Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
Previous Comment     Next Comment     Back to List of Comments
6/5/24  1:08 pm
Commenter: Anonymous

HHS said scheduling Kratom was NOT supported by data
 

I DO NOT SUPPORT THE PETITION TO MAKE THE ALKALOIDS IN KRATOM A SCHEDULE I SUBSTANCE.

Below is an excerpt from a letter from Brett P. Giroir, M.D., ADM, U.S. Public Health Service, Assistant Secretary for Health, Senior Advisor for Opioid Policy, Department of Health & Human Services, that was sent to the Acting Administrator of the Drug Enforcement Administration (DEA) in 2018 when the FDA made a push for Kratom to become a controlled Schedule I substance. The science did not support that action then, and it does not support that action now. 

“I have reviewed the Acting Assistant Secretary’s earlier recommendation as well as previous and new scientific data. In light of this review, combined with concerns for unintended public health consequences, I now conclude that while mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature. For example, one recently published peer reviewed animal study indicated that mitragynine does not have abuse potential and actually reduced morphone intake. As such, these new data suggest that mitragynine does not satisfy the first of three statutory requisites for Schedule I, irrespective of broader considerations of public health. While a single study is rarely dispositive, it strongly suggests that further evaluation is warranted.” 

“…the level of scientific data and analysis presented by the FDA and available literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I in the CSA (Controlled Substance Act) at this time.”

https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/60145eab6df59e7e36a7cfc1/1611947693695/dhillon-8.16.2018-response-letter-from-ash-radm-giroir.pdf

CommentID: 225125