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Extractables & leachables testing for e-cigarettes: What are the risks and challenges?

With 'smokeless' e-products growing in popularity, there has been an increased interest in extractables & leachables testing for e-cigarettes devices and refill containers.

E-cigarettes, like other inhalation products such as asthma inhalers, generate aerosol carrying the nicotine and other chemicals (such as the flavouring) directly into the respiratory tract. The devices and refill containers can consist of multiple polymer and/or metallic parts, all of which are potential sources of impurities that might leach into the e-liquid and, upon vaporisng, also enter the respiratory tract.

Testing for extractables and leachables, however, is not easy. There are many factors that make the task extremely challenging and complex. Dr Gyrogy Vas, a Research Fellow at Intertek highlights some of these factors;

  • The extraction media poses a difficulty in even designing an appropriate extraction study
  • The complexity of the vapors (the vast array of different flavourings for example) could cause interferences
  • Non-routine extraction methods are required to evaluate the actual leachables

The US Food and Drug Administration (FDA) is also currently reviewing the manner in which e-cigarettes should be classified and regulated. Dr Allen Kesselring, Chief Science Officer of E.K.G Life Science Solutions notes that as part of this, there is a need to evaluate extractable profiles from the atomizers and containers holding the vapor solutions. This again poses another challenge to manufacturers and those carrying out extractables & leachables testing on these devices.

Despite these difficulties and challenges, the devices must be tested in order to ensure consumer safety. Pete Watts, Director of Toxicology at bibra toxicology advice and consulting highlights that the revised Tobacco Products Directive (TPD2; 2014/40/EU) will require e-cigarette manufacturers to take responsibility for the quality and safety of their products, via a product notification scheme. Human-health hazard and risk assessments of the e-liquid components, emissions and of any leachables (as identified through extractables and leachables testing) are all components of a robust assessment of product safety.

With a complex and challenging task ahead, join us at ENDS 2017 to discuss these challenges and learn how you can ensure compliance. Book your ticket to join us here.