FDA Urges Restrictions, Education on Illegal 7-OH Opioid Products

TUESDAY, July 29, 2025 (HealthDay News) — The U.S. Food and Drug Administration is recommending that certain products containing 7-hydroxymitragynine (7-OH) — an illegal opioid easily accessible in high-concentration versions online and at gas stations, corner stores, and vape shops — be controlled under the Controlled Substances Act.

A concentrated compound derived from the kratom plant, 7-OH has a great potential for abuse. The agency is not focusing on natural kratom leaf products. A new report issued by the FDA aims to inform the public about the health risks of 7-OH and to clarify how it differs from the kratom leaf.

The FDA recommendation follows a detailed scientific review and is part of broader efforts to address concerns about the rise of 7-OH opioid products. Currently, 7-OH has no FDA-approved drug uses and is not legally permitted in dietary supplements or conventional foods.

The FDA has issued educational materials to inform consumers about the dangers of 7-OH products, as well as warning letters to seven companies for illegally selling 7-OH in forms like tablets, gummies, drink mixes, and shots. The FDA is also alerting health care professionals about the risks of these products.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

The Drug Enforcement Agency is reviewing the FDA recommendation on 7-OH and holds final authority on drug classification, which involves public input before any decision is finalized.

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