Warnings On Kratom Opioid Withdrawal Claims Mark Tip Of FDA Concerns
This article was originally published in The Rose Sheet
Executive Summary
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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