I read many comments in opposition to this petition arguing that Kratom is "safe" and "effective." If this was true, it would have FDA-approval for use in the United States. Current review of clinicaltrials.gov does not show any current studies that might lead to FDA approval of this substance, but rather studies looking at withdrawal management and drug-plant interactions.

The other argument I see is that Kratom is plant-based and thus should not concern medical professionals. There are plant-based products that are approved for use - digoxin (derived from the foxglove plant), melatonin, and warfarin (derived from sweet clover in found in Wisconsin) are widely used agents that come to immediate mind as a medication expert with a Doctor of Pharmacy degree, Board Certification in Pharmacotherapy, and 15+ years of bedside clinical experience. So, ask yourself a question - if plant-based products can be FDA-approved, especially in the age of opioid abuse and the need for more effective pain management strategies, why is Kratom not being studied in this capacity and why has a New Drug Application not been filed? Also, why has the FDA stated that Kratom may not be marketed as a dietary supplement because it violates 402(f)(1)(B), 402(a)(2)(C)(i), and 409 of the FD&C Act?

Plants can be medicine, but every medicine has not only side effects, but also drug-interactions. In my clinical experience, I have watched at least 1 patient die of acute liver failure from Kratom. I've also had to deal with countless admissions for hallucinations, altered mental status, and abuse to our staff as a result of Kratom abuse. Drug-herb interactions are numerous, including a number of commonly prescribed cardiovascular medications, agents used for treatment of diabetes, and treatment of pain. Until there is data to support both the safety and the efficacy of a Kratom-based product, I support the petition to classify Kratom as a Schedule I substance.

Kratom interactions - Exhaustive List of Kratom Drug Interactions: (260+ Medications) - Kratom.org 

FDA Statement on Kratom - https://www.fda.gov/news-events/public-health-focus/fda-and-kratom