Abstract
Introduction:
In March 2022, FDA granted its first marketing orders for e-cigarettes. Few studies have assessed awareness of FDA e-cigarette regulation and authorization in the era of premarket review. This study describes prevalence of awareness as well as beliefs about regulation among adults who smoke and youth.
Methods:
We conducted a cross-sectional, nationally representative online survey of 866 adults who currently smoke cigarettes and 859 youth (ages 15–20) in June 2022 using Ipsos KnowledgePanel. Population prevalence of regulatory awareness and beliefs are reported. Pearson χ2 and multivariable logistic regressions were conducted to assess dependent and independent associations with demographic and tobacco use characteristics.
Results:
Awareness that FDA regulates e-cigarettes was low among adults who smoke (25.4%) and youth (18.5%). Awareness that FDA authorizes e-cigarettes was also low among adults who smoke (10.8%) and youth (12.7%). Agreement with both positive and negative beliefs regarding FDA e-cigarette regulation was below 50%. Current e-cigarette use was significantly associated with agreeing that regulation: makes e-cigarettes safer (adult aOR: 2.90, youth aOR: 2.51), helps prevent youth initiation (adult aOR 1.92), takes away freedom to choose to use e-cigarettes (adult aOR: 3.02, youth aOR: 2.58), and limits types of e-cigarettes available (adult aOR: 2.22, youth aOR: 2.49).
Discussion:
There is low awareness of FDA e-cigarette regulation and authorization and relatively low agreement with positive beliefs about e-cigarette regulation. Further study is needed to assess how the changing regulatory environment impacts product perceptions, intentions, and behaviors.
Introduction
United States (US) e-cigarette policy has changed significantly in the past decade. The Food and Drug Administration’s (FDA’s) regulatory authority over tobacco products was extended to include e-cigarettes through the Deeming Rule in 2016.1 The Deeming Rule instituted initial regulations including a premarket review requirement for e-cigarettes.1 Other events have also shaped the regulatory environment since the Deeming Rule, including the rise in youth vaping,2 and an outbreak of lung injuries erroneously attributed to nicotine vaping.3 These events were followed by some state policies banning flavored e-cigarette products,4 as well as discretionary enforcement by FDA that prioritized removing cartridge-based flavored e-cigarettes without premarket authorization from the marketplace.5
Research has documented e-cigarette policy awareness and support surrounding the proposed Deeming Rule in 2014,6–14 and its implementation in 2016.15,16 However, no nationally representative surveys have examined public awareness of and beliefs about FDA e-cigarette regulation since the initiation of Premarket Tobacco Product Application (PMTA) review. After an initial period of nonenforcement, then several extensions, the deadline for e-cigarette manufacturers to submit PMTAs was set as September 2020. FDA reviews are based on the risks and benefits products pose to both people who do and do not use tobacco (e.g., reducing use among current users or initiation among non-users) to determine if products meet the authorization standard of being “appropriate for the protection of public health.”17 The PMTA process has the potential to reduce youth use (e.g., removing flavored products with youth appeal ), but could also impact adults who smoke cigarettes who may use e-cigarettes to quit. At the time the study was conducted (June 2022), 18 products from only three brands had been authorized, while over one million individual products had been denied marketing orders.18 PMTA review could also potentially impact harm perceptions about authorized e-cigarettes.
The extent to which the public is aware that the FDA regulates and is now in the process of authorizing e-cigarettes is unknown. This study examines awareness of and beliefs about FDA e-cigarette regulation in the US among adults who smoke cigarettes and youth. These groups have been targets of e-cigarette marketing,19–21 have high prevalence of e-cigarette use,22,23 and are relevant stakeholders whose opinions should be monitored in light of regulatory processes intended to balance the risks and benefits to both groups.17
Methods
Data were collected as part of an online survey (June 2022). Participants were 866 adults who currently smoke cigarettes (ages 21+ - legal age of tobacco product purchase, have smoked at least 100 lifetime cigarettes and currently smoke every day or some days) and 859 youth (general population of youth ages 15–20, no other inclusion criteria). Participants were recruited by Ipsos from their commercial panel (KnowledgePanel) designed to be representative of the US, using probability-based address sampling.24 Data were weighted to produce nationally representative estimates. Youth under 18 were recruited by first inviting a sample of parents of 15–17-year-olds from the panel, and asking permission to survey their child (parental consent). Ipsos recruited those ages 18–20 years using a combination of invitations through parents, and direct invitations to eligible individuals in their adult panel. All participants provided informed consent before beginning the survey.
