"It's not surprising that kratom is often taken recreationally by users for its euphoric effects, [however, ] at a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning", he wrote.
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. "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", Gottlieb said in the statement.
In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said. And 36 deaths have been linked to kratom-containing products.
The scientific research about kratom and its potential medical uses are very limited, but evidence of its risks are clear.
In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida. Kratom use can also cause seizures, liver damage and withdrawal symptoms, the FDA said.
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"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", former principal deputy FDA commissioner under the Obama administration, Joshua Sharfstein, told the news site. The Drug Enforcement Administration temporarily listed kratom as a Schedule 1 controlled substance last August, but withdrew the decision after an outcry and a targeted petition effort.
The United States is in the grip of an opioid epidemic.
The federal government has not classified kratom as illegal, but some states, including Alabama, Arkansas, Indiana, Tennessee and Wisconsin, have banned it, according to the Associated Press.
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. Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.
More than 340 million shipments of kratom reach the USA each year, even though the FDA has seized hundreds more.
"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.