In 2016, the FDA Center for Tobacco Products (CTP) extended its regulatory authority to include ENDS, or e-cigarettes. Manufacturers of ENDS and nicotine containing liquids offered for retail sale must now submit pre-market applications (PMTA) for all new products. Every PMTA must include extractable and leachable (E&L) information, and this is where VR Analytical can help.
For decades extractable and leachable testing has been performed for pharmaceutical products, and the experience of pharmaceutical inhalation products is driving the science behind the design and execution E&L programs for ENDS. This is not novel to us.
With over 17 years of experience in pharmaceutical E&L testing, we have the knowledge to guide the E&L program for your ENDS product. We are already applying our E&L knowledge and experience to the evaluation of ENDS, and have performed several of extractable evaluations of multiple ENDS components. Our abilities include analysis of e-liquids, aerosols, and all components inhaled by the user.
Our labs include a Cerulean SM450e 20 Channel Vaping Machine, housed in a temperature and humidity controlled room. This machine is capable of vaping up to 20 e-cigarettes, and can use 4 different vaping regimes at a time.
Contact us today to discuss your ENDS characterization project.