The FDA is pushing to ban a powerful compound found in small amounts in kratom.
For years, state lawmakers have taken the lead on regulating kratom — the controversial herbal supplement used for pain relief, anxiety and opioid withdrawal symptoms. Some states have banned it entirely. Others have passed laws requiring age limits, labeling and lab testing.
At least half of the states and the District of Columbia have enacted some form of regulation on kratom or its components — building a patchwork of policies around a product largely unaddressed by the federal government.
But that may soon change. The U.S. Food and Drug Administration is pushing to ban 7-hydroxymitragynine, or 7-OH — a powerful compound found in small amounts in kratom and sometimes concentrated or synthesized in products sold online, at smoke shops or behind gas station counters.
Federal health officials announced last month that the compound poses serious public health risks and should be classified as a Schedule I controlled substance, alongside heroin and LSD.
The move marks a significant shift in how federal regulators are approaching kratom, which they attempted to ban in 2016. It also has sparked debate about how the change could impact the growing 7-OH industry and its consumers.
This year, at least seven states have considered bills to tighten kratom regulations, including proposals for bans, age restrictions and labeling requirements.
Kratom, which originates from the leaves of a tree native to Southeast Asia, can have a wide range of mental and bodily effects, according to federal officials, addiction medicine specialists and kratom researchers. Reports of fatal kratom overdoses have surfaced in recent years, though kratom is often taken in combination with other substances.
Kratom and 7-OH are distinct products with separate markets, but they are closely connected. 7-OH is a semi-synthetic compound derived from kratom and only emerged on the market in late 2023, while kratom itself has been available for decades.
Leading kratom researchers also say more research is needed to fully understand the long-term effects of using both substances.
“There’s much we don’t know, unfortunately, on all sides,” said Christopher R. McCurdy, a professor of medicinal chemistry at the University of Florida. McCurdy is a trained pharmacist and has studied kratom for more than 20 years.
Research suggests kratom may help with opioid withdrawal and doesn’t seem to cause severe withdrawal on its own. Smaller amounts seem to act as a stimulant, while larger doses may have sedative, opioidlike effects. Very little is known about the risks of long-term use in humans, according to McCurdy.
As for 7-OH, it shows potential for treating pain, but it hasn’t been studied in humans, and it may carry a high risk of addiction. Researchers don’t yet understand how much is safe to take or how often it should be used, McCurdy told Stateline.
While some leading kratom experts agree that kratom and 7-OH should be regulated, they caution that placing 7-OH under a strict Schedule I classification would make it much harder to study — and argue it should instead be classified as Schedule II like some other opioids.
A federal survey from 2023 estimated that about 1.6 million Americans age 12 and older used kratom in the year before the study. The American Kratom Association, a national industry lobbying group, estimated in 2021 that between 11 million and 16 million Americans safely consume kratom products each year.
