e-Liquids and Vapor
Prior to Deeming Regulations for e-Vapor products published on May 10, 2016, we had analyzed thousands of e-Vapor devices and liquids for from hundreds of manufacturers, vendors, and consumers. Our thorough knowledge of FDA HPHCs in tobacco and smoke has allowed for quick and robust method transfer to e-Vapor products.
Enthalpy operates three smoke labs capable of e-Vapor sample collection between its Richmond and Durham laboratories, allowing for redundancy and flexibility in our testing processes. Enthalpy offers analysis and testing of e-Vapor and e-Liquids for the presence of nicotine, propylene glycol, glycerin, carbonyls (ie, diacetyl, formaldehyde, etc), particle sizing, and the FDA’s abbreviated list of HPHCs, including tobacco specific nitrosamines (TSNA). Enthalpy has analytical methods in place to meet requirements of the 2016 FDA Deeming Regulations and European Union Tobacco Product Directive (EU-TPD).
Our scientists utilize internationally recognized test methods, enhanced and adapted for our laboratories, to deliver accurate, reliable, consistently high-quality data. All e-vapor and e-liquid methods have been validated for quality assurance, including evaluation for linearity, recovery from the matrix, and verification of detection limits. All analytical equipment is qualified and calibrated with full documentation. Our laboratories offer testing that is internationally accredited by A2LA to the ISO 17025 standard.
Enthalpy’s e-Vapor Product services fulfill the requirements of:
- FDA (USA) HPHC Testing
- FDA (USA) Substantial Equivalence (SE) Testing
- FDA (USA) Premarket Tobacco Application (PMTA) Testing
- EU-TPD Testing