FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Flags Ongoing Concerns Over Illegal Kratom Sales

Sept. 13, 2018

The FDA issued warning letters to two marketers of kratom products and Commissioner Scott Gottlieb said the agency is concerned about the ongoing availability of such products with unsubstantiated claims.

Mitra Distributing claimed that its products could cure conditions like opiate withdrawal, alcoholism, obesity, diabetes, depression and diarrhea. Chillin Mix Kratom claimed its kratom products could relieve opium withdrawals and said many users were seeking to cure opioid addictions.

“Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims,” Gottlieb said.

He noted that “to date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans.”

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