2
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      research-article
      , BA , , PhD, , PhD
      Nicotine & Tobacco Research
      Oxford University Press

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Introduction

          E-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 Methods

          We 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.

          Results

          The 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.

          Conclusions

          Our 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.

          Related collections

          Most cited references26

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market

          Background While national surveys showed declines in e-cigarette use in the USA between 2015 and 2016, recent reports indicate that JUUL, a sleekly designed e-cigarette that looks like a USB drive, is increasingly being used by youth and young adults. However, the extent of JUUL’s growth and its marketing strategy have not been systematically examined. Methods A variety of data sources were used to examine JUUL retail sales in the USA and its marketing and promotion. Retail store scanner data were used to capture the retail sales of JUUL and other major e-cigarette brands for the period 2011–2017. A list of JUUL-related keywords was used to identify JUUL-related tweets on Twitter; to identify JUUL-related posts, hashtags and accounts on Instagram and to identify JUUL-related videos on YouTube. Results In the short 3-year period 2015–2017, JUUL has transformed from a little-known brand with minimum sales into the largest retail e-cigarette brand in the USA, lifting sales of the entire e-cigarette category. Its US$150 million retail sales in the last quarter of 2017 accounted for about 40% of e-cigarette retail market share. While marketing expenditures for JUUL were moderate, the sales growth of JUUL was accompanied by a variety of innovative, engaging and wide-reaching campaigns on Twitter, Instagram and YouTube, conducted by JUUL and its affiliated marketers. Conclusions The discrepancies between e-cigarette sales data and the prevalence of e-cigarette use from surveys highlight the challenges in tracking and understanding the use of new and emerging tobacco products. In a rapidly changing media environment, where successful and influential marketing campaigns can be conducted on social media at little cost, marketing expenditures alone may not fully capture the influence, reach and engagement of tobacco marketing.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Notes from the Field: E-Cigarette Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2021

              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              E-cigarette Unit Sales, by Product and Flavor Type — United States, 2014–2020

