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The U.S. Food and Drug Administration on Tuesday waded once again into the hotly contested debate over the safety of kratom, a botanical substance that advocates say can help ease pain and reduce symptoms of opioid withdrawal, but which critics say can lead to addiction and death.
The regulator said it was aware of 36 deaths associated with kratom, which can have similar effects to narcotics like opioids.
Kratom, a natural plant grown in parts of Asia, is available in the United States as a dietary supplement and the FDA has said kratom products have been crossing into the U.S. in increasing amounts.
"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," FDA Commissioner Scott Gottlieb said.
In 2012 and 2014 the FDA placed import alerts on kratom, allowing FDA agents to detain the products at the border. U.S. Marshals have since seized thousands of pounds of raw kratom and dietary supplements.
In August 2016, the Drug Enforcement Administration (DEA) announced it would temporarily reclassify kratom as a Schedule 1 drug, a class that includes heroin and marijuana. Schedule 1 drugs are considered to have a high potential for abuse.
However, the DEA's proposal generated public demonstrations and opposition, prompting the DEA to reverse course.
The FDA declined to say over what period the 36 deaths occurred, directing reporters to file a Freedom of Information Act request to access the data.
However, the DEA said last year that roughly 30 deaths have been reported since 2009, with most occurring since 2014.
Advocates noted that the number of deaths associated with kratom pale when compared to deaths associated with opioids, which in 2015 claimed more than 33,000 lives. President Donald Trump recently declared the opioid epidemic a public health emergency.
Kratom is already a controlled substance in 16 countries, including two of its countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany.
It is also banned in a number of U.S. states, including Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.