Head of FDA has harsh words about kratom use

A strongly worded statement this week from the commissioner of the Food and Drug Administration (FDA) warns of dangers of the plant-based product kratom and suggests that to this point it has no place in any treatment associated with opioid use disorders. Shortly after the statement was released, the consumer-based American Kratom Association (AKA) announced that it would ask the Department of Health and Human Services (HHS) to have this week's FDA public health advisory related to kratom risks overturned, saying it is based on discredited claims.

The Nov. 14 statement from FDA Commissioner Scott Gottlieb, MD, says that kratom is increasingly being marketed to treat a variety of conditions, including symptoms of opioid withdrawal, despite risks of addiction and even death.

“The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions,” Gottlieb said.

The AKA countered in a news release this week that there have been no documented deaths caused by kratom in the U.S., and suggested that any attempts to place restrictions on the product's availability could drive consumers toward more harmful use of opioids.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the [Drug Enforcement Administration], states and various local governmental entities,” a statement from the AKA reads.

The DEA last year slowed plans to place kratom under the same Schedule I classification as heroin (signifying no accepted medical use and a high potential for abuse), amid significant public protest. In addition, some researchers want to see more inquiry into the properties of the plant, which grows naturally in parts of Asia, because they believe this research could lead to more effective and less addictive pain treatments.

Gottlieb's statement says that while the FDA remains open to kratom's possible medicinal uses, more research is needed and a proper evaluative process involving both the FDA and the DEA would have to take place.

“It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” Gottlieb said, adding, “There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom users have reported euphoric effects, but without the same type of intensity common to opioids. Withdrawal effects that have been cited as being associated with kratom's use include muscle aches, mood swings and hallucinations.