Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Pharmacy
 
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]

19 comments

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5/6/24  3:41 pm
Commenter: Bobby Ison, MBA, RPH , Retired Director of Pharmacy, Passed BOP member

I am in support of this Petition
 

As someone deeply committed to the well-being of our communities and families , I am in support of this petition because I believe in taking a firm stance against substances that have the potential to cause harm and endanger lives. The push to classify kratom as a Schedule 1 controlled substance is not just about legislation; it is about prioritizing public health and safety over the interests of those who profit from its sale. The evidence pointing to the risks and negative implications of kratom use especially among the most vulnerable populations, including children and those in socioeconomic distress cannot be ignored.

Promoting kratom as a harmless herbal supplement is both misleading and dangerous. The addiction potential, coupled with the lack of comprehensive studies on its long-term effects, demands our immediate attention and action. By supporting this classification, I am advocating for necessary research, regulation, and oversight to prevent abuse and protect future generations of Virginians from harm.

It's crucial that we listen to the voices of those who have witnessed the darker side of kratom firsthand--families torn apart by addiction, deaths and communities facing the consequences of widespread kratom availability. Their experiences underline the urgent need for this petition and for increased awareness and stricter regulations.

This is about more than just one substance; it's about setting a precedent for how we deal with emerging threats to public health. By supporting this petition, I stand with all who value safety and health over unregulated, potentially dangerous supplements. Let us unite in this cause for the greater good of the citizens of Virginia.

 

CommentID: 222597
 

5/9/24  8:57 am
Commenter: Lori Palagyi, Bon Secours Mercy Health Maryview Medical Center Hospital

I am in support of classifying Kratom as a Schedule I controlled substance.
 

Advocating for Kratom's Schedule I classification emphasizes public health protection.  Key concerns include its potential for abuse, similarity to controlled substances, and the lack of FDA-approved research confirming safety and effectiveness.  Scheduling kratom would enhance regulatory control, ensuring any therapeutic claims are scientifically validated.  This approach aims to safeguard consumers from unproven treatments and align with efforts to maintain public health standards.

CommentID: 222636
 

5/15/24  11:50 am
Commenter: KA, BSMH MMC Lead Pharmacist

Kratom Restriction
 

I am in support of this petition. Similar substances have been deemed appropriate for class 1 or 2 status. This petition will help assist community health safety measures.

CommentID: 222643
 

5/15/24  3:20 pm
Commenter: Linda St. George Rappahannock General Hospital

Kratom class 1
 

I am in support of this petition. Similar substances have been deemed appropriate for class 1 or 2 status. This petition will help assist community health safety measures.

CommentID: 222644
 

5/16/24  8:56 pm
Commenter: WW3

Addition of Kratom to Schedule I
 

I support the initiative to classify Kratom as a Schedule 1 substance.

CommentID: 222645
 

5/18/24  2:13 pm
Commenter: Lan Dhillon

I support this petittion
 

I support the classification of kratom as a Schedule I controlled substance. This is to protect public health due to its abuse potential, unregulated usage leading to potential adverse effects and lack of approved benefits. Scheduling kratom would prevent unverified therapeutic claims, promote research and enhance tighter regulatory control. 

CommentID: 222646
 

5/20/24  12:23 pm
Commenter: Shane Knisley, Maryview Medical Center

Community Health Advocacy
 

The endorsement of this measure reflects our role as advocates for the health and safety of our community. We stand with the decision to regulate substances that pose significant health risks.  

CommentID: 222649
 

5/22/24  6:24 am
Commenter: Anonymous

i support this Petition
 

I support the classification of kratom as a Schedule I controlled substance. This is to protect public health due to its abuse potential, unregulated usage leading to potential adverse effects and lack of approved benefits. Scheduling kratom would prevent unverified therapeutic claims, promote research and enhance tighter regulatory control. 

