Hannah M Baker1, Joseph G L Lee2, Leah M Ranney2, Adam O Goldstein2. 1. Tobacco Prevention and Evaluation Program, Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC hmbaker2@unc.edu. 2. Tobacco Prevention and Evaluation Program, Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Abstract
IMPORTANCE: Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. OBJECTIVE: To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. DESIGN: Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. SETTING: All 50 states and the District of Columbia. PARTICIPANTS: Tobacco retailer inspections conducted by FDA (n = 33 543). EXPOSURES FOR OBSERVATIONAL STUDIES: State cigarette tax, youth smoking prevalence, poverty, and tobacco production. MAIN OUTCOMES AND MEASURES: State proportion of FDA warning letters issued for single cigarette violations. RESULTS: There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. CONCLUSIONS AND RELEVANCE: Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections.
IMPORTANCE: Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. OBJECTIVE: To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. DESIGN: Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. SETTING: All 50 states and the District of Columbia. PARTICIPANTS: Tobacco retailer inspections conducted by FDA (n = 33 543). EXPOSURES FOR OBSERVATIONAL STUDIES: State cigarette tax, youth smoking prevalence, poverty, and tobacco production. MAIN OUTCOMES AND MEASURES: State proportion of FDA warning letters issued for single cigarette violations. RESULTS: There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. CONCLUSIONS AND RELEVANCE: Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections.
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