A recent directive from the Drug Enforcement Administration (DEA) to classify concentrated forms of 7-hydroxymitragynine (7-OH), a prominent alkaloid found in the kratom plant, as an illegal controlled substance has reignited a contentious debate: Is kratom itself an opioid? This question, far from purely academic, carries profound implications for public health, regulatory policy, and the millions of individuals who rely on kratom for various reasons.
Kratom, derived from the leaves of the Mitragyna speciosa tree indigenous to Southeast Asia, has been an integral part of traditional medicine for centuries. Historically, it has been consumed for its natural stimulant properties at lower doses and as a potent pain reliever and sedative at higher doses. Belonging to the coffee family, kratom shares botanical lineage with a plant known for its globally consumed alkaloid, caffeine, which also possesses mild analgesic properties. Yet, no one labels coffee or caffeine an opioid. This stark contrast highlights the unique and often politicized scrutiny applied to kratom.
The "Opioid" Label: A Regulatory Flashpoint
The designation of kratom as an "opioid" is a relatively recent phenomenon, largely emerging from government regulatory bodies and elements within the addiction treatment industry in Western nations. A pivotal moment occurred in 2018 when then-FDA Commissioner Scott Gottlieb, MD, publicly declared kratom an opioid, issuing a stark warning against its use for pain or any other medical condition. Gottlieb, now serving on the board of directors for Pfizer, asserted, "Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous. It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally."
Gottlieb’s pronouncement was underpinned by an FDA computer analysis which suggested that 7-hydroxymitragynine (7-OH), mitragynine, and other kratom alkaloids exhibited structural and functional similarities to opioid analgesics. Like conventional opioids such as morphine and oxycodone, these alkaloids do bind to mu-opioid receptors in the brain, thereby eliciting pain relief. However, a crucial distinction often highlighted by proponents of kratom is that its primary active compounds, mitragynine and 7-OH, act as partial agonists at these receptors. This pharmacological characteristic means they stimulate the receptors to a lesser extent than full agonists like heroin or prescription opioids, and critically, they generally do not induce the severe respiratory depression that is the hallmark cause of death in opioid overdoses. The vast majority of reported kratom-related "overdoses" have, in fact, been attributed to polydrug use, where kratom was consumed in conjunction with other central nervous system depressants like alcohol or benzodiazepines, which do suppress breathing.
Despite these nuanced scientific understandings, Gottlieb remained steadfast in his classification. "Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids," he stated.
Scientific Counterarguments and Regulatory Pushback
The FDA’s analysis, however, was met with significant skepticism and outright criticism from various quarters, with some labeling it "junk science" due to perceived errors and biases. One prominent critic was Brett Girior, MD, who served as the Assistant Secretary for Health and Senior Advisor for Opioid Policy at the Department of Health and Human Services (HHS). Dr. Girior openly disparaged the FDA’s analytical work as "embarrassingly poor evidence." His intervention proved instrumental in temporarily halting the FDA’s aggressive efforts to persuade the DEA to classify kratom’s alkaloids as Schedule I controlled substances, the most restrictive category for drugs deemed to have no accepted medical use and a high potential for abuse.
In a 2018 letter to the DEA administrator, Girior articulated his concerns, stating, "While mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature. There is significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I." This moment represented a rare instance of inter-agency disagreement that prioritized public health implications over a swift regulatory crackdown.
A Decade of Regulatory Scrutiny and Public Engagement
The 2018 episode was not the first time kratom faced a federal scheduling threat. In 2016, the DEA had issued a notice of intent to place kratom’s main alkaloids, mitragynine and 7-hydroxymitragynine, into Schedule I. This move sparked an unprecedented public outcry, mobilizing kratom users, advocates, and some scientists. Over 140,000 people signed a White House petition, and numerous protests were held. Faced with overwhelming public opposition and a lack of robust scientific consensus, the DEA took the unusual step of withdrawing its intent to schedule, instead initiating a public comment period and requesting a scientific and medical evaluation from the FDA. This historical context underscores the deeply polarized nature of the debate and the significant public interest in kratom’s legal status.
Fast forward eight years to the present, and the FDA, now under new leadership, is once again advocating for the scheduling of 7-OH, and the "opioid" label for kratom persists, despite the fundamental scientific understanding of its pharmacology remaining largely unchanged.
