Home clinician Kratom Identified as Natural Opioid by the FDA: Here’s What Consumers Should Know
Kratom Identified as Natural Opioid by the FDA: Here’s What Consumers Should Know

Kratom Identified as Natural Opioid by the FDA: Here’s What Consumers Should Know

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By Dr. Jennifer Sedillo, Faculty Member, Public Health, and Nirav Patel, Master of Public Health Student, American Military University

Kratom is a tropical tree (Mitragyna speciosa), which is only found in Southeast Asia. It has been traditionally used for centuries for medicinal purposes. Recently introduced in the United States as an herbal supplement, kratom has gained popularity as “a safe and legal psychoactive product that improves mood, relieves pain and may provide benefits in opiate addiction.”

[Related: How Infants Are Falling Victim to the Opioid Crisis]

Currently, kratom is legally sold in the U.S. However, the Food and Drug Administration (FDA) and other federal agencies have been investigating this herbal supplement to determine its future status.

Kratom Contains Compounds Similar to Opioids

The psychoactive substances found in kratom (mitragynine and 7-hydroxymitragynine) are thought to act on opioid receptors in the brain. But until recently, it was not known whether the active substances found in kratom were opioids.

A recent study using computational modeling from the FDA found that the most prevalent compounds in kratom, including mitragynine, have the most structural similarity to controlled opioid analgesics such as morphine derivatives. These compounds also bind to receptors that act as strong opioid agonists.

Kratom Has Led to Overdose Deaths

For over a decade, kratom has been used for the self-treatment of opioid withdrawal in the U.S. However, continued claims that it can ease opioid dependence are unsubstantiated and may lead to an addiction and withdrawal from kratom itself.

[Related: Surveillance Tactics to Find and Stop Opioid Dealers]

In fact, kratom overdose has led to at least 44 deaths in the U.S. Although this number pales in comparison to the 197,000 deaths from prescription opioid overdose from 1999-2016, both the addictive potential and potential harm of kratom warrants further investigation into its regulation as a controlled substance.

Furthermore, the risks of combining kratom with other prescription drugs may be similar to that of FDA-approved opioids. However, definitive studies have not been conducted.

Kratom Recalls Issued Due to Salmonella Contamination

So far in 2018, kratom products have been recalled 19 times by the FDA. These recalls did not occur due to the potential opioid effect of kratom, but for its contamination with a rare strain of Salmonella that poses food safety risks.

The FDA urges consumers who use kratom supplements to dispose of them and contact a healthcare provider if they experience symptoms such as “fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses

such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.”

DEA: Kratom Is a ‘Drug of Concern’

The Drug Enforcement Administration (DEA) currently lists kratom as a “drug of concern” and states that it is an addictive drug that “causes hallucinations, delusion and confusion.” It is neither illegal nor approved for medical use in the U.S. However, seven states, three cities and the District of Columbia currently prohibit the possession and use of kratom.

[Related: Illegal Synthetic Drugs Prompt Amendments to Federal Sentencing Guidelines]

If You Use Kratom, Report Adverse Reactions to the FDA

If you currently use kratom as an herbal supplement and experience an adverse reaction, report it through the FDA’s MedWatch program. This will provide the FDA with additional information for determining the safety of kratom use.

About the Authors: Dr. Jennifer Sedillo is an Associate Professor for the APUS Public Health Program. Her training is in cellular and molecular microbiology. She has been a co-author on many peer-reviewed articles. Her dissertation research was in molecular biology of malaria. Her current research interests are in public health community outreach and food safety. Follow the AMU & APU Public Health Facebook Page

Nirav Patel, EN VSP, is an active-duty officer in the United States Army pursuing a master of public health with American Military University. Nirav’s background is in environmental engineering, in which he possesses tremendous leadership skills. Nirav is currently a digital volunteer for AMU and a coach for Cricket Academy in Austin, Texas. To contact the authors, send an email to IPSauthors@apus.edu.com. For more articles featuring insight from industry experts, subscribe to In Public Safety’s bi-monthly newsletter.


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  1. This article is misleading. Please educate yourself on this matter. Kratom has NOT resulted in the overdose deaths that you are referring too here in your article. That has actually been debunked at this point, and even NIDA (National Institute on Drug Abuse) has stated that most of the 44 deaths in the FDA warning were the result of ADULTERATED product.


    They do not list the cause of the other deaths involving unadulterated product, but if you do a little digging, you’ll find that they were not directly related to kratom.

