KCAC Position
Statements
Expert guidance for a safer leaf kratom future.
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Leaf Kratom’s Path Forward:
Insights from the KCAC
The Global Kratom Coalition is proud to host the work of the Kratom Consumer Advisory Council (KCAC), an independent body providing evidence-based analysis on the most critical issues facing the leaf kratom community. Led by inaugural chairman Dr. C. Michael White, an internationally respected clinical pharmacologist , the KCAC unites a broad spectrum of perspectives—from consumers and researchers to advocates and critics—to build a strong foundation for science-based regulation.
The KCAC develops clear position statements to guide consumers, industry stakeholders, and policymakers toward responsible practices. This work fosters crucial education and engagement, bridging the gap between public perception and scientific evidence to ensure a balanced, informed, and safe future for leaf kratom.
KCAC Position Papers
Expert Policy Guidance from the KCAC
Comprehensive position statements addressing the most critical issues in kratom regulation, consumer safety, and market integrity. Led by Chairman Dr. C. Michael White, the KCAC produces evidence-based recommendations that inform policy and protect consumers.
Dr. C. Michael White
Dr. C. Michael White is an internationally respected clinical pharmacologist and pharmacist serving as the inaugural Chairman of the KCAC. He has published extensive reviews on kratom and directed an Agency for Healthcare Research and Quality-designated Evidence-based Practice Center for over a decade.
KCAC Position Statement:
Kratom Use in Children
An Unacceptable Risk to Developing Brains
This KCAC position statement addresses the paramount importance of protecting children from leaf kratom products. The developing adolescent brain, with a prefrontal cortex that does not fully mature until the mid-20s, is uniquely susceptible to risk-taking behavior and addiction. Children are also more vulnerable to adverse events like agitation and seizures. Furthermore, due to their lower tolerable limits for heavy metals like lead, normal adult servings of some kratom products could deliver unsafe levels to a child. These combined risks make youth access to these products an unacceptable danger that demands strict preventative measures and industry-wide responsibility.
Child-Appealing Marketing
The KCAC is deeply concerned by marketing tactics that appeal to children, including cartoon mascots and candy-like formulations such as gummies and lollipops. These strategies mirror the youth vaping crisis and increase the risk of accidental ingestion. To counter this, the KCAC advocates for uncompromising regulations, including a minimum purchase age of 21 with mandatory age verification. We call for a complete ban on child-friendly marketing and packaging, and demand that products only be sold through direct clerk interaction, never in self-service displays. All labels must also clearly warn that the product is not suitable for anyone under 21.
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KCAC Position Statement:
Kratom Use in Children
Advocates for strict regulations, including a minimum purchase age of 21 and a ban on child-friendly marketing, to protect children from potential harm.
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KCAC Position Statement:
Legality of 7-OH Products
Not Kratom: A Fundamental Scientific Distinction
This statement explains the crucial pharmacological and chemical differences between natural leaf kratom and synthetic 7-hydroxymitragynine (7-OH) products. Traditional leaf kratom’s effects arise from an “entourage effect” of dozens of alkaloids interacting with serotonin, adrenergic, and opioid receptors. In stark contrast, 7-OH, a compound not present in fresh leaves and only a trace degradant in dried material, acts exclusively and potently on opioid receptors, mimicking morphine’s action. This key distinction is supported by leading scientists who have expressed grave concern that high-dose 7-OH products pose a greater risk of harm and should not qualify as natural products.
Separate Regulatory Pathway
High-dose 7-OH products are created through chemical oxidation, making them semi-synthetic drugs. Animal studies powerfully illustrate the danger, suggesting 7-OH has an abuse potential as high as morphine and reinforces opioid use disorder. Based on this evidence, the KCAC’s position is that any product with over 2% of 7-hydroxymitragynine in its total alkaloid content is not a kratom product. These substances must be treated as experimental pharmaceuticals requiring a rigorous New Drug Application (NDA) pathway. The council also condemns the recklessly dangerous practice of providing free samples of these substances to consumers given their high potential for addiction.
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KCAC Position Statement:
The Status & Legality of 7-OH Products
Asserts that synthetic 7-OH products are not kratom, possess a dangerous pharmacological profile, and should be regulated as experimental drugs, not dietary supplements.
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KCAC Position Statement:
Proper Labeling of Kratom Products
Empowering Consumers Through Transparency
This statement details why proper labeling is the cornerstone of consumer safety, communicating the information needed to use leaf kratom products responsibly. The KCAC has identified numerous market failings, including products sold with no labels, a lack of clear serving size instructions, and multi-serving liquids sold without measuring devices. These ambiguities can lead to uninformed decisions and unintentional over-exposure, especially with concentrated products that carry increased risks. Furthermore, many products fail to provide critical warnings about habit-forming potential or the presence of common allergens from shared processing equipment, creating unacceptable risks for consumers.
