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  10:10 pm
Commenter: Julie Rauch

Follow the Science Against Scheduling Kratom
 

The CSA sets specific and intentionally restrictive standards for scheduling of substances in Schedule I, including conclusive scientific and legally defensible proof that the substance has (1) a high abuse potential; and (2) there is a lack of accepted safety for use of the drug or other substance under medical supervision. Kratom is not an opioid, it is a natural supplement made from the leaves of a tropical tree native to Southeast Asia and a relative of the coffee plant. In the U.S., kratom has been used as an herbal supplement by consumers for managing their personal health and well-being. Numerous scientific studies, including studies funded by the NIH, have shown the addiction potential for kratom is substantially lower than that of “narcotic-like opioids” and it does not produce the deadly respiratory depressant effects that is the primary cause of opioid overdose deaths. Kratom does not fit the criteria for a schedule I substance. The FDA is wrong on the science, and wrong on the policy. Other federal and international agencies have carefully evaluated the FDA’s claims and they find they lack sufficient evidence to support the FDA claims.

On December 1, 2021, the Expert Committee on Drug Dependence at the World Health Organization and the U.S. Commission of Narcotic Drugs, comprised of 12 international experts on substance safety and addiction, unanimously concluded that there was insufficient evidence to recommend a critical international scheduling review of kratom.

On March 16, 2022, a letter from HHS Secretary Becerra acknowledged “knowledge gaps” on kratom and that “kratom-involved overdose deaths have occurred after use of adulterated kratom products or taking kratom with other substances.”

As of today, 9 states have passed similar versions of the Kratom Consumer Protection Act (KCPA): Utah, Georgia, Arizona, Nevada, Oregon, Colorado, Oklahoma, West Virginia, and Virginia. The Texas Senate passed the KCPA on a vote of 28-2 on March 16 and is now being considered by the Texas House. Additional states currently deliberating on KCPAs are Kansas, Illinois, Indiana, Michigan, Minnesota, Tennessee, Ohio, Pennsylvania, New Jersey, New York, Florida, North Carolina, Arkansas, Louisiana, South Carolina, Vermont, Wisconsin, and Rhode Island.

Banning kratom would have a significant impact on my quality of life. I was born with hypermobile Ehlers Danlos Syndrome, hEDS (a connective tissue disorder), tethered spinal cord, and syringomyelia, a painful, progressive untreatable spinal cord condition. I’ve undergone four neck surgeries, two spinal cord surgeries, and one brain surgery. Since stopping my opioid pain medications in 2017 and using kratom, I have become a board-certified patient advocate and manage a support group of over 530 people who also have the conditions I do. I have created presentations and given lengthy talks to the support groups and non-profit organizations. I speak with people across the country who are newly diagnosed to help them start their long journey living with these conditions. Narcotic pain medication kept me in a fog, something that has resolved since stopping opioids. I have become the person I wanted to be again- a mom, wife, volunteer, and use my nursing skills to advocate for the thousands of people with rare diseases and chronic illnesses.

As our country continues to deal with the damage and pain the opioid crisis is causing our communities, it is important to consider all scientific research that has been conducted on the use and safety of kratom. Banning kratom will block the research that will help us better understand kratom’s risk and benefit profile. However, I do believe, should the DEA schedule kratom through the CSA, it will greatly reduce the public’s ability to conduct this important research. I am concerned that any scheduling of kratom would likely create a substantial illicit market where consumers would be put at significant safety risks, or drive consumers to the dangerously addictive and potentially deadly use of opioids.

Again, I only ask that you do your due diligence and review all data and make an unbiased decision. I have long trusted that the United States government represented its citizens and that the members of all three branches and government agencies make decisions based on what is best for the people.  It is with a heavy heart that I feel decisions such as banning kratom are not made to protect me.  They are made to protect large corporations and powerful people with special interests. It is your obligation to consider all of the scientific research and data available on kratom before deciding to schedule kratom.

Some of the information from this comment is available through the American Kratom Association and published, scientific studies. I am happy to provide those documents if needed.

CommentID: 225619