PMTA Toxicological Risk Assessment Services

Quantitative Exposure & Health Risk Evaluation for ENDS, Pouches, Lozenges & Gums

At Gegahelix, we specialize in building complete, FDA-acceptable Toxicological Risk Assessments (TRAs) to support PMTA submissions for all modern tobacco and nicotine products. While toxicology summaries tell you what an ingredient is, the TRA tells FDA what that ingredient does at the exposure levels relevant to your product—and whether it poses any health risks to users.

TRA is not optional. It is the core of your PMTA's nonclinical safety justification, especially under Module 7 – Health Risk Assessment, and often the most scrutinized section by CTP reviewers.

What is a Toxicological Risk Assessment?

TRA is a quantitative, route-specific evaluation of risk, comparing user exposure levels to known toxicity thresholds. It integrates:

  • Product-specific use patterns (e.g., puffs/day, servings/day)
  • Aerosol yield or oral absorption estimates
  • Scientific literature on toxicity endpoints
  • Regulatory reference values (e.g., NOAELs, TTCs, MOEs)

The TRA answers a fundamental regulatory question:

Are users of your product likely to be exposed to any ingredient or byproduct at a level that exceeds safe limits?

What Our TRA Services Include

Each Gegahelix TRA is constructed by toxicology and regulatory science experts to satisfy the expectations of the FDA's CTP. Our reports are detailed, cross-referenced, and ready for direct inclusion in your PMTA.

1. Exposure Scenario Development

  • Modeled around realistic use patterns (adults, dual users, youth)
  • Adjusted for product format: ENDS, pouch, lozenge, gum, spray
  • Consideration of worst-case, average, and intended use scenarios

2. Ingredient-Level Risk Characterization

For every ingredient or known byproduct, we evaluate:

  • Estimated Daily Intake (EDI)
  • Comparison to toxicological thresholds (NOAELs, TTCs, PDEs)
  • Margin of Exposure (MOE) calculations
  • Risk level classification (negligible, low, moderate, high)

3. Route-Specific Toxicity Modeling

  • Inhalation exposure for ENDS/aerosol products
  • Oral cavity exposure for pouches, gums, and lozenges
  • Mucosal and sublingual absorption for sprays or films

4. Population Risk Consideration

  • Differential impact on adult vs. youth populations
  • Potential impact on vulnerable subgroups (pregnant users, those with preexisting conditions)
  • Cross-product comparative risk modeling (e.g., vs. cigarettes or other PMTA-approved products)

5. Product System Integration

  • Inclusion of thermal degradants, leachables, and reaction byproducts
  • Risk from device materials, heating elements, adhesives, or packaging
  • Cumulative exposure modeling across multi-component systems

Scientific Integrity Meets Regulatory Readiness

Gegahelix TRAs are supported by:

  • Curated peer-reviewed literature and global databases (PubChem, ToxNet, REACH, IARC)
  • Regulatory precedents (past PMTAs, MDOs, GRAS/Inactive Ingredient Database)
  • Expert-authored justifications for data gaps or modeled substitutions
  • Clear, FDA-ready formatting for submission and internal QA review

Optional Add-Ons

  • Customized TRA Response Letters for FDA deficiency (def) or refuse-to-accept (RTA) notices
  • Toxicologist Sign-Off & Certification Letters
  • Exposure Simulation Tables based on lab-aerosol test results
  • Alternatives Evaluation for high-risk ingredients or degradants
  • Multilingual Summaries for international partners or investors

Ideal For

  • ENDS manufacturers (disposable, pod, refillable)
  • Nicotine pouch brands (synthetic or tobacco-derived)
  • Oral nicotine product developers (gums, lozenges, sprays)
  • Regulatory consultants submitting complete PMTAs
  • Private label/OEM brands seeking defensible safety reports

Why Gegahelix?

  • Regulatory Precision: We specialize in FDA CTP logic, not general toxicology. Our TRAs speak the FDA's language.
  • Speed Without Sacrificing Rigor: We combine structured workflows with deep scientific expertise to deliver fast, accurate assessments.
  • Full-System Viewpoint: We don't just evaluate ingredients—we assess your entire product system for regulatory success.

Ready to Get Started?

Ready to get started?
Request a sample TRA report, a quote, or a live consultation with a senior toxicologist.

Gegahelix: Where science meets strategy in nicotine product regulation.

Talk to a PMTA Expert

Our dedicated FDA regulatory experts partner closely with your team, guiding you step-by-step through the PMTA submission process. Receive tailored support in toxicological assessments, ingredient evaluations, and compliance strategies, ensuring your ENDS, e-liquid, nicotine pouch, or nicotine patch products confidently navigate FDA approval.

Navigate FDA submissions with clarity—partner with Gegahelix to streamline your path to regulatory compliance and sustained market success.

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