Does Kratom Need Tighter Regulation?

A few years ago, government agencies were debating how to handle kratom, a substance made from the leaves of a Southeast Asian tree, which was being used by millions of Americans for everything from pain relief to stress management. However, since then, efforts to regulate or ban kratom have largely fizzled.

In 2016, the Drug Enforcement Administration (DEA) announced plansopens in a new tab or window to make kratom a Schedule I drug, putting it in the same category as heroin and LSD. HHS initially issued a letter in supportopens in a new tab or window, which they later rescinded after public outcry. The DEA then changed courseopens in a new tab or window a few months later, though it still includes kratom in their Drugs of Abuseopens in a new tab or window resource guide.

As of now, kratom is considered to be an herbal supplement and therefore falls under the FDA's jurisdiction and is largely unregulated.

Mac Haddow, senior fellow on public policy for the American Kratom Association (AKA), said his advocacy group wants the FDA to regulate kratom for consumer safety reasons.

"Bad actors are using industrial-grade solvents, and you end up with a very powerful and potent product because they've enhanced it synthetically," he explained.

Of the thousands of kratom businesses and products, the AKA has only endorsed three dozen that meet their safety and quality standards.

Emily Einstein, PhD, chief of the science policy branch at the National Institute on Drug Abuse (NIDA), said the agency is working towards safety and efficacy data.

"Some of the research underway at NIH is working to produce a formulation of mitragynine [the primary compound in kratom] that is going to be standardized so it has established purity, stability, safety, and it'll have a reproducible way that it's absorbed by the body," Einstein told MedPage Today in an interview in which a NIDA press officer was also present.

Over the past few years, the NIH has gotten a better idea about why people use kratom, she noted. "People very frequently report self-treatment of pain, self-treatment of psychiatric disorders, and importantly, self-treatment of substance use disorders, including opioid, alcohol, and stimulant use disorders," she said.

What Do We Know About Kratom?

While considered an herbal supplement, kratom is technically an opioid. When mitragynine is ingested, it breaks down into a similar compound, 7-hydroxymitragynine, according to NIDAopens in a new tab or window.

In response to the Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health, more than 1.7 million people in the U.S. said they used kratom in 2021opens in a new tab or window. That's down slightly from the 2.1 million people who said they used kratom in 2020opens in a new tab or window when the survey first asked questions about kratom use.

Kratom is sold in many places, from gas stations to health food stores, in powder, capsule, and liquid form. Online retailers charge more than $20 for an ounce of powdered kratom and more than $15 for a small bottle of it. Because kratom isn't regulated, it's nearly impossible to know the strength and quality of the product.

Both the pleasurable and dangerous effects of kratom vary with the amount, potency, and method of use, according to NIDAopens in a new tab or window. In low doses, kratom has stimulant-like effects, and in higher doses, taking kratom can result in sedative or psychotic effects, though part of the problem is that research hasn't definitively proven the relationship between the amount of kratom ingested and the types of effects. Research from the past several years has identified outsized proarrhythmic risksopens in a new tab or window linked to kratom use, as well as kratom-associated liver injuryopens in a new tab or window.

Lewis S. Nelson, MD, chair of the department of emergency medicine at Rutgers University in Newark, New Jersey, said that even if a drug has a small risk, the risk to the broad public is significant when it's available to millions of people.

"There's nothing that's not toxic if you take enough of it," Nelson told MedPage Today. "It's all relative to the degree of toxicity of a compound. So there's no doubt that you could overdose on kratom or mitragynine. It probably takes a fair amount of it to do it, and most people don't take doses like that."

"The fact that kratom is not regulated, yet mitragynine is an opioid, is simply a regulatory issue, not a medical issue," he added. Nelson explained that kratom primarily binds to the mu-opioid receptor, and there is also activity in the serotonin and alpha-2 receptors.

In 2019, the CDC released a reportopens in a new tab or window on unintentional overdose deaths with kratom from 11 states. Among more than 27,000 overdose deaths from July 2016 to December 2017, 152 decedents tested positive for kratom. In 91 of those cases, kratom was determined to be the cause of death, yet there were only seven cases in which kratom was the only substance in their system.

Einstein noted that "the majority of ill effects that have been reported result from polysubstance use," while in other cases, kratom has been contaminated. For instance, in 2018, the FDA recalled kratom products from Triangle Pharmanaturalsopens in a new tab or window due to salmonella contamination.

Another popular use of kratom is as a treatment akin to buprenorphine for opioid use disorder. NIDA, among other government agencies, has noted kratom may have the therapeutic potential.

"I would urge people to view kratom use in the context of the overall overdose crisis," Einstein said. "People are employing new harm reduction strategies faster than we are able to develop the evidence to support them."

Nelson said that while it's exciting that kratom might be a new treatment option for opioid withdrawal, scientists still don't know enough about the drug. "The other side of the coin is if you're able to treat opioid withdrawal, you're also able to cause opioid intoxication," he cautioned.

Kratom's Victims

Susan Eppard hasn't been the same since her son Matthew died after using kratom in 2021. She said when Matthew first started using kratom years before, it gave him energy during the day and helped him sleep at night. But she said he soon became addicted to it. In 2021, Matthew had a seizure and was in cardiac arrest and suddenly died. His toxicology report noted "toxic effects of mitragynine."

Eppard is not alone. She and several other families of people who died from kratom banded together to form Kratom Awareness, Prevention and Education (KAPE)opens in a new tab or window, which is now led by Dana Pope.

Unlike Eppard, Pope and her husband had never heard of kratom before their son Ethan died from it 2 years ago. They learned his cause of death was "cardiac arrest due to mitragynine toxicity" and found empty kratom containers in his apartment. Searching his credit card statement, they found that Ethan had first purchased kratom at a health food store and then started buying it at gas stations. While many people use kratom in conjunction with other substances, neither Ethan nor Matthew had any other drugs in their system when they died. Both were in their early 20s.

"I just keep thinking, how can you go to the gas station and buy this and then it kills you. How is this possible?" Pope told MedPage Today.

Pope and her husband filed a wrongful death lawsuitopens in a new tab or window against a slew of kratom companies and manufacturers, as well as the AKA.

Once her name was public, families with similar stories of losing loved ones to kratom reached out to join her in raising awareness about the potential harms of its use.

Tamara J. Williams, an attorney at mctlaw, based in Sarasota, Florida, has represented more than a dozen clients alleging wrongful deaths from kratom in the last 5 years, including the family of a Florida momopens in a new tab or window who was just awarded $11 million in damages. She said that it's tricky to get to the bottom of kratom companies to find who to sue.

"Companies create a bunch of shell companies where it's really hard to target who's behind what product," said Williams, who is not part of Pope's legal team. "So you have a company within a company, and then sometimes you have individuals thrown in the mix. It's pretty much like the wild wild west."

Both Advocates and Critics Want Regulation

Some states, including Alabama, Arkansas, and Indiana, have banned or limited kratom. Others have passed the Kratom Consumer Protection Actopens in a new tab or window, which made 18 the minimum age for purchase and requires dealers to only sell products that meet quality standards. It also bans synthetic alkaloids, which both the AKA and NIDA call dangerous.

However, in most states, kratom is legal without restrictions. While KAPE warns about the potential dangers of kratom, Pope supports more research.

"There's just not enough studies, which is why I would like it to be banned or scheduled until there are more studies so we know how much kratom ... is safe," said Pope. "But because it's just not regulated, nobody knows. So it's just kind of a game of Russian roulette."

Does Kratom Need Tighter Regulation? | MedPage Today