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.
Calls to USA poison control centers about kratom, which is made from a plant that grows in Asia, jumped tenfold from 2010 to 2015, according to the FDA.
More than 340 million shipments of kratom reach the US each year, even though the FDA has seized hundreds more. The plant is used in a supplement and is marketed for a variety of uses, including everything from treating pain and anxiety to helping people recover from opioid withdrawal.
The FDA says kratom carries similar risks of abuse, addiction and in some cases, death, as opioids. "Calls to USA poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year", said FDA Commissioner Dr. Scott Gottlieb in a statement.
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.
In August 2016, the Drug Enforcement Agency moved to make kratom a Schedule I drug, a substance that has "no now accepted medical use and a high potential for abuse". (A representative from the association could not be reached on Tuesday.) STAT reporter Eric Boodman even found a kratom vending machine in a sub shop in Arizona. "Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product's dangers, potential side effects or interactions with other drugs".
In 16 countries, kratom is a controlled substance.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said.
The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at worldwide mail facilities. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks. Hundreds of shipments have already been detained and many are seized.
Gottlieb, who did two previous stints at the FDA, has publicly expressed misgivings about how long it took the agency to truly address the crisis. "From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".