Dr. Scott Gottlieb, the Commissioner of the US Food and Drug Administration, put out a warning to the public about the herbal supplement kratom. Gottlieb’s statement said, “There is no evidence to indicate that kratom is safe or effective for any medical use.”
The kratom plant is native to Malaysia and its leaves are usually crushed and made into tea for pain treatment. It has also been used to treat heroin and morphine dependence to help reduce withdrawal cravings. The American Kratom Association claims that there are 3 to 5 million users in the United States.
Kratom is loosely regulated by the FDA and can be purchased from head shops and gas stations. It is generally sold as powders, pills, capsules, and even energy drinks.
According to the US Centers for Disease Control and Prevention, calls about kratom to poison control centers increased tenfold over a 5 year span. Although most of the calls were made to report minimal side effects, 7% of the calls were for serious side effects, including one death.
However, concerns from the FDA have grown since its Adverse Event Reporting System revealed that 44 deaths were associated with kratom. The Drug Enforcement Administration announced its intentions to temporarily list kratom as a Schedule I controlled substance back in 2016. But after push back from the public and members of Congress, the DEA pulled back on its plan. Instead, the DEA called for a scientific review from the FDA. Although the DEA has not taken any subsequent actions, kratom is still listed as a drug of concern.
A statement made by the FDA said the agency is “ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.”
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