12-03-2018 | Science
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Prominent Scientists Believe FDA Hasn't Done Sufficient Analysis On Kratom
Jack Henningfield and several other scientists who have been studying kratom for years have publicly released a 33-page letter they sent to heads of the US Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) as well as the Drug Enforcement Association (DEA). This follows shortly after HHS urging the DEA to schedule kratom as a schedule I substance believed to have potential for great harm and no medicinal value along with heroin, LSD and marijuana.
Scientists led by former lead pharmacologist for the National Insitute on Drug Abuse (NIDA), Dr. Jack Henningfield objected to the methodology and lack of scientific rigor of the FDA's 8-factor analysis (8 FA) of kratom.
Dr. Henningfield and the others pointed out that the FDA ommitted key data sources and were unreliable and incomplete in their research. Dr. Henningfield had previously referred to the FDA's conception of kratom as being based on "junk science."
"These preeminent scientists have demonstrated that the FDA is a long way away from providing sufficient analysis of kratom to back up its recommendation that this natural botanical be listed as a Schedule I substance," David Herman, Chairman of the American Kratom Association said.
Herman felt there was "sufficient information in what the FDA has released to reflect that they did not engage in a comprehensive, scientifically-based process, but rather what appears to be an exercise to reinforce it's fight against kratom."
The scientists urged the DEA to work with the NIDA to look over the FDA's claims regarding kratom's potential for abuse and work with industry groups like the American Kratom Association to ensure vendors are abiding by Good Manufacturing Practices and proper marketing.
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