Electronic Nicotine Delivery Systems Testing

Electronic Nicotine Delivery Systems Testing

 

In 2016, FDA extended its authority to include electronic nicotine delivery systems (ENDS) (e.g. e-cigarettes). FDA now regulates the manufacturing, importing, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. As a result, manufacturers of ENDS must submit premarket applications (PMTA) for “new” products to stay on the market. The PMTA must include extractable and leachable (E&L) information from the ENDS. This is where VR Analytical can help.

Extractable and leachable testing has been performed for decades by pharmaceutical manufacturers and CROs. As such, the experience of pharmaceutical inhalation products is driving the science behind the design and execution ENDS E&L programs. As a leader in pharmaceutical E&L testing, we have the experience and know-how to help ENDS manufacturers. We are applying our E&L  knowledge and experience to the evaluation of ENDS. We have performed several extractable evaluations of ENDS components and have identified the resulting extractables, our abilities include analysis of e-liquids, aerosols produced by ENDS, and characterization of the components inhaled by the user.

To facilitate leachable evaluations and e-liquid characterization VR Analytical has a Cerulean SM450e 20 Channel Vaping Machine on site, (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 at info@vranalytical.com to find out how we can help you complete your PMTA.