CommentID: 222651
 

5/22/24  6:26 am
Commenter: Aditya Veldurthy

Support Kratom as Schedule I
 

I support the classification of kratom as a Schedule I controlled substance. This is to protect public health due to its abuse potential, unregulated usage leading to potential adverse effects and lack of approved benefits. Scheduling kratom would prevent unverified therapeutic claims, promote research and enhance tighter regulatory control. 

CommentID: 222652
 

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
 

5/24/24  1:30 pm
Commenter: Lisa Wilson

I support this petition
 

Advocating for kratom's Schedule I classification emphasizes public health protection. Key concerns include its potential for abuse, similarity to controlled substances, and the lack of FDA-approved research confirming safety and effectiveness. Scheduling kratom would enhance regulatory control, ensuring any therapeutic claims are scientifically validated. This approach aims to safeguard consumers from unproven treatments and aligns with efforts to maintain public health standards.

CommentID: 222659
 

5/31/24  7:39 am
Commenter: Sheneka Ramdon, Bon Secours Mercy Health

Classify Kratom as Schedule 1
 

The FDA has issued multiple warnings about the safety of kratom, including reports of deaths associated with its use. Let's support this petition to classify kratom as a schedule I controlled substance to prevent further tragedies

CommentID: 222662
 

5/31/24  9:27 am
Commenter: S. Brown

I support classifying Kratom as Schedule 1 controlled substance
 

I am in support of the petition to classify Kratom as a Schedule 1 controlled substance.  Kratom has been linked to numerous overdose deaths.  We must classify it as a Schedule 1 controlled substance to protect our communities from its harmful effects.

CommentID: 222663
 

5/31/24  10:32 am
Commenter: Joshua Crawford - Virginia Society of Health-System Pharmacists

Classifying Kratom as Schedule I Controlled Substance
 

Virginia Society of Health-System Pharmacists (VSHP) Letter of Support to Classify Kratom as Schedule 1 Controlled Substance 

 

Pharmacological studies show that the active compounds contained in Kratom, mitragynine and 7-hydroxymytragynine, are opioid agonists producing analgesic, sedative and stimulant effects. The potential for abuse of the alkaloids mitragynine and 7-hydroxymytragynine, is well documented due to the opioid and stimulant effects when ingested orally or smoked. Hallucinogenic and sedative effects are also documented at an increased dose. The National Institute for Drug Abuse reports mitragynine and 7-hydroxymytragynine are increasingly being used by the public to self-treat drug withdrawal symptoms and cravings and to manage mental health problems, despite the FDA continuously ruling that these compounds have no therapeutic use. The potential for misuse and harm to the public has been so alarming, several states have banned the sale and distribution of Kratom.

The FDA recently studied Kratom using Public Health Assessment via Structural Evaluation (PHASE) methodology, a tool designed to evaluate pharmacologic data via a 3D computer model using chemical structure. Results confirmed that mitragynine and 7-hydroxymytragynine bind strongly and activate the mu-opioid receptors. In a statement released by the FDA February 6, 2018, FDA Commissioner Dr Scott Gottlieb, MD reported “Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in Kratom, opioids.”

 While research has expanded in recent years, current scientific knowledge is limited due to few human mitragynine pharmacologic studies. Gaps exist in long term use safety, efficacy, and impact on public health.

 Kratom has a history of traditional use in Southeast Asia for medicinal and recreational purposes prior to gaining popularity in the United States. In 2021, the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health found that an estimated 1.7 million Americans, 12 years and older, used Kratom in a 12-month time frame. A DEA Scheduling Action published in 2016 documented the use of Kratom rising among heroin users for self-treatment of withdrawal symptoms and in patients with chronic pain. This scheduling action also stated that the recreational drug market is driving increased quantities of Kratom, of uncertain purity and quality, through various points of entry into the US.

