Kratom

WARNING: KRATOM IS NOT FDA APPROVED- Labels and serving sizes are set by manufacturer with NO FDA safety guidelines. [1]

POTENCY, SERVING SIZE, AND IMPAIRMENT ARE UNPREDICTABLE

Warning: The FDA warns consumers not to use kratom. Its unpredictable potency and opioid-like effects can cause serious side effects, dependence, overdose, and death—especially with

concentrated products or when mixed with other substances.

MIT (mitragynine) is kratom’s primary active alkaloid. 7-OH (7-hydroxymitragynine) is more potent at opioid receptors, but larger amounts of MIT may also cause substantial impairment.

Package milligrams and “serving sizes” are determined by manufacturers—not established through FDA-approved dosing standards. Products containing widely different amounts of MIT and 7-OH may each be labeled as “1 serving,” making their strength and effects difficult to compare or predict.

Unlike alcohol, there is no scientifically validated dose or blood-level standard that determines impairment. Consuming any kratom product may cause unpredictable impairment—do not drive, operate machinery, or combine it with alcohol, opioids, sedatives, or other drugs.

WHY IS MIXING KRATOM AND ALCOHOL (OTHER DEPRESSANTS TOO) SO DANGEROUS?

[2]

KRATOM + ALCOHOL = COMPOUNDED DANGER

Kratom’s opioid-active compounds and alcohol depress the brain through different pathways. Together, their effects can compound—causing deeper sedation, dangerously slowed breathing, loss of consciousness, aspiration, overdose and death.

MIT can be converted by the body into the more potent opioid-active compound 7-OH. Adding alcohol increases concern because both substances can impair the brain systems that keep you awake and breathing.

RX NARCOTICS → μ-opioid receptors → reduced brainstem respiratory drive → slower, shallower breathing → hypoxia → overdose/death

KRATOM → MIT → some MIT converted to 7-OH → μ-opioid receptor activity

ALCOHOL → CNS depression through primarily GABA/glutamate pathways

They do not need to act on the same receptor to become dangerous together. The two drugs can converge on functions necessary for survival:

↓ alertness + ↓ respiratory drive + ↓ airway-protective reflexes

A person can become progressively more sedated, breathe more slowly or shallowly, become difficult to awaken, vomit without protecting the airway, develop hypoxia, and potentially progress to overdose.

Kratom (the plant) contains both mitragynine (MIT) and 7-hydroxymitragynine (7-OH). MIT is the primary alkaloid in kratom, and the body can also convert some MIT into the much more potent 7-OH.

So the concern is not limited to products labeled “7-OH.” Kratom products themselves can produce opioid-like effects and have been associated with

dependence, withdrawal, poison-center exposures, serious adverse effects, and deaths—particularly when combined with other substances.

The newer concentrated 7-OH products raise additional concern because they may contain much higher amounts of 7-OH than naturally occur in the kratom plant. Meanwhile, kratom is increasingly packaged and marketed like energy shots, drinks, gummies, and supplements, which can make these products appear harmless or familiar.

Consumers need to understand the whole picture: MIT and 7-OH are both part of the kratom issue. Easy access and familiar packaging do not mean these products are safe.

Kruegel et al., 2019 — ACS Central Science

7-Hydroxymitragynine Is an Active Metabolite of Mitragynine and a Key Mediator of Its Analgesic Effects.

DOI: https://doi.org/10.1021/acscentsci.9b00141 [3]

This is especially important for your presentation. The researchers found that MIT is converted in human liver preparations to 7-OH through CYP3A enzymes, and describe 7-OH as a much more potent μ-opioid-receptor agonist. Their receptor studies found 7-OH approximately 10 times more potent than MIT at the human μ-opioid receptor in that particular in-vitro assay. This does not mean ten times more dangerous in people, but it establishes the opioid mechanism.
Kruegel et al., 2016 — Journal of the American Chemical Society

Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids.

DOI: https://doi.org/10.1021/jacs.6b00360

Demonstrated that mitragynine and 7-OH interact with μ-opioid receptors, with 7-OH showing substantially greater potency. This helps substantiate describing kratom as having opioid-active pharmacology, rather than simply calling it an herbal stimulant.
van der Schrier et al., 2017 — Anesthesiology

Influence of Ethanol on Oxycodone-induced Respiratory Depression: A Dose-escalating Study in Young and Elderly Individuals.

