Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
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6/5/24  2:06 pm
Commenter: Anonymous

FDA unable to get Kratom Scheduled
 

I do not support this petition.  

The FDA has been pushing for Kratom to become a Schedule I substance for over a decade. But when a Federal Judge called on the FDA in February 2024 to present witnesses or testimony under oath on whether Kratom was dangerous, the FDA refused. The reason they gave was that they have not yet made a determination regarding whether Kratom was dangerous. However, the FDA completed a kratom “dose finding study” on humans where no significant adverse events were observed even at very high doses. The FDA acknowledged the data showed no significant safety concerns in the ascending dose study on kratom use.

FDA Dose finding study: https://speciosa.org/fda-dose-finding-study-what-it-actually-means-to-kratom-consumers/

FDA in Federal case: https://e17085.p3cdn1.secureserver.net/wp-content/uploads/2024/03/Screenshot-2024-03-04-at-11.38.26%E2%80%AFAM.png

CommentID: 225196