Another Kratom NDI Fails — The Evidence Does Not Carry the Argument
TNT Manufacturing (d/b/a MitWellness) submitted a 75% mitragynine extract as a New Dietary Ingredient. FDA found identity, safety, and manufacturing gaps. The conclusion: introduction into interstate commerce is prohibited under federal law.
— FDA letter to Todd Underwood / TNT Manufacturing (NDIfail2.pdf)
Inside the Kratom Advocacy Machine: One Click, Identical Letters
The Global Kratom Coalition’s “Advocacy Buddy” generates complete, persuasive letters from minimal input — including the placeholder “Xx”. The tool standardizes language, assigns identity labels, and delivers identical messages to legislators, creating the illusion of grassroots testimony.
Kratom Shots, Alcohol Content, and Kansas Lab Testing
Independent laboratory testing of popular kratom shot products revealed undeclared alcohol content, significant label inaccuracies, and marketing that obscures actual ingredients. The findings raise questions about product safety, consumer deception, and the gap between KCPA labeling requirements and real-world compliance.
FDA and Kratom — Official Agency Statement
U.S. Food & Drug Administration public health summary on kratom
FDA NDI Review & Denial — Dried Kratom Leaf
Johnson Foods, LLC (2023)
Kratom Vendor Terms of Service Admit Opioid-Like Risks
Vendor Policy Disclosure Analysis
Kratom: Consolidated Briefing for Lawmakers
This page provides a centralized, source-based briefing on kratom for legislators, regulators, and policy staff. It consolidates MAHA’s surveillance data, scientific literature, regulatory analysis, and legislative case studies into a single reference point.
I. Surveillance & Harm Data
FDA Adverse Event Reporting
Poison Control & Mortality Data
Medical Examiner Data
II. Core Alkaloid & Scientific Information
III. Current Regulatory Claims & Industry Submissions
FDA Human Kratom Study: Why the Results Strengthen the Case for Schedule I
MAHA analysis of the Phase I human dose study showing opioid-like effects, statistically significant drug liking, and measurable exposure to 7‑hydroxymitragynine.
Pinney Associates “Eight-Factor Analysis”
Review of the industry-funded report submitted to regulators, highlighting buried admissions about metabolism and opioid potency.
Michigan HB 4969: What Lawmakers Were Told
Structured review of testimony regarding FDA posture, natural leaf claims, and 7‑hydroxymitragynine distinctions.
How Kansas Was Misled to Pass the KCPA
Analysis of exhibits submitted to lawmakers and what the underlying science actually demonstrates.
2004 Opioid Testimony & Today’s Kratom Debate
Compares early opioid-era risk framing with arguments currently raised in kratom policy discussions.
IV. State Regulatory Outcomes & Enforcement Gaps
- California: Treating Kratom as an Unapproved Drug
- What Congress Wasn’t Told
- FD&C Act Violations Explained
- New York Statutory Contradiction
- Florida SB 994 Enforcement Issues
- Wyoming Kratom Bill: A Fig Leaf, Not Public Health
V. Scheduling, Registries & Structural Analysis
- Ohio Board of Pharmacy – 8-Factor Analysis
- Extraction & Scheduling Rationale
- KCPA Structural Limitations & Public-Health Risk
- Nebraska Kratom Registry Review
- FDA NDI Loophole & Enforcement Discretion
- Limitations of the Huestis Human Dose Study
VI. Intended Use
This briefing is intended to support legislative research, regulatory review, enforcement hearings, and policy analysis. All materials are provided as primary sources or direct analyses without editorial framing.
Mothers Against Herbal Abuse (MAHA)
https://www.mothersagainstherbalabuse.org