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 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).
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.
Keywords: Food and Drug Administration; Synar; compliance checks; point-of-sale; retail violation rate.