In a bold move to curb potential addiction, Health Secretary Robert F. Kennedy Jr. announced a plan to limit access to a powerful kratom derivative on Tuesday.
According to Axios, this initiative targets 7-hydroxymitragynine (7-OH), a potent compound derived from the kratom plant, with the Food and Drug Administration (F.D.A.) and Drug Enforcement Administration (D.E.A.) collaborating to classify it based on its risk for abuse.
For years, kratom, a plant native to Southeast Asia, has been used by millions of Americans to manage pain. Recently, manufacturers have isolated and enhanced a specific component of kratom to produce 7-OH, a more intense substance. This compound, available online and in vape or smoke shops, comes in forms like gummies, tablets, chewables, or small drinks.
Often labeled simply as kratom, 7, or 7-OH, the product has raised alarms due to its ability to bind to opioid receptors in the brain. This interaction mimics the effects of traditional opioids, though 7-OH is not derived from the poppy plant. Health officials have noted growing worries about its potential for dependency among users.
In response, the F.D.A., led by Commissioner Dr. Marty Makary, has intensified efforts to address the issue. In recent months, the agency issued seven warning letters to companies producing 7-OH items, signaling possible fines or product seizures if compliance is not met. Dr. Makary emphasized a proactive stance, saying, "Let’s be honest. There’s also a lot we don’t know."
He continued, "This may be the calm before the storm. It may be the tip of the iceberg, but let’s be aggressive and proactive." The F.D.A. also clarified that 7-OH is not permitted in dietary supplements or food products. Additionally, there are no approved medications containing this compound, and claims of pain or anxiety relief lack regulatory support.
The F.D.A. has faced ongoing challenges with dangerous psychoactive substances sold in gas stations and smoke shops. Last summer, over 160 individuals became ill, and three died after consuming Diamond Shruumz candy bars containing unauthorized psychedelic ingredients, leading to severe symptoms like seizures and hallucinations. The agency has also targeted tianeptine, dubbed "gas-station heroin," due to reports of injury and addiction.
To inform the public about 7-OH, the F.D.A. is releasing a detailed report, a letter to healthcare providers, and a consumer advisory on associated dangers. The agency warned, "Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use." This statement underscores the lack of established safety data for these widely available items.
Under the new plan, the F.D.A. will initiate the process to "schedule" 7-OH, assessing its risk for misuse and potential benefits. The D.E.A. will handle the final stages of this classification, with federal officials recommending placement in Schedule I, the strictest category. This involves an eight-factor analysis to evaluate the substance’s harm potential and abuse likelihood.
This restrictive approach to 7-OH stands in contrast to the Biden administration’s efforts to ease marijuana regulations by moving it from Schedule I to Schedule III, citing medical benefits. However, that proposal has encountered procedural delays, slowing its implementation. The differing strategies highlight the complex landscape of substance control in the United States.
Dr. Kirsten Elin Smith, an assistant professor at Johns Hopkins University studying kratom, noted that 7-OH emerged online roughly two years ago. She initially viewed it with suspicion, stating, "If you had asked me a year ago, I would have said this is evil." Now, she added, "At this point I’m a little more equivocal."
Dr. Smith is surveying hundreds of users and conducting detailed interviews about 7-OH. Some report positive effects, such as better mood and enhanced quality of life, while others describe it as habit-forming. She also noted, "Kratom is not a panacea without risk either. Both kratom products and 7-OH products have a benefit-risk profile."
While most surveyed users oppose a full ban on 7-OH, about 15% support tighter controls. Dr. Smith observed no surge in harm reports, possibly due to the absence of blood tests to detect 7-OH specifically. Routine testing for another kratom component similarly shows no rise in negative outcomes.
Mac Haddow, a senior fellow at the American Kratom Association, warned of the substance’s dangers, stating, "You can get addicted to 7-OH in a couple of days, and it’s a horrible situation to get off of it." Meanwhile, Jeff Smith from Holistic Alternative Recovery Trust questioned the urgency, saying, "If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented." He concluded, "It was not." As the F.D.A. and D.E.A. move forward with scheduling 7-OH, the debate over its risks and benefits continues. Health officials aim to balance public safety with access to alternative pain relief options. The outcome of this regulatory effort could set a precedent for handling similar substances in the future.