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The US Food and Drug Administration on Tuesday issued a new warning to two companies that make unproven medical claims about herbal kratom.
The kratom, derived from the leaves of a tree of Southeast Asia belonging to the coffee family, has gained popularity in recent years. The FDA has stated that the active ingredient in kratom, mitragynine, is an addictive substance that acts on opioid receptors in the brain.
The FDA sent warning letters to Chillin Mix Kratom and Mitra Distributing to assert that the herbal product "would relieve opium withdrawals" and would treat diseases such as
Until now, there has been no "adequate and well-controlled scientific study" involving the use of kratom as a treatment for medical conditions or diseases in humans, the warning indicated.
"Fraudulent health claims can pose serious health risks," said Commissioner Scott Gottlieb in the announcement. Consumers who rely on such products may not seek appropriate therapies and may be at risk of overdose and death, he said.
The product is sold online, at gas stations and in smoke shops, and is usually prepared in the form of tea, chewed, smoked or ingested in capsules. It is banned in several countries, including Australia, Denmark, Germany, Malaysia and Thailand, as well as in several US states and municipalities. New York State has two pending bills on kratom: one would make kratom illegal for minors and the other would make kratom totally illegal.
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