Regulatory, excise tax, and institutional governance of electronic nicotine delivery systems in low- and middle-income countries: A comparative policy analysis

BACKGROUND: Tobacco use remains a major global cause of preventable mortality, with a disproportionate burden in low- and middle-income countries (LMICs). Electronic nicotine delivery systems (ENDS) have entered these markets rapidly, but governance frameworks remain fragmented, unstable, and poorly compared across LMIC settings. This study examined variation in the regulatory, excise tax, and institutional governance of ENDS across eleven LMICs and identified the structural patterns underlying that variation. METHODS: We conducted a structured comparative policy analysis of Bangladesh, Brazil, Egypt, India, Indonesia, Kenya, Mexico, Pakistan, the Philippines, South Africa, and Vietnam. Data were extracted from primary regulatory documents, published national survey data, and peer-reviewed and policy literature. Countries were coded using a predefined framework covering regulatory stance, product differentiation, market access, primary regulatory authority, ENDS excise tax structure, and policy stability. For descriptive presentation, countries were grouped according to their final regulatory-stance classifications, and the remaining governance variables were used to characterise each group. The grouping was treated as an exploratory heuristic rather than an algorithmically derived taxonomy. RESULTS: Three descriptive governance groups were identified: a prohibitionist group (India, Brazil, Mexico, and Vietnam), a transitional group (Bangladesh, Pakistan, and South Africa), and a differentiated group (the Philippines, Indonesia, Egypt, and Kenya). Institutional location co-varied with regulatory orientation, but the cross-sectional design does not establish causal direction. Six countries had explicit ENDS-specific excise tax schedules, whereas the four prohibitionist countries had no legal commercial ENDS market and thus no market-based excise tax framework. Every country accorded ENDS explicit product-specific legal treatment; what differed was the direction of that treatment, not its presence. Cross-country tobacco-use and ENDS-use estimates were too heterogeneous for direct comparison. CONCLUSIONS: Across the eleven LMICs, the institutional locus of regulatory authority, ENDS-specific excise tax structure, market access, and policy stability distinguished ENDS governance more clearly than economic capacity alone. Explicit ENDS-specific excise tax frameworks were present in most countries with a legal market, but their existence did not track regulatory permissiveness. The design could not measure the influence of the tobacco and nicotine industry, which remains the best-resourced actor in this policy space and a plausible determinant of both regulatory and excise tax design. Longitudinal comparative research is needed to determine how these governance configurations influence implementation, product uptake, and public health outcomes.