FDA Warns of Herbal Supplement Kratom's Opioid-Like Harms

Henrietta Strickland
November 14, 2017

The Food and Drug Administration issued a public health advisory Tuesday about the use of kratom, a herbal supplement known to ease the side effects of opioid withdrawals that's linked to 36 deaths.

Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. The FDA is aware that individuals have been using kratom to treat pain, anxiety, and depression, as well as for recreational purposes for its euphoric effects.

The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage. Between 2010 and 2015, kratom-related calls to USA poison control centers jumped 10-fold.

Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says. According to Bloomberg Businessweek, the American Kratom Association-yes, it exists-has lobbied to have kratom recognized as "a safe alternative to legal and illegal opioids".

Last year, the US Drug Enforcement Administration announced its plans to name the substance a Schedule I drug, the most restrictive classification alongside heroin and LSD which restricts medical research. The FDA noted the risk for addiction and misuse.

"Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic". Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US. But for now, no company has tried to properly develop a drug that includes kratom.

For now, the FDA treats kratom as an unapproved drug, and the agency has taken action against dietary substances that have it. The agency has already detained hundreds of packages at worldwide mail facilities. Some products have risky substances other than kratom in them, including opioids.

Kratom is already a controlled substance in more than a dozen countries around the world, and it's banned in several states in the U.S. Still, proponents argue it could have potential medical benefits that should be studied.

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.

"From the outset, the FDA must use its authority to protect the public from addictive substances like kratom", Gottlieb wrote, "both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".

Other reports by Click Lancashire

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