Warnings On Kratom Opioid Withdrawal Claims Mark Tip Of FDA Concerns
This article is powered by The Rose Sheet
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.
You may also be interested in...
FDA warns MA Labs and Jack B Goods about online claims that their tianeptine-containing products treat opioid use disorder, pain and anxiety and other violative and unproven claims. CDC reports a jump in poison control center reports on tianeptine, which is approved outside the US to treat depression.
“We want to show that the kratom industry is maturing, that people want to do the right thing,” says AKA Chairman Dave Herman. The standards go “well beyond” FDA's minimum GMP requirements for dietary supplements, AKA says.
American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.