WASHINGTON, D.C. — In a decisive step aimed at curbing the proliferation of potentially dangerous synthetic opioids, the U.S. Food and Drug Administration (FDA) announced recently that it is recommending a scheduling action under the Controlled Substances Act (CSA) to regulate 7-hydroxymitragynine, or 7-OH—a powerful compound derived from the kratom plant.
Unlike the natural kratom leaf, which remains outside the scope of the proposed action, 7-OH is a concentrated, semi-synthetic byproduct that has drawn increasing concern due to its potent interaction with opioid receptors in the brain. Public health authorities have identified it as a substance with significant abuse potential, and one that may contribute to a new wave in the opioid crisis if left unchecked.
“We’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
The FDA’s recommendation is grounded in a scientific and medical evaluation, and forms part of a broader federal strategy to limit access to unregulated opioids. Unlike approved medications, 7-OH has no recognized medical use, is prohibited in dietary supplements, and cannot lawfully be added to conventional food products. Nevertheless, it remains widely available for purchase online and in retail outlets such as gas stations, corner stores, and vape shops.
FDA Commissioner Dr. Marty Makary emphasized the urgency of regulatory action. “7-OH is an opioid that can be more potent than morphine,” he stated. “We need regulation and public education to prevent another wave of the opioid epidemic.”
Health officials are particularly alarmed by the marketing tactics used to promote 7-OH products, which often appear in candy-like forms such as fruit-flavored gummies and ice cream cones. These products, sometimes mislabeled or falsely presented as natural kratom, pose an elevated risk to children and adolescents who may unwittingly consume them.
To combat misinformation, the FDA is releasing new educational materials aimed at helping consumers distinguish between kratom and 7-OH and understand the associated risks. In addition, the agency has issued a letter to healthcare professionals warning about the dangers of these unregulated products and is urging providers to be vigilant in recognizing symptoms of use or misuse.
The FDA has already taken enforcement actions against companies marketing these substances illegally. In June, seven firms received warning letters for selling 7-OH-laced items, including tablets, drink mixes, and concentrated shots.
Last week’s recommendation initiates a formal review by the Drug Enforcement Administration (DEA), which has final authority over scheduling substances under federal law. The rulemaking process includes a public comment period before any classification can be finalized.
Under the CSA, substances are classified into one of five schedules based on their medical value, abuse potential, and risk to public health. If scheduled, 7-OH would join a growing list of synthetic opioids regulated to protect against misuse and overdose.
As federal agencies move toward a more proactive posture in confronting emerging threats, the FDA’s latest action underscores a commitment to regulatory vigilance and public safety in the face of evolving opioid dangers.
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