The supplement, kratom, is made from a plant native to Southeast Asia. In his statement, he wrote that calls to USA poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year.
Because kratom is largely unregulated, "you never know the real strength, ingredients, or how it's prepared", says Chris Barth, who used the medication Suboxone to recover from a pain pill addiction a decade ago. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms", Gottlieb noted.
Until it is tested like any other drug and shown to be safe and effective, Gottlieb said the FDA would work to keep marketers from selling it.
But it may be laced with other substances, such as opioids like hydrocodone, the FDA says. "Before it can be legally marketed for therapeutic uses in the US, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with".
The health regulator said kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in worst cases, death.
In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida.
"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".
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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.
FDA commissioner Scott Gottlieb released a statement on Tuesday warning people to stay away from the herb.
The FDA's chief, Scott Gottleib, asked Congress for more power and expanded resources to combat the opioid epidemic on Tuesday. "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.
"We've learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene", said Gottlieb in his prepared remarks.
"At global mail facilities, the FDA has detained hundreds of shipments of kratom".
For now, the FDA said it is working to prevent shipments of kratom from entering the country.
"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote.