A Home for
Kratom Businesses
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Are You a
Responsible Business?
Welcome to the Global Kratom Coalition’s Business Hub, your central resource for navigating the evolving leaf kratom industry with integrity and confidence. Here, we provide manufacturers, distributors, and retailers with the essential tools and guidance needed to ensure product quality, maintain regulatory compliance, and build consumer trust. For a comprehensive collection of our resources, we encourage you to explore our Vendor Toolkit, which contains detailed guidelines on everything from compliant marketing to quality control. We believe that by working together to uphold the highest standards, we can foster a safe and sustainable market for everyone.
Kratom Restricted
Zip Code Checker
This tool allows you to enter your zip code and instantly check whether kratom is legal to ship to your area. The system scans an updatable spreadsheet of restricted zip codes. If your zip code is found in the spreadsheet, kratom CANNOT be shipped to that location. If it’s not found, kratom may be available for shipping.
IMPORTANT: While we strive to keep this information accurate, local laws change frequently. Always verify kratom regulations with local authorities. This tool is for reference only and may contain errors
Kratom Product
Labeling Standards
Know What’s on Your Label
Proper kratom product labeling is essential for consumer safety and informed decision-making. Understanding what should be on kratom labels helps consumers identify compliant, trustworthy products.
Key Label Requirements:
- Clear alkaloid content per serving
- Age restrictions and safety warnings
- Serving size recommendations
- “May be habit-forming” advisory
- No illegal health claims
Responsible labeling protects consumers and demonstrates industry commitment to safety standards.
GMP Compliance
1. What GMP is and why it ensures quality and safety
GMP ensures consistent, safe, high-quality supplements, meeting FDA standards, building trust, and preventing errors across production.
2. Standards for clean facilities and trained personnel
Clean, controlled facilities and trained staff prevent contamination, ensuring safe production with proper equipment and hygiene.
3. Controlling raw ingredients and manufacturing processes
Verified raw materials and consistent production processes ensure supplement purity, potency, and safety every batch.
4. Testing, monitoring, and documenting every step.
Testing, monitoring, and detailed records ensure quality, accurate labeling, and traceability for safe, compliant supplements.
5. Meeting regulations, labeling, and passing inspections.
We develop educational materials and campaigns to inform the public, media, and policymakers about the truth behind kratom.
Marketing Guidelines
Kratom is regulated as a dietary supplement, not a drug, which means specific federal restrictions apply to marketing claims. Understanding these guidelines is essential for industry compliance and consumer protection.
Some Key Compliance Points:
- No therapeutic or medical claims without FDA approval
- Must include FDA disclaimer about disease treatment
- Avoid claims about clinically diagnosed conditions
- Customer testimonials must also comply with restrictions
Responsible marketing practices help maintain kratom’s availability as a dietary supplement while protecting the industry from regulatory enforcement actions.
Kratom Compliance &
Industry Standards
The Global Kratom Coalition advocates for proactive industry self-regulation, especially in states without Kratom Consumer Protection Acts (KCPA). Responsible kratom businesses can voluntarily adopt evidence-based standards to strengthen consumer trust and help prevent restrictive future regulations.
Recommended
Voluntary Standards
- Product Testing: Third-party testing for purity, accurate alkaloid labeling, GMP compliance
- Alkaloid Guidelines: Maintain 7-hydroxymitragynine at less than 1% of total alkaloids, avoid synthetic isolates
- Consumer Protection: Age verification, clear safety warnings, “may be habit-forming” advisories
- Marketing Compliance: No medical claims, avoid child-appealing packaging, proper FDA disclaimers
By proactively self-regulating, kratom businesses support long-term market sustainability and consumer access to safe kratom products.
Building Trust in Kratom:
Key Areas for Quality & Compliance
The GKC Guidance on Testing, Sampling & Quality Control outlines critical best practices for kratom businesses, ensuring every product meets strict safety, quality, and transparency standards. By following these guidelines, your company demonstrates a commitment to ethical sourcing, accurate labeling, comprehensive testing, and full regulatory compliance—building trust with consumers and partners alike.
Stability & Shelf-Life Assurance
Ensure consistent quality and consumer safety by conducting thorough stability and shelf-life testing of kratom products. Follow standardized long-term and accelerated testing conditions, evaluating factors like moisture content, microbial growth, alkaloid levels, and physical characteristics to reliably determine product efficacy and safety over time.
Comprehensive Product Testing
Implement a robust and rigorous product testing regime tailored specifically for kratom products. This involves confirming product identity, assessing potency accurately, screening for harmful contaminants like heavy metals, microbes, residual solvents, pesticides, mycotoxins, and adulterants to guarantee consumer safety, regulatory compliance, and product integrity.
Ethical Sourcing & Manufacturing
Commit to ethical practices by ensuring traceability and accountability throughout the kratom supply chain. Adhere to Good Manufacturing Practices (GMP) outlined in regulatory frameworks, verify the purity and authenticity of raw materials, and ensure all manufacturing processes reflect transparency and ethical sourcing standards.
Accurate Labeling & Transparency
Promote trust and consumer confidence by maintaining accurate and transparent product labeling. Clearly specify product identity, potency, composition, storage conditions, shelf life, and packaging details. Consistent, accurate labeling helps consumers make informed decisions and ensures regulatory compliance.
Adherence to Regulatory Standards
Consistently comply with the regulatory requirements of 21 CFR Part 111 governing dietary supplements. Adopt comprehensive risk-based approaches, meticulous documentation, and strict quality control measures to ensure regulatory compliance, mitigate risks, and maintain high safety and quality standards throughout the product lifecycle.
Required Testing by
Product Type
Found on Page 9 of our Quality control Handbook, the chart below outlines the essential safety and quality tests for kratom products, ensuring compliance with industry standards and regulatory expectations.
*Risk-Based approach examples noted specifically in test guidelines.
| Raw Leaf Powder | Extracts | Gummies | Tablets & Capsules | Tinctures | Beverages & Shots | Topicals & Other | |
|---|---|---|---|---|---|---|---|
| Identity | Yes | Risk-Based | No | Risk-Based | No | No | Risk-Based |
| Alkaloid Content | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Active Ingredients (Other) | No | Yes | Yes | Yes | Yes | Yes | Yes |
| Heavy Metals | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Microbials | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Residual Solvents | No | Yes | Yes | Yes | Yes | Yes | Yes |
| Moisture Content | Yes | No | No | No | No | No | No |
| Water Activity | Yes | Yes | Yes | Yes | Yes | No | Yes |
| Pesticides | Yes | Yes | Risk-Based | Risk-Based | Risk-Based | Risk-Based | Risk-Based |
| Myotoxins | Yes | Risk-Based | No | No | No | No | No |
| Adulterants | No | Risk-Based | Risk-Based | Risk-Based | Risk-Based | Risk-Based | Risk-Based |
Get the Comprehensive
Quality Control Guidelines
for Leaf Kratom Businesses
GKC & KCAC:
A Stronger Kratom Future
The Global Kratom Coalition (GKC) and Kratom Consumer Advocacy Council (KCAC) work together to protect consumers and strengthen the industry. GKC ensures businesses uphold safety, transparency, and ethical standards, while KCAC holds companies accountable to consumer-focused protections.
This partnership creates a trusted, regulated kratom marketplace, where businesses that meet KCAC’s safety standards and earn GKC’s Seal of Approval set the gold standard for quality.
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
Dr. Erin Berthold