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WASHINGTON - The Food and Drug Administration Tuesday issued a strong warning to consumers to stay away from the herbal supplement kratom, saying regulators are aware of 36 deaths linked to products containing the substance.
Consumers are increasingly using the supplement, which comes from a plant in Southeast Asia, for pain, anxiety and depression, as well as symptoms of opioid withdrawal. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally. Proponents say it is a safe way to deal with chronic pain and other ailments, and some researchers are exploring its therapeutic potential, including helping people overcome addictions.
But in a statement, FDA commissioner Scott Gottlieb said there is no "reliable evidence" to support the use of kratom as a treatment for opioid-use disorder, and that there are no other FDA-approved uses of kratom.
Rather, he said, evidence shows that the herb has similar effects to narcotics like opioids, "and carries similar risks of abuse, addiction and, in some cases, death." He said that calls to U.S. poison control centers involving kratom increased 10-fold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms.
Last year, the Drug Enforcement Administration proposed banning the use of kratom. But the agency backtracked after public outcry and pressure from some members of Congress. It asked the FDA to expedite a scientific and medical evaluation and a recommendation for how to handle the compounds in kratom.
The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin. Gottlieb said the FDA is treating kratom as an unapproved drug and also has taken action against kratom-containing dietary supplements. If the plant is useful in treating various conditions, it should go through the agency's regular drug-approval process to provide it is safe and effective, he added.
Meanwhile, the FDA is working to prevent shipments of kratom from entering the country, he said.