A conceptual framework for assessing the public health effects from snus and novel non-combustible nicotine products.

Objective: The tobacco industry plans to base their future earnings on the production of non-combustible nicotine products. These might replace or come in addition to the more harmful cigarettes that historically have dominated the nicotine market in the Nordic countries. The authorities in each country must decide whether the products should have market access and, in that case, how strictly they should be regulated. Our aim is to present a framework that can assist the health authorities to make a regulation where benefits will outweigh the harms. Method: In a public health perspective, health gains from substitution must be weighed against the health loss from additional use. The main elements of the weighing will be based on the information about the absolute risk of the products, their relative risk compared to conventional cigarettes and how the users are composed according to smoking status. We apply the framework on snus as used in Norway - a product with an established usage pattern and epidemiologically assessed health risks. Results: The framework consists of (i) a comprehensive set of specific user patterns that may result in health deterioration and user patterns that may result in health benefits, (ii) an estimation of the number of people with health-augmenting and health-impairing user patterns, respectively, and (iii) an estimation of the degree of health deterioration or health benefit that will affect the persons with the different user patterns. Conclusion: The net effect on public health will appear as an overall result of the number of people with positive and negative user patterns, respectively, in combination with the magnitude of the change in health status these people will experience. The use of an explicit framework highlights how a political decision may affect nicotine use and health-related outcomes. The framework breaks open a large and complex question into smaller pieces and requires the authorities to expose and explain the kind of evidence and reasoning behind regulations of novel nicotine products.