To measure awareness that FDA regulates and authorizes the marketing of e-cigarettes, participants were asked: “Before taking this survey, were you aware that e-cigarettes are currently regulated by the FDA?” and “Before taking this survey, had you ever heard of any e-cigarettes/vaping products being ‘authorized’ by the FDA?” Because we were interested in presence of awareness/knowledge, we dichotomized responses to yes versus other responses (no or not sure). Participants were then asked to what extent they agreed or disagreed, on a 6-point Likert scale (1=strongly disagree – 6=strongly agree), with statements that FDA regulation of e-cigarettes 1) ‘Helps make e-cigarettes safer for consumer use,’ 2) ‘Helps prevent young people from starting to use e-cigarettes,’ 3) ‘Takes away people’s freedom to choose whether or not to use these products,’ and 4) ‘Limits the choices of e-cigarettes available (e.g., flavors, styles),’ adapted from existing measures.12 The order of these statements was randomized. Responses were dichotomized as any agreement and any disagreement. Analyses were conducted in Stata version 17 and include descriptive statistics and Pearson χ2 tests to detect differences in awareness and agreement between groups. Multiple logistic regression was used to identify independent associations between participant characteristics and awareness and belief outcomes. Because the broader study included an experimental manipulation (in which participants viewed one of 3 versions of an experimental ad for a fake e-cigarette brand or fake press release stating the product has been “authorized for sale” by the FDA, or control ad that made no reference to FDA), we checked for potential differences in weighted outcome prevalence estimates by condition. Among both samples, there were no significant differences between experimental groups and control on the outcomes reported in this study with one exception. The belief that FDA regulation limits choices significantly differed in one of the experimental groups (among the adult smoking group only) and were therefore excluded from analysis for that outcome among adults only. This study was approved by the Institution’s Institutional Review Board.
Results:
The sample of adults who smoke cigarettes (n=866) was 54% male, had an average age of 44 years, and primarily identified as non-Hispanic White (67.4%, non-Hispanic Black: 13.3%, non-Hispanic other race: 8.3%, Hispanic: 10.8%). Most had not attended any college (58.8%) and smoked cigarettes daily (76.4%). Only 14.9% had used e-cigarettes in the past 30 days. The youth sample (n=859) was 50.4% male, had an average age of 17.5 years (SD: 1.7), and primarily identified as non-Hispanic White (52.2%, non-Hispanic Black: 13.3%, non-Hispanic other race: 10.1%, Hispanic: 24.5%). Only 3.1% were established cigarette smokers; 11.0% had used an e-cigarette in the past 30 days (Supplemental Table 1).
Regulation and Authorization Awareness
Only 25.4% of adults who smoke cigarettes and 18.5% of youth were aware that e-cigarettes are regulated by the FDA. Awareness was associated with having any college education among adults who smoke (aOR: 1.65, 95% CI: 1.15–2.37) and current e-cigarette use among youth (aOR: 2.29, 95% CI: 1.27–4.12) (Table 1). Hispanic youth had significantly lower odds of awareness compared to White youth (aOR: 0.45, 95% CI: 0.25–0.82).
Table 1.
Prevalence of awareness that FDA regulates and authorizes e-cigarettes among US adults who smoke cigarettes and youth
| Aware that FDA regulates e-cigarettes | Heard of e-cigarettes being ‘authorized’ by FDA | |||||||
|---|---|---|---|---|---|---|---|---|
| Adults who smoke cigarettes (n=866) | Adolescents 15–20 (n=859) | Adults who smoke cigarettes (n=866) | Adolescents 15–20 (n=859) | |||||
| Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | |
| Total | 25.4 (22.2–28.8) | 18.5 (15.7–21.7) | 10.8 (8.6–13.6) | 12.7 (10.3–15.6) | ||||
| Aware FDA regulates e-cigs | N/A | N/A | N/A | N/A | 25.6 (19.2–33.2) | 7.22 (4.1–12.71) | 29.2 (21.9–37.8) | 4.47 (2.67–7.51) |
| P-value | <.0001 | <.0001 | ||||||
| Sex | ||||||||
| Male | 28.3 (23.5–33.5) | 1.37 (0.96–1.93) | 20.7 (16.6–25.5) | 1.32 (0.88–1.97) | 11.7 (8.3–16.2) | 1.16 (0.65–2.06) | 16.4 (12.7–21) | 1.94 (1.17–3.22) |
| Female | 22 (18.2–26.4) | ref | 16.2 (12.6–20.6) | ref | 9.8(7.3–13.2) | ref | 9(6.3–12.6) | ref |
| P-value | 0.0576 | 0.1419 | 0.4398 | 0.0047 | ||||
| Age Categories | ||||||||
| 15–17 | N/A | 15.1 (11.6–19.5) | 0.67 (0.4–41) | N/A | 12.3 (9.2–16.4) | 1.06 (0.64–1.77) | ||
| 18–20 | N/A | 22.1 (17.9–27) | ref | N/A | 13.1 (9.8–17.5) | ref | ||
| 21–29 | 26.8 (16.1–41.1) | ref | N/A | N/A | 14 (6.1–29) | ref | N/A | N/A |
| 30–44 | 27.7 (22.1–34) | 1.09 (0.52–2.29) | N/A | N/A | 10.7 (7.3–15.3) | 0.53 (0.18–1.6) | N/A | N/A |
| 45–59 | 23.5 (18.7–29) | 0.87 (0.41–1.85) | N/A | N/A | 7.5 (4.81–1.4) | 0.47 (0.15–1.49) | N/A | N/A |
| 60+ | 24.2 (18.9–30.4) | 0.94 (0.44–2.02) | N/A | N/A | 13.2 (9.3–18.5) | 0.77 (0.24–2.46) | N/A | N/A |
| P-value | 0.7695 | 0.3354 | 0.7649 | |||||
| Education | ||||||||
| No college | 21.3 (17.3–26) | ref | N/A | N/A | 12.8 (9.7–16.9) | ref | N/A | N/A |
| Any college | 31.2 (26.3–36.5) | 1.65 (1.15–2.37) | N/A | N/A | 8 (5.3–11.9) | 0.41 (0.22–0.77) | N/A | N/A |
| P-value | 0.0041 | 0.0537 | ||||||
| Race/ethnicity | ||||||||
| White, Non-Hispanic | 24.3 (20.6–28.3) | ref | 23.1 (19–27.7) | ref | 8.7(6.3– 11.9) | ref | 11.8 (8.9–15.6) | ref |
| Black, Non-Hispanic | 27.2 (19.4–36.7) | 1.18 (0.72–1.95) | 13.4 (7.4–23) | 0.54 (0.26–1.11) | 21.1 (13.6–31.2) | 2.96 (1.44–6.11) | 12.2 (6.5–21.9) | 1.36 (0.61–3.01) |
| Hispanic | 25 (16.2–36.6) | 1.02 (0.57–1.85) | 12.2 (7.6–19) | 0.45 (0.25–0.82) | 12.2 (6.8–21.1) | 1.49 (0.62–3.57) | 14.2 (9.1–21.4) | 1.58 (0.84–3.00) |
| Other, Non-Hispanic | 32 (19.2–48.3) | 1.44 (0.69–3) | 16.5 (10.2–25.5) | 0.68 (0.36–1.28) | 10.2 (4.1–23.1) | 0.99 (0.34–2.87) | 14.5 (8.5–23.6) | 1.3 (0.63–2.68) |
| P-value | 0.6558 | 0.0151 | 0.0121 | 0.8645 | ||||
| E-cigarette use | ||||||||
| Never tried e-cigarettes | 22.9 (18.7–27.7) | ref | 16 (13–19.5) | ref | 13 (9.7–17.3) | ref | 12.7 (10–16) | ref |
| Former user, but not past 30 days | 27.7 (22.5–33.7) | 1.28 (0.87–1.89) | 20.5 (13.8–29.3) | 1.3 (0.77–2.22) | 6.8 (3.911.6) | 0.46 (0.25–0.85) | 12.3 (7.2–20.3) | 0.9 (0.45–1.79) |
| Current user, past 30 days | 27.7 (19.5–37.8) | 1.29 (0.74–2.25) | 31.9 (21.3–44.9) | 2.29 (1.27–4.12) | 13.7 (8.2–22) | 0.91 (0.43–1.94) | 12.2 (5.8–24) | 0.72 (0.28–1.85) |
| P-value | 0.3685 | 0.0052 | 0.0571 | 0.9895 | ||||
| Smoking Frequency | ||||||||
| Smoke daily | 25.3 (21.8–29.2) | ref | N/A | N/A | 11.3 (8.7–14.6) | 0.82 (0.4–1.71) | N/A | N/A |
| Smoke some days | 25.7 (19.2–33.5) | 0.88 (0.56–1.38) | N/A | N/A | 9.3 (5.7–14.7) | ref | N/A | N/A |
| P-value | 0.9249 | 0.4708 | ||||||
Notes: bolding indicates significance at p<.05
Having heard of any e-cigarette products being “authorized” by FDA was uncommon (10.8% among adults who smoke; 12.7% among youth). Awareness was negatively associated with having any college education for adults who smoke (aOR: 0.41, 95% CI: 0.22–0.77). Odds of hearing about authorizations were higher among those who were aware that FDA regulates e-cigarettes (aOR: 7.22, 95% CI: 4.1–12.71) and Black compared to White adults who smoke (aOR: 2.96, 95% CI: 1.44–6.11). Among youth, those who knew FDA regulated cigarettes (aOR: 4.47, 95% CI: 2.67–7.51) and males had higher odds of hearing about authorization than females (aOR: 1.94, 95% CI: 1.17–3.22).
