause dependence like opioids do. The only problem with kratom is that it’s a threat to pharmaceutical industry profits.

    • “the side effects are minimal and it doesn’t cause dependence like opioids do” im so glad i have personal experience with the withdrawals from kratom so i can truly appreciate the stupidity, ignorance and deception being dropped here by this fine gent/gal. Withdrawals are full blown oxy level if you are using for a few months straight.

    • ah, I see a big pharma worker trolling this story. Did all of you know that Big Pharma is developing a “synthetic kratom”? Do you know why? Because they can patent the synthetic and have Scott Gottlieb their lap dog snuff out competition of natural kratom.

      Be WOKE people! The govt gives you a “food pyramid ” that causes disbetes, so big pharma can “treat” it. The govt wants you to believe the “treatment ” will save you. But insulin and medicines will kill you before you are 70 so they can use your social security money to line their pockets.

      STOP feeding your kids patent medicines and SUGAR. STOP eating processed foods that ALL CONTAIN SUGAR.

      FIGHT the government control of your body and what you comsume.

  • Thanks Dr Dave,
    The FDA is not regulating thousands of products already. The supplements and herbals products have no regulation at all. They are not even monitored for purity or containing what the labeling indicates. The FTC has failed to regulate the misleading marketing of these products, that might even contain lawn clippings. Kratom has already gotten attention because it was contaminated with Salmonella, not because of its properties. These industries make too much money already peddling false health claims. They fight against any regulation or even quality standards. The FDA and the pharma industry are no longer protecting public health, they are ensuring profits. Listing Kratom as Schedule One will mean there will be no research into any properties that could be useful, as we have seen with other listed drugs. It will create a profitable black market, and might inspire more usage.

    It is really clear that the FDA has failed to protect us, and thanks to the current anti science and post fact era, this will not protect public safety. Thanks to the status of Marijuana, there are no real regulations on that either, the FTC does not protect the public from false health claims from that industry. In Fact our regulatory agencies are not functioning as intended, leaving millions of Americans misinformed. The FTC failed to upgrade its policies in the age of social media, and deceptive marketing on all levels, from healthcare to alternative medicine.
    The FDA and the FTC should be looking at why so many Americans refuse to get Flu Shots, or improvements to existing Laws that help people addicted to drugs get treatment. Unfortunately the only things our regulatory agencies are doing is protecting corporate profits. This is the end of science!

    • Are you serious? Name the last time someone was killed by some herbs they bought at the health food store. I’ll wait here. Meanwhile, pharmaceutical companies and device manufacturers have killed thousands of people. Kratom is not dangerous! A study came out October 30th that it takes 100 times the INJECTED equivalent normal dose in mice for the active components in kratom to kill. Inject yourself with 100 times your normal dose of water and see how you do. Your regulatory agencies are run by pharma and you somehow think they protect your welfare. Do you keep a fox in charge of your henhouse too?

  • This is ludicrous!!! If they think the opioid epidemic is bad now, tv hey are going to be astounded at what is next!! More heroin, more suicides it’s ridiculous that politicians can do this when they probably NEVER used kratom in their lives…yet they believe they know all the answers!!! They are going to find out the hard way what this will do to our country!!!

    • I’ve used Kratom for three years now. I’ve completely gotten of pain pills. I am a disabled veteran and this has changed my life completely. I now feel like I can function like a normal person. People need to understand if you take this away it will affect millions of people. I know a lot of veterans at the VA who use Kratom as well. I just hope the DEA understands what will happen to these men and women who served this country.

    • Realize that Kratom is not some major consumable like heroin or cocaine or even MJ so making it a Schedule 1 won’t really affect all that many people in the big scope of things. (I know many of you are speaking out of personal need but the Gov can’t worry about a few individuals it needs to be generalized across all aspects of the 300M of us)
      They are doing it to head off any potential claims by PharmaCos that they aren’t protecting their side of the equation equally
      The issue is if the DEA and FDA require PhamraCos to jump thru billions of dollars worth of testing then they are going to push them to require the same from all other products as well
      The Gov can’t just look the other way on “selected” products it must treat all equally so if they don’t regulate Kratom then it could be said they should allow some drug say for cancer that hasn’t been tested or actually shows any absolute results to be left alone as well
      Dr. Dave

    • Fda ridiculous schedule it like a level 1 I get more of a buzz eating a jelley doughnut ..They are truly embarrassing this fda dea whoever …just cause dumbasses are mixing fentynal and heroin together ..just Darwin going to work ….we’re not stupid and all kratom does is even u out like coffee does a schedule one what a JOKE

    • I’ve used kratom significantly. Put me in rehab twice, lost my job, live at home broke 34 y/o. Should be banned. Will there be fallout from a ban for current users? Yes (and i am one) but it is the best course of action. Put a tourniquet on the problem. Hurt 1 to save 5.

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