 The duration and scope of Kratom abuse is increasing. Between 2014 and 2016, 55,000 kg of Kratom were encountered by law enforcement. On April 28, 2023, the FDA reported US Marshals seized 250,000 units of dietary supplements containing Kratom. Poison control center calls have also increased from 26 in 2010 to 2,312 in 2019 and the DEA has noted an increase in requests for mitragynine and 7-hydroxymytragynine analysis in human toxicology panels. Concerns for abuse and an increase in adverse effects have driven other states to issue a complete ban on Kratom and the active compounds mitragynine and 7-hydroxymytragynine, including Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin. Currently, Virginia restricts the sale of Kratom to those aged 21 years and older and requires a warning label on all packages containing Kratom. In Virginia, Kratom is conveniently sold at smoke shops, gas stations, and online. Within a five-mile radius of the Virginia Board of Pharmacy, there are at least 15 smoke shops selling Kratom that were able to be easily identified. 

 Common adverse effects associated with mitragynine and 7-hydroxymytragynine include irritability, tachycardia, nausea, drowsiness and hypertension and serious adverse effects include seizure, coma, hallucinations, liver failure and respiratory depression. A 2019 CDC report detected 152 deaths associated with Kratom in 27 states from July 2016 to December 2017, with 91 deaths listing Kratom as the only cause. Further review of the deaths showed that 80% of the decedents had a positive history of substance abuse and 90% had no evidence they were receiving medically supervised pain management. Lack of purity and quality of Kratom products continue to be a threat to public safety, as a 2018 CDC report linked Kratom to a Salmonella outbreak that sickened 199 across 41 states. The FDA also found that laboratory testing on Kratom products yielded the heavy metals, nickel, and lead, at levels unsafe for human consumption prompting a published warning that long term use could be associated with heavy metal poisoning, including anemia, kidney damage, and increased risk for certain cancers.

Mitragynine and 7-hydroxymytragynine are associated with dependence. A 2014 study on Kratom use, conducted by surveying 293 long term, regular users, resulted in greater than 50% developing severe dependence with physical withdrawal symptoms of muscle spasms, pain, insomnia, fever, and psychological withdrawal symptoms of restlessness, anger, sadness, and nervousness. Similarly, a 2024 study found that 66.7% of patients met the DSM-5 criteria for Kratom use disorder (≥2 symptoms), with withdrawal symptoms, tolerance, using more Kratom than intended, and cravings being the most common symptoms. Various studies have also shown the presence of neonatal abstinence syndrome in infants born to mothers who used Kratom during pregnancy. While methadone and buprenorphine, the opioid in Suboxone, are available to treat some of the withdrawal effects associated with Kratom, there are no known medications to alleviate the non-opioid withdrawal symptoms.

Due to the similarities in opioid-like side effects, Kratom has been questioned as being a “gateway” drug. There is currently limited literature demonstrating this. However, a case report describes a patient with Kratom tolerance who started consuming opioids to obtain Kratom-like effects, leading to opioid dependence.

Kratom’s alkaloids, mitragynine and 7-hydroxymytragynine, are not immediate precursors of a substance already controlled under existing regulations. While the chemical composition of mitragynine and 7-hydroxymytragynine differs from opioids, the effects need to be considered in the scheduling process. Our communities are besieged by an ongoing opioid epidemic and a lot of resources and effort are being utilized to help combat this plague. The ease of Kratom’s availability in our communities help fuel the opioid-epidemic. The Virginia Society of Health System Pharmacists support the petition to make mitragynine and 7-hydroxymytragynine Schedule I substances.

