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FDA Regulation of Cigars under the Final "Deeming" Rule

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Objectives: Since 2009, the United States Food and Drug Administration (FDA) has regulated cigarettes, smokeless tobacco, and roll-your-own tobacco through the authorities granted in the 2009 Family Smoking Prevention and Tobacco Control Act. With passage of the final regulation in May 2016, deeming all products that meet the definition of a tobacco product to be under the FDA's regulatory authorities, the provisions of the Tobacco Control Act extend to cigars. This paper explains how those provisions apply to cigars. Methods: This paper summarizes the automatic provisions that now apply to cigars as well the provisions in the rule related to free samples, minors' access, health warnings, and vending machine access. Results: Cigars are now subject to general regulatory requirements, including registration and listing, ingredient reporting, reporting of harmful and potentially harmful constituents, submission of health information, and premarket review of new tobacco products and modified risk tobacco products, as well as additional provisions, including a free sample ban, minors' access provisions, vending machine restrictions, and health warnings. Conclusions: This regulation enables the agency to use its authorities for the protection of public health across the spectrum of tobacco products.
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Document Type: Research Article

Publication date: 2017-04-01

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  • 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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