WASHINGTON - In an agency first, the Food and Drug Administration said Tuesday it issued warning letters to three marketers and distributor of kratom products.
Front Range Kratom of Aurora, CO; Kratom Spot of Irvine, CA and Revibe Inc. of Kansas City, MO are being warned against illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Scott Gottlieb, M.D.
The FDA said all three companies make claims about treating pain and other medical conditions like lower blood pressure, treating cancer and reducing neuron damage caused by strokes.
The warning letters included more than 65 kratom products with names like "Red Thai Kratom Powder" and "Super White Elephant."
According to the FDA, health fraud scams like these can pose serious health risks. It requested responses from each of the companies within 15 working days.