A Patchy Prohibition: Product and Flavor Substitution After the Food and Drug Administration's Prioritized Enforcement Policy on Flavored E-cigarettes.

introductionE-cigarettes have rapidly grown in use among U.S. adolescents; in response, the Food and Drug Administration (FDA) engaged in an "enforcement policy on banned e-cigarette flavors" ("enforcement action") for pod-based e-cigarettes in January 2020, which accounted for most U.S. e-cigarette sales. No literature has yet examined long-term changes in e-cigarette sales patterns changed in relation to the FDA enforcement action. AIMS AND

methodsWe analyzed U.S. e-cigarette sales using Nielsen retail scanner data between March 2017 and December 2021, describing e-cigarette sales trends overall, by device type, and by flavor category. We also performed joinpoint regression analysis on the sales trends to detect significant changes in the rate of change of sales over time.

resultsThe FDA enforcement action was associated with a sharp initial decrease in prefilled pod dollar sales, followed by a steady increase from April 2020 through the end of 2021, growing beyond the previous maximum in August 2019. We also observed a dramatic change in the composition of flavors sold: A large decline in mint-flavored pod sales was offset by a similar increase in menthol-flavored sales. Simultaneously, disposable product sales increased nearly ten-fold from July 2019 to July 2020 before stabilizing, dominated by fruit-flavored products.

conclusionsOur findings suggest rapid product substitution without a long-term decline in e-cigarette sales in association with the enforcement action, along with a growing dominance of youth-friendly flavors, contrasting against FDA policy goals. Our study revealed the weakness of the "patchy" enforcement action, raising concern about its unintended consequences as consumption simply shifted to other e-cigarette products. IMPLICATIONS: This is the first detailed longitudinal study on e-cigarette sales trends in the United States following the FDA flavor enforcement action, with novel findings on flavor trends and their relation to policy events. We report sales overall, by product type, and by flavor category, and highlight several important trends following the action, such as the rise and persistence of disposable e-cigarettes increasingly and overwhelmingly dominated by youth-friendly flavors, and likely substitution of prefilled e-cigarette flavors without any long-term decline in sales. Our results highlight the weaknesses of "patchy" regulation and suggest the need for a more comprehensive approach to flavor regulation.