The Food and Drug Administration is taking action against dietary supplements containing the plant Kratom.
The FDA said over the past several years, the botanical substance raised significant concerns given its increasing prevalence and potential safety risks. That is why the agency issued a public health advisory regarding risks associated with the use of kratom.
Kratom grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The FDA says it has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties.
While proponents argue that it is a safe substance because it is plant-based, the FDA said it is being marketed and used to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. The FDA said patients also believe they can use it to treat opioid withdrawal symptoms. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.
Meanwhile, the FDA is aware of an increase in calls to U.S. poison control centers and deaths associated with the use of kratom-containing products. There have also been reports of kratom being laced with other opioids like hydrocodone. The FDA says the use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
The agency has exercised jurisdiction over kratom as an unapproved drug. As a part of this, the FDA said it detained hundreds of shipments of kratom at international mail facilities. It has also conducted seizures and oversaw the voluntary destruction of kratom products.
The FDA is working with federal partners to address the risks posed by these imports. One of these partners is the Drug Enforcement Administration. The Associated Press reports the DEA had planned to ban the plant by adding it to a list of illegal drugs that includes marijuana, heroin and LSD. The agency backed away from the plan last October following public complaints including a letter signed by 62 members of Congress and a protest at the White House organized by the American Kratom Association.
Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it.
Despite Tuesday's warning, the FDA said the agency's scientific review is ongoing.