Kratom is an herb derived from a plant native to Southeast Asia. Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills.
People are taking the unapproved supplement to treat conditions like pain, anxiety and depression - without medical supervision, FDA Commissioner Dr. Scott Gottlieb said in a statement.
Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said.
But the FDA said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments.
"There's clear data on the increasing harms associated with kratom".
Meanwhile, a similarly troubling trend has been seen with kratom.
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The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage. "In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom".
Specifically, Gottlieb noted, poison control centers received ten times more calls about kratom in 2015 than they did in 2010.
The fact Gottlieb is speaking to the investigations staff is significant because "if they find people here who are opening the gates to these drugs, there may be opportunities for the FDA to investigate at a high level", says Joshua Sharfstein, former principal deputy FDA commissioner in the Obama administration. "Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it", Gottlieb stated. "In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health", Gottlieb said in the statement. 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".
"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".
"At worldwide mail facilities, the FDA has detained hundreds of shipments of kratom".
Nevertheless, the drug has continued to pop up in supplements, prompting the FDA to issue a health alert in 2014 about kratom-containing dietary supplements and bulk dietary ingredients.