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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  • This is ridiculous and another way for the government to control us!! It HELPS people..I haven’t heard any negative remarks about KRATOM…OK 44 PEOPLE DIED but from other things combined..not kratom alone…if the FDA CAN NAME ONE MEDICATION OR ANYTHING FOR THAT MATTER THAT HASN’T KILLED SOMEONE FOR SOME REASON OR OTHER THEN THEY MAY HAVE A POINT BUT THEY CAN’T!!! If it’s a good thing svc people have more quality off life leave it alone!!!

  • People are not happy !!!! If people intend to escape their minds they are going to..but taking away something that helps for pain without making me vomit or any other horrible side effects like DEATH!!!

  • This is plain to see. There is no way it can be denied …if this happens it will be an abuse of power. God knows you don’t want disabled veterans to have any peace only toxic mind numbing psychosomatic drugs designed to literally take your life away. I know it’s true because I was one of the “lab rats” Even after telling my dr lyrica gave me night terrors she said I has to continue taking it if I wanted to continue to receive treatment…it ended up sending me to the hospital with anaphylactic shock..then she said I could stop taking it but night terrors wasn’t enough of a reason. This drug has been approved. That is ridiculous. Dr are not required to receive nutrition training …meanwhile sugar is mimicking fibromyalgia in my body..seriously MR GOVERMENT SIR YOU NEED TO FOCUS ON THE REAL PROBLEMS INSTEAD OF TRYING TO TAKE PEACE AWAY FROM OUR VETERANS AND DISABLED PEOPLE..AND GIVE A LIFE LINE TO ADDDICTS!!!! JUST DO IT!! And don’t take as long as you did with the TYLENOL WARNINGS ETC.

    • I’m so sorry that happened to you, but thank you for sharing it here. People are ignorantly blissful too often when it comes to the pharmaceutical industry, the FDA, and the approved drugs that actually do damage. This drug is a safe alternative for so many dangerous medications out there, even something like Lyrica, which you don’t hear a lot about, but still, it proves the point perfectly.

  • If the WAISMANN comment or the page it cites appeal to you, PLEASE read the Waismann home page, which is http://www.opiates.com (don’t let the generic sounding web-page name confuse you). Waismann appears to be an expensive, for-profit DETOX CENTER, which also offers addiction treatment as an optional add-on. Detox is not treatment, and Detox without treatment very rarely works to cure addiction.

    The Waismann TREATMENT options offered are:
    1. psychotherapy (not psychiatric care by an MD)
    2. yoga
    3. accupuncture
    4. massage therapy
    You can also get a mani-pedi or play billiards.

    They claim tremendous positive results for their DETOX program, but I could not find any information on the success rate of their TREATMENT program. Anyone could get a high DETOX success rate if they padded their spare bedroom, supplied it with water and some food, put a lock on the door, and checked in on their customers now and then. Addiction TREATMENT is the hard part.

    In any case, I would not assume that Waismann employees are experts on any medication-assisted addiction treatment program. They certainly have the motive to knock any such treatment, or the medications used.

  • The war on Kratom is pushed by Big Pharma. In particular the billionaire
    Sackler family – the owners of Purdue Pharma, the makers of OxyContin.

    Kratom is actually helping people break their addiction to Oxycodon – the main ingredient in OxyContin.

    The REAL reason for the FDA’s attack on Kratom is because safe and nonaddictive Kratom helps free people from the highly addictive and toxic Oxycodon. Basically Kratom threatens Purue Pharmas profits. This is all about money, not public health.

    • Anyone know of any scientific studies on Kratom, either “Is it safe?” or “Does it work?”? Double blind controls or not.

  • Alcohol is legal but they are fighting Kratom and Marijuana. This country is messed up. If the government can’t make big money on it…they don’t want it.

  • Kratom got me off heroin , suboxone and saved my life. No Kratom and it’s back to opiates which I don’t want to do. I went through many rehabs and only Kratom helped me kick. It’s a shame. I guess pharma companies and the government wants us on opiates

  • The track record of government officials concerning information about drugs which they consider to be “recreational” is quite poor – they’ve been lying about them for over 100 years. Any sane intelligent person who was aware of this track record would assume they are probably lying about Kratom, too.

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