Despite Multiple Legal Setbacks, the Regulatory Tide May be Ready to Turn for Kratom
Kratom. Even the name sounds otherworldly, almost magical if you let that long1 “a” sound linger on the tongue. And that’s part of the deal with this traditionally used yet now controversial plant product making the news in these parts, these days: consumers are fascinated with kratom. User reactions on Erowid, an internet compendium of consumer use and experimentation have recently included comments like, “Kratom helped me defeat my own personal issues that were a result of opiate addiction” and “[Kratom] provided me a wave of deep aesthetic pleasure beyond normal sensation.”
The dried leaves of the kratom plant have been used for centuries in Southeast Asian culture for their transcendent psychoactive properties, and since 1936 for medicinal and healing practices, according to the American Psychological Association. In reality, Mitragyna speciosa isn’t otherworldly at all. It’s very much of this Earth. It’s just another plant from the coffee family, after all, albeit a species with unique pain relieving, social interaction-improving, and even opioid withdrawal-easing effects.
And of course, when writers resort to vernacular phrases like “these parts,” (see the first paragraph) it means they’re talking to a familiar audience: Here, we’re talking about kratom and smoke shop culture. We’re including attention to the consumers who’ve helped make kratom such a big deal. A key federal survey estimated that more than 1.7 million Americans used some form of kratom in 2021.
That sounds like the makings of a worthwhile relationship between the retail industry and the people it serves. But it’s more complicated than that. Kratom, though effective and pleasant enough in low doses, is said by its detractors to be dangerous when taken in high doses or in combination with other psychoactive substances or alcohol—and past anecdotal evidence has tended to agree. Such “evidence” has led to calls for a crackdown on the import of this herbal remedy, which in reality, is just a leaf from a tree. Currently, kratom import,* processing and sales are not regulated in America, though the industry’s chief lobbying arm maintains that sales of the herbal remedy amount to a billion-dollar industry. The kratom business imports more than 2000 tons of leaves and plant material into the USA on a monthly basis.
In a press release dated February 26, 2024, it has been noted that FDA Deputy Commissioner Kimberlee Trzeciak has signaled a ‘significant shift in FDA policy on kratom.’
Those facts, about kratom’s usefulness and market potential, as well as the substance’s alleged dangers, have come up recently in mass-media reporting on the subject. Last summer, National Public Radio reported that “dozens of wrongful death lawsuits have been filed over the product and how it is marketed.” In recent court cases, both originating in the state of Florida, kratom was listed as a contributing cause of the death for at least two casual users of the plant, according to NPR reporter Peter Haden.
As for the kratom industry itself, the American Kratom Association has been actively lobbying for a more truthful approach to the plant. Association lobbyist Mac Haddow went on the record recently, telling NPR, “The (wrongful death) case in Florida was egregious . . . It’s the poster child for why regulations need to be put into effect.” Such regulations would include better, more accurate labeling and dosage information for Kratom-related products.
AKA maintains that it wants better regulation of its product, as long as federal regulations related to kratom import, use and production continue to fall under the aegis of the Food and Drug Administration, and that it’s categorized as an herbal supplement.
The death of Krystal Talavera of Boynton Beach, Florida, on a weekend in June of 2021 was ruled to be kratom-related. She had consumed a packet of powder containing a kratom concentrate labeled “Space Dust.” Had the product been properly labeled and its sale adequately regulated on the internet, Talavera’s death could have been avoided, industry advocates have argued in the press and on the AKA website.
But the association’s website goes further than merely supporting consumer use of kratom and assenting to the need for better labeling and sales practices; the site actively calls out the FDA for its efforts to do “everything it can do to interfere with the right of consumers to make informed choices about products they use for their health and well-being . . . and their war on kratom” which AKA says “includes distributing disinformation on kratom that materially misleads consumers and policy makers.”
The FDA’s position, until very recently, has been clear. CBS news reporter Mark Strassman reported in December that the feds have been working to ban imports of kratom since 2014. This intractability seems to be evolving, though.
In part designed to protect consumers such as Krystal Talavera, the official government position on kratom reads, in part, “until the agency scientists can evaluate the safety and effectiveness of kratom (or its components) in the treatment of any medical conditions, FDA will continue to warn the public against the use of kratom for medical treatment. The agency will also continue to monitor emerging data trends to better understand the substance and its components.”
The focus on a ban and the lack of regulation of a product commonly sold under a variety of names and concentrations are at the heart of the issue, Haddow told CBS. “They simply say, ‘We’re not gonna regulate. We wanna ban it,’” he said. “They should be regulating and protecting consumers.”
Notably, Strassman’s reporting also revealed a key fact about the kratom industry: “The group’s spokesman, Mac Haddow, told CBS News that out of about 8,000 players in the kratom industry, only around ‘three dozen’ are legitimate.”
