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During the toxicological assessment of extractables and leachables in drug products, localized hazards such as irritation or sensitization may be identified. Typically, because of the low concentration at which leachables occur in pharmaceuticals, irritation is of minimal concern; therefore, this manuscript focuses on sensitization potential. The primary objective of performing a leachable sensitization assessment is protection against Type IV induction of sensitization, rather than prevention of an elicitation response, as it is not possible to account for the immunological state of every individual. Sensitizers have a wide range of potencies and those which induce sensitization upon exposure at a low concentration (i.e. strong, or extreme sensitizers) pose the highest risk to patients and should be the focus of the risk assessment. The Extractables and Leachables Safety Information Exchange (ELSIE) consortium has reviewed the status of dermal, respiratory, and systemic risk assessment in cosmetic and pharmaceutical industries, and proposes a framework to evaluate the safety of known or potential dermal sensitizers in pharmaceuticals. Due to the lack of specific regulatory guidance on this topic, the science-driven risk-based approach proposed by ELSIE encourages consistency in the toxicological assessment of extractables and leachables to maintain high product quality and ensure patient safety.

Electronic cigarettes, battery-powered nicotine delivery devices, have been increasingly used in the past decade. This critical review provides a qualitative research synthesis of the human health risks associated with E-vapor inhalation in the peer-reviewed literature and our own preliminary experimental results. E-cigarettes may be as efficient as traditional cigarettes in nicotine delivery, especially for experienced users, and studies suggest lower emissions of air toxics from E-cigarette vapor and lower second- and third-hand vapor exposures. Some toxic emissions may however surpass those of traditional cigarettes, especially under high voltage vaping conditions. Experimentally, E-vapor/E-liquid exposures reduce cell viability and promote pro-inflammatory cytokine release. User vulnerability to concomitant environmental agent exposures, such as viruses and bacteria, may potentially be increased. While evidence to date suggests that E-cigarettes release fewer toxins and carcinogens compared to...