The Drug Enforcement Administration’s arbitrary 7-OH ban is not rooted in science

The Drug Enforcement Administration (DEA) announced plans July 1 to temporarily place certain kratom-derived substances into Schedule I of the Controlled Substances Act (CSA). This action would criminalize products used by millions of Americans as a safer alternative to opioids for chronic pain, mental health, and opioid use disorder, potentially pushing many back toward the use of illicit opioids. Given that the federal government can only plausibly point to a handful of deaths linked to these products over the last near-decade and the opioid overdose crisis this country continues to face, the move is likely to cause far more harm than it prevents.

The Notice of Intent specifically targets 7-hydroxymitragynine (7-OH), one of the two active alkaloids found in kratom plants. An additional Notice of Intent would also place three related compounds—mitragynine pseudoindoxyl, MGM-15, and MGM-16—in Schedule I. Schedule I is the most restrictive category of controlled substances, for drugs the government claims have a high potential for abuse, no currently accepted medical uses, and lack of accepted safety for use under medical supervision. Examples include heroin, LSD, and MDMA, among others.

Surveys of U.S. kratom users indicate that a majority use kratom to reduce chronic pain, often citing their inability to get adequate relief through standard methods as their motivation for trying kratom. A significant portion of users, over 40% in some surveys, also report using kratom products as a long-term replacement for opioids and rate it as effective for addressing withdrawal symptoms and cravings. Many report continuous opioid abstinence at six months and one year. 

The move to ban kratom follows calls to control 7-OH made last summer by Health and Human Services Secretary Robert F. Kennedy and Food and Drug Administration Commissioner Marty Makary. It also follows more recent and seemingly contradictory comments from President Donald Trump made in May 2026 that his administration was “looking very seriously at natural 7-OH and getting that approved.” 

In a press release announcing the order, the DEA claimed its action will protect the public from an “imminent threat” posed by these products, with Kennedy stating that “7-OH, MP, MGM-16, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk.” But, the available data, including evidence cited in DEA’s own notice, do not support claims of a major looming threat from kratom-derived products that would warrant emergency scheduling. 

For background, kratom products are derived from the leaves of Mitragyna speciosa, a tropical tree native to Southeast Asia where, for generations, its leaves have been chewed or brewed into tea to boost energy or self-manage depression, chronic pain, and substance use disorders. Kratom has only recently gained popularity in Europe and the U.S., with “kratom” products extending from more-traditional raw leaf products to more concentrated extracts. 

Early research indicates kratom compounds hold great promise as a safe and effective tool to address opioid addiction. In fact, the National Institutes of Health (NIH) has already awarded millions of dollars in grants to study kratom derivatives for exactly this purpose. 

Kratom’s effects stem from the plant’s natural alkaloids, the most prominent of which is mitragynine. A second alkaloid, 7-hyroxymitragynine (7-OH), occurs naturally in kratom leaves in much smaller amounts. 7-OH can also be produced by converting mitragynine into this more potent form, which happens after consuming kratom as liver enzymes metabolize and convert mitragynine into 7-OH. It can also be produced by processing kratom extract in a lab to make concentrated products. 

At low-to-moderate doses, kratom can be both stimulating and pain relieving. At higher doses, the increasing levels of 7-OH created by the body metabolizing mitragynine leads to a more sedative effect and stronger pain relief. For mitragynine, there is no apparent risk of suppressed breathing—the side effect that causes most opioid overdose deaths.  Direct administration of 7-OH, on the other hand, has been shown in at least one animal study to slow down breathing.

 For raw, unconcentrated kratom, there appears to be no risk of fatal respiratory problems, as the liver enzymes needed to convert mitragynine into 7-OH are naturally limited, creating a “ceiling” effect. For concentrated 7-OH products, the same may not be true. This risk, while serious, is likely not as a dire a threat is it may seem or the DEA would have the public believe. 

The good news is that naloxone—the same medication used to reverse opioid overdose—appears to be equally effective at reversing respiratory effects induced by 7-OH. More importantly, while those taking very high doses may face some respiratory-related risk, the available data, including that cited by DEA, indicates that this is risk is low and can be reduced further by simply providing consumers with vital information about how these products should be consumed. 

