T

he Food and Drug Administration on Tuesday issued a public health advisory about the potential risks of an herbal supplement called kratom, warning that people who use it to treat pain in place of opioids or to wean themselves off opioids are exposing themselves to an unregulated product that has not been proven safe or effective.

The announcement from FDA Commissioner Scott Gottlieb is sure to rile devoted kratom users, who contend the supplement has provided them with a way to manage pain, anxiety, and a range of other conditions.

“Kratom has raised significant concerns given its increasing prevalence and potential safety risks,” Gottlieb said in a statement, adding that regulators know of 36 deaths tied to products containing kratom and that related calls to poison control centers spiked tenfold from 2010 to 2015.

advertisement

Kratom is a plant from Southeast Asia that taps into some of the same brain pathways as opioids. It can be purchased easily online and in some stores, and even from a vending machine in Arizona.

Newsletters

Sign up for our Morning Rounds newsletter

Please enter a valid email address.

Last year, the Drug Enforcement Administration announced it intended to temporarily list ingredients found in kratom as Schedule 1 drugs — defined as having no accepted medical use and a high risk for addiction — before abandoning the plan after an outcry from kratom advocates.

But Gottlieb’s statement shows the government is still worried about kratom, which people often use to treat conditions without seeing a doctor. Because the product is not regulated and is often bought online, it can sometimes be laced with other substances.

The FDA’s public health advisory was focused on kratom broadly, but Gottlieb seemed to focus on its use as an opioid-replacement therapy. While there are medications that can help people ease opioid addictions, there is no reliable evidence to support kratom’s effectiveness for that, nor has its safety profile been tested, Gottlieb said.

“Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects, or interactions with other drugs,” Gottlieb said.

Gottlieb said the plant should go through the FDA’s regulatory process to determine if it is safe and effective, but that no company has tried to develop kratom as an actual regulated product yet.

“While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse,” Gottlieb said. “They must be put through a proper evaluative process that involves the DEA and the FDA.”

He added: “If proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these health benefits.”

Leave a Comment

Please enter your name.
Please enter a comment.

  • The war has begun. I feel sorry for those who infringe on the rights of all of those vets with PTSD and chronic pain. As you can read on the FDA’s facebook page, so many vets are contemplating suicide now as a result of the kratom bans. That is just what this country needs. A lot of suicidal, disgruntled, highly trained, killing machine vets, whose government has infringed on their rights, after they have went to war and fought for our freedoms.

  • The FDA & DEA as well as the media need to stop demonizing Kratom. No one has ever died from Kratom. No one.
    Here we are in the middle of an Opiod crisis and people are dropping like flies with opiate and heroine overdoses, and the government wants to take the ONE ANSWER AWAY!
    Kratom is safer than COFFEE. It is saving thousands of people by helping them get OFF OPIATES & HERIONE, and providing pain relief effectively without horrible side effects. Kratom WORKS.

    I’m wondering how long it’s going to take the medical community to realize Kratom is the answer?? Probably when they take away all the opiates, and people with real, chronic pain start resorting to suicide because all their options are gone…and families begin sueing Doctors and the government. Must it really come to that?? Because that is very probable.

    Wake up… Kratom gives people their life back. No one is getting high off it and no one has EVER died. Oh yeah..you can pull up statistics..but all Kratom related deaths had secondary conditions or were mixed with multiple substances.

    Please educate yourselves.
    Thank you.

  • The FDA, only approves drugs that will knowingly cause severe side affects and are known to cause death. It’s a well known fact Also it has been mentioned in a previous post, unless billions of dollars can be profited, it won’t hit the legal drug market under FDA approval. The best medicinal pharmacy has been forgotten and suppressed. It’s called nature. Every yard is growing pharmacy.

  • a
    ALL this anti Kratom is BS, The fact is again the FDA cant make billions of$$$$$ of us kill us at the same time like all opiods dugs they are selling.

    Well it works no side efects.

  • What medicinal uses does alcohol provide? I’m not even sure how alcohol is regulated, but for whatever reason it’s passed all scrutiny of the FDA and kills more than 36 people per year (and many deaths from alcohol are not related to interactions or accidents, just alcohol itself, although plenty are). I can guarantee you there are people who drink in the evening to treat anxiety but there’s no concern about it even though doing so is probably far less efficient and you’re significantly impaired. If they do ban kratom I’m going to have to make an immediate appointment with my doctor to find something to help with panic and anxiety which will probably be xanax and to tell you the truth, I’m terrified of being prescribed xanax. It causes significant drowsiness (and I need it for a physical job) is one of the most addictive medications out there and the withdrawl can literally kill you, its far worse than opiate withdrawal. I always thought it was a conspiracy that pharma wants things like kratom off the market so they can make more money, but in my case that’s exactly what will happen. Thank god I have good health insurance at least.

    • Yeah Xanax is really bad. I tell my doctors specifically that I don't want it. I was once severely hooked on it,and it was worse than crack. Xanax gives a great feeling but it doesn't last long, the withdrawal is the worst of any drug. says:

      .Yeah Xanax is really bad. I tell my doctors specifically that I don’t want it. I was once severely hooked on it,and it was worse than crack. Xanax gives a great feeling but it doesn’t last long, the withdrawal is the worst of any drug.

  • Even if there were 36 deaths from it, which I highly doubt, there’s way more than 36 deaths every day from prescription drugs, and those are legal.

  • Of those 36 deaths a majority of them them had harder drugs or other issues. They just took deaths from people who had kratom in their system and said it was from kratom. Also these last two deaths were shown to have other issues with drug interaction and health issues

  • Of course the fda is concerned. The government hasn’t found a way to regulate it yet and the big pharma companies that caused the opioid crisis are threatened that a plant can help people get off the even worse opiate pain medications the cabal doctors prescribe. Its disgusting.

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.