US Food and Drug Administration Inspection of Tobacco Sales to Minors at Top Pharmacies, 2012-2017

Pharmacies face increasing pressure to abandon tobacco sales, as CVS Health did in September 2014.¹ Although selling tobacco, the leading cause of preventable death and cardiovascular disease, is incongruous with promoting health and wellness, tobacco sales in pharmacies totaled almost $5 billion in 2012.² At one pharmacy chain, approximately 1 in 20 customers who filled prescriptions for conditions that are exacerbated by smoking also purchased cigarettes.³ Corporate-owned pharmacies also sell cigarettes at significantly lower prices than most other types of tobacco retailers.⁴ Low prices raise concern about pharmacies as a source of illegal tobacco sales to minors. In 2012, an estimated 7% of youths who smoked reported purchasing cigarettes at pharmacies in the past month.⁵ For these reasons, we examined the inspections of tobacco sales to minors conducted by the US Food and Drug Administration (FDA) in approximately 13 200 pharmacies in 49 states and Washington, DC, from January 1, 2012, to December 31, 2017.

The results of the FDA’s purchase attempts by minors (individuals ages 16-17 years who attempted to purchase tobacco on behalf of the FDA) are public. Using a customized search and coding process (details available online at the University of North Carolina Dataverse [https://dataverse.unc.edu/dataverse/drugstoresales]), we identified inspections at 3 major pharmacy brands (CVS, Rite Aid, and Walgreens) and other branded top 50 standalone pharmacy chain brands.⁶ We used the first inspection of each calendar year and excluded pharmacies in grocery and discount stores. Addresses for the resulting 23 863 inspections were geocoded (23443 [98.2%] to address latitude and longitude) and linked to state policy and census tract information. We computed the violation rate (sales to minors divided by total inspections) by pharmacy chain and year. Because sampling procedures and violation rates vary by state and neighborhood demographics, generalized linear mixed modeling assessed sales of tobacco to minors as a function of pharmacy chain, state policy environment, and neighborhood demographics. Walgreens was used as the reference group because it was the largest chain at the time of analysis. As an analysis of publicly available government data with no human participants, this study did not require institutional review board approval.

Between 2012 and 2017, chain pharmacies in the United States failed 1833 of 23 863 federal inspections (7.7%) of sales of tobacco to minors. Violation rates varied by pharmacy brand and increased among the included pharmacies during the study period, from 159 of 2942 federal inspections (5.4%) in 2012 to 376 of 4575 federal inspections (8.2%) in 2017 (Table 1). The results suggest that all pharmacy chains were significantly less likely than Walgreens to sell tobacco to minors (Table 2). After controlling for state policy and neighborhood demographics, Rite Aid had 59% lower odds than Walgreens of selling tobacco to minors (adjusted odds ratio, 0.41; 95% CI, 0.35-0.47), and other chain pharmacies had 35% lower odds than Walgreens of selling tobacco to minors (adjusted odds ratio, 0.65; 95% CI, 0.47-0.89).

The violation rate for tobacco sales to youths in FDA inspections at the top US pharmacies varied by chain and was highest at Walgreens. Selling tobacco to any customer, let alone to minors, is inconsistent with Walgreens’s corporate image describing the chain “at the corner of happy and healthy” and the “pharmacy America trusts.” Decisions of physicians and consumers about where to fill prescriptions could be informed by the degree to which pharmacies comply with minimum age-of-sale laws for tobacco. As recommended by the Campaign for Tobacco-Free Kids and other public health groups, patients and health care professionals should consider the commitment of different pharmacy chains to eliminating tobacco sales and ending tobacco use.

The FDA does not have authority to ban tobacco sales in pharmacies. Therefore, this research could inform public opinion about such regulation at the state and local levels. Although strong public support for tobacco-free pharmacies exists, only 4 states have adopted such local ordinances, and efforts to pass state legislation have stalled. In the absence of voluntary or legislated actions to establish tobacco-free pharmacies, corporate-owned pharmacies should better prevent tobacco sales to minors, especially given the rapid adoption of state and local policies to increase the minimum legal purchase age from 18 to 21 years. Federal and state enforcement should consider targeting pharmacy chains with higher levels of noncompliance with the minimum legal sale age.

Accepted for Publication: May 29, 2018.

Corresponding Author: Joseph G. L. Lee, PhD, MPH, Department of Health Education and Promotion, College of Health and Human Performance, East Carolina University, 1000 E Fifth St, Mail Stop 529, Greenville, NC 27858 (leejose14@ecu.edu).

Published Online: September 4, 2018. doi:10.1001/jamapediatrics.2018.2150

Author Contributions: Dr Lee had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lee, Schleicher, Henriksen.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Lee, Leas, Henriksen.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Lee, Leas.

Obtained funding: Henriksen.

Supervision: Henriksen.

Conflict of Interest Disclosures: Dr Lee reported receiving licensing royalties from a store audit/compliance and mapping system owned by the University of North Carolina at Chapel Hill (the tools and audit mapping system were not used in this study) and serving as the principal investigator of Tobacco-Free Generation Campus Initiative grant from the American Cancer Society, which was funded by the CVS Health Foundation (this grant did not support the research reported in this letter). No other disclosures are reported.

Funding/Support: This research was funded by grant 25IR-0026 from the California Tobacco-Related Disease Research Program. Dr Leas was supported by National Institutes of Health grant T32-HL007034 from the National Heart, Lung, and Blood Institute.

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the California Tobacco-Related Disease Research Program, National Institutes of Health, or National Heart, Lung, and Blood Institute.