Molecular Biologist Takes Issue With 'Exaggerated Claims' From FDA Regarding Kratom

Dr. Jane Babin, Ph.D. in Molecular Biology from Purdue University, J.D. from University of San Diego School of Law, has authored a policy report taking the FDA to task for "Exaggerated claims, discredited research, and distorted data [which] fail to meet the evidentiary standard for placing kratom as a Schedule I Controlled Substance." Dr. Babin had previously debunked the "36 deaths" claim that the FDA was floating around regarding kratom. As Dr. Babin pointed out, in each case, there were multiple other potential causes of death, mostly due to dangerous interactions involving prescribed medications the users were taking at the time.

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The 36 figure has been raised to 44 at present, but as Dr. Babin points out in her paper, a review of the data "fails to provide a cohesive or reasonable scientific basis to conclude any of the deaths were caused by kratom." She also points out that apart from kratom being present in the system at the time those listed died of other causes, there is no association (other than coincidental) related to these deaths.

https://thegoldwater.com/news/12348-Dr-Jane-Babin-Weighs-In-On-Kratom-Safety

The information the FDA relies on their claims are the CFSAN Adverse Event Reporting System (CAERS) and the FDA Adverse Event Reporting System (FAERS), in both cases these are voluntary reporting systems that may not provide other valid information related to the decedent's health and physical condition. The CAERS database is published "as reported" and admittedly doesn't represent any conclusion by the FDA on causality from consumption. Dr. Babin takes issue with the fact the FDA "has clearly intentionally mischaracterized kraotm using these unverified reports." Despite FDA claims of transparency, their own data fails to meet the criteria for CSA scheduling under Schedule I or any other schedule.

http://www.thegoldwater.com/news/13202-FOIA-Docs-Reveal-FDA-Lied-About-Evidence-Of-Kratom-Danger

Kratom is a Southeast Asian plant that is related to coffee and has been safely used for centuries as a folk medicine. Recent research shows it may have multiple applications.