Kratom shows promise as a treatment for opioid addiction and chronic pain — why aren’t regulators working to ensure it’s safe?
Sheila Baylis
Despite the controversy surrounding kratom, most agree the marketplace is like the wild Weststevecoleimages/ Getty Images
The packet had no ingredient list or dosage instructions, but was bought legally, likely online. The incident illustrates the urgency of a booming market that has little regulation, in part because kratom is not fully understood by scientists and misunderstood by many policymakers.
The year that Talavera died with a high level of kratom and no other drugs in her system, at least 1.7 million Americans used kratom as well. Data from 2019 showed overdose resulting in death to be “extremely rare,” according to The National Institute on Drug Abuse (NIDA). The institute reports that between 2011 and 2017, there were 11 kratom-related deaths in the U.S., and most involved other drugs. Only two of the deaths were associated with kratom exposure alone. During that same time period, there were 200,000 opioid deaths in America.
“From published clinical case reports, we see very few kratom-related fatalities in which kratom was the only substance found, and of those, there are potentially other health factors or even genetic factors that could affect how kratom is metabolized,” Kirsten Smith, Ph.D., assistant professor and researcher at the Behavioral Pharmacology Research Unit at Johns Hopkins School of Medicine, tells The Messenger.
In recent years, the market has been growing quickly, but the prevalence of kratom use is not fully known.
“Any prevalence estimated would be an underestimate by a long shot, but when you look at the import data in a given month, it’s a lot. I would say there’s 15 million people regularly using kratom in the United States,” Dr. Smith says.
The people using kratom are doing so for a variety of reasons — to boost energy and productivity, to help with anxiety, depression and chronic pain or to self-treat opioid addiction or illicit drug use.
Dr. Smith and many scientists agree that more research is required to fully understand the toxicology of kratom, a need reiterated in a paper published this week by the Department of Pharmaceutical Sciences at Washington State University.
Despite the lack of scientific data, the Federal Drug Administration (FDA) recommended to the Drug Enforcement Administration (DEA) that kratom be classified as class I substance alongside heroin and ecstasy in 2016. At the time, the DEA agreed, and then reversed its decision in an unprecedented move that shocked policy experts and angered former FDA commissioner Scott Gottlieb, M.D.
In 2021, Dr. Gottlieb tweeted that kratom was “fueling the opioid addiction crisis” and that the Biden administration should move forward with banning it. In response, former Assistant Secretary of Health and Human Services Brett Giroir, M.D., wrotethe “FDA’s recommendation was rejected because of embarrassingly poor evidence [and] data, and a failure to consider overall public health. If kratom is fueling opioid addiction, prove it; and then HHS should reconsider.”
A Lack of Regulation, a Wild West Scenario
This disagreement about the safety of kratom among top health officials is mirrored throughout the general health community, with no clear consensus on whether the supplement poses more of a threat than a benefit.
What everyone appears to agree on, however, is that the kratom market is a “wild West” scenario that leaves consumers at risk for purchasing kratom laced with other substances, including fentanyl and morphine.
Mac Haddow from the American Kratom Association (AKA) says that the product found near Krystal Talavera’s body “never should have been allowed in the marketplace.”
“The [space dust] is the poster child for the kind of potentially dangerous product that the FDA had an absolute duty to regulate,” Haddow tells The Messenger.
Without formal governance, business owners have decided to self-regulate — the AKA has a program that requires a kratom company to get a third-party audit of the supplement’s manufacturing process and have proper labeling. Manufacturers who meet so-called good manufacturing practices, or GMP, carry an AKA GMP Qualified certification on their products.
“I always make sure that I find kratom vendors that laboratory test to make sure that what I’m buying doesn’t have contaminants and salmonella,
Lora Romney”
“Without regulations, requirements for testing and proper labeling, it’s the wild wild West,” Haddow says.
“Unscrupulous vendors are out there spiking their products to give it an effect it doesn’t naturally have. If you’re an unsuspecting consumer, you purchase this product and it hits you in a far different and more powerful way than the kratom you were taking the previous week, and you may say, ‘wow this is much better quality’ when in fact it’s an adulterated product with a dangerous substance that’s been introduced to get a market advantage.”
This sentiment was echoed by Michael Cowgill, who is on a different side of the kratom question entirely. Cowgill is an attorney who helped Talavera’s children get awarded $11 million in damages last week in the wrongful death lawsuit against the “space dust” manufacturer.
“What we have essentially is a wild West marketplace and that’s creating a lot of misinformation, it’s a situation that’s ripe for exploitation of already vulnerable people,” Cowgill tells The Messenger.
