The drug has been rising in popularity as an opioid alternative.
"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", Gottlieb added. Some chemists figure it's a promising starting point for new, less addictive painkillers. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more. These anecdotal reports aren't the same as real medical research - and more is needed to determine the plant's medical benefits. 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.
Additionally, the FDA said it has identified kratom products on two import alerts, and is working to prevent shipments of the substance from entering the US, as well as detained hundreds of shipments at global mail facilities. The DEA said last October it would delay a decision until the FDA issued a recommendation.
The potential safety risks for kratom raise "significant concerns", according to the FDA. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms", Gottlieb said. The FDA noted a 10-fold increase in calls made to USA poison control centers regarding kratom from 2010 to 2015, and reports of 36 deaths linked to the substance.
The drug is kratom, and despite failing to gain FDA approval, it continued to be available for sale online and in stores - including inside a vending machine in Arizona.
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Advocates say kratom can ease pain and make it easier to get through opioid withdrawals.
Kratom is an unapproved substance touted as a treatment for depression, pain, anxiety and even opioid addiction. That way the product can be assessed for its safety and effectiveness. Around the same time in 2012, the FDA "first put kratom on import alert" FDA press officer Lyndsay Meyer told Business Insider.
"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse", Gottlieb wrote.
Gottlieb said the agency has seized and destroyed shipments of kratom at global mail facilities. Hundreds of shipments have already been detained and many are seized. Across the United States, several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of "drugs and chemicals of concern". The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.