Agency hopes education, legal action will help prevent a second opioid crisis\n<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
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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.<\/p>\n
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<\/a> 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.<\/p>\n 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.<\/p>\n The FDA has issued educational materials<\/a> to inform consumers about the dangers of 7-OH products, as well as warning letters<\/a> 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<\/a> about the risks of these products.<\/p>\n “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.”<\/p>\n 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.<\/p>\n