Further, Cowgill says kratom manufacturers “often use shell companies to avoid being uncovered and detected for purposes of being sued. So actually locating them and serving them with a lawsuit is difficult.” Cowgill says these manufacturers make it difficult on purpose with many creating a web of companies, so it’s hard to know exactly who is behind each product.
However, Cowgill, who has filed several wrongful death lawsuits against kratom companies, disagrees that there is no regulation of kratom.
“The FDA regulates food, and within food there’s a subcategory of supplement regulations. There’s also a different category that applies to drugs,” he explains. “And as it stands right now, both supplement and drug regulations can and do apply to kratom in part depending upon how the manufacturer or distributor is marketing and selling it … and the FDA has enforced them in certain cases. But I don’t speak for the FDA and, I can’t say why there isn’t broader action.”
A Better Treatment for Chronic Pain
Despite the lack of regulation and the potential for accidental overdoses, kratom has become an answer for those with chronic pain.
Lora Romney, who uses kratom daily to treat her pain, wants more regulation as well. “I don’t want things to get out of hand and then they ban it, and then I’m back at the doctor asking for a prescription of oxycodone,” she tells The Messenger.
Romney, 53, has type 2 trigeminal neuralgia, a chronic condition that breaks down the sheath around the trigeminal nerve in the face, causing persistent and sometimes severe pain. “It’s a persistent burning sensation over my left eye,” she says of the pain, which has spread to the top half of her face. “I always picture it as a gas burner, the pain just goes up really high and then it can go down a little bit, and then really high again, but it never goes away.”
After she was diagnosed, Romney, a real estate accountant, had microvascular decompression surgery, a brain surgery to release the nerve from an artery to help relieve the pain. When that didn’t work, she had a stimulator implanted in her face.
“I have wires implanted over each eyebrow and on my cheekbone and the wire goes down my neck and into my chest. There’s a battery pack there I actually still have.” She also tried 25 different pharmaceuticals and medical cannabis. After 13 years, oxycodone was the only thing that would help.
“My doctor had me on two oxycodone per day, which only gave me relief for about four to five hours, which was hard because I had pain 24/7, so I had to choose which hours,” she explains. “If I took it during the day, I would have pain at night and couldn’t sleep, and if I took it at night, I couldn’t work during the day. The doctors didn’t want to give me more, and I didn’t want to be on more either.”
In the years following her diagnosis, Romney found others with her condition online — eventually one of them recommended she try kratom.
Within the first week, Romney felt better and cut her oxycodone dosage by half. Now, she takes a regular dose of 2.5g of kratom five times total within 24 hours and only takes oxycodone when she has a flare up, but is careful not to mix the two.
“I always make sure that I find kratom vendors that laboratory test to make sure that what I’m buying doesn’t have contaminants and salmonella,” she says.
“I’ve been able to maintain that dose for six years, and I know I’m always going to have pain, but this is livable pain. I can deal with it. I can work and function at a three, but cannot work and function at an eight or a nine,” she says, referring to the commonly used one to 10 pain scale.
An Uncharted Future
But not everyone has success maintaining the same dose. There is evidence that people can build up tolerance to kratom, and experience withdrawal when they stop taking it. “We do see that people can become physically dependent on kratom products,” Dr. Smith says, “but we have to differentiate between dependence and addiction.”
“Many people who use kratom regularly or daily develop some tolerance and would have a mild to moderate withdrawal syndrome if they discontinued use, which is dependence,” she says. However, Dr. Smith points out, substance use disorders often go hand in hand with other mental health conditions. In other words, the dependence can have less to do with the substance and more to do with environmental and social factors. “That’s true with alcohol or cocaine or any substance.”
Further, Smith says there is evidence of kratom helping people with opioid addiction. Out of 357 kratom users that participated in a 15-day NIDA study that is coming out this year, 100 of them were using kratom as a long-term opioid substitute for several years on average. Kratom advocates, including Rep. Jack Bergman (R-Mich.), argue the plant could be used to widely treat opioid addiction.
“One of the tools and resources many veterans have used to quit their opioid dependence, manage pain, improve mood and focus, and get their lives back on track has been through controlled use of a pure, unadulterated kratom product. For many, it is literally a miracle solution keeping them from a downward spiral of addiction and destruction,” Bergman wrote last week in an op-ed for The Hill.
Bergman has introduced The Federal Clarity for Kratom Consumers Act in the House with Bipartisan support. In December 2022, it was introduced in the Senate by Sens. Mike Lee (R-UT) and Cory Booker (D-NJ) and Rep. Mark Pocan (D-WI).
A representative from Bergman’s office tells The Messenger the language is still being finalized, but the bill would affect the FDA’s regulation of kratom and create a Kratom Research Task Force established under HHS in order to coordinate research conducted or funded by the government. The bill is expected to go to a vote in the coming weeks.
