Why the supplement kratom is starting a new war on regulation.
“There have been a lot of anecdotal reports suggesting kratom has some pain-relieving properties and has helped transition users from prescription opioids to this product. What we learned was that across a wide dosing range — all the way up to the average human equivalence dose that people use — kratom was very safe and did not affect respiration or coordination.” Chris McCurdy, Ph.D.
The supplement known as kratom has been in the news a lot lately.
Unfortunately, it’s connected to deaths from using it. While those deaths are related to careless use of an unregulated supplement, exactly what does proper regulation look like? The reality is, not much.
According to a federal lawsuit filed in Florida, Krystal Talavera, 39, died on June 20, 2021, after using a kratom product. The previous night she celebrated her oldest son’s high school graduation.
Talavera collapsed while preparing breakfast in their Palm Beach County, Florida home. A relative discovered her unconscious on the living room floor on Father’s Day morning. Her 14-month-old daughter was found playing next to her body, alongside a hot cup of coffee and an open bag of “Space Dust,” a kratom-derived product (I’ll get to exactly what this product is later).
Her official cause of death was listed by the coroner as “acute mitragynine intoxication” (mitragynine is one of the main psychoactive components of the kratom plant and one of its many alkaloids).
What is Kratom?
Kratom, or mitragyna speciosa, is a conifer tree indigenous to Southeast Asia, and its leaves are marketed as herbal supplements. These leaves contain bioactive alkaloids, notably mitragynine and 7 hydroxymitragynine, which influence the body in various ways.
Kratom induces effects similar to opioids and stimulants. Users report heightened energy, alertness, rapid heart rate, relaxation, and pain relief. Although smaller doses tend to evoke stimulant-like effects and larger doses mimic opioids or sedatives, studies haven’t conclusively linked these effects to dosage or consumption methods.
Despite lacking FDA approval for medical use, individuals report using kratom to mitigate drug withdrawal symptoms, alleviate pain, and manage mental health issues, particularly related to opioid dependency.
Kratom’s connection to opioids — research shows that normal doses of mitragynine and 7-hydroxymitragynine won’t trigger severe adverse effects linked to opioid use — has made it extremely popular for those detoxing from painkillers, and even called a miracle by those that use it. Evidence demonstrates that with proper guidance, kratom is an effective supplement for opioid withdrawal.
And like opioids, kratom is addicting when misused and taken in large doses.
Additionally, scientists have noted that mitragynine binds to adrenergic, serotonin, and dopamine receptors — the same receptors as opioids — potentially contributing to the stimulating effects reported by kratom users. And this is also the reason the FDA attempted to label kratom as a Schedule I drug.
Southeast Asians have chewed kratom leaves for centuries with no ill effects, so why are people dying?
The Wild Wild West of Supplements
Kratom has become a booming industry in the United States, with 11 to 16 million consumers using it yearly. It is commonly ingested through capsules or powder, mixed into food or beverages, brewed as tea, or more precariously, consumed as a liquid extract.
Historical evidence indicates kratom’s longstanding use in Southeast Asia for various medicinal purposes.
Much of the muddy waters concerning supplements like kratom arise from the confusion of supplement regulation. The Food and Drug Administration (FDA) refrains from “approving” dietary supplements as it does not extend approval to food items. Instead, the FDA actively monitors the manufacturing and labeling of supplements, conducting regular inspections of companies to verify compliance with all regulations. Should a supplement company fail to adhere to FDA regulations, the FDA reserves the authority to prohibit the sale of their product.
Big deal. That “authority” does not show up with supplements — and every type of health supplement on the market might contain stuff you don’t want in your body.
Before 1994, natural products in the U.S. were shimmied in under the FDA’s list of dietary supplements — yet kratom arrived on the market later. Like most natural products, the FDA found that kratom, as long as it’s used as recommended (whatever that means), is safe. For the most part, this is true for kratom — when it’s manufactured and prepared safely.
In the United States, this is not the case.
“In a controlled animal study, UF scientists found kratom — which comes from the leaves of a tropical tree originating in Southeast Asia — delivered significant pain-relieving benefits, reduced opioid withdrawal symptoms and caused minimal respiratory depression.” -University of Florida College of Medicine
Like many natural substances, bad things began happening with kratom (or what was labeled as kratom). Case reports show rare adverse effects associated with kratom or its compounds, but just like any supplement, mixing kratom with other drugs and alcohol is not a good idea. Bad stuff will happen. But people do it anyway.
After calls to poison control centers began to multiply in 2016, the Drug Enforcement Administration (DEA) attempted to ban kratom by labeling it a Schedule I drug.
It meant the agency concluded that there was no beneficial medical use for the supplement and that the potential for abuse was high.
Then organizations such as the American Kratom Association (AKA) and the public got involved. With support from Congress, the decision was postponed and instead, kratom is listed as “a drug of concern.” While it was a major victory for consumers, the AKA would later face more adversity in defending kratom.