  2. Are you aware of the many scientists that have combed over the “Kratom related” deaths and have found that none of them are from the plain leaf. Did you know that one of the 44 deaths was a gunshot wound to the chest. Another was a suicide from hanging. Another had no less than 9 substances including several illicit ones in their system. 9 were from Sweden where all of them drank a cocktail which had toxic levels of tramadol. Even the NIDA for the second time has verified that zero of them were from plain unadulterated Kratom

    ”WASHINGTON, Sept. 24, 2018 /PRNewswire/ — The American Kratom Association (AKA) today called upon the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) to recall its recommendation to make the botanical a Schedule I drug after the National Institute on Drug Abuse (NIDA) confirmed that it is the illegal adulteration of kratom with other substances that is responsible for the deaths cited by the FDA in its recommendation. Following confirmation from NIDA last week that it is the deliberate and illegal adulteration of kratom that has resulted in the deaths claimed by FDA, AKA requested that HHS Assistant Secretary of Health Brett Giroir, M.D., immediately recall the scheduling recommendation from the U.S. Drug Enforcement Administration (DEA) and direct the FDA to implement a complete reevaluation of the science on kratom. ”


    1. Melody, Thank you for the comment. It seems that everyone is having trouble with the 44 deaths due to kratom that is reported by the FDA. See my comment above to see the records. In general, kratom acts as an opioid and while it may have beneficial uses, it may have potential side effects and other drug interactions and therefore should be studied further.

  3. I use Kratom and it’s the only thing that’s ever helped me stay off hard drugs and start living my life again. I can’t imagine why anyone would want to take that away.

  4. Why can’t you tell the truth? How disappointing that you spout the knee-jerk reactionary rhetoric without doing your own investigations. Having a condition that causes chronic pain for 34 years I took hundreds of pharmaceutical pain pills a month, which debilitated me beyond the point of functioning. I have been using Kratom for 4 years & pharm-free for 3 years with absolutely no addictive repercussions. I am only one of tens of thousands who use Kratom daily. Try the truth for a change. It fits real nice if you have the proper intentions!

    1. Kristina, Thank you for your comments. I appreciate that you have found a drug that helps you deal with chronic pain without side effects. My point is that more studies should be conducted to see both medicinal use and safety of the drug. I promise you my only intentions are to discuss important public health topics so thank you for the discussion.

  5. Drug companies have synthetic kratom tested and waiting in the wings to spin bucks for them. Hence the smear campaign. Look up the clinical trials. Already in the pharmaceutical pipeline, synthesized from the alkaloids (not opioids) found in kratom: mitragynine & 7-hydroxymitragynine. Big Pharma needs to get rid of nature’s less expensive version.

    Kratom is to Heroin or Opiates = what Caffeine is to Cocaine or Meth.

    1. Fred, Yes, clinical trials are ongoing! I am not sure how much kratom supplements cost but yes prescription drug prices in the U.S. are too high. There are actually many studies that show the active compounds in kratom act as opioid agonists so this is fact. I am not sure that pharmaceutical companies need to remove an herbal supplement from the market in order to sell drugs. However, if the supplement can cause adverse health effects, in my opinion, it should be regulated so that consumers know the dosage they are taking. Similar to how marijuana is now required to have the amount of THC on the label. It helps the consumer make the proper decision when taking the supplements. Thank you for your discussion.

  6. Thanks for reflecting both sides. My twin brother passed with solely Kratom in his system and no other drugs. His quantity was very low, so yes you can die of Kratom and not from an excess amount. Check out reddit.com/quittingkratom to see many people suffering from the painful side effects this drug causes.

  7. I feel better today than I have in decades.
    Granted, I am and always will be disabled, but my quality of life, attitude, and even my blood work has improved over the past year.
    That’s right! My primary care Dr is fully aware of the changes to my lifestyle and he is monitoring my blood work every 6 months.
    In the past yr my blood sugar dropped from 104 to 85, my cholesterol dropped 42 points and my depression is gone as long as my pain is managed. All my numbers are perfect including my liver panel.
    What did I do? What changes to my lifestyle have I made?
    I’ve made only one change. I took myself off opiates over a yr ago. I did not change my diet or exercise. I have not changed anything except adding 2-4 cups of Kratom to my day. Dispute these findings! You can’t! Blood work doesn’t lie.
    Do the research, ask open and honest questions and report facts rather than being a puppet for the FDA.

    1. Eadie, I am glad you are healthy and taking good care to stay healthy. Clinical trials can help determine if there is a placebo effect and other safety issues. I very much agree with your last statement “Do the research, ask open and honest questions and report facts.”

  8. I commend you on replying to all the rebuttals you have received. You repeatedly mention more studies need to be done. I agree completely. In the meantime, keep kratom available to the people who want it without threatening to take it away. You should have freedom of choice in this matter, much like marijuana. I personally don’t use either, but don’t see any harm in either, also.

  9. Once again a journalist who is behaving like a puppet for the FDA instead of doing their research before reporting incorrect information. So sad.

  10. How can these clowns even think about classifying kratom as schedule 1 is beyond me, I mean it’s almost like classifying coffee, and caffeine as schedule 1. In fact kratom is really not that much more psychoactive than those two, so yeah there’s either a lot of money or politics behind the scenes pulling the puppet ropes. Come to think about it, soda pop and energy drinks have more psychoactive properties than kratom, and they are perfectly legal. This is screwed up paranoid thinking imho.


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