Warnings On Kratom Opioid Withdrawal Claims Mark Tip Of FDA Concerns

Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.

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Kratom marketers shouldn't let down their guard about FDA's position on the herb.

The Office of Compliance in FDA's Center for Drug Evaluation and Research on Sept. 11 published warning letters submitted earlier in the month to an online retailer identified as "Chillin Max Kratom" and a North Carolina business, Mitra Distributing Inc

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