FDA seeks controlled substance status for potent synthetic opioid
The FDA recommended classifying 7-OH as a Schedule I controlled substance due to its opioid-like effects and its use in unregulated products.
Benzinga – News
The Food and Drug Administration (FDA) is recommending banning a compound found in unregulated tablets, gummies and drink mixes sold online and at gas stations and convenience stores, the Trump administration announced this week.
The substance, known as 7-OH, will be scheduled as an illicit drug if the Drug Enforcement Administration − a branch of the US Justice Department responsible for classifying drugs as controlled substances − approves the sanction after a review.
“Dark innovations in chemistry have exacerbated the addiction crisis in this country,” US Department of Health and Human Services Deputy Secretary Jim O’Neil told reporters during a Tuesday, July 29, press conference in Washington DC. “Synthetic opioids like carfentanill and the substance we’re here to take action on today: 7-Hydroxymitragynine.” O’Neil said 7-hydroxymitragynine, 7-OH, is deliberately addictive and a powerful opioid agonist many times more potent than morphine.
Calling it “a recipe for public health disaster,” O’Neill, said 7-OH products are often sold without warnings or controls.
“We’ve seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,” O’Neil said. “These substances are often sold online or in convenience stores with no quality control, no dosage control and no warnings.”
‘They’ve killed thousands and thousands’
During the press conference, FDA commissioner Martin Makary spoke alongside US Health and Human Services Secretary Robert F. Kennedy, Jr., as they announced they planned to send warning letters to companies for illegally marketing products containing 7-OH in an effort to combat the country’s opioid addiction problem.
“We have a history in public health of being asleep at the wheel,” Makary said. “Public health is supposed to prevent disasters, not just clean them up after they’ve killed thousands and thousands of people.”
What is 7-OH?
The compound 7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), according to the FDA, but only a minor component comprising less than 2% of the alkaloid content in natural kratom leaves.
“However, 7-OH demonstrates substantially greater mu-opioid receptor potency than kratom’s primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine,” the FDA wrote in its findings.
Mu-opioid receptors, found in the brain and spinal cord, are primarily responsible for pain relief and other opioid effects like euphoria and respiratory depression, according to research published on the National Institutes of Health’s National Library of Medicine.
Contributing: Adrianna Rodriguez
Natalie Neysa Alund is a senior reporter for USA TODAY. Reach her at nalund@usatoday.com and follow her on X @nataliealund.
(This story was updated to include video.)
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