Kratom: All Questions On Pre-DSHEA Ingredient Evidence In One Package
This article was originally published in The Rose Sheet
"Kratom illustrates the promise and the peril of dietary supplement regulation," says Jack Henningfield, Pinney Associates consultant and an expert on abuse liability of various substances. Kratom firms agree NDI notifications are needed for ingredients made from separate kratom alkaloids, but say the botanical itself has decades of safe use in the US.
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FDA regulation of kratom as an NDI is necessary to avoid untenable state regulations, says AHPA chief Michael McGuffin, adding the trade group's support to kratom experts' push to keep the herbal ingredient available. Experts also say salmonella issues currently linked to kratom could be an indirect result of FDA's import alert as noncompliant suppliers filled continued demand.
Now that FDA has completed its evaluations of two compounds in kratom – mitragynine and 7-hydroxymitragynine – that DEA has proposed to schedule as controlled substances, researchers who attest to the ingredient's safety and its value in helping opioid abusers through withdrawal or as a natural pain reliever or mood enhancer say time could be running short to convince federal officials against ending consumer access to kratom products due to fear that the ingredient is an opioid.