This controlled human study showed that alcohol worsened oxycodone-induced respiratory depression. That does not directly prove the magnitude of the interaction with kratom, but it demonstrates the medical principle behind the warning: alcohol can amplify respiratory depression produced by μ-opioid-receptor agonism.
CDC, 2019 — MMWR

Unintentional Drug Overdose Deaths with Kratom Detected — 27 States, July 2016–December 2017.

https://doi.org/10.15585/mmwr.mm6814a2 [4]

CDC found that multiple substances were detected in the great majority of kratom-positive overdose deaths. This supports emphasizing the danger of combining kratom with other substances, although it does not prove that alcohol specifically caused those deaths.
Anwar et al., 2019 — Clinical Toxicology

Kratom exposures reported to United States poison control centers: 2011–2017.

https://doi.org/10.1080/15563650.2019.1569236

Poison-center data documented serious medical outcomes from kratom exposures and found important concerns involving co-exposures to other substances.

une 2025 - DOSAGE- An exploratory study of the safety profile and neurocognitive function after single doses of mitragynine in [5]

humans [5]

Kratom Emergency Rule effective August 13, 2025

myfloridalegal.com/newsrelease/attorney-general-james-uthmeier-files-emergency-rule-immediately-removing-dangerous-7 [6]

TALLAHASSEE, Fla.—Attorney General James Uthmeier announced that an emergency rule has been filed to classify isolated and/or concentrated 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance in Florida. The rule, which takes effect immediately, makes it illegal to sell, possess, or distribute any isolated or concentrated form of 7-OH in the state.

[7]

Given the death toll—580+ in Florida, 5,800 nationwide—none of these bills fully protect consumers. The Florida bills (SB 1734 & HB 1489) provide stronger measures than the AKA KCPA, tackling potency and testing more directly, but both fall short of your threshold: comprehensive FDA testing to prove safety and efficacy. The persistence of kratom-only deaths (46 in Florida) and industry noncompliance (e.g., illegal imports, Courthouse News, 2023) suggest regulation, even Florida’s robust version, can’t eliminate the “Russian Roulette” risk you’ve described. A ban, as you advocate, aligns better with the evidence of ongoing harm these bills can’t fully prevent.

Updated Summary: Why Kratom Should Be Banned vs. Regulated

Kratom should be banned rather than regulated, as evidenced by the NBC News article "Kratom Targeted by Crackdowns in States, Cities" (NBC News [8], August 27, 2024), which highlights a growing patchwork of state and local bans driven by its deadly toll—such as Beth Quinn’s son Brendan’s kratom overdose death—and lack of federal oversight, alongside the Swedish Public Health Agency’s (PHA) proposal to classify kratom as a narcotic due to its lethal risks (Sweden Herald [9], January 27, 2025). These reports, combined with over 5,800 U.S. deaths, legal cases, rampant manufacturing and labeling violations, profit-driven predatory practices, and kratom’s likely rejection under FDA testing, reveal a public health crisis regulation cannot contain. A safety comparison of kratom forms—liquid, pills, powder, and leaves—further underscores the inherent dangers across all preparations, supporting a ban over the partial fixes offered by the Florida Kratom Consumer Protection Act (FKCPA, SB 1734/HB 1489) and the American Kratom Association’s Kratom Consumer Protection Act (KCPA), which fail to protect consumers, especially self-medicators.

Legal Cases, Deaths, and Health Risks

Death Toll: Over 5,800 kratom-related deaths occurred in the U.S. by 2024 (Washington Post), including 580+ in Florida with 46 kratom-only cases (Tampa Bay Times). The NBC News article details Brendan Quinn’s death from a kratom overdose, with only kratom, caffeine, nicotine, and a prescribed medication in his system (NBC News [8]), while the Swedish PHA reports mitragynine-related fatalities (Sweden Herald [9]). The SABER alert highlights 7-OH’s potency—30 times morphine—driving overdoses (WKRC).
Legal Cases: Lawsuits like Krystal Talavera’s (2021, $11 million, NBC News) and Patrick Coyne’s (2023, $2.5 million) tie deaths to mislabeling, amplifying risks for self-medicators.
Swedish and U.S. Evidence: The PHA’s forensic and emergency data (Sweden Herald [9]) align with U.S. trends (152 deaths, CDC MMWR), showing kratom’s inherent danger.