According to its order, the DEA has identified just 85 drug overdose cases involving 7-OH since 2019, 55 of which were fatal. Though “kratom-involved” deaths have recently made big headlines, the mere presence of kratom in autopsies does not tell us whether kratom contributed to a death. The fact is that exceedingly few—if any—of these deaths involved only kratom, with most occurring alongside the use of opioids, like fentanyl. That is not particularly surprising given the reasons users cite for kratom use. 

The most comprehensive federal analysis, which reviewed 27,338 overdose deaths between July 2016 and December 2017, identified just 152 deaths—about half of one percent—where kratom was involved. Of those 152, only seven cases involved only kratom. Even this low number may be an overestimate if postmortem testing failed to account for other potentially contributing substances, like Benadryl, which has been found in some “kratom-linked” deaths in an amount that could cause fatal outcomes on its own.

With estimates putting the annual U.S. sales of 7-OH in the billions of dollars—representing potentially hundreds of millions of doses consumed—the low number of deaths even tangentially linked to 7-OH use indicates a relatively low risk given these levels of consumption.

Of course, death is not the only side effect worthy of concern. There is evidence that kratom, and 7-OH in particular, can be habit forming, leading to symptoms of withdrawal with discontinuation (though these are typically reported as milder than those associated with classic opioids and treatable with the same medications used for opioid addiction). 

Other side effects reported by kratom users tend to be mild, such as nausea, constipation, drowsiness, or irritability, with less than one percent of users reportedly seeking medical treatment related to kratom use. Though rare, more serious side effects, like seizures and liver toxicity, have been reported.

In its order, the DEA notes “an increasing volume of calls to poison control centers” as evidence of widespread adverse events related to 7-OH use. But, as even DEA acknowledges, that increase is likely related to the fact that kratom only received its own code in the National Poison Data system in the spring of 2025, allowing such calls to be tracked, and the DEA does not provide the monthly data needed to substantiate how much of an increase in calls occurred. 

Still, over the seven months between January 1 and July 31, 2025, DEA reports just 165 exposure calls to U.S. poison centers involving 7-OH, with about 58 of those resulting in “serious health problems” These serious health problems reportedly ranged from relatively benign gastrointestinal symptoms, like vomiting, to more concerning effects, like loss of consciousness or difficulty breathing. But it is unclear how many of these 58 cases fell into the less or more serious category based on available information. More importantly, these calls only tell us what callers report, which may not include relevant information like the other substances they were using. 

None of this is to say that kratom or 7-OH products are without risk. Mixing kratom with other depressants, like alcohol, antihistamines, and certain prescription medications, may put users at increased risk due to the compounding effects on breathing. Mixing kratom with certain prescription and over-the-counter medications can also lead to those medications building up, as the liver enzymes needed to process mitragynine also process many common medications. Contamination of kratom products with heavy metals and pathogens, stemming from poor manufacturing practices, is also a real risk to consumers, but it is a risk that, as in other industries, is addressable through regulation. 

Rules stipulating safe manufacturing and testing practices, accurate labeling, and warnings about medication mixing would eliminate the bulk of the risk currently associated with kratom. Prohibition, on the other hand, addresses none of these risks and will likely exacerbate them as users seek alternatives in the illicit market, where manufacturers have even fewer incentives to follow such guidelines. 

A Schedule I designation would penalize consumers who are trying to reduce their risks by using a less harmful alternative to opioids, likely pushing many back toward potentially adulterated opioids, and stymieing the research needed to demonstrate kratom’s potential as a therapy. Thoughtful regulation on these products would be more likely to achieve the DEA’s stated public health goals than prohibition. 

The post The Drug Enforcement Administration’s arbitrary 7-OH ban is not rooted in science appeared first on Reason Foundation.

Source: https://reason.org/commentary/the-drug-enforcement-administrations-arbitrary-7-oh-ban-is-not-rooted-in-science/