ORLANDO, Fla. — The FDA suggests classifying 7-hydroxymitragynine (7-OH), a byproduct of kratom, as a controlled substance under the Controlled Substances Act to safeguard consumers from its opioid-like effects.
7-OH can be abused due to its opioid receptor binding, posing a public health concern. The FDA’s recommendation, based on thorough analysis, targets the increasing availability of 7-OH products sold in vape shops and online.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS Secretary Robert F. Kennedy, Jr.
The FDA worries about 7-OH products like fruit gummies and ice cream cones that might appeal to kids and are often mislabeled or disguised as kratom, increasing misuse risks. In June, it warned seven companies for illegally selling such items, including tablets, gummies, drink mixes, and shots.
Kennedy, Jr. continues, “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the need for regulation and public education, stating, “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 agency warns health care professionals and consumers about risks of these products. Under the Controlled Substances Act, drugs are scheduled by medical use, abuse potential, and safety. The DEA reviews the FDA’s recommendation, which needs rulemaking and public comment before finalizing scheduling.
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