  

  1. Huestis MA, Brett MA, Bothmer J, Atallah R. Human Mitragynine and 7-Hydroxymitragynine Pharmacokinetics after Single and Multiple Daily Doses of Oral Encapsulated Dried Kratom Leaf Powder. Molecules. 2024; 29(5):984. https://doi.org/10.3390/molecules29050984
  2. Swogger M.T., Walsh Z. Kratom use and mental health: A systematic review. Drug Alcohol Depend. 2018;183:134–140. doi: 10.1016/j.drugalcdep.2017.10.012
  3. Substance Abuse and Mental Health Services Administration. (2022). Key substance use and mental health indicators in the United States: Results from the 2021 National Survey on Drug Use and Health (HHS Publication No. PEP22-07-01-005, NSDUH Series H-57). Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report
  4. U.S. Food and Drug Administration.FDA orders mandatory recall for kratom products due to risk of Salmonella (2018) Available at .https://www.fda.gov/news-events/press-announcements/fda-orders-mandatory-recall-kratom-products-due-risk-Salmonella
  5. Olsen E.O., O’Donnell J., Mattson C.L., Schier J.G., Wilson N. Notes from the Field: Unintentional Drug Overdose Deaths with Kratom Detected—27 States, July 2016–December 2017. MMWR Morb. Mortal. Wkly. Rep. 2019;68:326–327. doi: 10.15585/mmwr.mm6814a2
  6. Anwar M., Law R., Schier J. Notes from the Field: Kratom (Mitragyna speciosa) Exposures Reported to Poison Centers—United States, 2010–2015. MMWR Morb. Mortal. Wkly. Rep. 2016;65:748–749. doi: 10.15585/mmwr.mm6529a4.
  7. DEA Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I. [(accessed on 05 April 2024)]; Notes: Document number: 2016-20803. Available online: https://www.federalregister.gov/documents/2016/08/31/2016-20803/schedules-of-controlled-substances-temporary-placement-of-mitragynine-and-7-hydroxymitragynine-into
  8. FDA Statement by FDA Commissioner Scott Gottlieb, M.D., on Risk of Heavy Metals, including Nickel and Lead, Found in Some Kratom Products. [(accessed on 05 April 2024]; Available online: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626738.htm
  9. Eastlack SC, Cornett EM, Kaye AD. Kratom-Pharmacology, Clinical Implications, and Outlook: A Comprehensive Review. Pain Ther. 2020 Jun;9(1):55-69. doi: 10.1007/s40122-020-00151-x. Epub 2020 Jan 28. PMID: 31994019; PMCID: PMC7203303.
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  13. Ellis CR, Racz R, Kruhlak NL, Kim MT, Zakharov AV, Southall N, Hawkins EG, Burkhart K, Strauss DG, Stavitskaya L. Evaluating kratom alkaloids using PHASE. PLoS One. 2020 Mar 3;15(3):e0229646. doi: 10.1371/journal.pone.0229646. PMID: 32126112; PMCID: PMC7053747.
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CommentID: 222664
 

5/31/24  11:33 am
Commenter: Kristy Ryman, Mary Immaculate Hospital

Support Kratom Petition
 

Please consider making kratom a schedule I substance due to it's addiction potential and unregulated production. 

CommentID: 222665
 

5/31/24  12:27 pm
Commenter: Pat Canady

Support for Kratom to be classified as a Schedule I drug
 

By signing this petition, I support the need for Kratom to be classified as a Schedule I drug. A Schedule I drug has high abuse potential with no accepted medical use. Currently Kratom has no use approved by the U.S. Food and Drug Administration (FDA) nor is Kratom regulated by other governing agencies. The use of Kratom has proven to have negative impact with regards to public health including psychiatric, cardiovascular, gastrointestinal and respiratory problems including a small number of deaths. We need to classify Kratom as a Schedule I controlled substance to ensure consumer protection. 

CommentID: 222666
 

5/31/24  1:39 pm
Commenter: Stephanie Davis

Kratom
 

I support to classify Kratom as a schedule 1.

CommentID: 222667
 

5/31/24  3:48 pm
Commenter: Anonymous

Kratom
 

 Kratom acts like an opioid and has been linked to numerous overdose deaths. We must classify it as a Schedule I substance to protect our communities from its harmful effects. 

CommentID: 222668
 

5/31/24  10:05 pm
Commenter: Anonymous

Danger to public
 

Kratom is a danger to the public.

CommentID: 222669