Key Takeaways
· FDA Commissioner links 7-OH, a potent opioid found in kratom, to the spread of unregulated products in U.S. vape stores.
· Makary warns that most vaping products sold today are illegal and target youth with flavored designs.
· The FDA and DEA are moving to classify 7-OH as a controlled substance amid rising concerns about new synthetic opioids.
· Unapproved vape products — many originating from Chinese manufacturing hubs — continue to flood U.S. retail channels.
· Makary’s comments underscore the FDA’s dual mission: promoting harm reduction while curbing youth addiction.
A Wide-Ranging Conversation on Public Health
In a recent episode of CNN’s Chasing Life hosted by Dr. Sanjay Gupta, U.S. Food and Drug Administration Commissioner Dr. Marty Makary discussed a wide range of health topics — from rebuilding public trust in the FDA to improving child nutrition and regulating emerging substances that fall outside traditional oversight.
Toward the end of the conversation, Makary turned to vaping and 7-OH, linking both to broader gaps in U.S. public health regulation.
7-OH: A Potent Opioid Hiding in Plain Sight
7-OH, or 7-hydroxymitragynine, is a powerful opioid compound naturally found in trace amounts in the kratom leaf. Makary explained that while kratom itself remains the subject of ongoing debate, concentrated forms of 7-OH — sold as powders, drinks, or gummies — have quietly spread across the U.S. market under names like hydroxy hydroxy metragynine.
“It’s extremely powerful,” he said, noting that it had “been off the radar” and was being sold in some vape stores.
Makary said the FDA and the Drug Enforcement Administration (DEA) have initiated a process to classify 7-OH as a controlled substance, emphasizing that there are currently no FDA-approved products containing the compound.
From Smoking Cessation Tool to Youth Addiction Risk
Makary acknowledged that vaping was originally marketed as a harm reduction tool for adult smokers. “When it first came out, it was pitched as an effective smoking-cessation tool,” he said.
“But now, many kids who have never smoked are starting to vape — often with illegal products, including those imported from China.”
He noted that in some U.S. vape stores, unapproved flavored products account for a large portion of sales, and many also contain THC, the psychoactive component of cannabis.
Makary added: “The vast majority of what’s being sold are illegal products designed to get kids addicted.”
Global Supply Chains, Domestic Enforcement Gaps
The FDA has long faced challenges in policing the fragmented vaping market. Unregulated imports — many originating from Chinese manufacturing hubs — continue to reach U.S. retailers through complex supply chains.
This dynamic, Makary suggested, reflects the intersection of global trade and limited domestic enforcement, where new consumer products often evolve faster than the rules designed to regulate them.
Balancing Innovation, Regulation, and Public Trust
Makary’s comments reveal how the FDA’s mission has expanded beyond traditional product approval toward a broader effort to sustain public trust amid technological and social change.
As FDA and DEA tighten cooperation — through new scheduling actions, expanded inspections, and technology-based tracking — the challenge remains how to regulate an industry that constantly reinvents itself.
