Botanical Kratom Contains Opioids, FDA Warns

Saturday, 10 Feb, 2018

For several months the regulator has expressed concerns about the product but after analyzing the effect kratom had on the body and then combining this with scientific data and research, the FDA declared that compounds found in kratom are opioids.

The Food and Drug Administration analysis, published Tuesday, makes it more likely that the supplement, kratom, could be banned by the federal government.

FDA Commissioner Scott Gottlieb reiterated that there are no FDA-approved medical uses for kratom, which is derived from a plant native to Southeast Asia. In 2016, the DEA announced plans to place kratom temporarily in Schedule 1 of the Controlled Substances Act, a category for drugs such as heroin. But it's still widely available, and in most states is readily sold as a dietary supplement in convenience stores, head shops, kratom specialty stores, and online.

Henningfield, who has done work for the nonprofit American Kratom Association, argued late past year that the substance's "overall abuse potential and risk of death isn't anything close to narcotics like opioids", and warned that restricting or banning it could drive some people onto the black market to buy it or push them back to opioids. Conway has been overseeing White House efforts to combat the national opioid crisis.

"The assertion that a scheduling recommendation can be based on a claim of deaths "associated with kratom" rather than deaths "caused by kratom" is not, in our judgment, either scientifically valid nor the standard that was contemplated by the U.S. Congress for the scheduling of any substance under the CSA". That made the FDA's warning puzzling-and frustrating-for some researchers.

The agency previously warned of kratom's side effects, including seizures and respiratory depression. "The problem with saying it's "an opioid" without qualification is that it just paints everything with this broad brush, and obviously carries a negative connotation given what's going on in the country right now", Kruegel says. But the process tends to be used in the early stages of drug development. "It's all done virtually in a computer". The agency is now aware of 44 kratom-associated deaths between April 2011 and last December, including one in which the individual had no known "historical or toxicologic evidence of opioid use, except for kratom". Skeptics say the deaths can't be conclusively attributed to kratom and point out that numerous people who died also had other drugs in their systems, from alcohol to morphine. In addition, kratom is at risk of being combined with other drugs that affect the brain, including prescription opioids, benzodiazepines, and over-the-counter medications, potentially leading to further misuse. However, critics said the research is flawed, noting some of the victims were mixing it with other drugs.