              Since electronic cigarettes (e-cigarettes) entered the U.S. marketplace in 2007, the landscape has evolved to include different product types (e.g., prefilled cartridge–based and disposable products) and flavored e-liquids (e.g., fruit, candy, mint, menthol, and tobacco flavors), which have contributed to increases in youth use ( 1 , 2 ). E-cigarettes have been the most commonly used tobacco product among U.S. youths since 2014; in 2019, 27.5% of high school students reported current e-cigarette use ( 3 ). To assess trends in unit sales of e-cigarettes in the United States by product and flavor type, CDC, CDC Foundation, and Truth Initiative analyzed retail scanner data during September 14, 2014–May 17, 2020, from Information Resources, Inc. (IRI). During this period, total e-cigarette sales increased by 122.2%, from 7.7 million to 17.1 million units per 4-week interval. By product type, the proportion of total sales that was prefilled cartridge products increased during September 2014–August 2019 (47.5% to 89.4%). During August 2019–May 2020, the proportion of total sales that was disposable products increased from 10.3% to 19.8%, while the proportion that was prefilled cartridge products decreased (89.4% to 80.2%). Among prefilled cartridge sales, the proportion of mint sales increased during September 2014–August 2019 (<0.1% to 47.6%); during August 2019–May 2020, mint sales decreased (47.6% to 0.3%), as menthol sales increased (10.7% to 61.8%). Among disposable e-cigarette sales during September 2014–May 2020, the proportion of mint sales increased (<0.1% to 10.5%), although tobacco-flavored (52.2% to 17.2%) and menthol-flavored (30.3% to 10.2%) sales decreased; during the same period, sales of all other flavors combined increased (17.2% to 62.1%). E-cigarette sales increased during 2014–2020, but fluctuations occurred overall and by product and flavor type, which could be attributed to consumer preferences and accessibility. Continued monitoring of e-cigarette sales and use is critical to inform strategies at the national, state, and community levels to minimize the risks of e-cigarettes on individual- and population-level health. As part of a comprehensive approach to prevent and reduce youth e-cigarettes use, such strategies could include those that address youth-appealing product innovations and flavors. Retail sales data were licensed from IRI, Inc., which included Universal Product Code sales from convenience stores, gas stations, grocery stores, drugstores/pharmacies, mass merchandiser outlets, club stores, dollar stores, and military sales. Sales from the Internet and tobacco-specialty stores, including “vape shops,” were not included. E-cigarette products were categorized as one of the following product types: prefilled cartridge devices, disposable devices, and e-liquids.* E-cigarette accessories and devices sold without e-liquids, which accounted for 9.4% of sales, were excluded. Products with explicit flavor names were categorized as tobacco, menthol, mint, or all other flavors (e.g., fruit, clove/spice, candy/desserts/other sweets, chocolate, alcoholic and nonalcoholic drinks). Ambiguous or concept flavors (e.g., “fusion”) (5.6%) were searched for online and back-coded into one of the four flavor categories. E-cigarette unit sales were standardized and aggregated in 4-week intervals from September 14, 2014, through May 17, 2020 † ( 4 ). Analyses were performed for total unit sales and the proportion of total unit sales by product type and flavor using Stata (version16; StataCorp). Trends during 2014–2020 were analyzed using Joinpoint (version 4.8.0.1; National Cancer Institute), and average 4-week interval percentage change (AIPC) with corresponding 95% confidence intervals (CIs) were calculated. Statistical significance was defined as p<0.05. This study did not involve human subjects, and thus, was not submitted for Institutional Review Board review. During September 2014–May 2020, total unit sales increased by 122.2% (p<0.05), from 7.7 million to 17.1 million units per 4-week interval. (AIPC = 1.1; 95% CI = 0.6 to 1.6); however, within the context of this general increase, sales fluctuated (Figure 1). During November 2016–August 2019, sales increased by 294.3%, from 5.6 million to 22.0 million units per period (AIPC = 4.1; 95% CI = 3.2 to 5.1) (p<0.05). During August 2019–February 2020, sales decreased 32.7%, from 22.0 million to 14.8 million units per period (AIPC = −5.1; 95% CI = −7.2 to −2.8) (p<0.05). No significant change in total sales occurred during February–May 2020. FIGURE 1 Total e-cigarette unit sales,* by flavor † — United States, September 14, 2014–May 17, 2020 § * Retail sales data were obtained from Information Resources, Inc. (IRI) for convenience stores, gas stations, grocery stores, drugstores/pharmacies, mass merchandiser outlets, club stores, dollar stores, and military sales; data from the Internet and vape shops were not collected. † The “All other flavors” category includes fruit, clove/spice, chocolate, alcoholic drink (such as wine, cognac, or other cocktails), candy/desserts/other sweets, or some other flavor. Unknown flavors were excluded from this figure (<0.1%). § Each bar in the figure represents a 4-week aggregate interval. The figure is a bar chart showing total e-cigarette unit sales, by flavor, in the United States during September 14, 2014–May 17, 2020. Among total e-cigarette unit sales during September 2014–August 2019, the proportion that were prefilled cartridges increased from 47.5% to 89.4% (AIPC = 1.0) (p<0.05) (Table). The proportion of total sales that were prefilled cartridges decreased thereafter (p<0.05), accounting for 80.2% of total sales in May 2020 (AIPC = −1.3). As the proportion of sales accounted for by prefilled cartridges decreased beginning August 2019, the proportion of sales that were disposable products increased from 10.3% of total sales in August 2019 to 19.8% in May 2020 (AIPC = 7.5) (p<0.05). TABLE Trends in e-cigarette unit sales, by product and flavor type — United States, September 14, 2014–May 17, 2020 Sales type* Period AIPC (95% CI)† Total sales, by product type Prefilled cartridges§ September 2014–August 2019 1.0 (0.8 to 1.2) August 2019–May 2020 −1.3 (−1.9 to −0.6) Disposable devices¶ September 2014–August 2019 −2.4 (−3.1 to −1.6) August 2019–May 2020 7.5 (4.6 to 10.5) E-liquid** September 2014–May 2020 −5.8 (−7.0 to −4.5) Total sales, by flavor type Mint September 2014–August 2019 10.5 (8.1 to 13.0) August 2019–May 2020 −28.3 (−36.9 to −18.5) Menthol August 2019–May 2020 18.9 (12.5 to 25.7) Tobacco August 2019–May 2020 4.6 (2.7 to 6.6) All other flavors † † September 2014–October 2018 2.0 (1.3 to 2.7) October 2018–May 2020 −5.9 (−8.3 to −3.4) Prefilled cartridge sales, by flavor type Mint September 2014–August 2019 14.1 (8.5 to 20.1) August 2019–May 2020 −42.3 (−54.6 to −26.7) Menthol August 2019–May 2020 22.3 (14.9 to 30.1) Tobacco August 2019–May 2020 6.1 (3.6 to 8.7) All other flavors September 2014–October 2018 3.3 (2.3 to 4.2) October 2018–May 2020 −18.1 (−28.6 to −6.0) Disposable sales, by flavor type Mint September 2014–May 2020 7.4 (4.7 to 10.1) Menthol September 2014–May 2020 −1.4 (−2.5 to −0.3) Tobacco September 2014–May 2020 −1.5 (−2.1 to −0.9) All other flavors September 2014–May 2020 1.6 (1.3 to 1.9) E-liquid sales, by flavor type Mint September 2014–May 2020 −3.5 (−4.9 to −2.2) Menthol September 2014–May 2020 —§§ Tobacco September 2014–May 2020 −4.5 (−6.7 to −2.3) All other flavors September 2014–May 2020 −4.2 (−5.9 to −2.4) Abbreviations: AIPC = average 4-week interval percentage change; CI = confidence interval. * Retail sales data were obtained from Information Resources, Inc. (IRI) for convenience stores, gas stations, grocery stores, drug stores/pharmacies, mass merchandiser outlets, club stores, dollar stores, and military sales; data from the Internet and vape shops were not collected. † AIPC (CI) calculated using Joinpoint (version 4.8.0.1; National Cancer Institute). § Prefilled cartridges include tanks, cartridges, and pods used in rechargeable and reusable e-cigarette device; the cartridges are not intended to be refilled after the liquid has been depleted. Unit sales were standardized to reflect the most common package size for each product type; a standardized unit was equal to five prefilled cartridges. ¶ Disposable devices include nonrechargeable and nonreusable e-cigarette devices that are not intended to be refilled with e-liquid after being depleted; the device is disposed of once the e-liquid has been consumed. Unit sales were standardized to reflect the most common package size for each product type; a standardized unit was equal to 1 disposable device. ** E-liquids are containers of the liquid used in e-cigarette devices, which typically contains a humectant (e.g., propylene glycol), nicotine, and flavoring. †† The “All other flavors” category includes fruit, clove/spice, chocolate, alcoholic drink (such as wine, cognac, or other cocktails), candy/desserts/other sweets, or some other flavor. Unknown flavors were excluded from this figure (<0.1%). §§ The dash indicates that Joinpoint regression could not be conducted because of small sales values. Among total e-cigarette unit sales during September 2014–August 2019, the proportion accounted for by mint products increased from 0.01% to 43.4% (AIPC = 10.5) (p<0.05) (Figure 1). During August 2019–May 2020, although mint sales declined from 43.4% to 2.3% of total e-cigarette sales (AIPC = −28.3), the proportion of menthol sales increased from 11.4% to 51.6% of total sales (AIPC = 18.9), and tobacco-flavored sales increased from 23.0% to 33.1% of total sales (AIPC = 4.6). During September 2014–October 2018, sales of all other flavored e-cigarettes increased from 17.6% to 52.4% of total sales (AIPC = 2.0) (p<0.05); however, sales of all other flavored e-cigarettes declined thereafter, from 52.4% to 12.8% of total sales by May 2020 (AIPC = −5.9) (p<0.05). Among prefilled cartridge sales during September 2014–August 2019, the percentage that were mint increased from <0.1% to 47.6% (AIPC = 14.1) (p<0.05) (Figure 2). During August 2019–May 2020, although the mint sales declined from 47.6% to 0.3% of all prefilled cartridge sales (AIPC = −42.3), the proportion of menthol sales increased from 10.7% to 61.8% (AIPC = 22.3), and the percentage of tobacco-flavored sales increased from 22.8% to 37.1% (AIPC = 6.1). During September 2014–October 2018, sales of all other flavors increased from 12.9% to 54.4% of prefilled cartridge sales (AIPC = 3.3) (p<0.05); however, sales of these products declined thereafter to 0.8% of all prefilled cartridge sales by May 2020 (AIPC = −18.1) (p<0.05). FIGURE 2 Percentage of prefilled cartridge* e-cigarette unit sales, † by flavor § — United States, September 14, 2014–May 17, 2020 * Prefilled cartridges include tanks, cartridges, and pods used in rechargeable and reusable e-cigarette device; the cartridges are not intended to be refilled after the liquid has been depleted. Unit sales were standardized to reflect the most common package size for each product type; a standardized unit was equal to 5 prefilled cartridges. † Retail sales data were obtained from Information Resources, Inc. (IRI) for convenience stores, gas stations, grocery stores, drugstores/pharmacies, mass merchandiser outlets, club stores, dollar stores, and military sales; data from the Internet and vape shops were not collected. § The “All other flavors” category includes fruit, clove/spice, chocolate, alcoholic drink (such as wine, cognac, or other cocktails), candy/desserts/other sweets, or some other flavor. Unknown flavors were excluded from this figure (<0.1%). The figure is a line chart showing the percentage of prefilled cartridge e-cigarette unit sales, by flavor, in the United States during September 14, 2014–May 17, 2020. Among disposable e-cigarette sales during September 2014–May 2020, the percentage of sales of tobacco-flavored and menthol-flavored products decreased; sales of tobacco-flavored e-cigarettes accounted for 17.2% and menthol-flavored accounted for 10.2% of all disposable e-cigarette sales in May 2020, (p<0.05). (Figure 3). During the same period, mint-flavored sales increased from <0.1% to 10.5% of all disposable e-cigarette sales (AIPC = 7.4), and the proportion of all other flavors increased from 17.2% to 62.1% (AIPC = 1.6). FIGURE 3 Percentage of disposable e-cigarette* unit sales, † by flavor § — United States, September 14, 2014–May 17, 2020 * Disposable devices include nonrechargeable and nonreusable e-cigarette devices that are not intended to be refilled