Kratom also has opioid-like effects - at low doses, it acts like a stimulant; at higher doses, it sedates, dulling pain - which has also made it popular as an over-the-counter remedy for opioid withdrawal.
Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. Last year, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction.
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. It asked the FDA to expedite a scientific and medical evaluation and a recommendation for how to handle the compounds in kratom.
Aside from being marketed online and in largely unregulated supplements as a concentration booster and workout enhancer, kratom is being advertised as a replacement for opioid painkillers.
The potential safety risks for kratom raise "significant concerns", according to the FDA.
Gottlieb also says in the remarks that a new working group with Customs and Border Patrol is working on stepped-up enforcement at entry points for illegal narcotics.
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Tablets of the opioid-based Hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017. Before it can be legally marketed for therapeutic uses in the USA, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with.
Gottlieb said the FDA is treating kratom as an unapproved drug and also has taken action against kratom-containing dietary supplements.
More than 340 million shipments of kratom reach the USA each year, even though the FDA has seized hundreds more. And in the United States, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have banned kratom.
"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", Gottlieb said.
Kratom is an unapproved substance touted as a treatment for depression, pain, anxiety and even opioid addiction. "From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".
"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. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks. That way the product can be assessed for its safety and effectiveness.
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