We perform Extractables & Leachables (E&L) testing for manufacturers of vaporizers, e-cigarettes and other Electronic Nicotine Delivery Systems/Devices (ENDS/ENDD) which are growing quickly in popularity.
Because of the potential for harm to smokers and non-smokers, the FDA has recently announced that it has extended its regulatory authority to cover all ENDS/ENDD. Among other requirements under this ruling, manufacturers are responsible for the following:
- Obtain FDA authorization to market a new tobacco product
- Register establishment(s) and submit product listing to FDA by December 31, 2016, with a list of ingredients
- Submit information on harmful and potentially harmful constituents (HPHCs)
Performing an E&L study is an important part of verifying the safety of any ENDS/ENDD. Design of an E&L study requires an understanding of the materials used to construct the device and the expected use conditions.
E&L studies are best conducted using an analytical strategy which is informed by expectations of potential extractables and which has sufficient breadth for discovery of unexpected components. The laboratory which conducts the study must have sufficient expertise in unknown identification to properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. Finally, they must also be experts at analytical method development such that they can utilize this knowledge to develop quantitative methods for the components identified.
Jordi Labs specializes in the analysis of plastics and has the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by more than 3 decades of analytical experience and state of the art instrumentation.