With Seizure in Florida, FDA Targets Kratom As Unsafe For Any Use
Kratom industry says complaint filed in Florida federal court shows FDA’s switching reasons to stop all sales of the ingredient in the US.
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Online retailer and supplement brand Kraken Kratom is first business American Kratom Association recognized with its GMP Qualified Vendor status. But, FDA reiterates kratom should not be used in supplements until an NDI notification is submitted showing a reasonable expectation of safety for its intended use, and DEA still has pending a proposed order to schedule kratom constituent ingredients as controlled substances.
FDA Commissioner Scott Gottlieb says kratom's apparently increasing use "as an alternative or adjunct to opioid use" has made enforcement on the ingredient more of a priority for FDA, and "given the scope of this crisis, we must do more."
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.