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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5/22/24  10:46 am
Commenter: John Austin, BSMH

Support for Kratom to be classified as a Schedule I
 

Based on the definition of a Schedule I drug, "high abuse potential with no accepted medical use; medications within this schedule may not be prescribed, dispensed, or administered", the active alkaloids of Kratom, mitragynine (MG) and 7-hydroxymytragynine (7-HMG), meet qualifications to be categorized as such.  MG is the main lipophilic alkaloid present in Kratom. Its psychoactive metabolite, 7-HMG, has been assessed in preclinical models for its analgesic properties, while few studies have been conducted on the other alkaloids present in this product derived from a plant.  Information related to the safety profile of MG is limited and health hazards from case reports associated with the use of Kratom have been linked to deleterious effects.  In February 2024, the Food and Drug Administration (FDA) warned the public about the abuse potential of the active ingredients contained within Kratom and in unregulated Kratom-related products.  In the FDA's public health focus post, it has been stated that Kratom is "not appropriate for use as a dietary supplement" due to the fact that there is "inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury..."  Similar concerns have been issued in European countries like Denmark, Finland, Sweden, Ireland, Latvia, Poland, Lithuania, and Romania which have categorized Kratom as an illegal drug/substance.  Rigorous high quality studies with meaningful outcome measures on the clinical efficacy aspects of Kratom and MG along with an assessment of any safety signals are necessary to be carried out in order to justify any potential therapeutic use and awarding a designation for this product outside of Schedule I drug status.  Please let this comment represent support for the measure to make Kratom a Schedule I drug.

CommentID: 222654