FDA recalls Kratom products: Says it is an opioid

The U.S. Food and Drug Administration announced Wednesday the destruction and recall of kratom-containing dairy supplements. The products have been distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. The company has reportedly agreed to stop selling all products containing kratom. The FDA is encouraging all companies involved in the sale of products containing kratom to take steps to take their products off the market.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, M.D.

Native to Malaysia, the leaves of the kratom plant are traditionally crushed and made into tea to treat pain as well as heroin or morphine dependence and possibly reduce withdrawal cravings. Kratom also found a following overseas. According to the American Kratom Association, there are 3 million to 5 million users in the US.

The FDA has linked the supplement to 44 deaths since 2011. Kratom side effects include seizures and depression. Some scientists have challenged the FDA's description of kratom as too broad. All agree that more research is needed. The supplement can be found in head shops and gas stations sold as powders, pills, capsules or even energy drinks. It is very loosely regulated by the FDA.

In 2016, the Drug Enforcement Administration announced its intention to temporarily list kratom as a Schedule I controlled substance, which would put it in the same category as heroin or LSD. But after a public outcry, including from some members of Congress, the DEA withdrew its plan. Instead, the agency requested public comment about the plant and called for a scientific review from the FDA. The DEA has not taken any action since then, but lists kratom as a drug of concern.

Currently, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have made the substance illegal.

Reference: http://www.wcvb.com/article/fda-recalls-products-containing-increasingly-popular-opioid-alternative/18657580
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