The U.S. Food and Drug Administration (FDA) is calling for tighter federal control over 7-hydroxymitragynine (7-OH), a potent psychoactive compound derived from the kratom plant, citing its high potential for abuse and opioid-like effects. The agency has formally recommended classifying 7-OH as a Schedule I controlled substance, aligning it with drugs such as heroin and cocaine under the Controlled Substances Act.
The move follows a surge in the popularity of 7-OH products sold in vape shops, gas stations, and online retailers. While kratom in its natural form has long been used as a stimulant or pain reliever, 7-OH appears in much higher concentrations in processed products such as tablets, gummies, drink powders, and oral shots.
These products are often marketed without regulatory approval, and some are packaged in formats like fruit-flavored edibles that may appeal to children, prompting further concern among health authorities. FDA Commissioner Dr. Marty Makary stated that 7-OH binds to the brain’s opioid receptors, potentially triggering respiratory depression, physical dependence, and withdrawal symptoms similar to those caused by prescription opioids.
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The compound has been shown to be more potent than morphine in animal models, raising alarms over its uncontrolled availability. The FDA emphasized that it has not approved any drug or dietary supplement containing kratom, 7-OH, or mitragynine, the plant’s other primary alkaloid.
Health and Human Services Secretary Robert F. Kennedy Jr. called the recommendation part of a broader strategy to reduce opioid misuse. “We’re taking action on 7-OH as a critical step in the fight against opioid addiction,” Kennedy said during a press briefing. He underscored the need to prevent unregulated psychoactive compounds from contributing to another addiction crisis, particularly among youth.
The FDA’s recommendation follows an earlier enforcement effort in which it issued warning letters to seven companies for the illegal marketing of 7-OH products. These companies were cited for distributing unapproved drug products, which the agency determined were neither safe nor effective for any medical use.
Under current law, the Drug Enforcement Administration (DEA) will review the FDA’s request and conduct its own scheduling process, which includes rulemaking and public comment. According to the Legislative Analysis and Public Policy Association, kratom’s legal status varies by state.
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As of March 2025, seven states and the District of Columbia classify kratom as a controlled substance, while 18 others regulate its sale or possession. The remaining 26 states do not have specific restrictions. The FDA clarified that its latest action targets 7-OH specifically and does not apply to kratom leaf products in general, though those too have been linked to adverse outcomes, including fatalities.
Researchers continue to study 7-OH’s health effects and potential risks. Dr. Kirsten Elin Smith of Johns Hopkins University, who is surveying users of the compound, noted that while some individuals report benefits such as pain relief or mood improvement, others experience strong addictive effects.
Smith said more scientific data is necessary to fully understand the substance’s safety profile. The FDA warns that consumers using 7-OH products are exposed to substances with no proven safety or therapeutic value. As the agency advances its regulatory actions, it aims to close the gap between rapid market proliferation and public health oversight. – By Content Syndication Services.