The Advocacy Divide: Industry, Activists, and Patients
Among the most vocal proponents for stricter regulation is Andrew Kolodny, MD, an addiction treatment psychiatrist and founder and president of Physicians for Responsible Opioid Prescribing (PROP). In a recent op-ed in The Washington Post, Kolodny asserted, "Like other opioids, kratom is highly addictive: Repeated use leads to tolerance, dependence and the need for progressively higher doses. The DEA should control kratom in all its forms. Until it does, an opioid will be available for purchase without a prescription, the number of Americans suffering from opioid use disorder will keep rising, and there will be no end to the opioid crisis in sight."
Kolodny’s name resonates with many chronic pain sufferers. PROP, the anti-opioid activist group he founded, played an influential role in the drafting of the Centers for Disease Control and Prevention’s (CDC) controversial 2016 opioid prescribing guideline. These guidelines, intended to curb the opioid crisis, had far-reaching and often devastating unintended consequences. Millions of patients experiencing chronic pain were abruptly tapered off opioids or had their dosages drastically reduced to ineffective levels. Reports from patient advocacy groups and medical associations documented a surge in suicides among those losing access to their medication, as well as a tragic turn towards the illicit market, inadvertently fueling the very fentanyl crisis the guidelines sought to prevent.
Meanwhile, Kolodny and several other PROP members reportedly earned millions of dollars as "expert witnesses" in opioid litigation cases. Critics argue that their sustained demonization of opioid medication contributed directly to a climate where many Americans, desperate for pain relief and unable to access adequate conventional care, turned to alternative substances like kratom. This irony is not lost on the patient community, whose online comments on platforms like PNN’s Facebook page reflect deep resentment: "He’s a pain grifter making his $$$$ off people suffering from chronic pain," one user posted. Another added, "He’ll naturally piss on any treatment for chronic pain that doesn’t include Suboxone or a shrink trying to gaslight you into saying nothing is wrong!"
Kolodny’s recent claims regarding kratom addiction have also drawn scrutiny. While he testified in federal court some years ago that he had ceased treating patients upon becoming Medical Director for Opioid Policy Research at Brandeis University, his recent op-ed states he is again treating addiction, with "a growing share" of his patients developing opioid use disorder from kratom. At a recent public hearing in Georgia, he went further, claiming "all of the patients" he was treating had become addicted to kratom. To support his argument that an opioid doesn’t necessarily have to derive from the opium plant, Kolodny cited the skin of the waxy monkey tree frog, which he claimed contains "an extremely potent opioid" stronger than morphine – an analogy that, while pharmacologically interesting, does little to clarify the complex debate surrounding kratom.
Kolodny also frequently references a CDC study highlighting a "1,200 percent increase" in calls about kratom to U.S. poison control centers over the past decade, a figure often presented to evoke alarm. However, a closer look at the underlying data reveals a more nuanced picture. This seemingly horrific percentage increase is based on relatively small absolute numbers. The total number of "adverse events" involving kratom reported to poison control centers was 538 in 2025, compared to just 43 cases in 2014. While an increase, this figure needs to be contextualized against the backdrop of rapidly expanding kratom use. Conservative estimates place the number of Americans using kratom at 2 million, with industry estimates ranging up to 20 million. Even using the lower figure, 538 reported cases out of 2 million users represents an extremely low rate of adverse events. For perspective, in 2025, the FDA received 538 reports of adverse events involving Suboxone, a medication commonly prescribed to treat opioid use disorder, and over 4,800 adverse events involving aspirin in the same year. Yet, there are no calls to ban Suboxone or aspirin, or to protect the public from waxy monkey tree frogs.
Kratom’s Dual Role: Pain Relief and Potential for Addiction Treatment
Ironically, while some in the addiction treatment community champion the concept of "kratom use disorder"—a term first appearing in 2021 as psychiatrists sought to establish a clinical consensus for diagnosis and treatment, often with Suboxone—other research points to kratom’s potential in addressing addiction itself. The National Institutes of Health (NIH) recently announced plans to investigate the kratom alkaloid mitragynine specifically as a treatment for opioid use disorder.
This research aligns with the experiences of many kratom users. A 2016 PNN survey of over 6,000 kratom consumers found that approximately one in ten used kratom to reduce cravings for opioids or alcohol, with over 90% reporting it as "very effective." One respondent noted, "This is an herbal blessing that has kept me from drinking. If it becomes illegal, I fear we may never truly be able to study and treat ailments that kratom helps with." More recently, a survey by the 7-Hope Alliance, an advocacy group for 7-OH, indicated that 23% of 7-OH consumers use it to self-treat opioid addiction, while a substantial 74% utilize it for chronic pain relief.
