FDA Warns Three Kratom Distributors Over Unproven Opioid Treatment Claims

The FDA sent out a volley of warning letters to three U.S. distributors of kratom products for sales of unapproved new drugs claiming effectiveness in treating opioid addiction and withdrawal.

The agency noted the companies’ deceptive claims, such as a product having “mood elevation qualities” that “reduce opiate withdrawal effects,” or that “kratom can be used as a remedy for stroke-related ailments.”

 “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction,” said FDA Commissioner Scott Gottlieb. “Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects.”