WASHINGTON – The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for marketing kratom—a Southeast Asian plant-based supplement that allegedly relieves joint pain and enhance mood levels—with false medical claims.
Chillin Mix Kratom and Mitra Distributing advertise wholesale quantities of powdered kratom online. Both companies have been accused of saying these supplements can “relieve opium withdrawals” and “treat a myriad of ailments,” such as diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety and alcoholism.
In each letter, Donald Ashley, director of compliance for the center for drug evaluation research with the FDA, said the marketing and sale of unapproved opioid addiction treatment products may be a significant threat to public health.
“[The] FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction,” he said in the letter.
Although kratom is legal in every U.S. state except Indiana, it is not federally regulated, making it prone to potentially harmful bacteria.
The FDA is giving each distributor 15 working days to illustrate how they will correct these faulty marketing violations. Failure to do so may result in legal action from the agency.
Scott Gottlieb, commissioner of the FDA, said there have been no adequate studies regarding the use of kratom as a treatment for opioid use withdrawal or how kratom may affect the body, its dangers and potential side effects, especially when combined with other drugs.
“Selling these unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law,” he said. “Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.”
The FDA’s concerns with kratom date back to 2011, Lindsay Meyer, press officer for the FDA, told CSP Daily News in August. She said the supplement carries the same risks of abuse and dependence as opioids, including withdrawal symptoms and risks of seizures. In April, the FDA ordered a mandatary recall for the supplement due to traces of salmonella.
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