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. Especially because the drug works on the same receptors, adherents believe it has therapeutic potential. "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder".
Kratom is far from the only risky ingredient that has shown up in supplements. 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 USA while it works on increasing regulatory oversight.
In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida. "We also know that this substance is being actively marketed and distributed for these purposes".
On Nov. 14, 2017, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding the risk of using kratom. He said that calls to US poison control centers involving kratom increased 10-fold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms. And 36 deaths have been linked to kratom-containing products. Some products have unsafe substances other than kratom in them, including opioids. "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.
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Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA. The drug has been rising in popularity as an opioid alternative. But the agency backtracked after public outcry and pressure from some members of Congress. "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.
In November, researchers at Harvard Medical School and independent product testing company NSF International identified four unapproved, unlisted stimulants in six supplements now marketed for weight loss and fitness.
"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.