Warning letters sent to companies illegally selling unapproved, misbranded kratom-containing drug products
TUESDAY, June 25, 2019 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday took two kratom marketers to task over false claims that their products can treat or cure opioid addiction.
The latest salvo is part of the agency’s continuing efforts to alert consumers about the potential dangers of the herbal drug. The warning letters were sent to Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make unproven claims that the products treat pain and other medical conditions such as depression, anxiety, and cancer.
The companies were given 15 working days to outline what actions they will take to address the FDA’s concerns. Failure to act may result in product seizures or injunctions. The FDA warns consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The U.S. Drug Enforcement Agency has also listed kratom as a “drug of concern.”
“We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls,” Acting FDA Commissioner Ned Sharpless, M.D., said in an agency news release. “As part of our efforts to assess kratom for contamination in the products tested, we also found high levels of heavy metals in kratom products. Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence.”