The FDA's cautioning comes after the Drug Enforcement Administration's delay in listing kratom, a plant found in countries like Thailand and Malaysia, as a controlled substance. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more. Taking kratom is also linked to serious side effects like seizures, liver damage, and withdrawal symptoms. According to Bloomberg Businessweek, the American Kratom Association-yes, it exists-has lobbied to have kratom recognized as "a safe alternative to legal and illegal opioids". But the DEA almost made kratom a Schedule 1 drug, the same as heroin and marijuana, last year, and the FDA is now trying to stop shipments of kratom from entering the United States while it works on increasing regulatory oversight. However, drugs made from these leaves carry "deadly risks", FDA Commissioner Scott Gottlieb warned in a statement on Tuesday afternoon.
Kratom, like opioids, is believed to relieve pain.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said.
"Evidence shows that kratom has similar effects to narcotics like opioids", the FDA statement reads, "and carries similar risks of abuse, addiction and in some cases, death".
The DEA almost made it a Schedule 1 drug in 2016, which would have put it in the same category as heroin, marijuana and LSD, but ultimately scrapped the plan.
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.
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In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida.
The FDA's chief, Scott Gottleib, asked Congress for more power and expanded resources to combat the opioid epidemic on Tuesday.
Gottlieb also acknowledged that if proponents are right, and kratom could be used alternatively as a tool to treat opioid addiction, the agency owes them clear, reliable evidence to support those benefits.
"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote.
The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin.
"At worldwide mail facilities, the FDA has detained hundreds of shipments of kratom". Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.