A Blueprint for a
Responsible Label
The council places special focus on protecting vulnerable populations, demanding labels include a minimum purchase age of 21 and clear warnings against use during pregnancy or breastfeeding. The statement provides a blueprint for what a responsible label must include: the processor’s name and business place ; quantitative declarations for total alkaloids, mitragynine, and 7-hydroxymitragynine per serving ; and clear directions for use. A responsible label must also feature a full suite of warnings regarding habit formation, age and pregnancy restrictions, the need to consult a healthcare practitioner, potential drug interactions, and the required FDA disclaimer.
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KCAC Position Statement:
Proper Labeling of Kratom Products
Details the essential components of a compliant leaf kratom label to ensure consumers have the information needed for safe and responsible use.
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KCAC Position Statement:
Registration of Kratom Products
The Case for a Public Registry
This statement outlines the critical need for a mandatory registration system for leaf kratom vendors and products. The current federal framework under DSHEA is insufficient, as it does not require companies to alert authorities when bringing products to market, creating a regulatory blind spot. This gap is immense for kratom; the NIH’s database contains only three kratom product labels, while just one list of approved vendors contains nearly 50 companies selling multiple products. In the absence of federal action, state-level Kratom Consumer Protection Acts (KCPAs) provide a workable model for the transparent product registration that consumers deserve.
A Need for Enforcement
Registration alone is not enough. A third-party audit of vendors in Utah revealed that while most sold registered products, an alarming 85.7% were also selling mislabeled synthetic “7” products, and 82.1% were selling unregistered kratom products in violation of state law. This data powerfully illustrates that consumers are highly likely to be exposed to illegitimate products even when shopping at registered vendors. A robust registration system modeled on the KCPA requires company details and a certificate of analysis, but these rules are meaningless without action. The KCAC concludes that meaningful enforcement and defined penalties are necessary to ensure compliance, as voluntary measures have proven insufficient.
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KCAC Position Statement:
A Fact Check Regarding the Product ‘7’
Advocates for a mandatory public registry of leaf kratom vendors and products to enhance transparency and enforcement.
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KCAC Position Statement:
A Fact Check Regarding the Product ‘7’
Correlation is Not Causation
This fact-check directly refutes unsubstantiated claims that the sale of synthetic 7-OH products has reduced opioid mortality rates. The KCAC clarifies there are zero published clinical trials or observational studies to support this assertion. The entire claim rests on the logical fallacy that correlation implies causation, simply because sales of these products increased in a year when opioid deaths decreased. This argument is dangerous misinformation that promotes an untested substance under a false premise. It is disingenuous for any group to claim these products provide greater safety for consumers without any clinical trial data to support such a statement.
The Proven Solution
Saving Lives
The KCAC presents overwhelming evidence that the actual driver of enhanced survival from opioid overdose is expanded community access to naloxone. This is the proven solution, not the dangerous, untested synthetics often called “Gas Station Heroin” for their potency and addictiveness. Hard data from large-scale studies in North Carolina and Pennsylvania confirm that naloxone distribution leads to dramatic drops in overdose deaths. These proven public health initiatives are the true success story. Claims that synthetic 7-OH is responsible for saving lives are baseless myths that recklessly distract from the strategies that are actually working to combat the opioid crisis.
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KCAC Position Statement:
A Fact Check Regarding ‘7′
Refutes the unsubstantiated claim that synthetic 7-OH sales have reduced opioid deaths, presenting evidence that naloxone distribution is the actual driver of improved outcomes.
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2024 Kratom Consumer Survey
This survey review offers key insights into the kratom user base, revealing who they are, why they use kratom, and their perspectives on its health effects. -
The Evolution of Kratom: A Historical Timeline
An infographic tracing kratom’s journey from its traditional origins in Southeast Asia to its current complex legal and political landscape in the United States. -
Not All Kratom Is Equal
An infographic of clear visual guide comparing the potency, history, alkaloid sources, and common product forms of leaf kratom, kratom extract, and synthetic 7. -
The Differences Between Kratom Products
A detailed diagram visual comparison of leaf kratom, extracts, and synthetic “kratom,” highlighting distinctions in their market entry, alkaloid profiles, and appropriate regulatory approaches. -
Kratom Safety, Taxonomy, and Regulation
Provides a general overview of kratom, addressing common confusion between product types and outlining the GKC’s goals for a safe and regulated marketplace.
