Consumer-Reported Adverse Health Events and Product Problems Associated with E-Cigarettes: Evidence from FDA Tobacco Product Problem Reports

Background The U.S. Food and Drug Administration (FDA) monitors potential health risks associated with electronic cigarettes (e-cigarettes) through Tobacco Product Problem Reports (TPPRs), which document adverse health events (AHEs) and product-related problems. This study characterized AHEs and product problems associated with e-cigarette use reported in TPPRs from 2017 to 2025. Methods We analyzed 883 TPPRs. Descriptive statistics summarized report- and AHE-level frequencies and percentages across predefined health categories, while exploratory analyses assessed temporal trends in AHE and product-problem distributions. Categories included respiratory, neurological, psychological, cardiovascular, oral/dental, integumentary, musculoskeletal, digestive, addiction, physical trauma, death, laboratory tests or treatments, and nonspecific symptoms. Product problems were classified using FDA Safety Reporting Portal categories to identify commonly reported issues. Results Reports most frequently contained neurological AHEs (n=418, 47.3%), followed by respiratory (n=336, 38.1%), nonspecific (n=196, 22.2%), digestive (n=93, 10.5%), and cardiovascular AHEs (n=86, 9.7%). Report-level AHE categories were not mutually exclusive. Less common categories included laboratory tests or treatments (n=63, 7.1%), physical trauma and psychological AHEs (n=59, 6.7% each), oral/dental (n=50, 5.7%), addiction (n=32, 3.6%), musculoskeletal (n=22, 2.5%), integumentary (n=14, 1.6%), and death (n=13, 1.5%; reported by secondary individuals). Device malfunctions were the most frequently reported product problem category (n=131, 26.3%), followed by packaging issues (n=118, 23.6%), other or unspecified issues (n=102, 20.4%), and sensory-related product issues (n=87, 17.4%). Less frequently reported problems included labeling and marketing concerns (n=34, 6.8%), contamination or foreign material (n=17, 3.4%), and counterfeit or unauthorized products (n=10, 2.0%). Common examples included device malfunctions resulting in explosions, packaging damage, taste complaints, labeling errors, incorrect products, and foreign material contamination. Temporal analyses identified increasing psychological AHEs, decreasing device malfunctions, and increasing packaging issues over time. Conclusion This analysis highlights frequently reported neurological and respiratory AHEs and serious product safety concerns, underscoring the need for continued surveillance and regulatory oversight of e-cigarettes.