Kirchner Thomas R, Villanti Andrea C, Tacelosky Michael, Anesetti-Rothermel Andrew, Gao Hong, Pearson Jennifer, Ganz Ollie, Cantrell Jennifer, Vallone Donna M, Abrams David B
Global Institute of Public Health, New York University, New York, NY.
The Schroeder Institute for Tobacco Research and Policy Studies at Legacy, Washington, DC.
Tob Regul Sci. 2015 Apr;1(1):24-35.
To describe patterns in the enforcement of the US Food and Drug Administration's current compliance check program.
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.
As of July 2013, 42 states and 3 US territories 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).
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.
描述美国食品药品监督管理局当前合规检查计划的执行模式。
分析合规检查导致的零售违规率(RVR)数据。开发了新方法来量化违规行为,并统一零售地点和违规类型的数据。
截至2013年7月,42个州和3个美国属地进行了合规检查。96%的警告信和100%的民事罚款涉及向未成年人销售。零售违规率随时间(OR = 1.15)和各州之间(ICC = 0.18)有显著差异。
合规检查数据库使人们能够研究零售执法如何随时间和地点展开。结果显示重点在于青少年获取违规行为,为旨在减少青少年获取机会的法规研究提供了机会。