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Risk Assessment for Tobacco Regulation

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Objective: Risk assessment is a process that uses a transparent, reproducible and pre-established methodology to evaluate alternatives for managing health-related risks. Although an array of federal agencies regularly use risk assessment to inform regulatory decisions, its application to tobacco regulation is new. Methods: This paper provides an overview of the risk assessment framework developed by the National Research Council and typically applied by federal regulatory agencies. It then reviews examples of the US Food and Drug Administration's (FDA's) application of this risk assessment framework to both food and tobacco, identifying some of the challenges involved in applying standard risk assessment methodologies to tobacco regulation. Results: There are inherent challenges in applying standard risk assessment methodologies to tobacco regulation, including the need to: (1) apply a unique population-level legal standard; and (2) consider many factors that risk assessments have not emphasized traditionally, including marketing and promotion, packaging/branding, price, social influences, consumer perception, and addiction. Conclusion: For the FDA to address these challenges, it must work with researchers to develop a tobacco-specific approach to risk assessment that reflects the Tobacco Control Act's regulatory framework and the distinctive features of tobacco products and tobacco use.
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Keywords: MODELING; POPULATION HEALTH; PRODUCT STANDARD; RISK ASSESSMENT; TOBACCO REGULATION

Document Type: Research Article

Publication date: January 1, 2019

More about this publication?
  • Tobacco Regulatory Science (Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. The journal content includes a broad array of research domains, including chemistry, biology, behavior, community, and population-level surveillance and epidemiology, as well as knowledge syntheses (eg, meta-analyses or state-of-the-art reviews) and analytic modeling. All articles describe the policy relevance of the research outcomes. Given the global nature of tobacco regulation, particularly as a result of international and national policies, Tobacco Regulatory Science publishes high quality research that is relevant to global regulatory needs and requirements. Tobacco Regulatory Science is published electronically 6 times per year.
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