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Open Access National Enforcement of the FSPTCA at Point-of-Sale

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Objective: To describe patterns in the enforcement of the US Food and Drug Administration's current compliance check program. Methods: Data on retail violation rates (RVR) resulting from compliance checks were analyzed. Novel methods were developed to quantify violations and unify data on retail location and violation type. Results: As of July 2013, 42 states and 3 US ter- ritories conducted compliance checks. Ninety-six percent of warning letters and 100% of Civil Monetary Penalties addressed sales to minors. RVRs varied significantly over time (OR = 1.15) and between states (ICC = 0.18). Conclusions: The compliance checks database makes it possible to examine how retail enforcement is unfolding over time and place. Results reveal an emphasis on youth access violations, presenting opportunities for research on regulations designed to reduce youth access.

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Keywords: COMPLIANCE CHECKS; FOOD AND DRUG ADMINISTRATION; POINT-OF-SALE; RETAIL VIOLATION RATE; SYNAR

Document Type: Research Article

Publication date: April 1, 2015

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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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