September 18th, 2020
The AKA receives and reviews many questions about kratom and the inaccurate attacks from the FDA that deliberately distort the facts. To help combat this process, the AKA is providing a top ten list of questions and answers that refute unfair claims and pervasive misconceptions.
1) Is the FDA right that kratom is an unapproved drug?
No, kratom is properly classified as a food under the provisions of the U.S. Food Drug & Cosmetic Act.
The FDA regulates a product based on its intended use as evidenced by the product’s labeling and claims. The FDA does not have statutory authority to make premarket approval of food products.
When kratom products are marketed with the intent for use as a food, it is immaterial that kratom does not have any “approved uses” since food products are not approved by the FDA.
When kratom is marketed with a therapeutic claim, then it is properly subject to regulation by the FDA.
2) Is the FDA right that kratom is an opioid?
No, kratom’s alkaloids do hit the mu-opioid receptors in the brain, but kratom is a plant from the coffee family and it does not have the same pharmacologic activity as classic opioids like heroin, morphine or fentanyl.
Kratom is properly classified as a “partial agonist” which has dramatically different effects than opioids on the brain or respiratory system.
Kratom does not give a consumer a reinforcing high that leads to addiction (consumers can become dependent on kratom, like a caffeine dependance).
Kratom does not have any significant impact on a consumer’s respiratory system – and it is “suffocation” that is the primary cause of opioid overdose deaths.
3) Is FDA’s claim you can you overdose on kratom true?
Consumers can harm themselves from overusing virtually any product, but research shows kratom does not cause overdose deaths like opioids do.
This question is definitively answered by the peer-reviewed published literature that specifically concluded “it appears that the risk of overdose death is >1000 times greater for opioids than for kratom.” (see https://pubmed.ncbi.nlm.nih.gov/31647958/)
The bottom line is that kratom carries little of the signature respiratory depressing effects of morphine-like opioids and kratom’s pharmacology is vastly different from opioids where most overdoses occur.
4) Is the FDA right that kratom is dangerously addictive?
No. The National Institutes on Drug Abuse (NIDA) funded studies to test the FDA claims that kratom should be a Schedule I drug because it poses a high potential for abuse. NIDA research shows kratom does not have a significant abuse liability.
The Hemby study (June 2018) concluded kratom does not have abuse potential and reduces morphine intake . . .” (see https://doi.org/10.1111/adb.12639 )
The Yue study (July 2018) concluded kratom has limited abuse liability of mitragynine and potential for mitragynine treatment to specifically reduce opioid abuse. (see DOI: 10.1007/s00213-018-4974-9 )
5) The FDA claims more than 44 people have died from kratom. Is that true?
No. An independent review of the FDA claimed deaths, and then confirmed by NIDA’s own review, found these deaths to be from polydrug use, adulterated kratom products, or an underlying health condition. The FDA’s claims are UNTRUE!
NIDA conducted its own independent review, and they came to the same conclusion.
The FDA kratom death claims are bogus, and the most egregious example is the autopsy report they tried to hide, but when disclosed, the truth was the decedent died from 2 gunshot wounds. He had also consumed a kratom tea earlier in the day. The FDA called that a ”kratom associated death.”
6) Can public health officials trust the FDA on kratom?
No. Every public policy that protects the health of the American public should be based on science, not a self-serving expansion of regulatory powers that will increase the control the FDA has over the decisions Americans make to manage their health and well-being.
In the early 1990’s the FDA made the same adverse event and death claims about vitamins and dietary supplements, and Congress was forced to step in and UNANIMOUSLY pass the Dietary Supplement Health & Education Act (DSHEA) in 1994 to reign in the FDA’s aggressive attempt to ban all dietary supplements and vitamins unless the product was submitted as a new drug application. Today, the FDA is waging the very same disinformation campaign against kratom and cannot be trusted.
7) The FDA claims kratom marketing is rampant with impermissible health claims. Is that true?
No. It is accurate that some unscrupulous vendors are making illegal therapeutic claims for kratom products. The FDA is the enforcement agency responsible for stopping that kind of advertising. The solution is for the FDA to do their job.
The vast majority of kratom products are legally marketed and labeled properly as foods. Individual consumers have the legal right to make informed choices about foods they want to consume to maintain their health and well-being. The FDA is wrong on the kratom science and wrong on the policy!
8) The FDA warns that only FDA approved drugs can help in addiction recovery. It that true?
No. The FDA insists that only FDA approved drugs are the answer to addiction recovery – and those recovery centers can only use those drugs for addiction recovery if they want to be reimbursed. The Johns Hopkins report proves the FDA is wrong and their policy traps those trying to recover.
Every American family has been impacted by the opioid crisis and the FDA has remained tone deaf to the possible solution for some by using kratom. NIDA gets it, and they are the leading federal agency helping to find solutions to the opioid crisis. The FDA has made itself part of the problem by trying to ban kratom rather than protecting the public from adulterated kratom products.
9) Does the FDA influence and manipulate content of medical news articles about kratom?
Alarmingly, it appears that is exactly what is happening. An article that appeared in MedScape Medical News (an outlet for US physicians) on August 10, 2018 on the NIDA-funded Hemby study on the addiction liability of kratom had this headline:
“No Doubt Kratom Is an Opioid With High Abuse Potential”
The problem: The Hemby study found the EXACT OPPOSITE about kratom:
“The present findings indicate the MG [kratom] does not have abuse potential and reduces morphine intake . . .”
The author, Scott Hemby, told MedScape they ”misrepresented” his comments and the research and demanded MedScape ”either change the title to accurately represent the content of our findings and of my interview OR retract the story.” More than 2 years later this inaccurate article is still on the MedScape website for physicians to rely on.
MedScape published this inaccurate article at the same time they had an MOU with the FDA on information collaboration. How can anyone doubt the FDA influences and manipulates information on kratom?
10) The FDA tells medical examiners to classify any death where kratom is detected as a kratom death. That’s bad science, but great propaganda for the FDA.
The FDA fuels its War on Kratom by telling medical examiners to list kratom as the cause of death whenever it is detected in the toxicology screen of a decedent. The problem is even researchers who are anti-kratom cannot point to any data showing a toxic level of kratom that would cause a death in a human. But the FDA wants them reported as kratom deaths anyway.
All fatalities the FDA report as kratom deaths actually involve polydrug use, adulterated kratom products, or underlying health conditions. Research has shown that many addicts are using kratom to try to replace highly addictive and potentially deadly drugs, so it’s not surprising that a person who overdoses or who is trying to wean off dangerous drugs, would have kratom in their system. It is time for the FDA to stop their War on Kratom.
Leading scientists in Southeast Asia reported at a NIDA conference that “There are no known reported severe toxicity or fatality incidents in Malaysia or Thailand where there are large populations of long-term daily users of kratom.”
