Health officials, including HHS Secretary RFK Jr. and FDA Commissioner Dr. Marty Makary, are calling for the classification of 7-hydroxymitragynine (7-OH) — a byproduct of the kratom plant — as a Schedule I drug. The agency has labeled the substance ‘gas station heroin’ due to its widespread availability, opioid-like effects, and potential for abuse. Makary compared the situation to the early days of opioid prescriptions, warning that without intervention, a new wave of addiction could emerge.
The FDA notes that 7-OH is increasingly recognized for its ability to bind to opioid receptors, making it more potent than morphine. The agency is also concerned about the misleading labels of 7-OH products, which are often disguised as kratom and may be appealing to children and teens due to their fruit-flavored gummies and ice cream cones. Public health experts argue that regulation and education are critical to addressing this growing threat.
Kennedy, who has personal experience with heroin addiction, emphasized the role of availability in enabling substance abuse. He recounted how his own battle with addiction was fueled by the ease of access. Sen. Markwayne Mullin, R-Okla., supported the recommendation, citing his family’s experience with addiction. Meanwhile, the CDC reported a 26.9% decrease in drug overdose deaths in 2024, though opioid-related deaths still declined from 83,140 in 2023 to 54,743 in 2024.
Despite kratom’s use in self-treating conditions like pain and anxiety, the FDA has not approved any prescription or over-the-counter drugs containing kratom or its components. As the agency moves to classify 7-OH as a controlled substance, health officials are calling for swift action to prevent another public health crisis.