Health Editor’s Note: Kratom is not safe for consumption in any form. Read below for important information…..Carol
No FDA Approved Uses for Kratom
The U.S. Food and Drug Administration is warning consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.
There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert in February 2014 regarding kratom-containing dietary supplements and bulk dietary ingredients, FDA has taken a number of additional actions, including:
- In September 2014, U.S. Marshals, at the FDA’s request, seizedExternal Link Disclaimer more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
- In January 2016, U.S. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro.
- In August 2016, U.S. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy.
While FDA evaluates the available safety information about the effects of kratom, the agency encourages health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:
- Complete and submit the report online: MedWatch Voluntary Reporting Form
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
Related Information
- FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
- FDA releases test results identifying dangerous levels of heavy metals in certain kratom products
- Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
- Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products
- FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
- FDA orders mandatory recall for kratom products due to risk of salmonella
- FDA objects to kratom compound intended for use as an alternative to prescription opioids and promoted with unproven claims to treat addiction
- FDA Letter to Industrial Chemicals LLC and INI Botanicals Regarding Mitrasafe (mitragynine extract)
- FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
- FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
- Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
- Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
- Remarks by Dr. Gottlieb at FDA’s Office of Criminal Investigations Meeting
- CFSAN Adverse Event Reporting System: Kratom Deaths (December 1, 2017) (PDF – 1.9MB)
- FDA Adverse Event Reporting System: Kratom Deaths (February 6, 2018) (PDF – 37MB)
Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.
She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – one daughter-in-law; Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with her husband Gordon Duff, many cats, and two rescues.
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The DEA followed the guidance of the FDA and tried to schedule in 2016. But, like I said this effort was quickly ended once lawmakers saw thru the FDA’s misinformation. Here is a report on all the shortcomings of the FDA’s claims https://www.americankratom.org/images/FDA_Fails_to_Follow_the_Science_-_Babin_-_August_2018.pdf
There is ongoing research now and it is showing promise.
Therapeutic potential of kratom:
https://www.americankratom.org/images/3_HembyKratomAddicitonBiology2018.pdf
Study showing limited abuse potential
https://www.americankratom.org/images/Yue_-_Abuse_Liability_of_mitragynine.pdf
There is an issue, like you raised, on adulteration
https://www.americankratom.org/images/Lydecker_7-OH_Adulteration.pdf
The KCPA attempts to address this troubling issue
I think we are at a stalemate if you refuse to look at anything outside of the FDA’s weak talking points
Article parrots the FDA talking points that have been used for years to try and get Kratom scheduled. Does not provide any new information or show much research at all into the topic.
Dr. Christopher McCurdy is the lead researcher at UF College of Pharmacy that is conducting research into kratom’s potential to wean addicts off opioids. The National Institute on Drug Abuse (NIDA) awarded millions in funding to research. You can listen to one of his lectures here:
https://youtu.be/F_yY99gkvX8
Also studies out of John Hopkins
https://www.hopkinsmedicine.org/news/newsroom/news-releases/natural-herb-kratom-may-have-therapeutic-effects-and-relatively-low-potential-for-abuse-or-harm-according-to-a-user-survey
and
University of Rochester Medical Center Department of Psychiatry
https://www.sciencedirect.com/science/article/abs/pii/S0376871617305586
Would also recommend watching the documentary “A Leaf of Faith”
https://www.netflix.com/title/81009815
There is a strong push from the community to pass the Kratom Consumer Protection Act (KCPA). The KCPA has passed in Georgia, Arizona, Utah, and Nevada. The KCPA regulates the preparation, distribution, and sale of kratom products; to prohibit the preparation, distribution, and sale of adulterated or contaminated kratom products. An article on the KCPA would be more beneficial than just an article that recites FDA’s talking points that have been shown to be misleading and not in line with ongoing research.
dirtdiver33, This article IS the FDA report and warning on kratom. There is reason for control of kratom as it uses the same opioid brain receptors as morphine and has properties that can lead to dependence, abuse, and addiction. There are no approved uses for kratom, and kratom’s safety is in question as it is psychoactive and since not regulated can be sold in just about any concentration which is a major wild card for a substance that acts like an opioid. The use of every opioid is controlled and prescribed for medical purposes. Just like heroin, fentanyl, morphine, crack, etc., kratom hits the opioid brain receptors, which is why you would defend the use of kratom. Chasing the high becomes a way of life. Opioids are controlled substances for a reason……
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There is a lot of information available that shows the FDA is providing misleading information. This is why the FDAs push to schedule fell apart quickly in 2016. There is a lot of testimony on how kratom has improved the quality of life of many veterans, I would recommend doing a little more research outside of just what the FDA has pushed out.
dirtdiver33, Not just the FDA is against the use of kratom. Kratom has no medical purpose and its usage carries a risk of psychological and physical dependency in some…in other words an addiction. The DEA also threatened to prohibit the sale of kratom and its use inside the U.S. other than for research purposes. Just because kratom is made from a plant, it is still addictive and not safe to use. Kratom is not regulated so you do not really know what you are ingesting. Addicts look upon it as a ‘God send” because it is not restricted. There have been no well-controlled scientific studies showing that kratom is effective for opioid abuse withdrawal or any other conditions in humans. There is also no research on how kratom may interact with other medications. Treating an addiction to kratom is very difficult since there is more going on than just the opioid effect. This is not something you need to be taking or should be taking, but it is your choice. If you think that the FDA has an agenda to somehow harm the way you want to live your life you are well into the conspiracy theory world.
Of course the fda wants us all to think its harmful. Anything they don’t make money from they want to stop. This is like when they wanted to stop sales and use of chamomile as people use it for anxiety, sleep etc. it’s ridiculous that they want to call anything we use for something they consider a medical problem, a drug. And therefore they need to regulate it. When will they start regulating coffee? and considering it a drug has people use pharmaceuticals for energy as well. They figure over 11 million people in the United States alone are using kratom for everything from pain to anxiety to depression and energy. We’re not dropping dead like flies. As a matter of fact they cannot contribute a single death to do you of pure kratom leaf. The actual science, and there’s a lot of it …points to it being safe for us to use kratom when no adulterants are added to it and in its natural leaf/powder form. there aren’t many plants shrubs trees that nature provides for us to use for our health. It is ridiculous that the FDA and the pharmaceutical companies want to look at all of its chemical constituents and make a chemical version of it and call it a drug simply because we’re using it for our health. By saying health I am meaning they twist that to mean it must be a medical problem therefore it’s now a drug.
Stand Up For Right and others,
It is not just the FDA that deems Kratom unsafe to use. Although people who take kratom believe in its value, researchers who have studied kratom think its side effects and safety problems more than offset any potential benefits. Poison control centers in the United States received about 1,800 reports involving use of kratom from 2011 through 2017, including reports of death. About half of these exposures resulted in serious negative outcomes such as seizures and high blood pressure. Five of the seven infants who were reported to have been exposed to kratom went through withdrawal. This information comes from medical establishments.
But of course you can ingest whatever you want to….good luck with that. VT sticks with medical facts and medicine says this has great potential for harm…ask those babies that were born addicted and went through withdrawal…..
Thanks for the tip ! If it’s FDA blacklisted, then it it must be good. Will research it…
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