Leaf Kratom
Vendor Toolkit
Your all-in-one resource for compliance and quality.
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Resources for the
Responsible Leaf
Kratom Vendor
The Global Kratom Coalition is dedicated to fostering a safe, transparent, and responsible market for leaf kratom. We recognize that vendors are on the front lines of the industry, playing a crucial role in upholding standards and protecting consumers. This toolkit provides comprehensive guidance and essential resources, developed through rigorous scientific research and policy analysis, to support your commitment to regulatory compliance and industry integrity.
Implementation Guidance:
Putting It All into Practice
This page is designed for action. In a rapidly evolving industry, adhering to the highest standards is not just a matter of compliance—it is a commitment to consumer safety and the long-term viability of the legal leaf kratom market. By proactively implementing these best practices, your business helps build consumer trust, demonstrates industry-wide accountability, and provides a strong counter-argument to the push for prohibition. Use these steps to align your business with a framework of excellence that protects your customers and the future of leaf kratom.
Audit for KCPA Compliance
Conduct a comprehensive self-audit of your current operations against the Kratom Consumer Protection Act (KCPA) requirements outlined in our state-level guides. This ensures your business meets foundational legal standards.
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Perfect Your Product Labels
Review all product labels for absolute accuracy and completeness. Use the GKC Perfect Label as your benchmark to guarantee you are providing the transparent information consumers need for safe use.
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Enforce Strict Age Verification
Verify that your age verification systems are robust and consistently enforced at every point of sale. Protecting minors is a non-negotiable pillar of responsible industry conduct and a key requirement in regulated states.
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- Being A Responsible Person
Mandate Certificates of Analysis (COAs)
Confirm that every product you sell is supported by a valid Certificate of Analysis (COA) from an accredited, third-party laboratory. This is essential for verifying purity, potency, and safety.
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Maintain Meticulous Records
Keep organized and readily accessible records of all batch testing and COAs. This practice is critical for ensuring full traceability and demonstrating accountability in the event of a product inquiry or recall.
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Schedule Regular Compliance Reviews
Proactively schedule periodic reviews of your internal processes and procedures. This ensures your business remains fully compliant and up-to-date with any changes in state or federal kratom regulations.
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Stay Informed on Regulatory Changes
Continuously monitor regulatory updates and policy news from the Global Kratom Coalition and other industry leaders. Staying informed is key to navigating the evolving legal landscape and maintaining compliance.
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Become an Industry Advocate
Actively participate in responsible industry initiatives and advocacy efforts. Your engagement helps protect the future of leaf kratom by promoting a unified, safety-conscious, and science-backed approach to regulation.
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Federal Considerations
Under federal law, it is important to understand the distinction between different product categories.
- Old Dietary Ingredient (ODI): Whole-leaf kratom has a history of use in the U.S. predating October 15, 1994, which qualifies it as an Old Dietary Ingredient.
- New Dietary Ingredient (NDI): Concentrated extracts, which entered the market after 1994, are considered NDIs and require a formal notification with safety data to the FDA to be sold legally.
- Unapproved Drugs: Isolated or synthetic alkaloids like 7-hydroxymitragynine (7-OH) are not dietary ingredients. They are unapproved new drugs that cannot be legally sold as supplements.
Key Resources:
- Leaf Kratom is an Old Dietary Ingredient
- Our Regulatory Philosophy
- Watch Class Module on why ‘Not All Kratom Is Equal
Product Quality:
Exceeding the Standard
Consumer trust is built on quality and consistency. Implementing a robust quality control program is not just good practice—it’s essential for the long-term sustainability of the industry.
Good Manufacturing Practices (GMP): All facilities should adhere to GMP standards. This includes FDA Food Facility registration, third-party audits, comprehensive documentation, and staff training on preventing contamination.
Comprehensive
Testing Obligations
Ensure every batch of your product is subjected to pre-release testing from an ISO/IEC 17025 accredited lab. Testing must verify:
- Identity: Confirming the material is authentic Mitragyna speciosa.
- Purity: Screening for microbial contaminants, heavy metals, pesticides, residual solvents, and mycotoxins.
- Potency: Quantifying the alkaloid content, specifically mitragynine and ensuring 7-hydroxymitragynine levels are within the legal limit (typically <2% of total alkaloids).
- Safety: Screening for adulterants like unapproved synthetic drugs.
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Compliant Versus
Prohibited Claims
It is illegal to make therapeutic, diagnostic, or medical claims about leaf kratom products.
- Acceptable: Structure/function claims related to wellness, such as “promotes better sleep” or “helps with productivity enhancement.”
- Unacceptable: Disease claims such as “relieves pain,” “treats depression,” or “cures substance use disorders.”
Labeling & Marketing:
Communicating with
Clarity and Integrity
Your product label and marketing materials are your most direct lines of communication with consumers. They must be accurate, transparent, and compliant.
Required Label Elements: A compliant label empowers consumers to make informed choices. Key elements include:
- Clear declaration of alkaloid content per serving, including mitragynine and 7-hydroxymitragynine.
- Recommended serving size and servings per container.
- Warnings regarding age restrictions and use during pregnancy.
- Advisories that the product may be habit-forming and to consult a healthcare professional.
- The required FDA disclaimer: “This product is not intended to diagnose, treat, cure, or prevent any disease.”
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Scientific Foundation:
Arming Your Business
with Facts
The GKC’s advocacy is grounded in science. These resources provide the evidence-based foundation for our policy positions and can help you understand the science behind leaf kratom.
- FDA Safety Research: An FDA-commissioned Single Ascending Dose study concluded that leaf kratom is well-tolerated in humans, with no serious adverse events reported even at high servings.
- Expert Scientific Consensus: Leading scientists from institutions like the University of Florida and Johns Hopkins have stated that synthetic isolates like 7-OH “should not be scientifically considered or commercially categorized as kratom.” They recommend that regulation focus on quality standards, accurate labeling, and limiting 7-hydroxymitragynine content.
- Professional Recognition: The American Herbal Products Association (AHPA) has formally recognized kratom in its Botanical Safety Handbook, establishing it within a professional, scientific safety framework.
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The Market & Our Mission
As a vendor, you are also an advocate. Understanding your customers and the broader policy landscape empowers you to be a more effective voice for the industry.
Your Customers
A national survey shows approximately 24 million Americans use kratom, with the majority using it daily for legitimate wellness purposes like occasional pain relief, relaxation, and boosting energy.
Join the GKC’s Advocacy
The GKC actively engages with policymakers to promote sensible, science-backed regulation. In a recent letter, U.S. Representatives McCormick and Bergman wrote to the FDA expressing concern over the proliferation of synthetic 7-OH products being mislabeled as kratom.
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Your Comprehensive Resource Library
Navigate effortlessly between General, Scientific, Legal and Regulatory and Product Safety resources— with just a single click. Join the fight against misinformation by sharing fascinating facts you discover. Simply hit ‘Download’ to receive the knowledge and invite others to explore our rich repository of information!
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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
