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Lessons Learned From the FDA Compliance Checks

Pamela I. Clark, PhD; Sharon L. Natanblut, MPA; Carol L. Schmitt, MA; Charles Wolters, MS; Ronaldo Iachan, PhD

JAMA. 2000;284:729-734.

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.

Author Affiliations: Centers for Public Health Research and Evaluation, Battelle Memorial Institute, Baltimore, Md (Drs Clark and Iachan, Ms Schmitt, and Mr Wolters); and Office of Tobacco Programs, US Food and Drug Administration, Rockville, Md (Ms Natanblut).

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