T

he Food and Drug Administration launched the latest attack on Tuesday in a drawn-out war between regulators and patients over the safety of a popular herbal supplement called kratom, branding the plant a dangerous drug.

“Compounds in kratom make it so it isn’t just a plant — it’s an opioid,” FDA Commissioner Scott Gottlieb declared in a statement.

Some users have argued that kratom is a safe way to treat pain and wean oneself off opioids, but the agency concluded otherwise — based on case reports and a computer analysis of the molecular structure of kratom ingredients.

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“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids,” Gottlieb said. “There is no evidence to indicate that kratom is safe or effective for any medical use.”

The debate had exploded in the summer of 2016, when the Drug Enforcement Administration announced, on an emergency basis, that it would unilaterally classify ingredients in the herbal supplement as a Schedule I drug. If it had gone through, that action would have made kratom as illegal as heroin or LSD. But there was an outcry from the American Kratom Association and the community of patients who say they rely on the greenish powder — the response included a petition with over 140,000 signatures, and criticism from lawmakers. The DEA changed course: In October 2016, the agency announced that it would delay its decision until there had been time for a public comment period and for a scientific evaluation by the FDA.

Kratom advocates celebrated the fact that the substance would still be legal, at least for now. But since then, the FDA has issued a series of findings that made it seem as though that may not be true for long.

In November, Gottlieb issued a warning about kratom’s “potential safety risks.”

On Tuesday, the commissioner gave more details about his concerns. Agency scientists used a 3-D computer model to look at the structure of 25 ingredients in kratom, and reported that these molecules seem similar to those found in controlled opioids. Then, using the same digital simulation, the researchers tried to figure out the path these chemicals might take in the body. Their findings predicted that 22 of the 25 compounds analyzed would bind strongly to specific opioid receptors, which led the commissioner to write that “kratom compounds are predicted to affect the body just like opioids.”

The statement was also based on a review of the kratom-related literature. It did not specifically address previous research showing that when tested on cells in lab dishes, some of these compounds only partially activated certain opioid receptors. Those experiments had led the scientists involved to wonder whether these chemicals might reduce pain like some opioids without some of the harmful side effects.

Gottlieb warned of side effects that could be caused by kratom, such as changes in neurological and cardiovascular function. He also cited 44 reported deaths “associated with the use of kratom.” In the past, advocates for the herbal supplement have argued that many of these cases involved other drugs besides kratom.

“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” Gottlieb said. “After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.”

While the DEA has already received the report it had requested from the FDA, this newly released evidence may influence the decision as to whether the substance should remain legal, the agency said Tuesday. A spokesperson could not say when that would be determined. “For any substance that goes through this process, it can be months, or it can be years,” said spokeswoman Katherine Pfaff. She added that a number of states have banned kratom, but for the time being, “federally, it is still a legal substance.”

The American Kratom Association did not immediately respond to requests for comment, but on a Facebook page devoted to the substance, frequent users reacted to the FDA’s findings with anger and fear. They questioned the results, predicted that it would lead to a federal kratom ban, and called for kratom supporters to contact the FDA to express their dismay. One man who said he was from Hingham, Mass., described a litany of health problems for which kratom gave him some relief. “If kratom were banned, I’d probably go on disability and live at home for the rest of my life,” he wrote.

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  • What a load of garbage coming from the FDA…I hope people don’t actually believe the FDA is trying to help them in this case? Kratom causes zero deaths, is all natural and good for you. The irony of this whole witchhunt is that the biggest killers of Americans today are FDA APPROVED! Come on people…somebody is being paid to keep you sick and addicted to their pharmaceuticals.