Mac Haddow, a lobbyist and spokesman for the American Kratom Association (AKA), suggests that the persistent framing of kratom as an opioid is significantly influenced by the addiction treatment industry. "I think the more difficult problem is with addiction recovery centers because they’ve become very active in the kratom space, and they’re calling it an opioid. They want to say that because they have to be able to qualify a so-called kratom addicted person in order to be reimbursed for the treatments that they provide," Haddow told PNN. "To me, that’s problematic because that’s a profit-centered assessment as opposed to a medical assessment, and clearly they are in the business of calling it an opioid so they can get reimbursement."
The Internal Conflict: AKA’s Stance on Concentrated 7-OH
Adding another layer of complexity to the debate is the position of the AKA itself. While typically advocating for the legality and accessibility of natural leaf kratom, the AKA is surprisingly leading the charge to ban highly concentrated 7-OH products. In a recent PNN op-ed, Haddow referred to these as "7-OH opioid products," stating, "They took a naturally occurring trace alkaloid found in kratom leaf and chemically manipulated it into highly concentrated 7-OH-dominant opioid products, then pushed those products into the marketplace without the guardrails that would apply to any legitimate opioid drug product."
Advocates for 7-OH products contend that the AKA’s stance is motivated by a desire to eliminate competitors who have carved out a significant market share with what they perceive as a superior product. When questioned on how 7-OH could be considered an alkaloid in trace amounts but an opioid in concentrated doses, Haddow explained, "I could be wrong, but I think that the conversion from its trace amounts into a highly concentrated amount, then its activity on the new opioid receptors, is what distinguishes it. It’s not natural. There’s nothing natural about the 7-OH that’s sold in these highly concentrated forms because it’s been chemically managed."
However, the DEA’s own scheduling order for 7-OH products, published in the Federal Register, directly contradicts this assertion. The DEA explicitly states that the 7-OH molecule chemically remains identical, irrespective of whether it originates from natural leaf kratom or synthetic, concentrated versions: "Despite the different origins of 7-hydroxymitragynine, the chemical structures of synthetic and naturally occurring 7-hydroxymitragynine are identical. Consequently, the intrinsic pharmacological profile, receptor affinity, and mechanism of action of 7-hydroxymitragynine molecule remain unchanged regardless of its source."
Despite this molecular identity, the DEA’s current action targets only concentrated 7-OH formulations, not natural leaf kratom, asserting that these specific products "pose significant safety risk to unsuspecting consumers by exposing them to high doses of opioids." The term "opioids" resurfaces, a pejorative label that underpins the regulatory intent.
Implications of Prohibition: Unintended Consequences on the Horizon
Undoubtedly, concentrated 7-OH products are potent analgesics. Like any powerful substance, excessive or irresponsible use carries inherent safety risks. Some manufacturers of 7-OH products have exacerbated these concerns through questionable marketing practices, including the absence of warning labels and the use of child-friendly, candy-like packaging. This lack of self-regulation has provided ammunition for those advocating for a ban. Consequently, 7-OH products, once readily available in gas stations, smoke shops, and online, are rapidly becoming illegal. Several states, along with dozens of cities and counties, have already enacted bans, with a nationwide prohibition on the horizon.
However, history offers cautionary tales regarding prohibition. Past attempts to ban alcohol, marijuana, or even restrict prescription opioids have consistently demonstrated a propensity for unintended consequences. The impending ban on 7-OH products is likely to create a thriving black market, where quality control is nonexistent, and consumers face heightened risks from unregulated, potentially adulterated, or dangerously potent counterfeit products. It is reasonable to anticipate that criminal organizations and drug cartels will capitalize on this new illicit market, introducing unverified 7-OH tablets or novel, untested formulations of other kratom alkaloids.
In this scenario, the DEA will inevitably find new substances to target and more individuals to arrest, while the addiction treatment industry may indeed find a new cohort of patients requiring Suboxone prescriptions for "kratom use disorder."
The central thesis of many kratom advocates is succinct and powerful: "No one called kratom an opioid until they wanted it banned. And figured out a way to make money from it." This perspective posits that the "opioid" label is not merely a scientific classification but a strategic tool employed to facilitate prohibition and generate revenue for specific stakeholders. When presented with this assessment, Mac Haddow, the AKA spokesman, simply stated, "That’s a fair assessment. I agree."
The ongoing saga of kratom’s classification encapsulates a complex interplay of traditional use, emerging science, regulatory imperative, economic incentives, and patient autonomy. As concentrated 7-OH products transition into the realm of illicit substances, the broader debate surrounding kratom’s nature and its place in society remains unresolved, promising continued contention and unforeseen consequences for public health and drug policy.
