E-cigarettes

FDA generally regulates e-cigarettes and other electronic nicotine delivery systems that meet the statutory definition of a tobacco product under its tobacco-product authorities, while products marketed for therapeutic purposes may instead fall under FDA's drug or device authorities. Depending on the dispute, relevant materials can include marketing authorization information, regulatory submissions produced in discovery, manufacturing and testing records, labeling, product specifications, and communications concerning the device. An appropriately qualified expert can address the technical significance of those materials while remaining within the expert's qualifications and avoiding impermissible legal conclusions.

When it can be done safely and in accordance with appropriate evidence-handling procedures, preserving the complete device can be particularly important because the battery, pod or cartridge, atomizer, charger, cable, and other components may need to be examined together. Packaging, instructions, receipts, photographs, remaining e-liquid, replacement parts, and information about charging or modifications can provide additional context. Maintaining the items in their post-incident condition can also reduce uncertainty about later changes to the evidence.

When the expert's qualifications cover the relevant chemistry or testing, the work may include examining e-liquid ingredients, product formulations, laboratory results, aerosol testing, or how operating conditions affect what the device emits. Questions involving diagnosis, toxicological dose-response, or medical causation may require separately qualified medical or scientific experts.