WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has recommended new restrictions on products containing 7-hydroxymitragynine (7-OH), a powerful and unapproved opioid compound derived from the kratom plant, citing growing concerns over its potential for abuse and appeal to young consumers.
The FDA’s move aims to classify 7-OH under the Controlled Substances Act following a comprehensive scientific and medical review. The agency emphasized that this recommendation does not apply to natural kratom leaf products, but specifically to the concentrated synthetic or semi-synthetic byproducts, which have demonstrated opioid-like effects.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
FDA Commissioner Dr. Marty Makary added that many 7-OH products are more potent than morphine and are being sold in locations such as gas stations and vape shops, often in the form of gummies and flavored treats designed to appeal to children and teenagers. Some of these products are disguised or mislabeled as kratom, further complicating consumer awareness.
The FDA issued warning letters in June to seven companies selling products containing 7-OH in forms such as tablets, shots, and drink mixes. Today, the agency also issued a letter to healthcare professionals and launched an educational campaign aimed at helping consumers identify and avoid these potentially dangerous products.
“There are vape stores in nearly every neighborhood selling addictive products like 7-OH,” Makary said. “We cannot afford to repeat the mistakes of the last opioid epidemic.”
Currently, there are no FDA-approved drugs containing 7-OH, and it is not legal in dietary supplements or food products. The Drug Enforcement Administration (DEA) will now review the FDA’s recommendation, initiating a rulemaking process that includes a public comment period before any final scheduling decision.
For more information, the FDA has published public education materials about the risks of 7-OH products and how they differ from traditional kratom.
Consumers with questions can contact 888-INFO-FDA or visit www.fda.gov.
