Kratom Import Alert Clarifies FDA Deems The Botanical An Unsafe NDI
This article was originally published in The Tan Sheet
FDA cautioned manufacturers about kratom’s safety as a dietary ingredient in 2013, but industry stakeholders posited that the agency should clarify whether the botanical is a legitimate supplement ingredient. The import alert and recall announcement should answer that question for manufacturers.
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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.
"Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids," says Commissioner Scott Gottlieb.