FDA’s war and unfounded bias against kratom must stopFDA’s war and unfounded bias against kratom must stop
Mac Haddow of the American Kratom Association warns about an attempt by FDA to create its own "utopian nanny state” and identifies three myths about kratom that the agency continues to promote. “Why would anyone not allow access to kratom if it helped someone wean off dangerous drugs — especially when the safety risk for kratom itself has proven dramatically lower?” Haddow, AKA's senior fellow on public policy, asked in this op-ed.

At a Glance
- FDA has abandoned science on kratom in favor of a “utopian nanny state” and overregulation.
- States have been forced to step in to protect consumers from spiked and adulterated kratom products.
- FDA has lost the trust of the American people in regulating all dietary supplements, including kratom.
The U.S. Food and Drug Administration is on a crusade to create its own “utopian nanny state” that would ban kratom and strip consumers of any freedom to make informed choices about supplements they use to maintain their health and well-being.
This nanny state would deprive those who use kratom to reduce feelings of anxiety or to just generally feel better (like a cup of coffee does), as well as ban kratom use completely by people trying to wean off highly addictive and potentially deadly prescription opioids or illicit drugs.
FDA asserts its biggest concern about kratom is that consumers are using kratom products to self-medicate for medical conditions rather than using prescription medications that FDA itself has approved for those conditions. The director of the National Institute on Drug Abuse (NIDA), Nora Volkow, M.D., has testified before Congress that kratom may be a valuable harm-reduction tool for some people with substance use disorders trying to wean off dangerous opioids or illicit drugs.
A person can walk into any dietary supplement store and see hundreds of products consumers are using in attempt to “self-medicate” a variety of health challenges — products that also have not been approved by FDA for any medical use.
Why would anyone not allow access to kratom if it helped someone wean off dangerous drugs — especially when the safety risk for kratom itself has proven dramatically lower? FDA abuses its strong bully pulpit to declare that people cannot be trusted to use kratom to self-medicate in this way.
The agency tried a similar attack on all dietary ingredients and supplements in the 1990s, and that forced Congress to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA). The law stopped FDA from imposing its self-serving agenda to ban every dietary supplement and force those products through the average multibillion-dollar and 10-year new drug application process.
Congress must rein in FDA in the same way on kratom right now.
There are an estimated 20 million kratom consumers in the U.S., despite the persistent war on kratom being waged by FDA. Americans have the right to make informed decisions about dietary and botanical supplements to manage their health and well-being, including when they choose to use such products in lieu of prescription medications to avoid potential addiction and side effects associated with those drugs.
A responsible regulatory pathway to protect kratom consumers
The American Kratom Association (AKA) has turned to individual states to fill the safety gap that FDA has deliberately created for kratom consumers. Six states were duped early on by FDA’s promise that a federal ban would be enacted. Not only was that a false promise, the assistant secretary of health for the U.S. Department of Health and Human Services (HHS) under the first Trump administration excoriated FDA’s safety claims on kratom.
In a 2018 letter to the acting director of the Drug Enforcement Administration, Brett Giroir, M.D., then-assistant secretary of health for HHS, recommended that two constituents of kratom — mitragynine and 7-hydroxmitragynine (7-OH) — not be controlled either temporarily or permanently until such action is supported by scientific research. Three years later, in a social media post, he described FDA’s recommendation to control kratom as a Schedule I drug as “embarrassingly poor evidence [and] data, and a failure to consider overall public health.”
Unfortunately, in 2025, FDA is using that same flawed evidence and data when the real science on the safety of kratom has moved well past the agency. FDA’s kratom policy is not based on science. Instead, it is rooted in a long-standing bias against any consumer product that is not an FDA-approved drug — over which the agency has complete and total control and can obtain user-fee money.
Today, 13 states have enacted a Kratom Consumer Protection Act (KPCA), which requires responsible manufacturing, proper labeling and age restrictions on kratom products. This year, more state legislatures are looking to do the same to protect their constituents. The regulatory model protects consumers from improperly formulated kratom products, including adulterated 7-OH products that synthesize components and are dangerous.
Below, I have identified false myths about kratom that FDA continues to promote.
