PDE Database for PMTA Toxicology | ENDS Ingredient Limits

Toxicological Exposure Limits for ENDS Ingredients, Devices & Byproducts

The PDE (Permissible Daily Exposure) value is a cornerstone of FDA's evaluation of whether a tobacco product ingredient poses a risk under intended use conditions. As part of a complete Premarket Tobacco Product Application (PMTA), the FDA requires manufacturers to justify exposure levels of each ingredient and byproduct—especially those with known toxicological concerns.

At Gegahelix, we maintain a proprietary PDE Database specifically designed to support ENDS PMTA submissions. Our data is formatted to accelerate risk assessment calculations, such as Margin of Exposure (MOE), and support toxicology evaluations across e-liquids, aerosols, and device-related materials.

What is a PDE?

Permissible Daily Exposure (PDE) refers to the maximum acceptable intake of a substance per day without expected adverse effects, based on known toxicity data and safety factors. It is derived from endpoints like:

  • NOAEL (No Observed Adverse Effect Level)
  • LOAEL (Lowest Observed Adverse Effect Level)
  • Benchmark Dose (BMD)
  • Human clinical or animal study data

For PMTA submissions, PDEs are essential for:

  • Calculating estimated daily exposure
  • Performing quantitative toxicological risk assessments
  • Justifying ingredient use and concentration
  • Responding to FDA Module 6 & Module 7 requirements

What Gegahelix's PDE Database Covers

Our database supports ENDS-specific toxicological thresholds with FDA-relevant exposure values. All data is curated from authoritative sources and formatted for seamless PMTA integration.

Substance Categories Included:

  • E-liquid ingredients (flavors, solvents, humectants, sweeteners, acids)
  • Aerosol degradants (carbonyls, VOCs, reactive aldehydes)
  • Device-related leachables (plastics, rubbers, adhesives, glues, polymers)
  • Thermal byproducts (e.g., formaldehyde, acetaldehyde, acrolein)
  • Metallic contaminants (from heating coils, tanks, soldering)
  • Packaging-related compounds (extractables and volatile substances)

Data Fields per Entry:

  • Substance name and identifiers (CAS, FEMA, IARC, GHS)
  • Route-specific PDEs (inhalation, oral, dermal where available)
  • Toxicological basis (NOAEL/LOAEL/BMD references)
  • Uncertainty factors applied
  • Source of data (EMA, FDA, ICH, literature, REACH, ECHA)
  • Relevance for ENDS delivery formats

Applications in PMTA Submission

Our PDE database enables fast, defensible integration with:

1. TRA Calculations (Module 7)

Use PDE values to compute Margin of Exposure (MOE), Cumulative Exposure, and Safety Factors for all ingredients and known byproducts.

2. Ingredient Justification Reports

Support the inclusion of new or uncommon ingredients by referencing established safe exposure thresholds.

3. Device Material Safety Evaluations

Quantify risk associated with inhalable leachables from plastics, seals, coils, and wicks using PDE-based exposure comparisons.

4. Aerosol HPHC Risk Characterization

Interpret lab-detected HPHCs using our PDE database to determine if detected levels exceed toxicological concern thresholds.

Why Gegahelix's PDE Support Is Different

Unlike generic toxicology tools, our database is built for ENDS products under FDA's tobacco regulation framework. Every PDE value is hand-validated by toxicologists for relevance to:

  • Inhalation route
  • ENDS-specific exposure conditions
  • FDA's PMTA review priorities and terminology

Add-On Services

  • PDE Gap Analysis for missing or unlisted substances
  • Custom PDE Derivation from published toxicological studies
  • Integration with TRA & Toxicology Summary Services
  • Toxicologist Sign-Off Letters for critical high-risk ingredients

Who This Is For

  • ENDS brands filing full PMTA submissions
  • OEM/white-label vape manufacturers
  • Regulatory consultants managing PMTA pipelines
  • Ingredient suppliers supporting client submissions
  • Labs and CROs conducting aerosol and toxicology testing

Streamline Your PMTA with Trusted Toxicological Thresholds

With the Gegahelix PDE database, you're no longer guessing if an exposure level is defensible—you're referencing validated thresholds built for your exact use case.

Contact us to request database access, a sample report, or to integrate PDE values into your ongoing PMTA projects.

Gegahelix: Defining safety. Enabling submission. Powering PMTA success.

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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