The Federal Drug Association (FDA) issued this week a public health advisory on the herbal supplement kratom, outlining concerns about its “deadly risks.” To date, there have been reports of 36 deaths associated with kratom-containing products, as well as a tenfold increase in calls to U.S. poison control centers about the substance between 2010 and 2015.

While kratom itself is not associated with fatal overdose, commercial forms of the drug are often laced with other compounds that have caused deaths, according to the National Institute on Drug Abuse (NIDA).

Made from a plant native to Southeast Asia, kratom has been touted for its treatment for pain, anxiety and as an alternative to opioid pain pills. In recent years, some people have used kratom as an herbal alternative to medical treatment to control withdrawal symptoms and cravings caused by addiction to opioids or other addictive substances like alcohol. There is no scientific evidence that kratom is effective or safe for these purposes, says the NIDA.

Scott Gottlieb, commissioner of the Food and Drug Administration, called the use of kratom as an opioid substitute “extremely concerning,” noting its potential to “expand the opioid epidemic.”

“We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene,” said Gottlieb, in a statement. “From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.”

Kratom remains legal under federal law, although some states have banned the plant. After a public outcry about the potential benefits of kratom, the DEA withdrew its intent in August 2016 to make it a Schedule I drug, defined as a substance that has “no currently accepted medical use and a high potential for abuse.”

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