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2024 FDA Study: Kratom Dosing & Safety Results
A summary of an FDA-commissioned study that found controlled servings of dried leaf kratom were generally well-tolerated and resulted in no serious adverse events. -
FDA Pilot Study: Updates on Kratom Alkaloid Research
A presentation from the FDA detailing updates on its pilot dose-finding study of kratom alkaloids, including study design, preliminary observations, and next steps. -
Scientists’ Statement on 7-OH and MGPI Products
A statement from leading scientists clarifying that products with high amounts of 7-OH and MGPI are synthetic and do not constitute natural kratom. -
Scientific Statement on Kratom Products
An overview by scientists covering the history of kratom use, its current regulatory status, and the scientific understanding of its effects in the United States. -
Comprehensive Report on Substance Use Disorders
A detailed analysis comparing the prevalence, severity, and symptoms of Substance Use Disorders (SUDs) associated with kratom, caffeine, alcohol, opioids, and other substances. -
The Science of Leaf Kratom: Psychoactive Effects
This document reviews scientific evidence on leaf kratom’s effects, refuting claims about cognitive impairment and abuse potential while clarifying its atypical opioid profile. -
2024 FDA Pilot Study on Kratom Dose Response
Details of the FDA’s pilot study evaluating the effects, safety, and pharmacokinetics of orally administered botanical kratom in non-dependent, recreational polydrug users. - Show more
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Congressional Letter to the FDA on Kratom
A letter from members of Congress to the FDA expressing concerns about mislabeled kratom products and requesting information on consumer protection measures. -
GKC Letter to FDA on Public Safety Guidance
A letter from the Global Kratom Coalition to the FDA, expressing a desire to collaborate on public safety guidance for kratom products and regulatory approaches. -
Louisiana Voter Poll on Kratom Regulation
This poll assesses public opinion in Louisiana regarding kratom’s legality and regulation, including support for banning synthetic drugs while keeping leaf kratom accessible. -
List of Banned Zip Codes: USA
A data file listing zip codes across the country where the sale, possession, or distribution of kratom is currently illegal. -
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KCAC Position: Registration of Kratom Products
This statement advocates for a public registry of kratom vendors and products to ensure transparency, accountability, and a safer market for consumers. -
GKC Statement on Synthetic 7-OH Products
The GKC clarifies its opposition to synthetic 7-hydroxymitragynine (7-OH) products, arguing they are not kratom and should be regulated as new drugs, not supplements. -
KCAC Position: Status and Legality of 7-OH Products
This KCAC statement discusses the legal and regulatory status of 7-OH products, arguing they are not “kratom” and require a distinct regulatory approach. - Show more
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The Severity and Prevalence of Addictive Substances
This infographic visually compares Substance Use Disorder (SUD) severity and prevalence across various substances, including kratom, heroin, alcohol, tobacco, and caffeine. -
Comparative Safety Analysis of Kratom
This document provides a comparative risk analysis of kratom versus other legal and illicit substances, using data from the FDA and poison control centers. -
Contaminants in 7-Hydroxy Mitragynine Products Report
A detailed report identifying synthetic alkaloid contaminants found in 7-Hydroxymitragynine products and discussing the serious implications for regulatory oversight and consumer safety. -
Botanical Safety Handbook: Kratom Entry
An entry for Mitragyna speciosa from the American Herbal Products Association’s handbook, providing safety classifications, contraindications, and potential drug interactions for kratom leaf. -
Debunking Myths About “7”: The Facts
A fact sheet refuting misleading claims about “7” (a synthetic substance), arguing that it is not natural kratom, is not safe, and is deceptively marketed. -
In-Depth: Debunking Myths About “7”
A more detailed version of the fact sheet refuting claims about “7,” providing comprehensive evidence that it is a dangerous, unapproved, and illegal synthetic drug. -
KCAC Position: Proper Labeling of Kratom
This statement advocates for the importance of clear, comprehensive labeling on kratom products to ensure consumer safety and outlines essential information that should be included. -
KCAC Position: Kratom Use in Children
This statement outlines concerns about kratom use by minors, highlighting potential adverse events and the issue of products being marketed in ways that appeal to children. -
UCONN Continuing Education: Kratom Course for Pharmacists
An educational program from the UCONN School of Pharmacy designed to inform pharmacists about natural kratom, its effects, and key points for patient education. -
The Fourth Wave of the Opioid Epidemic
This presentation warns of a potential “fourth wave” of the opioid crisis driven by dangerous and addictive synthetic opioid stimulators, arguing they must be banned. -
Fact Check: “Synthetic 7” and the Opioid Crisis
This KCAC statement fact-checks and refutes misleading claims that the sale of “synthetic 7” products has reduced opioid-related deaths, citing a lack of evidence. -
GKC Perfect Label – Kratom Product Label Guidelines
This document from the Global Kratom Coalition provides comprehensive guidelines for labeling kratom products to ensure consumer safety and regulatory compliance. - Show more
