The Food and Drug Administration (FDA) on Tuesday said it is recommending a scheduling action to control certain 7-hydroxymitragynine products (7-OH) under the Controlled Substances Act (CSA).
The agency said it is specifically targeting 7-OH, a concentrated byproduct of the kratom plant. According to the FDA website, 7-OH products are concentrated derivatives often falsely marketed as kratom.
“We are facing a new addiction crisis because of the availability of synthetic kratom, which is also called gas station heroin,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said.
FDA Commissioner Marty Makary said at a news conference Tuesday that 7-OH is an opioid and yet it is sold in vape stores, smoke shops, convenience stores and gas stations.
“A dangerous opioid called 7-OH is being sold in pills, drink mixes, candies, gummies and even ice cream cones at vape shops across the country,” Makary posted on his X account. “The public should know these aren’t just dangerous for kids—they’re dangerous for everyone.”
The agency said it is not focused on natural kratom leaf products and released 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 a thorough medical and scientific analysis by the FDA.
“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,” the FDA said.
In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots.
“This is a known problem,” Curtis Bramble, a former state senator from Utah’s senate district 24 who sponsored the Utah Kratom Consumer Protection Act in 2019, told CSP.
“It’s only in the last 18 months that the market has found that what the bad actors have found is 7-OH isn’t scheduled federally,” he said. “There are 32 states that don’t limit 7-OH and they have found it is highly addictive and enormously profitable.”
Bramble told CSP that he “completely” agrees with the FDA that 7-OH is a dangerous opioid that needs to be prohibited.
Bramble isn’t the only one to applaud the FDA. Earlier this month, the American Kratom Association (AKA) applauded the agency for issuing the warning letters.
“The companies that received these warning letters are just some of a significant number of companies engaged in transparently improper marketing—misleading consumers by branding these 7-OH products as ‘kratom’ while making illegal health claims and using unsafe synthetic or semi-synthetic formulations—and none of these products are kratom,” said Mac Haddow, senior fellow on public policy for the AKA. “This is a massive fraud on consumers that puts their safety directly at risk.”
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 Administration (DEA) 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.
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