  • I am going to make it my mission to inform everyone I know or who knows someone with pain problems or addiction problems or children with an addiction problem about this and what the goverment plans to do about it .. Even the people I have talked to who don’t need it are angry about the FDA and DEA are trying to do..If people want to get intoxicated they are going to do it ..but when responsible people that want to contribute to society or save their family members,neighbors, friends from misery or opiate addiction..and you tell them “no I’m sorry this is helping too much..we’ll take that: this is not going to go down the way you guys want..This is blatant show of how much you want us to suffer. Its really disgusting honestly people get your life together. If you people don’t realize you are going to have to pay for the horrible inhumane decisions that you are making or trying to make!!!

  • I’m so angry. This claim is just stupid. Kratom contains a chemical no where near similar to an opioid. Further more the whole ” it’s caused deaths” is BS. Look at how many deaths oxycodone or morphine have caused. KIDS have died and became dependant on it. What bans have been made on that? They can get it at school or home. But under FDA guidelines ITS safe. Look at this agency’s long history on how many things they’ve declared safe and it’s killed people or hurt people. Soldier are given FDA approved drugs and they kill themselves with their safe drugs. People crash their vehicles on safe drugs. Just saying kratom is natural and it’s changed and saved lives.
    We STAND by Kratom

  • Waismann Method. Whoever wrote on your behalf. How much pain do you live in Daily just out of curiosity? Do you live with cancer? Do you live with 5 different autoimmune illnesses were you can’t get out of bed daily? Or can’t walk because of the pain? What you stated may or may not be facts. Opiates and Kratom have helped millions of people be able to live a quality of life. The government the FDA DA has made it impossible for people like myself and millions of others to get pain management that we need. Because of addicts and abusers. Regardless of why they became addicts. It’s still stepped on our toes. So a lot of us over the years have tried to find a more natural way to alleviate some of our pain. Kratom does the job. For thousands if not more people now the same people that had put strict guidelines on opiates for people that need them are trying to do the same with kratom. So now what? What is your solution? Just out of curiosity? Tylenol? Ibuprofen? Cortisone shots? Oh yeah we can only get those twice a year. And sometimes they don’t even work. We tried that. As a matter of fact many of us have tried just about everything under the sun before we had to reach out for something that really helped us. There are thousands and thousands of very responsible opiate users and Kratom users. So please by all means. If you’re going to make the statement that you just made. Tell all the cancer patients that suffer and pain and all us autoimmune suffers and hidradenitis suffers with covered in boils by the way. What do we do for pain relief so we can have a small quality of life? Where’s the happy medium where is our support? Maybe I’m reading your post wrong but it sounds like you are backing up this article. And that is a shame. If so. That just tells me you live a pretty decent quality of life pain free or at least minimal pain free. As far as the people who use it to get off opiates? I cannot speak on their behalf. But my goodness if it works for them applaud them for god sakes. That is awesome if they found something that works. But no let’s take that away as well. And let them turn to something else to feed their addiction.

    • Waismann Method also. I did read your website. And I just wanted to add. Did you know that caffeine is addictive? Sugar is addictive? Did you know gambling was addictive? Did you know that most of the population has addictive personalities? So I was just curious if other things that were addictive we’re going to be banned as well? I think that your website has some good facts regarding Kratom I truly do. But I really really think you should be promoting it and understanding more what it does for people instead of what it does to people. And for those who use it for pleasure. I’m sorry but that is their problem. Because people will get high off paint thinner glue cough medicine or anything else they want to get high off from and we certainly aren’t going to make those things illegal now where are we

  • Kratom comes from Southeast Asia where they use it to treat pain conditions. Over the past few years we have detoxed patients from Kratom who exhibited withdrawal symptoms very similar to that of painkillers like oxycodone. Therefore, from a medical treatment perspective, we consider it an opiate. Scientific research shows that the main chemical in kratom attaches to the opioid receptors. Although researchers consider it less potent than painkillers, it’s effects, both good and bad, mirror opioids. It can offer pain relief and help suppress coughing but there is potential for harmful side effects, abuse and addiction. Unfortunately, there is no simple cure for the opioid epidemic. Suboxone, methadone, and kratom are far from cures. You can find more information on Kratom here: https://www.opiates.com/kratom-opiate-withdrawal-treatment-or-another-drug/

    • I frankly don’t care if Kratom kills me somewhere down the road. I battle constant pain while being a working tax payer. Very consciously, I choose to take this substance. I know the risks, and taking it is my business, not the government’s. Simply put, once all of my options for living a normal life are removed, I will resort to ending my life. And that would be a choice I make based on what folks like you and the FDA have left me. That is, once you’ve robbed me of any alternative.
      Give me the facts, and then give me a better option. Stop wasting time by trying to take my rights away.

  • Yes, it feels like a weak opiate…. however being non addictive, with no negative health effects I or anyone I know have experienced, and I’ve been using it as a pre-workout for 5+ years.,, I think the FDA should worry more about our obese, legally poisoned by the foods we eat, disgusting general population and less about the tea I drink before I go to the gym.– But what do I know, I’m only a 47 year old former athlete who has zero health problems runs 3 miles in 27 minutes and still benches around 300lbs… maybe I should drink a few energy drinks are go get some prescription right?, LOL

    • Disgusting general population, nice. Somehow I see the general population not wanting to support anything you’d desire. As the old saying goes, “You catch more flies with honey…….”

  • I am a recent addict that was using suboxone that doctors gave me for hundreds of dollars every month to “control” my addiction.it wasnt until I started taking kratom that I was able to get myself off of the Suboxone that were costing me thousands of dollars a year. Suboxone is a horrible man made drug given to us to make us “better” when in all actuality it makes things worse especially when you try to get yourself off of them. People like me need kratom in order to get off of the opioids that are made by man. Kratom is a simple plant put here by God how dare the government try to take a natural herb away from so many people that it helps on a daily basis. Some of us don’t need it everyday some do. It depends on their pain levels and their addiction problems. Kratom helps so many people stay away from other drugs real drugs… Please please don’t try to take something away from the people just because it doesn’t work for some doesn’t mean it isn’t a good medication. It’s an all-natural medication thank you Jesus it’s not in a pill form to create more addicts in this world thank you doctors!!!

    • First congratulations Lisa for working on and kicking the addiction. And yes I agree it’s such a sad sad world. They have absolutely no heart. They do not care to look into how many people this is helping. They only want to look at the negative. Surprise surprise right. And the same goes for opiate use. I know not so much and you are case. And no offense. But for people like me my pain medicine saves me daily. It’s the only thing that helps me walk literally. And on the days I want to take a break from the opiates. I use kratom. It may not work as well for me. But it still gets me through the days that I want to take a break from the opiates. The reason I take a break is so I can stay on the lowest dose possible. And so that I do not become addicted. So in my case. Taking Kratom away would be devastating for me. In our state Marijuana is not legal. I have no desire to turn to street drugs. They’re making it harder and harder for people like me to get opiates even at the lowest dose possible. And now the Kratom thing.. and in this particular article. They’re completely contradicting themselves. Because they’re telling us that opiates are available and we should be using them. And they are not available at least not easy to get at all anymore. And then they’re trying to pull the plug on kratom. And so what if they found a trace of opiate in this natural leaf. Certainly better than the synthetic crap that they make. Anyway I didn’t mean to Ramble On You made a very good point. I pray that they keep this on the market so I can help people like you as well

  • Kratom helps me with pain I cannot take opiates because they are addictive and i dont like the high feeling, kratom is like aspirin to me and it doesn’t destroy my body, the government makes their money off of addicts and the dysfunctions of this country but they cannot patent a natural herb so of course something so high in the market that they can’t control and that keeps people off of the man made drugs they have is an issue it’s an easier way to kill off an overpopulated country when you set them up to kill them selves, I’ve mey people whose lives kratom has saved they have no use for heroine hydrocodone or suboxon, taking kratom away will only lead to more deaths and higher addiction ratings

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