The Regulation of Kratom is Non-Regulation Foo-Foo
While the AKA fervently backs FDA enforcement action against any deceitful kratom marketer who labels products with illegal therapeutic claims, it’s not stopping the unregulated production of kratom. Most kratom vendors are not making outlandish claims but failing miserably at transparency in how their product is made — and what’s in it.
Like street fentanyl and other drugs, other shitty substances are winding up in kratom (much like cannabis before it became highly regulated and legal). And my prediction is that psychedelic mushrooms will face the same fate before they become legal.
Yes, AKA advocates are supporting a regulatory framework to guarantee that kratom products adhere to Good Manufacturing Practice (GMP) standards for food items, ensuring consumer protection, yet marketers see monetary incentive and not the well-being of consumers.
Space Dust
Krystal Talavera died when she legally purchased an unregulated kratom product called “Space Dust” from an online vendor, one she had purchased from before after friends told her about the magic of kratom.
On the website where she purchased the product, a disclaimer read that it was “a safe and natural dietary supplement.”
What Talavera didn’t know was how the product was made.
Space Dust uses 200 grams of kratom leaf — 200 grams — to make one gram of extract. Talavera ingested over fifty times the average dose of kratom in one serving (an average dose of kratom powder is around 3–4 grams). This is why kratom extracts are so dangerous yet you can buy them at convenience stores all across the US.
Talavera was your typical kratom consumer — “informed” about the supplement but lacking in formal knowledge of what she was taking. Yes, part of this blame is on the manufacturer for inconsistent labels — and in reality — how toxic it is if too much is taken (easy to do when a label says “a safe and natural dietary supplement”).
Talavera died of respiratory distress. At that dose — a dose that might have been 400 grams in her coffee— acute mitragynine intoxication means her lungs shut down. She could not breathe.
She drowned in her own body.
“In vitro radioligand binding studies revealed that kratom alkaloids interact with opioid μ, δ, κ subtypes, and non-opioid receptors including alpha-1A, alpha-2A, 5-HT1A, 5-HT2A, D1, and D2.” — -Takayama et al., 2002
It’s a scientific fact that the opioid effects of mitragynine are around 13 times the potency of morphine and 7-hydroxymitragynine contains a CNS stimulant with depressant effects. Yet those effects are only lethal in exceptional doses, just like opiates. If you take a bottle of Oxycodone you will stop breathing and die.
Unregulated kratom is causing a ruckus with the FDA — and unfortunately, it’s causing a stampede of fear.
And that’s understandable. According to the World Health Organization (WHO), since 2017 kratom caused 91 overdose deaths in 27 states (and some statistics are muddled with opioid and fentanyl overdoses, so the actual cases involving kratom are skewed. But, hey, why not mix a death cocktail of fentanyl with a little kratom?)
The Kratom Protection Act
The AKA established the Kratom Protection Act in 2022 which “requires dealers who prepare, distribute, sell, or expose for sale kratom, to disclose on the factual basis on which this representation is made. A dealer is prohibited from preparing, distributing, selling, or exposing for sale kratom that does not conform to these labeling requirements.”
It’s a good start. And the Bill also contains a clause that will help future consumers like Talavera understand what they are consuming:
“a dealer may not prepare, distribute, sell, or expose for sale kratom that is adulterated or contaminated with a dangerous non-kratom substance, contains a level of 7-hydroxy mitragynine in the alkaloid fraction that is greater than 2% composition of the product, contains any synthetic alkaloids, or does not include on its package or label the amount of mitragynine, 7 hydroxy mitragynine, or other synthetically derived compounds of the plant mitragyna speciosa.”
Kratom fear is rampant. According to the AKA, over a dozen states have implemented kratom legislation to ban kratom or limit its use, yet the legislation is spotty at best. In Florida, for example, kratom is legal yet banned in Sarasota, a small city on the west coast, just south of Tampa.
And in states like Alabama, where then-Gov. Robert Bentley signed a bill making kratom a controlled substance, consumers have been arrested for possessing kratom. Just ask Shaina Brown, 34, of Atmore, Alabama. She was charged with trafficking synthetic drugs, a Class A felony, that could mean life in prison.
And all she was trying to do — like so many that use kratom — was negate her dependence on other substances.
Regulate, Educate, Live
Could the Kratom Protection Act have saved Talavera? If she had read the label, I think there’s a good chance it could have. Unfortunately, many users don’t read labels and they sure as hell don’t understand the science behind the substance they’re ingesting.
What remains is that, statistically, kratom helps many people, from US veterans recovering from opioid addiction and symptoms of PTSD, to those afflicted with anxiety and depression. Kratom does have merit — it just needs — as most supplements need — regulation.
And consumers need to be encouraged to educate themselves on what substances they are considering putting into their bodies, and about the dangers of mixing other concoctions with it.
The kratom vendor that sold the supplement to Talavera was ordered to pay more than $11 million in damages to Talavera’s family. Dozens of other settlements are on the books for other kratom-related deaths.
Perhaps the most prudent message with the kratom hysteria is the dire need for FDA regulation on dietary “food” supplements. Yet like the absent traffic lights at dangerous intersections all across America, we must ask how many people must die before solidifying regulation.
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