Certainly, such admissions require a second look at current regulatory efforts by the FDA. This could happen as FDA regulation ramps up based on scientific evidence of kratom’s usefulness. Despite the recent legal setbacks, there are signs that the tide is turning. In a press release dated February 26, 2024, it has been noted that FDA Deputy Commissioner Kimberlee Trzeciak has signaled a “significant shift in FDA policy on kratom.” This shift includes thinking about “what a regulatory framework” for kratom would look like, as well as increased efforts to work with Congress to ensure that all kratom products are “clearly labeled with all ingredients,” as well as a new, active investigation by FDA regulators of industry manufacturing and production techniques.
In further developments related to the marketing of kratom and kratom products in the US, the AKA also released some policy briefs in addition to the February announcement referenced above. In these published findings, the AKA reiterated some very interesting facts and processes discovered by the federal government. These include a report on a recent “dose finding study,” on kratom, conducted under FDA auspices, which found no adverse events related to dosage. The document highlighting these findings also noted that some government scientists “were profoundly disappointed” in the initial results of the clinical study.
Despite the ostensibly negative attitude displayed by some within the regulatory status quo, officials at the FDA accepted the results and are making plans to make a public presentation on those results at a scientific conference happening in Fall 2024.
A second white paper published by AKA in the past month calls out hypocritical stances and tactics undertaken by the feds. Although the FDA and other agencies have repeatedly called for a ban on kratom, their tactics have been far from transparent, as the press release notes:
“The FDA has repeatedly made claims over the past 12 years that kratom is a dangerous substance thatshould be classified as a Schedule I substance under the federal Controlled Substances Act (“CSA”). Yet, when called by a Federal Judge to present witnesses and testimony under oath in a case in the Southern District of California at a Hearing on February 8, 2024, on whether kratom is dangerous, the FDA refused to attend the Hearing or even provide under oath any documents or testimony to the Court. The explanation provided by the U.S. Attorney to the Court explaining the FDA’s decision stated the following: They [FDA] have refused to provide us with witnesses or documents to support our position . . . The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous.”
To get a clearer idea of concepts related to kratom’s safety, as well as issues surrounding issues such as kratom concentrates and product labeling, we had a conversation with a noted industry insider who has been working with the kratom industry for well over a decade.
“The people who originally got into this business did so for a reason,” they stated, after reaffirming their sincere belief that kratom is indeed safe. “Many of them had personal experiences with opiate withdrawal, long-term chronic pain management, and anxiety-reduction strategies.”
Unfortunately, due to lack of federal regulation, “non-kratom” people eventually got involved in this demonstrably profitable market, creating and selling “adulterated” extracts from the plant–usually featuring 7-Hydroxymitragynine3, according to our trusted source. This substance, which is present in low levels in naturally processed kratom leaves, can be used as a psychotropic substance if distilled into a concentrate. The problem is, 7-Hydroxymitragynine can be dangerous at high doses, something folks like our esteemed insider believe to be true.
The solution–according to our source–is federal regulation that focuses on quality production standards and accurate product labeling. He admits that as far as smoke shops and smoke shop culture is concerned, “These should be happy, carefree, safe places for both consumers and retailers, but there are always going to be negative elements that pop up over the years. Usually, they run their course and then lose popularity . . . until now I haven’t been in a position to be able to say, ‘don’t let that stuff (7-Hydroxymitragynine concentrate) into that safe space. It’s going to do something bad.’”
Our source went on to emphatically state that they would love to see federal regulation of kratom become a reality.
“I know the word ‘regulation’ has negative connotations these days, for some reason,” our anonymous colleague offered. “In this case, I really don’t understand why. But some people are always trying to make a buck. They’ll cut corners, they won’t test or use sterile lab equipment. Some of them will find a way to exploit substances by adulterating them, concentrating potentially dangerous ingredients to expand their marketing reach and increase profitability. But we’re at this stage now where it could go to a federal level, where, with further testing, it could be classified as a regulated dietary supplement. That would mean an end to the only problems–because on its own, there were no dosage-related dangers discovered in clinical trials–we’ve encountered with kratom.”
While the effects of kratom may indeed seem magical, it’s important to keep both feet firmly planted in the good earth as our scientists investigate and report so that the government can effectively regulate. In the meantime, consumers, given the right to choose, must continue to be diligent and sometimes wary as they interact with businesses that may or may not be grounded in the precepts defined by the AKA:
“AKA supports appropriate FDA regulations to ensure the safety and purity of kratom products. The American Kratom Association (AKA) recognizes that every effort should be made to keep kratom risks low, and protect consumers from adulterated and contaminated kratom products. With appropriate FDA consumer regulation, we can maximize the potential for kratom to be responsibly used for the improvement of health and well-being of individuals and public health in America. We are committed to work with the FDA to share information and collaborate in the development of regulations that will protect consumers from adulteration and contamination of kratom products.”
By Rudy Carrillo
