FDA's Opioid Label For Kratom Called Misbranding By Marketers
This article was originally published in The Rose Sheet
"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.
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As in previous warnings to kratom supplement marketers linked to opioid addiction treatment claims, FDA tells Cali Botanicals and Kratom NC that HHS in 2017 found opioid abuse was nationwide public health emergency and FDA is targeting products that without approval claim to diagnose, mitigate, prevent, treat or cure opioid addiction. Contract manufacturer Somlabs' GMP problems also were identified in FDA's latest warning letters.
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.