with e-liquid after being depleted; the device is disposed of once the e-liquid has been consumed. Unit sales were standardized to reflect the most common package size for each product type; a standardized unit was equal to 1 disposable device. † Retail sales data were obtained from Information Resources, Inc. (IRI) for convenience stores, gas stations, grocery stores, drugstores/pharmacies, mass merchandiser outlets, club stores, dollar stores, and military sales; data from the Internet and vape shops were not collected. § The “All other flavors” category includes fruit, clove/spice, chocolate, alcoholic drink (such as wine, cognac, or other cocktails), candy/desserts/other sweets, or some other flavor. Unknown flavors were excluded from this figure (<0.1%). The figure is a line chart showing the percentage of disposable e-cigarette unit sales, by flavor, in the United States during September 14, 2014–May 17, 2020. Discussion During November 2016–August 2019, total e-cigarette unit sales in the U.S. increased nearly 300%. Although prefilled cartridges remained the leading product type sold, disposable sales increased beginning in August 2019, reaching 19.8% of total sales by May 2020. Among prefilled cartridge sales, the proportion of mint-flavored products declined beginning in August 2019; by May 2020, menthol (61.8%) and tobacco (37.1%) flavors dominated the market. Among disposable e-cigarette sales, tobacco-flavored and menthol-flavored sales decreased during September 2014–May 2020; during the same period, the proportion of sales that were mint and all other flavors increased, with mint reaching 10.5% and all other flavors reaching 62.1% of total sales by May 2020. Continued monitoring of e-cigarette sales could inform strategies to reduce use among U.S. youths, including strategies that address youth-appealing product innovations and flavors (1,2). The increase in total e-cigarette sales that occurred during November 2016–August 2019 was driven by sales of prefilled cartridges, which made up nearly 90% of the market by August 2019. Previous research indicates this increase in total sales was primarily driven by JUUL ( 5 ), a prefilled cartridge-based e-cigarette that accounted for approximately 75% of total U.S. e-cigarette sales by December 2018. § The rise in JUUL sales occurred during the same period as when youth e-cigarette use increased considerably; during 2017–2018, current e-cigarette use increased 78% among U.S. high school students and 48% among middle school students ( 6 ). The decline in total e-cigarettes sales during August 2019–February 2020 might be attributable, in part, to shifts in consumer behaviors following the national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) ( 7 ). Among prefilled cartridge e-cigarettes, sales of mint and other flavors declined beginning in August 2019, after which menthol and tobacco-flavored sales increased considerably. During the same period, overall disposable e-cigarette sales increased, particularly mint and other flavored (excluding menthol or tobacco) products. Flavored e-cigarette sales patterns by product type are likely influenced by multiple factors. For example, JUUL voluntarily removed mango, creme, fruit, and cucumber flavored cartridges from retail stores (November 2018) and online (October 2019) ¶ and removed mint-flavored cartridges entirely from the market in November 2019.** Moreover, on January 2, 2020, the Food and Drug Administration (FDA) finalized an enforcement policy that prohibits the sale of prefilled cartridge e-cigarettes in any flavor other than tobacco or menthol. †† The findings in this report are subject to at least three limitations. First, sales data did not include purchases from the Internet or “vape shops,” which accounted for approximately one half of U.S. e-cigarette sales in 2019; §§ a data source for Internet and “vape shop” sales does not currently exist. Second, the study could not assess purchaser age. These sales could reflect products purchased by adults or those obtained directly or indirectly by youths; however, three quarters of youths who use JUUL, the mostly commonly sold e-cigarette brand in the United States, reported obtaining it from a physical retail location. ¶¶ Finally, ambiguous or concept flavors were back-coded using online searches and might be subject to misclassification; however, this only applied to 5.6% of total sales. Youth use of tobacco products in any form, including e-cigarettes, is unsafe (1,2). In the U.S., e-cigarette use is markedly higher among youths than adults; in 2018, current use of e-cigarettes was 20.8% (past 30-day use) among high school students, 7.6% (everyday/someday use) among adults aged 18–24 years, and 3.2% (everyday/someday use) among adults aged ≥18 years ( 6 , 8 ). In addition to regulation of the manufacturing, marketing, and sale of e-cigarettes by FDA,*** strategies to reduce e-cigarette use among youths include increasing price, implementing comprehensive smoke-free policies that include e-cigarettes, restricting youths’ access to e-cigarettes in retail settings, licensing retailers, developing educational initiatives targeting youths, curbing youth-appealing advertising and marketing, and implementing strategies to reduce youth access to flavored tobacco products ( 1 , 2 , 9 ). Summary What is already known about this topic? Since electronic cigarettes (e-cigarettes) entered the U.S. marketplace in 2007, the landscape has evolved to include disposable e-cigarettes and rechargeable e-cigarettes with prefilled cartridges and flavored e-liquids (e.g., fruit, candy, and mint). What is added by this report? During September 2014–May 2020, e-cigarette sales increased by 122.2%. Sales of prefilled cartridges increased during September 2014–August 2019; since then, sales of disposable products have increased. Prefilled mint cartridge e-cigarette sales increased from September 2014 to August 2019, then decreased, as menthol sales increased during August 2019–May 2020. What are the implications for public health practice? Continued monitoring of e-cigarette sales and use is critical to inform strategies to minimize risks. As part of a comprehensive approach, such strategies could include those that address youth-appealing product innovations and flavors.
                Bookmark

