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  3:30 pm
Commenter: Jason Heflin

Statutory requirements likely preclude scheduling on June 25
 

As I previously noted, I oppose scheduling these alkaloids. Doing so would be unscientific and harmful to my fellow Virginians. The FDA itself admitted in litigation that it has made no finding that kratom is harmful to human health.

I write separately to note that VA ST § 54.1-3443 sets forth the means by which the Board may schedule substances. One avenue, set out in subsection (d) of  the statute, is for the Board to consult with DFS before making a determination. When this option is used, the substance is descheduled after  18 months unless a law is enacted adding the substance to schedule I or II. If the Board must schedule these alkaloids, I encourage the Board to take this route. In the absence of good science, kratom is essentially a political issue. The Assembly has many options the Board does not have to address the kratom question. The Board should leave room for the democratic process to resolve the question. 

If the Board takes the other avenue, subsection (b) of the statute, it must make findings after considering several enumerated factors. I believe an honest assessment of these factors and the existing evidence must lead to the conclusion that these alkaloids should not be scheduled.

In either event, I believe the law requires the Board to either consult with DFS or perform a detailed assessment and make findings before scheduling these alkaloids. I doubt that it could do either in its meeting on June 25. 

For the avoidance of doubt: None of the above is intended to be or is legal advice or counsel. I am not a member of the Bar of Virginia, though I am a Virginia resident. I am a member of the Bars of New York and DC. I make these comments solely on my behalf as a citizen. 

CommentID: 225274