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Extractable and Leachable Studies on Electronic Nicotine Delivery System (ENDS) Components and E‑liquid Containers
Samantha M Reilly1, Saibal Chakraborty1
1Division of Product Science, Office of Science, Center for Tobacco Products, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
ACS Omega
|August 8, 2026
Summary
Extractable and leachable studies reveal chemicals migrating from electronic nicotine delivery system (ENDS) components and e-liquid containers. Established pharmaceutical methods can assess ENDS risks, but require optimization for these products.
Area of Science:
- Analytical Chemistry
- Materials Science
- Public Health
Background:
- Electronic Nicotine Delivery Systems (ENDS) components and e-liquid containers can affect aerosol chemical composition, influencing user exposure and public health impact.
- Limited published extractable and leachable (E&L) studies exist for ENDS, hindering comprehensive risk assessment.
- Understanding chemical migration from ENDS materials is crucial for evaluating product safety and public health implications.
Purpose of the Study:
- To comprehensively examine and determine chemicals migrating from closed ENDS components and e-liquid containers (LDPE, PET bottles) into e-liquids.
- To apply and evaluate established pharmaceutical E&L methodologies for ENDS products.
- To identify unique and unknown volatile compounds, semi- and nonvolatile compounds, polycyclic aromatic hydrocarbons (PAHs), and metals.
Main Methods:
- Utilized extractable testing followed by leachable testing on 47 ENDS products and containers.
- Employed gas chromatography-mass spectrometry (GC-MS) for volatile compounds and polycyclic aromatic hydrocarbons (PAHs).
- Used ultra-high-performance liquid chromatography-photo diode array-mass spectrometry (UPLC-PDA-MS) for semi- and nonvolatile compounds and inductively coupled plasma MS (ICP-ICP-MS) for metals.
Main Results:
- Identified numerous unique and unknown compounds across volatile, semi- and nonvolatile categories, along with PAHs and metals in extractables.
- Leachable studies revealed 243 compounds from closed ENDS, and 53-65 compounds from LDPE and PET bottles.
- Demonstrated the applicability of pharmaceutical E&L methods to ENDS, with specific parameters needing optimization.
Conclusions:
- Established pharmaceutical E&L methodologies are applicable to ENDS components and e-liquid containers.
- Optimization of methodological parameters, such as solvent selection and spectral libraries, is necessary for accurate ENDS E&L analysis.
- This study provides a comprehensive approach to ENDS E&L analysis, informing potential risks to public health.
