| Maybe you've never heard of kratom, but it's been around — possibly forever. It comes from the leaves of a tropical tree in Southeast Asia, where people have long chewed it for pain relief and other properties. Like some other products derived from botanicals, not much is known about its long-term effects. That's why its skyrocketing popularity in the US, where 1.7 million to 15 million people are using it each year, has regulators concerned. The Drug Enforcement Agency wanted to classify it as a scheduled drug in 2016, which would have made its possession and sale illegal. The US Food and Drug Administration pointedly notes that it's "not appropriate" to consider kratom a dietary supplement, a category that garners less oversight. Currently, there's no formal regulatory authority over it at all. And yet Americans are buying it at gas stations, bars, smoke shops and supplement stores. They swallow it in capsules, sip it in drinks, chew it in gummies and toss it back in shots. The potential effects are broad. Some use it in hopes of improving their mood, alleviating their pain, boosting their energy or kicking an opioid addiction. How it actually performs is up for debate. PubMed, a database of scientific literature, includes data from just two clinical trials of kratom. ClinicalTrials.gov, which tracks ongoing studies, notes eight. But like other active compounds, it does have side effects, including high blood pressure, confusion and seizures. It's also been linked to death in rare cases. That's what makes the FDA's first formal study of kratom so noteworthy. My colleagues, Fiona Rutherford and Immanual John Milton, got ahold of the still-unpublished findings from one of the researchers. They were reassuring, showing no significant complications even at the highest doses studied. But there are caveats. The work involved just 40 people, given a placebo or increasingly higher doses of the dried, ground leaves in capsule form. So the findings may not apply to the more popular drinks and concentrates. The volunteers were monitored for side effects for two days, meaning complications from long-term use — or cumulative exposure — remain unclear. Oliver Grundmann, a kratom researcher at the University of Florida, says the effects, both positive and negative, increase with the amount consumed. "It appears that kratom only shows drunk-like intoxicating effects at a very high single dose," Grundmann says. "Aside from nausea, kratom even at high single doses does not appear to be different from placebo in regards to unwanted or adverse effects." Even common complications might not show up in a study so small, however. And the results don't apply to the products that are being most widely used, offering potentially false reassurance. More research is needed. Until we have it, users should proceed with caution. — Michelle Fay Cortez | 
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