                Author and article information

                Contributors
                Journal
                Nicotine Tob Res
                Nicotine Tob Res
                nictob
                Nicotine & Tobacco Research
                Oxford University Press (US )
                1462-2203
                1469-994X
                May 2024
                08 November 2023
                08 November 2023
                : 26
                : 5
                : 527-535
                Affiliations
                Department of Public Health, NORC At The University of Chicago , Chicago, IL, USA
                Department of Public Health, NORC At The University of Chicago , Chicago, IL, USA
                Department of Public Health, NORC At The University of Chicago , Chicago, IL, USA
                Author notes
                Corresponding Author: Mateusz Borowiecki, BA,30th Floor, 55 E Monroe, Chicago, 60603, USA. Telephone: 1 2483762734; E-mail: Borowiecki-Mateusz@ 123456norc.org
                Author information
                https://orcid.org/0000-0002-2079-0658
                Article
                ntad212
                10.1093/ntr/ntad212
                11033575
                37948576
                d17ec734-4915-45dc-8b37-623ca19cb414
                © The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 09 March 2023
                : 09 October 2023
                : 21 October 2023
                : 20 November 2023
                Page count
                Pages: 9
                Funding
                Funded by: National Cancer Institute, DOI 10.13039/100000054;
                Award ID: R01DA051000
                Funded by: National Institutes of Health, DOI 10.13039/100000002;
                Award ID: R01DA051000
                Categories
                Original Investigations
                AcademicSubjects/MED00010
                AcademicSubjects/SOC02541

                Agriculture
                Agriculture

                Comments

                Comment on this article