Violations of Manufacturing Laws and Labeling Regulations

Manufacturing Violations: FDCA breaches include the 2018 salmonella outbreak (199 cases, FDA News Release) and Guthery’s $60 million illegal imports (Courthouse News). Sweden’s 40-ton import surge (Sweden Herald [9]) and the NBC News report of unregulated sales with no dosage guidance (NBC News) reflect this chaos.
Labeling Failures: Products like 7OHMZ (15.27 mg 7-OH, Tampa Bay Times) and “Kosmic Ludes” lack warnings (WKRC), violating FDCA rules. Quinn’s “not our problem” critique (NBC News [8]) and Goblin’s video (WKRC) expose predatory marketing.

High Profits and Predatory Practices

Profit Motives: The $1.5 billion industry (NBC News) pushes potent products, dubbed “gas station heroin” (NBC News). Sweden’s import boom (Sweden Herald) and 7-OH sales (WKRC) mirror this trend.
Predatory Exploitation: Goblin’s insider account (WKRC) and Emmy Hartman’s uninformed use (NBC News) target vulnerable users (10-16 million, Scientific American), amplifying the 5,800-death toll.

FDA Testing Rejection

Safety Risks: The 5,800 deaths, including 46 kratom-only cases, would fail FDA trials (FDA 2024), per Bextra’s precedent (4 deaths, NEJM). Sweden’s PHA (Sweden Herald), 7-OH potency (WKRC), and 91 deaths (2016-2017, CDC MMWR) in the NBC News article (NBC News) confirm this.
Efficacy Gaps: No RCTs (9 trials, 495 patients, BMJ) prove efficacy, as you’ve noted. Variable potency (4-367 mg mitragynine, Tampa Bay Times) defies standardization.
Conclusion: The FDA would reject kratom as Schedule I (DEA 2016), aligning with Sweden’s stance and your view on its unproven safety.

Safety Comparison: Liquid Kratom, Pills, Powder, and Leaves

Liquid Kratom:
- Risks: Highly concentrated extracts (e.g., OPMS Black Liquid Kratom) are linked to severe adverse events, including death (FDA Warning, September 12, 2024)). The Tampa Bay Times found liquid shots with nine times the safe mitragynine level (Tampa Bay Times), and the NBC News article implies Brendan Quinn’s death involved a liquid form given the empty box found (NBC News). The FDA notes risks like withdrawal, addiction, and respiratory depression (FDA 2024).
- Safety Concerns: High potency and lack of dosing clarity amplify overdose risks, as seen in Sweden’s mitragynine fatalities (Sweden Herald). No standardization exists, per Michael White’s heavy metal contamination warning (NBC News).
Pills:
- Risks: Concentrated tablets (e.g., 7OHMZ) contain extreme 7-OH levels, likened to “legal morphine” (Tampa Bay Times), posing overdose and addiction risks. The NBC News article notes pills among widely sold forms (NBC News), with no alkaloid levels disclosed.
- Safety Concerns: Variability and lack of warnings increase danger, as in Talavera’s case (NBC News). The Swedish PHA’s narcotic classification applies to all forms, including pills (Sweden Herald).
Powder:
- Risks: Less potent than liquids or pills (8.7 mg mitragynine/gram, Tampa Bay Times), but large packages enable high intake, linked to deaths (e.g., 580+ in Florida, Tampa Bay Times). The NBC News article ties powder to unregulated sales (NBC News), and Sweden reports mitragynine risks in plant powder (Sweden Herald).
- Safety Concerns: No dosing guidance and potential for heavy metals (NBC News) or salmonella (FDA News Release) make it unsafe, despite lower potency.
Leaves:
- Risks: Traditional use involves chewing or brewing, with lower potency (1-25 grams, Healthline), but still tied to addiction and rare fatalities (NIDA). The Swedish PHA’s data includes leaf-derived mitragynine deaths (Sweden Herald).
- Safety Concerns: Variability (4-367 mg mitragynine, Tampa Bay Times) and lack of oversight mirror other forms, per the NBC News “gas station heroin” label (NBC News).
Comparison Summary: Liquid kratom poses the highest overdose risk due to concentration, followed by pills with synthetic enhancements. Powder and leaves, while less potent, remain dangerous due to inconsistent alkaloid levels and contamination risks. All forms lack FDA approval and carry addiction and lethality potential (FDA 2024, Sweden Herald), supporting a ban over regulation.

