FDA Moves to Classify Kratom Derivative as Controlled Substance
Washington – The Food and Drug Administration (FDA) has formally requested that a well-known derivative of Kratom be classified as a controlled substance. This decision comes as part of the Trump administration’s efforts to reduce the use of 7-hydroxymitraginine, or 7-OH, which is derived from the Kratom plant, native to Southeast Asia.
7-OH can be found in various local stores, such as vape shops and gas stations, typically in a concentrated synthetic form. This version has doses much higher than what you would find in traditional Kratom leaves. Its effects seem to interact with the same receptors in the brain as standard opioids like morphine and fentanyl, producing similar responses. There’s also accumulating evidence, including anecdotal reports from users on platforms like Reddit, suggesting that it may lead to addictive behaviors and withdrawal symptoms.
One user mentioned, “The way it’s been manipulated… not good.” They highlighted the surprising accessibility of these substances compared to previous addiction experiences. 7-OH is often marketed in colorful tablets, candies, and powders, disguising its potency and danger. According to the FDA, it poses a respiratory risk that is over three times more intense than morphine, with each serving averaging only $3.97.
FDA Commissioner Marty McCurry spoke about the need to differentiate the dangers of 7-OH from that of Kratom plants, advocating for tougher regulations on synthetic derivatives while still allowing the use of the traditional plant, which has a long history of use. He urged drug enforcement agencies to categorize high-concentration 7-OH as a Schedule I drug.
Health and Human Services Director Robert F. Kennedy Jr. shared insights from his own experiences with addiction, expressing concern about the easy availability of substances that can lead individuals down a path of addiction—“You used to have to seek out heroin; now you can just stop by the gas station.”
McCurry likened the situation to a public health issue, pointing out a history of negligence in addressing these risks. He noted, “Why do we keep repeating the same mistakes? Experts really need to visit vape stores to understand what’s at stake.” Alongside this new report, McCurry has reached out to healthcare providers to inform them of the risks and dangers associated with these products.
Oklahoma Senator Mark Wayne Marin commented on the troubling implications of 7-OH, suggesting it could hinder recovery from opioid addiction. “It’s really just that same path to addiction all over again,” he stressed.
The data surrounding 7-OH is still developing, and more findings are anticipated from organizations like the National Institutes of Health. However, an early warning from the National Drug Early Warning System (NDEWS) indicated an uptick in Reddit discussions regarding 7-OH from January to September 2024.
Between 2019 and 2025, inquiries into the Drug Enforcement Bureau’s toxicology database yielded 103 reports related to mitraginine and 7-OH, some of which were fatal. Additionally, the FDA’s Adverse Event Reporting System (FAERS) recorded 13 adverse events linked to 7-OH, including two deaths. Notably, while the National Survey on Drug Use and Health explores use of Kratom, it does not yet account for 7-OH.
