Feds, states scrutinize addictive supplements often sold at gas stations Image By HPN Staff Key Points The FDA is moving to classify 7-hydroxymitragynine (7-OH), a concentrated kratom byproduct, as a controlled substance due to its opioid-like potency and addiction risks. Florida became the first state to ban 7-OH following the FDA announcement, with officials citing youth safety and addiction concerns. The DEA will review whether to place 7-OH on the federal schedule of controlled substances, with a public comment period before a final decision. The Food and Drug Administration is moving to reclassify 7-hydroxymitragynine — known as 7-OH — as a controlled substance, citing its potency and growing availability in convenience store products, such as powders, gummies and drinks. The decision comes amid evidence that the concentrated byproduct of the kratom plant carries significant addiction and overdose risks. Currently sold as an unregulated dietary supplement in gas stations and online, 7-OH does not require FDA approval. A scientific study has found that 7-OH is more potent than morphine, and the FDA has warned that concentrated forms represent an emerging public health threat. Heath and Human Services Secretary Robert F. Kennedy Jr. described the move as a key step in the administration’s anti-opioid efforts, saying it will “protect the health of our nation’s youth” while advancing the goal to “Make America Healthy Again.” Why it matters Studies and FDA analysis show 7-OH has opioid-like addictive qualities that can lead to dependence, withdrawal and other health risks. Officials warn that the substance’s growing presence in gas stations, convenience stores and online markets increases the likelihood of misuse, particularly among youth. The FDA has issued consumer advisories and sent letters to health care professionals urging caution. While 7-OH is derived from kratom leaves, the FDA emphasized that its actions do not target kratom leaf products. The focus is on concentrated 7-OH products, which pose a heightened risk of addiction due to their opioid-like potency. The big picture Florida this week became the first state to enact a ban after the federal announcement, with Attorney General James Uthmeier citing youth safety and addiction concerns. FDA officials have encouraged other states to adopt restrictions similar to Florida’s, saying coordinated action can help reduce access to 7-OH while the Drug Enforcement Administration reviews its federal scheduling recommendation. FDA Commissioner Marty Makary praised the decision and urged other states to adopt similar “common sense” safeguards. The FDA’s move reflects a broader trend in federal drug policy — targeting emerging substances that mimic the effects of opioids but have evaded regulation. By focusing on concentrated 7-OH products rather than natural kratom leaf, the agency aims to address an emerging public health threat without broadly restricting kratom. What's next The Drug Enforcement Administration will decide whether to place 7-OH on the federal schedule of controlled substances. That process requires a formal rulemaking period and will include an opportunity for the public to submit comments before a final decision is made. SUGGESTED STORIES Chronic health crisis doubles million-dollar medical claims, report says Poor health habits across the United States are driving up diagnosis rates for circulatory disease and cancer, causing a jump in medical treatments that cost more than $1 million per patient, according to a new report prepared for U.S. employers and labor unions. Read more Price transparency is necessary to bring down consumer and employer costs This is a lightly edited excerpt of testimony recently provided to the U.S. Senate’s Health, Education, Labor, and Pensions hearing " Making Health Care Affordable: Solutions to Lower Costs and Empower Patients." Price opacity in healthcare is n Read more Biden's diagnosis points to imperfect screening Former President Joe Biden’s recent prostate cancer diagnosis — and the revelation that his last known screening was more than a decade ago — highlights the double-edged sword of prostate testing. Prostate cancer is the second most common cancer in men, after skin cancer. And it’s t Read more
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