WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has formally recommended that 7-hydroxymitragynine, a potent opioid-like compound found in certain kratom-derived products, be classified as a Schedule I controlled substance.
This move signals a major crackdown on an increasingly popular, yet unregulated chemical sold in the form of tablets, gummies, and drink mixes at gas stations, convenience stores, and online platforms.
7-OH, a synthetic compound derived from the kratom plant, is significantly more potent than morphine and is often marketed as a natural aid for relaxation, pain relief, or improved focus. However, the FDA and health experts warn it carries serious risks, including seizures, liver and heart toxicity, withdrawal symptoms, shallow breathing, and even death.
FDA Commissioner Martin Makary stressed that the agency's focus is not on natural kratom leaf products, which contain only trace amounts of 7-OH, but rather on the concentrated and synthetic forms sold under misleading labels. 'We are going after the killer first,' Makary stated.
The FDA's recommendation will now be reviewed by the Drug Enforcement Administration, which will determine whether to classify 7-OH as a Schedule I substance, a category reserved for drugs with high abuse potential and no recognized medical use.
Health and Human Services Secretary Robert F. Kennedy Jr. expressed alarm at the widespread availability of 7-OH products, especially their appeal to youth, calling the industry 'sinister' for selling candy-flavored items near schools and military bases.
While proponents argue that kratom and its compounds may help manage pain or assist in opioid addiction recovery, federal health officials argue that the current market for 7-OH poses an urgent threat.
The public will have an opportunity to weigh in before the DEA issues a final ruling.
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