FDA Issues Warning Against Kratom, A Naturally Occurring but Unapproved Plant

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD has issued a public health advisory warning against the use of kratom, a plant that grows naturally in southeast Asia that has gained popularity in the US as an unapproved treatment for pain, anxiety and depression.

“The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers,” Gottlieb wrote in a statement. “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.”

Evidence suggests that kratom has similar effects to narcotics like opioids, and, according to Gottleib’s statement, it has similar risks of abuse, addiction, and in some cases death, too. “It’s not surprising that kratom is often taken recreationally by users for its euphoric effects, [however,] at a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning,” he wrote.

In August 2016, the US Drug Enforcement Agency (DEA) drew the ire of thousands when it announced plans to add kratom to its list of schedule I drugs. The agency eventually withdrew its proposal to ban the substance, and began accepting comments from the public.

Later in 2016, the DEA asked that the FDA provide a scientific and medical evaluation of the drug. The FDA evaluated 2 compounds found in kratom, according to the statement however, there was no mention of the evaluation’s outcomes in the statement. Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it.

According to Gottlieb, there is clear data on the increasing harms associated with kratom. In his statement, he wrote that calls to US poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone. Finally, the use of kratom is associated with serious side effects like seizures, liver damage and withdrawal symptoms, he wrote.

“Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain or other reasons – could expand the opioid epidemic,” he said.

Gottlieb also acknowledged that if proponents are right, and kratom could be used alternatively as a tool to treat opioid addiction, the agency owes them clear, reliable evidence to support those benefits.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence,” he wrote.

The FDA is taking action against kratom use by exercising jurisdiction of the substance as an unapproved drug, and warning against kratom-containing dietary supplements. The agency has also identified kratom products on 2 import alerts, and is actively working to prevent shipments of kratom from entering the US.

“While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighted appropriately against the potential for abuse,” he wrote.