The Food and Drug Administration chastised two companies for marketing the herb kratom as a treatment for opioid withdrawal and other ailments, as frustration mounts that a broader crackdown isn’t doing enough.
The FDA on Tuesday warned vendors Chillin Mix Kratom and Mita Distributing for claiming the herbal supplement kratom can help with opioid withdrawal and treat other ailments like diabetes and obesity. The warnings are the latest targeting retailers making false claims about the supplement that people primarily use for pain relief.
But FDA Commissioner Scott Gottlieb said it was frustrating that retailers are still making such claims after news of the FDA crackdown.
“Simply, 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,” Gottlieb said in a statement. “Yet despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims.”
The agency also warned three companies back in June for making similar claims about kratom, which is derived from a plant native to Thailand.
“While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse,” Gottlieb added.
He said kratom is already illegal in several other countries such as Germany, Australia and Denmark.
There are also no adequate studies on whether kratom can help with opioid addiction withdrawal or treat other diseases, Gottlieb added.
Kratom users and advocates have been pushing back hard on the crackdown by the FDA. The American Kratom Association slammed the FDA last month, claiming the agency falsely linked 44 deaths to the herbal supplement.
The association said that while the people who died may have taken kratom, other factors killed them, like a homicide or heart condition.
