FDA recommends controlling 7-OH opioid compound amid US rise

The U.S. Food and Drug Administration (FDA) is recommending that 7-hydroxymitragynine (7-OH), a synthetic concentrated byproduct of kratom found in vapes, gummies, drinks, and other products, be classified as a Schedule I controlled substance due to its opioid-like effects and high potential for abuse. FDA Commissioner Marty Makary highlighted that 7-OH can be significantly more potent than morphine and is increasingly available in products appealing to children, raising public health concerns. The FDA has issued warning letters to companies illegally marketing 7-OH products and is urging the Drug Enforcement Administration (DEA) to begin rulemaking, which includes public notice and comment before final scheduling. Health officials warn that 7-OH can cause addiction, withdrawal symptoms, seizures, and fatal respiratory depression, although its exact role in overdose deaths remains unclear. Both the FDA and Health and Human Services Secretary Robert F. Kennedy, Jr. emphasize the need for regulation and public education to prevent another wave of opioid addiction, especially given the widespread availability and potential for misuse of these products. The FDA also cautions healthcare providers and consumers about the risks and the possibility that 7-OH products may be mislabeled or disguised as kratom.