This briefing distinguishes natural kratom leaf — a botanical regulated as a consumer product — from synthetic and semisynthetic compounds sold under the same name. That distinction is central to any state or local government considering how, or whether, to regulate kratom.
1. What is Kratom and What It Is NOT
Natural kratom leaf is a botanical, not a synthetic drug. Under federal law, the FDA approves drugs, not plants. Botanicals fall under consumer product safety and local regulatory frameworks.
Since 2023, synthetic and semisynthetic products falsely marketed as "kratom" have proliferated. These substances are pharmacologically as far removed from natural kratom leaf as heroin is from a poppyseed muffin.
2. Federal Scientific Position
HHS Rescission (2018)
In 2018, the U.S. Department of Health and Human Services withdrew its prior recommendation to schedule natural kratom leaf. Assistant Secretary for Health Dr. Brett Giroir concluded that available evidence "does not meet the criteria for inclusion of kratom or its chemical components in Schedule I."
He warned that scheduling natural leaf could lead to:
- Intractable suffering for individuals with chronic pain
- Kratom users switching to highly lethal opioids
- Patients avoiding medical care due to fear of criminalization
- Misinterpretation of adverse events, which were primarily linked to adulterated or polysubstance products, not natural leaf
DEA Notice of Intent (July 1, 2026)
The DEA announced intent to temporarily schedule:
- 7-hydroxymitragynine (7-OH), only when present above natural levels
- Synthetic mitragynine analogs, including mitragynine pseudoindoxyl, MGM-15, and MGM-16
DEA stated these substances pose distinct risks because they are manufactured, concentrated, or synthetic compounds with potency not found in natural kratom leaf.
CSA 8-Factor Analysis
Federal findings
This distinction is directly relevant to local government evaluation.
3. Public Health Considerations
Peer-reviewed toxicology and pharmacology literature consistently shows that natural kratom leaf has a markedly different risk profile than synthetic or high-potency extract products.
Key scientific points:
- Mitragynine, the primary alkaloid, is a partial agonist with a ceiling effect that limits respiratory depression
- Severe adverse events are overwhelmingly associated with adulterated products, synthetic derivatives, high-potency extracts, and polysubstance use
- Natural leaf does not exhibit opioid-like mortality patterns
4. ADA Relevant Considerations
The Americans with Disabilities Act (ADA) applies to all municipal governments, including cities, villages, and towns. ADA concerns arise most clearly with possession restrictions, because possession directly affects individuals managing disability-related symptoms.
A policy may raise ADA issues if it:
- Disproportionately impacts people with disabilities
- Removes access to a tool used to manage disabling symptoms
- Reduces functional capacity (work, mobility, daily tasks)
- Eliminates a support without providing a reasonable alternative
For individuals who rely on natural kratom leaf to maintain daily functioning, a prohibition on possession may:
- Prohibit access to a disability-related support
- Reduce ability to work or perform daily tasks
- Disproportionately affect individuals with chronic pain, PTSD, or connective tissue disorders
- Eliminate a tool without offering a reasonable alternative
5. Consumer Demographics
A major Johns Hopkins University survey (2020) of 2,798 kratom consumers found the usage rates shown above for pain, anxiety, depression, and opioid withdrawal management.
Many respondents used kratom to maintain daily functioning, including the ability to work. These findings align with broader data showing kratom is disproportionately used by individuals living with chronic pain, PTSD, anxiety disorders, and other disabling conditions.
6. Summary
Federal scientific positions, public health evidence, ADA considerations, and consumer use data all support distinguishing natural whole-leaf kratom from synthetic or adulterated products.
Key Considerations
This evidence base indicates that natural whole-leaf kratom and synthetic or adulterated products present materially different risk profiles. Regulatory approaches that do not distinguish between the two carry potential unintended consequences worth weighing.
7. Closing
Thank you for reviewing this briefing. Additional materials are available upon request:
- Scientific summaries
- Consumer safety frameworks
- Compliance checklists
- Regulatory comparisons used in other jurisdictions
8. References and Sources
Federal Scientific Position
- U.S. Department of Health and Human Services. Letter from Assistant Secretary for Health Brett P. Giroir, MD, to DEA Acting Administrator Uttam Dhillon rescinding the prior recommendation to schedule mitragynine and 7-hydroxymitragynine. August 16, 2018. Scanned letter (PDF)
- Original scheduling notice referenced in the letter: DEA Notice of Intent, 81 Fed. Reg. 59,929 (August 31, 2016). Federal Register
- Drug Enforcement Administration. "DEA to Temporarily Schedule 7-OH and Related Substances to Protect Public Safety." Press release, July 1, 2026. DEA.gov
- Federal Register. "Schedules of Controlled Substances: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I." Notice of Intent, July 6, 2026 (Doc. 2026-13580). Federal Register
- Federal Register. "Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I." Notice of Intent, July 6, 2026 (Doc. 2026-13581). Federal Register
- U.S. Department of Health and Human Services. "HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products." News release, July 1, 2026. HHS.gov
- U.S. Food and Drug Administration. "Hiding in Plain Sight: 7-OH Products." Public health focus page. Confirms the synthetic 7-OH derivatives do not occur naturally in the kratom plant. FDA.gov
Public Health and Pharmacology
- Hill R, Kruegel AC, Javitch JA, Lane JR, Canals M. "The respiratory depressant effects of mitragynine are limited by its conversion to 7-OH mitragynine." British Journal of Pharmacology. 2022;179(14):3875-3885. Documents the ceiling effect on respiratory depression arising from metabolic saturation of CYP3A. doi:10.1111/bph.15832
- Kruegel AC, Gassaway MM, Kapoor A, Váradi A, Majumdar S, Filizola M, Javitch JA, Sames D. "Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atypical Molecular Framework for Opioid Receptor Modulators." Journal of the American Chemical Society. 2016;138(21):6754-6764. Documents partial agonism at the mu-opioid receptor and G-protein-biased signaling. doi:10.1021/jacs.6b00360
Consumer Demographics
- Garcia-Romeu A, Cox DJ, Smith KE, Dunn KE, Griffiths RR. "Kratom (Mitragyna speciosa): User demographics, use patterns, and implications for the opioid epidemic." Drug and Alcohol Dependence. 2020;208:107849. Johns Hopkins survey of 2,798 respondents; source of the 91% pain, 67% anxiety, 65% depression, and 41% opioid-withdrawal figures. doi:10.1016/j.drugalcdep.2020.107849
- Johns Hopkins Medicine. "Natural Herb Kratom May Have Therapeutic Effects and Relatively Low Potential for Abuse or Harm, According to a User Survey." News release, February 3, 2020. Hopkins Medicine
Note: DEA Notices of Intent are part of an ongoing federal process and are not final orders. Readers should confirm current federal status before citing.