Abstract
IMPORTANCE: Research demonstrates that policies aimed at retailers who sell to minors must be strongly enforced to have an impact on youth usage rates. OBJECTIVES: In the USA, the Food and Drug Administration (FDA) conducts compliance checks, issues fines, and can order retailers to stop selling tobacco products (ie, no-tobacco-sale orders (NTSOs)) to enforce the Family Smoking Prevention and Tobacco Control Act. We sought to assess FDA's utilisation of NTSOs. METHODS: We conducted a quantitative content analysis of FDA's enforcement actions for inspections decided between 1 October 2015 and 29 March 2019. From the 536 134 inspection records we identified 148 NTSOs and 249 720 unique retailer locations, of which 2095 had three or more violations. We randomly sampled NTSOs (n=76) and retail locations (n=152) with frequent violations. We calculated the proportion of NTSOs that could have been issued earlier by FDA. We then calculated the proportion of retailers that could have been issued an NTSO, and the proportion actually issued an NTSO using FDA's approach and a more stringent approach. RESULTS: Among NTSOs, 94.7% (95% CI: 89.8% to 97.4%) of NTSOs could have been issued earlier under a more stringent approach. On average, when an NTSO could have been issued earlier, it could have been issued 453 days earlier (95% CI: 418 to 489; range: 89-1159). Among frequently violating retail locations, 73.6% (95% CI: 66.0% to 80.0%) were eligible for an NTSO. Of those, 1.9% (95% CI: 0.5% to 7.0%) had received an NTSO. CONCLUSIONS: The FDA's failure to fully leverage its powers to address retailers' underage sales of tobacco products has weakened efforts to curb the youth e-cigarette epidemic.