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  4:20 pm
Commenter: Ben Howell

An In-Depth Argument Against Including Mitragynine and 7-Hydroxymytragynine in Schedule I
 

While the intention to protect public health is understandable, there are several compelling reasons to oppose this amendment.

1. Lack of Evidence for High Abuse Potential

One of the key criteria for a substance to be classified under Schedule I is a high potential for abuse. While kratom can lead to dependency and addiction, its abuse potential is significantly lower compared to stronger opioids like heroin, fentanyl, or oxycodone, which are associated with severe physical dependence and a high risk of overdose.

Research indicates that kratom has a lower risk profile. For example, the withdrawal symptoms associated with kratom, while present, are generally milder and less severe than those of stronger opioids. Furthermore, kratom's addictive properties are far less pronounced, with fewer cases of compulsive use and overdose compared to Schedule I opioids. This comparative analysis suggests that kratom's abuse potential, while notable, does not warrant Schedule I classification, which is reserved for substances with the highest potential for abuse and no accepted medical use.

2. Therapeutic Potential and Benefits

Another criterion for Schedule I classification is that the substance has no accepted medical use. However, emerging evidence suggests that kratom and its alkaloids have significant therapeutic potential. Research has demonstrated that kratom can be effective in managing chronic pain, reducing opioid dependence, and alleviating symptoms of anxiety and depression. Many individuals have reported positive outcomes using kratom as an alternative to more harmful substances, indicating its value in harm reduction strategies.

3. Negative Consequences of Scheduling

Scheduling mitragynine and 7-hydroxymytragynine as Schedule I substances could have unintended negative consequences. Firstly, it could push kratom users towards the illicit drug market, increasing their exposure to dangerous adulterants and unregulated products that kratom has been helping them abstain from. Secondly, it could hinder scientific research on kratom, as Schedule I status imposes significant regulatory barriers that complicate the process of obtaining research approvals and funding.

4. Regulatory Alternatives

Instead of a Schedule I classification, a more nuanced regulatory approach could be more effective in addressing concerns about kratom. For example, implementing quality control standards and proper labeling requirements could ensure that consumers have access to safe, uncontaminated kratom products. Additionally, public education campaigns could inform consumers about responsible use and potential risks.

5. Comparative Risk Analysis

Comparing the risks associated with kratom to those of other substances currently available, such as prescription opioids, is crucial. Prescription opioids, such as oxycodone and morphine, are not classified as Schedule I, and have been linked to significant morbidity and mortality due to overdose and addiction. In contrast, kratom-related deaths are rare and often involve polydrug use, suggesting that kratom itself may pose a lower risk to public health than many legally prescribed medications.

6. International Perspectives

Looking at how other countries regulate kratom can provide valuable insights. For instance, in Thailand, kratom has been decriminalized and regulated as a traditional herbal remedy, recognizing both its risks and benefits. This balanced approach has allowed for continued use and research, offering a model that could be adapted to fit the regulatory landscape in the United States.

Personal Testimony

As someone who has used kratom for a decade to manage depression and anxiety, I can attest to its benefits. It has significantly improved my quality of life and helped me abstain from much more harmful and destructive substances. Throughout my use, I have suffered no ill side effects, nor has it had any negative impacts on my health. That being said I've no intention to stay on it for the rest of my life and am currently tapering off. I believe it to be a very useful tool that can help countless people better their lives. Making kratom schedules 1 would be so wrong and counterproductive, we need more funded research and structured regulation for quality control. 

Conclusion

The petition to classify mitragynine and 7-hydroxymytragynine as Schedule I substances is not supported by the current evidence regarding their abuse potential, therapeutic benefits, and the broader implications of such scheduling. A more balanced regulatory approach that includes quality control, research facilitation, and public education would better serve public health interests without the severe drawbacks of Schedule I classification.


References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638880/pioid substitute: Evaluating its potential for abuse and therapeutic value
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423016/
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8427750/
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7309661/
  5. https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1416689/full
  6. https://www.rilegislature.gov/Special/comdoc/House%20Corporations%202024/03-14-2024--H7231--Kratom%20Science%20Update%202024.pdf
  7. https://www.americankratom.org/truth-in-labeling
  8. https://www.sciencedirect.com/science/article/abs/pii/S0091743519303275
  9. https://conventuslaw.com/report/thailands-new-legal-framework-for-kratom/
CommentID: 225330