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. 2018 Sep 4;172(11):1089–1090. doi: 10.1001/jamapediatrics.2018.2150

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

Joseph G L Lee 1,, Nina C Schleicher 2, Eric C Leas 2, Lisa Henriksen 2
PMCID: PMC6248162  PMID: 30193340

Abstract

This study examines the inspections of tobacco sales to minors conducted by the US Food and Drug Administration in approximately 13 200 pharmacies in 49 states and Washington, DC.


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.

Methods

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.

Results

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).

Table 1. Tobacco Sales to Minors Among US Pharmacy Chains, 2012-2017.

Pharmacy Chain No. of Inspections/No. of Violations (Violation Rate %)
2012
(n = 2942)
2013
(n = 3245)
2014
(n = 3755)
2015
(n = 4868)
2016
(n = 4478)
2017
(n = 4575)
2012-2017
(N = 23 863)
Walgreens 1121/96 (8.6) 1239/97 (7.8) 1764/177 (10.0) 2901/336 (11.6) 2825/300 (10.6) 2737/290 (10.6) 12 587/1296 (10.3)
CVSa 1038/45 (4.3) 1138/56 (4.9) 928/70 (7.5) 15/1 (6.7) 2/0 5/0 3126/172 (5.5)
Rite Aid 747/17 (2.3) 822/16 (1.9) 972/31 (3.2) 1763/94 (5.3) 1516/84 (5.5) 1663/72 (4.3) 7483/314 (4.2)
Other chains 36/1 (2.8) 46/2 (4.3) 91/8 (8.8) 189/21 (11.1) 135/5 (3.7) 170/14 (8.2) 667/51 (7.6)
a

Stopped selling tobacco products on September 3, 2014. US Food and Drug Administration inspections are dated with the decision date of the inspection, not the date the inspection took place; thus, some inspections were not decided until after the end of CVS tobacco sales.

Table 2. Association of Pharmacy Brand With Tobacco Sales to Minors in FDA Inspection of Chain Pharmacies, 2012-2017.

Factors Associated With Sale to Minor in Inspection (1 = Yes, 0 = No) OR (95% CI) for Model 1 aOR (95% CI) for Model 2
Pharmacy brand
Walgreens 1 [Reference] 1 [Reference]
CVS 0.63 (0.53-0.75) 0.70 (0.58-0.85)
Rite Aid 0.40 (0.34-0.46) 0.41 (0.35-0.47)
Other chains 0.61 (0.45-0.84) 0.65 (0.47-0.89)
Year NA 1.00 (0.96-1.04)
Lung Association grade (coded: 0 = F, 4 = A) NA 0.74 (0.52-1.04)
% of Non-Hispanic white individuals NA 0.95 (0.92-0.97)
Median household income, z-scored within county NA 1.00 (1.00-1.01)
Intercepta 0.10 0.12

Abbreviations: aOR, adjusted odds ratio; FDA, US Food and Drug Administration; NA, not applicable; OR, odds ratio.

a

Random intercept for state to address within-state dependence (intraclass correlation, 0.11). Intercept is exponentiated. In model 1, n = 23 841 (after exclusion of 22 CVS inspections decided in 2015-2017 after sales had stopped). Final model is n = 23802 owing to sporadic missingness in neighborhood-level variables, geocoding, and 2015-2017 CVS inspections. Neighborhood characteristics are scaled for ease of interpretation and model convergence; z scores were multiplied by 10 (eg, z = 0.13 is coded as 1.3), and the percentage of white individuals was divided by 10 (eg, 13% white is coded as 1.3). Nevada did not inspect any of the pharmacy chains we examined during this time period. We tested a quadratic term of year squared; it improved the fit of the model and was included in model 2. The model is not sensitive to inclusion or exclusion of the 22 CVS inspections conducted after 2014.

Discussion

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.

References


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