The FDA's enforcement of age restrictions on the sale of cigarettes and smokeless tobacco.

The nation's largest tobacco age-restriction enforcement program is described. Between 1997 and 2000, the U.S. Food and Drug Administration--working with state agencies--conducted nearly 200,000 compliance checks in 123,000 establishments in 44 states, 1 territory, and Washington, D.C. The overall violation rate was 26 percent (more than 40,000 violations), ranging from 9 percent in Maine to 54 percent in the Virgin Islands. Due to the recent Supreme Court ruling, the FDA has stopped conducting these checks and is shutting down its tobacco program. The protocol described in this article will prove useful to others conducting compliance checks and seeking to keep tobacco out of the hands of children.

Factors associated with tobacco sales to minors: lessons learned from the FDA compliance checks.

CONTEXT: Tobacco products continue to be widely accessible to minors. Between 1997 and 1999, the US Food and Drug Administration (FDA) conducted more than 150,000 tobacco sales age-restriction compliance checks. Data obtained from these checks provide important guidance for curbing illegal sales. OBJECTIVE: To determine which elements of the compliance checks were most highly associated with illegal sales and thereby inform best practices for conducting efficient compliance check programs. DESIGN AND SETTING: Cross-sectional analysis of FDA compliance checks in 110,062 unique establishments in 36 US states and the District of Columbia. MAIN OUTCOME MEASURE: Illegal sales of tobacco to minors at compliance checks; association of illegal sales with variables such as age and sex of the minor. RESULTS: The rate of illegal sales for all first compliance checks in unique stores was 26.6%. Clerk failure to request proof of age was strongly associated with illegal sales (uncorrected sales rate, 10.5% compared with 89.5% sales when proof was not requested; multivariate-adjusted odds ratio [OR], 0.03; 95% confidence interval [CI], 0.03-0.04). Other factors associated with increased illegal sales were employment of older minors to make the purchase attempt (adjusted ORs for 16- and 17-year-old minors compared with 15-year-olds were 1.52 [95% CI, 1.46-1.63] and 2.43 [95% CI, 2.31-2. 59], respectively), attempt to purchase smokeless tobacco (adjusted OR, 2.16 [95% CI, 1.90-2.45] vs cigarette purchase attempts), and performing checks at or after 5 PM (adjusted OR, 1.28 [95% CI, 1. 21-1.35] vs before 5 PM). Female sex of clerk and minor, Saturday checks, type of store (convenience store selling gas, gas station, drugstore, supermarket and general merchandise), and rural store locations also were associated with increased illegal sales. CONCLUSIONS: This analysis found that a request for age verification strongly predicted compliance with the law. The results suggest several ways in which the process of compliance checks might be optimized. JAMA. 2000;284:729-734