FDA Seeks to Restrict 7-OH Kratom Opiod Products

The effort aims to address the growing availability of 7-OH opioid products.

July 31, 2025

The U.S. Food and Drug Administration (FDA) is recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA), per a press release. 

“The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA is releasing a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf,” the agency said. 

The recommendation follows what the FDA said was a thorough medical and scientific analysis and is one of several FDA efforts to address its concerns around the growing availability and use of 7-OH opioid products. There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods, FDA said.  

Under the CSA, drugs, substances and certain chemicals are placed into one of five schedules based upon their medical use, potential for abuse and safety or dependence liability. The Drug Enforcement Agency is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.

The FDA has published educational materials for consumers about the products. The FDA is also issuing a letter to health care professionals and is warning consumers about the risks associated with 7-OH products. 

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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.” 

In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots.