Last week, the Food and Drug Administration (FDA) took a historic step to protect American communities by recommending that concentrated 7-hydroxymitragynine (7-OH) products be classified as a Schedule I substance under the Controlled Substances Act.
Here’s why that matters.
Natural kratom leaf — harvested from the Southeast Asian Mitragyna speciosa tree — has been used safely for centuries. It contains trace amounts of 7-OH, but nowhere near the levels found in the synthetic, concentrated 7OH opioid products flooding U.S. gas stations, and wellness shops. As warned by FDA Commissioner Dr. Makary, these dangerous 7-OH products are 13 times more potent than morphine, presenting extreme risks of addiction and overdose.
The FDA was clear: It is not targeting natural kratom leaf products, which millions of Americans consume in forms like capsules, teas, liquids, and powders with minimal health concerns. Instead, the warning and scheduling recommendation applies only to the highly concentrated 7-OH opioids being deceptively marketed as “kratom” — products that bear no resemblance to the natural leaf.
Some lobbyists have tried to defend these synthetic opioids. Dr. Michelle Ross, who is an advisor to a 7-OH trade group, even claimed: “I would much rather see someone take 7-OH than a fentanyl tablet.”
Their scheme is clear. The 7-OH lobby is advocating for replacing one highly addictive illegal drug with another — sold in smoke shops and convenience stores for $6 a pill, without restriction. These products are driving a new, fourth wave of the opioid crisis. Unlike the 7‑OH lobby, our coalition doesn’t want to see anyone consuming dangerous, chemically altered substances. We are in full alignment with the FDA that we must act swiftly and decisively to stop the next wave of addiction before it’s too late.
The FDA’s action marks a critical turning point in stopping the Gas Station Heroin crisis. We’ll be watching closely as the DEA considers this recommendation and urging swift adoption to keep American families safe.
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