Myth #1: Kratom is an opioid and is unsafe for consumer use
FDA still publishes on its website the false statement made in 2018 by former FDA Commissioner Scott Gottlieb, M.D. The agency claimed that kratom’s chemical compounds, mitragynine and 7-OH, both bind to the same mu-opioid receptors as opioid drugs.
Published research has concluded kratom’s alkaloids are only “partial agonists” that do not have the same effects as classic opioids on the respiratory system of users. Other examples of substances that have activity at the opioid receptors include St. John’s wort, naloxone (the anecdote or medicine for an opioid overdose) and cheese — none of which have similar effects on the respiratory system as do classic opioids.
Kratom is not an opioid by plant genetics, chemical structure or by legal definition.
In fact, FDA conducted its own safety study on kratom last year with the full expectation that the study would pound the final nail into the kratom coffin. It didn’t.
The results showed that study participants only experienced some nausea, and no significant adverse events, up to a dose of 12 grams ingested in a five-minute period. That is a huge dose of plant material consumed in a short period of time. The typical dose for a kratom consumer is 2-4 grams in any setting.
FDA has admitted that kratom appears to be well-tolerated at all dose levels.
Myth #2: Kratom is dangerously addictive
There is a significant difference between dangerous levels of addiction and simple dependency. Caffeine is the most widely used psychoactive drug in the world, and it has an addiction profile characterized by scientific research as having an acceptable dependency profile.
Kirsten Smith, Ph.D., with Johns Hopkins University, was the lead author on a research paper (“Ecological Momentary Assessment of Self-Reported Kratom Use, Effects, and Motivations Among US Adults”) that reported:
“Among the 357 kratom consumers surveyed using ecological momentary assessment in this cross-sectional study, most reported using kratom daily to relieve pain, improve mood, or increase productivity, and some used it as an opioid substitute. Most participants reported improvements in daily living and productivity; more frequent use was associated with tolerance.”
Myth #3: Kratom kills people
Both the FDA and NIDA websites on kratom report that kratom deaths are rare and when they do occur, they are typically associated with polydrug use or the use of dangerously adulterated products. The adage applies here: “The dose makes the poison.”
Kratom leaf and properly manufactured kratom extract products are safe under the conditions of use (labeling) with the same restraints that any other consumer product offers. In short, these products are generally safe when used responsibly and consumers follow the product’s serving size instructions.
But all too often, medical examiners and coroners follow the FDA narrative and mischaracterize deaths where kratom is detected in any case of a fatality. The detection of kratom in a forensic toxicology report should not be surprising — nor automatically damning — and is impetuously reported as a cause of death, or principal substance associated with the death, when it is merely detected. If someone is struggling with an addiction to a prescription opioid or an illicit drug and tries to use kratom to wean off that drug, it would not be a surprise that he or she failed in that journey. Opioids and illicit drugs have been proven to kill people.
Too many of these autopsy reports rely — wholly or at least in part — on the biased, inaccurate and incomplete information on kratom published on FDA’s website. Yet, medical examiners — and other critics of kratom — frequently cite FDA’s flawed data and conclusions.
The FDA adverse event reporting system (FAERS) does not require any distinction between mitragynine, 7-hydroxymitragyine or mitragynine pseudoindoxyl — or whether these compounds, if present in a toxicology screen, were adulterated or mixed with other dangerous substances. These gaps in reporting render FAERS nothing more than a “disinformation” database. FAERS should not be a part of any evidence-based assessment in a death investigation involving kratom.
Regaining trust of the American people
Public policy regarding kratom must be based on scientifically valid testing and investigation protocols to ensure decisions are informed by accurate and reliable data. Additionally, families of the deceased deserve accurate and transparent assessments of the true causes of death, which can only be achieved through comprehensive and standardized practices.
An institution like FDA now must work to regain the trust of the American people. It can start by removing all the egregiously biased anti-kratom claims and provide an evidence-based explanation of kratom and its benefits and risks. The “embarrassingly poor evidence and data” referenced by Giroir has been on the FDA kratom website for far too long — reflecting the agency’s continuing bias against a botanical that’s generally safe and used by millions of Americans.
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