Safety Of Unadulterated Kratom Affirmed By The National Institute Of Drug Abuse
Ruling highlights FDA's responsibility to seize illegal, counterfeit, and contaminated forms of popular dietary supplement
WASHINGTON, July 30, 2018 /PRNewswire/ -- In a recent update of its official position on the botanical kratom, the National Institute on Drug Abuse (NIDA) affirmed that, "Kratom by itself is not associated with fatal overdose," explaining that only when the natural ingredient is contaminated or "laced with other compounds" has it been associated with death.
NIDA's position clarifies and corrects an earlier statement by FDA Commissioner Scott Gottlieb that kratom has been associated with 44 deaths--sufficient, in his opinion, to justify placing the botanical on the Federal Drug Enforcement Agency's (DEA) schedule that would prohibit kratom's distribution and use, even in its natural form.
"NIDA's position does not come as a surprise," said Dave Herman, Chairman of the American Kratom Association (AKA), which is committed to protecting the rights of consumers who use kratom safely and successfully. "The data used by the FDA to make its original claim were clear that the adverse reactions were caused by adulterated or contaminated kratom, polydrug use, or unrelated underlying health conditions of the decedent. NIDA's statement is consistent with these findings, and we call upon the two agencies to work together to remove the FDA's scheduling recommendation for natural kratom and focus on protecting the rights of Americans who rely on it by removing adulterated and dangerous counterfeit products from the market."
The FDA and NIDA have a long-standing formal agreement that both agencies must concur on scheduling recommendations submitted to the DEA. "In extrapolating the data to a faulty conclusion--in an effort to place kratom on the DEA's schedule--the FDA's logic would require the prohibition of caffeine and even coffee because someone laced that product with fen-phen or any other contaminant," said Herman. "In fact, it could be applied to anything, even broccoli, once it has been contaminated with a dangerous substance."
NIDA's position clarifies that natural kratom does not present a public health risk, and the FDA already has statutory authority to seize all dangerous adulterated and counterfeit products. "The American Kratom Association joins the three to five million American consumers who safely use kratom, as well as the healthcare professionals and government leaders who support kratom in its natural form, in calling upon the FDA to follow the science, to allow consumer access to the natural botanical, and to use its efforts and energy to go after those who lace it illegally," said Herman. "We respectfully request that acting DEA Administrator Uttam Dhillon formally reject the FDA recommendation for the scheduling of kratom and return it to the FDA for immediate regulatory action against adulterated counterfeit kratom products. This may require a little more effort on behalf of the FDA, but it is consistent with the science. It is the right thing to do. And it will put to an end to the threat of criminalizing the actions of millions of Americans who rely on kratom for their health and well-being."
The AKA announced its recommended standards for kratom manufacturers and vendors on July 18, 2018 to promote self-regulation in the kratom industry so that consumers could identify vendors who comply with FDA good manufacturing processes.
The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom. AKA represents millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org
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SOURCE American Kratom Association