FKCPA (SB 1734/HB 1489) and KCPA: Partial Fixes, Persistent Risks

FKCPA Protections: Caps 7-OH at 2%, limits mitragynine to 40 mg/serving, mandates warnings, and enforces testing (s. 500.92), potentially reducing Florida’s 580+ deaths.
FKCPA Shortfalls: No FDA pre-market testing, tailored dosing, or efficacy proof fails self-medicators, as you’ve noted. The 46 kratom-only deaths and violations (WKRC) persist, per Sweden (Sweden Herald) and Quinn’s case (NBC News).
KCPA Weaknesses: No potency caps or FDA ties, with weak fines (Tampa Bay Times), align with the “Wild Wild West” industry (NBC News).

NBC News Article’s Role

Ban Promotion: Brendan’s death, state bans (e.g., six states), and unregulated sales (NBC News) bolster the case for a ban, aligning with Sweden (Sweden Herald) and your view that regulation fails.
Vs. Regulation: The “patchwork” of rules (NBC News) underscores the inadequacy of reactive measures against 5,800 deaths.

If kratom underwent standard FDA pharmaceutical testing:

Termination in Early Phases: The 5,800 deaths, including 46 kratom-only cases, would halt trials by Phase 1 or 2 due to unacceptable safety risks (e.g., seizures, respiratory depression). The FDA’s threshold for stopping trials—significant adverse events or deaths—is far exceeded by kratom’s real-world toll.
Non-Approval: Even if trials reached NDA review, the death count, variable potency (e.g., 4 mg to 367 mg mitragynine, Tampa Bay Times, 2023), and lack of efficacy data would lead to rejection. Kratom’s profile resembles failed drugs (e.g., Bextra), not approved ones (e.g., OxyContin, with controlled dosing despite risks).
Outcome: The FDA would conclude kratom is not approvable as a pharmaceutical drug, likely recommending Schedule I classification (no medical use, high abuse potential) under the Controlled Substances Act, as attempted in 2016 (DEA, 2016).

Regulation without FDA testing fails given the deaths—holds here. The 5,800 fatalities, including kratom-only cases, signal a safety profile incompatible with FDA standards, even for tightly controlled drugs. Issues you’ve raised (no disease-specific testing, no tailored dosing, severe risks) would doom kratom in trials, supporting your stance that a ban, not regulation, aligns with the evidence. Florida’s bills (SB 1734, HB 1489) and the AKA KCPA cap potency and mandate testing, but without pre-market FDA validation, they can’t prevent the inherent risks driving this toll.

Conclusion

Kratom should be banned, not regulated. The 5,800 U.S. deaths (Washington Post), Brendan Quinn’s case (NBC News), Sweden’s mitragynine fatalities (Sweden Herald), lawsuits (NBC News), and violations (Tampa Bay Times, Courthouse News) reveal an uncontainable crisis. Across liquid, pills, powder, and leaves, safety risks—overdose, addiction, contamination—persist due to potency variability and lack of oversight (FDA 2024, Tampa Bay Times). High profits ($1.5 billion, NBC News) fuel predatory practices (WKRC), while FDA rejection is assured (previous analysis). The FKCPA mitigates some risks but lacks FDA testing and dosing specificity, as does the KCPA. Sweden and state bans (NBC News) support halting this “monster drug” (WKRC) where regulation fails.

Resources with Links

NBC News [8], “Kratom Targeted by Crackdowns in States, Cities,” August 27, 2024.
Sweden Herald [9], “Public Health Agency: Kratom Classified as Narcotics,” January 27, 2025.
WKRC [10], SABER Alert on 7-OH, undated (accessed 2025).
Tampa Bay Times, [11] “Deadly Dose” Series, 2023.
Washington Post, [12] “They take kratom to ease pain or anxiety. Sometimes, death follows,” February 20, 2024. (/).
NBC News, [8] Kratom Industry Revenue, 2024.
NBC News, Talavera Case, 2023. [13]
Courthouse News, Guthery Case, 2023 [14].
CDC Archive [15] , Salmonella Outbreak, 2018.
CDC MMWR [16], Kratom-Related Deaths, 2019.
Scientific American [17], Kratom User Estimates, 2021.
BMJ, Limited RCTs, 2023 [18]. BMJ 2025 [19]
DEA 2016, [20] Scheduling Attempt. (Changing Stance) [21]