FDA regulation beliefs
Approximately 42.3% of adults who smoke cigarettes and 40.1% of youth agreed that FDA regulation of e-cigarettes helps make them safer. Among adults who smoke, agreement was associated with being male (aOR: 1.47, 95%CI: 1.07–2.02), and formerly (aOR: 1.60, 95% CI: 1.13–2.27) or currently (aOR: 2.93, 95% CI: 1.74–4.96) using e-cigarettes. Among youth, agreement was positively associated with current e-cigarette use (aOR: 2.35, 95% CI: 1.35–4.07) and awareness that FDA regulates e-cigarettes (aOR: 1.62, 95% CI: 1.07–2.46) (Table 2).
Table 2:
Estimated population prevalence and correlates of beliefs regarding FDA e-cigarette regulation
| Agree that FDA regulation makes e- cigarettes safer | Agree that FDA regulation helps prevent youth uptake | Agree that FDA regulation takes away freedom to choose | Agree that FDA regulation limits choices | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adults who smoke cigarettes (n=866) | Adolescents 1520 (n=859) | Adults who smoke cigarettes(n=866) | Adolescents 1520 (n=859) | Adults who smoke cigarettes (n=866) | Adolescents 1520 (n=859) | Adults who smoke cigarettes (n=675)* | Adolescents 1520 (n=859) | |||||||||
| Weighted % (95% CI) | aOR (95% CI) | Weigh ted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aOR (95% CI) | Weighted % (95% CI) | aO R (95 % CI) | Weighted % (95% CI) | aOR (95% CI) | |
| Total | 42.3 (38.5–46.2) | 40.1 (36.3–44.1) | 26.2 (22.8–29.9) | 28.3 (24.8–32.1) | 21.6 (18.6–24.9) | 15.7 (13–18.8) | 44.5 (40.3–48.8) | 38.4 (34.6–42.3) | ||||||||
| Aware FDA regulates e-cigs | 43.7 (36.3–51.4) | 0.98 (0.68–1.42) | 51.8 (43.0,.60.5) | 1.62 (1.07–2.46) | 19.3 (14.4–25.4) | 0.55 (0.36–0.84) | 34.1 (26.34–42.7) | 1.38 (0.90–2.14) | 22.9 (17.5–29.3) | 1.14 (0.75–1.73) | 14.1 (9.0–21.3) | 0.73 (0.42–1.28) | 50.4 (42.2–58.6) | 1.37 (0.93–2.03) | 50.5 (41.7–59.3) | 1.68 (1.11–2.52) |
| Gender | ||||||||||||||||
| Male | 47.3 (41.7–53.0) | 1.47 (1.07–2.02) | 41.5 (36.1–47.2) | 1.07 (0.77–1.49) | 30.7 (25.6–36.4) | 1.67 (1.16–2.41) | 32 (26.9–37.6) | 1.44 (0.99–2.08) | 22.1 (17.8–27) | 1.06 (0.72–1.54) | 19.4 (15.2–24.4) | 1.77 (1.13–2.77) | 44.2 (38.0–50.5) | 0.96 (0.68–1.35) | 39.9 (34.6–45.6) | 1.09 (0.78–1.53) |
| Female | 36.5 (31.8–41.5) | ref | 38.7 (33.4–44.3) | ref | 20.9 (17–25.4) | ref | 24.5 (19.9–29.7) | ref | 21.0 (17.0–25.6) | ref | 12.0 (9.0–15.9) | ref | 44.9 (39.3–50.6) | ref | 36.8 (31.5–42.4) | ref |
| Age Categories | ||||||||||||||||
| 15–17 | N/A | N/A | 40.2 (34.9–45.7) | 1.09 (0.78–1.52) | N/A | N/A | 26.6 (22–31.9) | 0.85 (0.58–1.22) | N/A | N/A | 14.7 (11.2–19.0) | 0.87 (0.55–1.37) | N/A | N/A | 37.7 (32.5–43.2) | 1.02 (0.73–1.43) |
| 18–20 | N/A | N/A | 40 (34.6–45.8) | ref | N/A | N/A | 30.1 (24.9–35.7) | ref | N/A | N/A | 16.8 (12.9–21.7) | ref | N/A | N/A | 39.1 (33.6–44.8) | ref |
| 21–29 | 53.6 (38.7–68.0) | ref | N/A | N/A | 29.2 (16.9–45.4) | ref | N/A | N/A | 24.6 (13.8–39.9) | ref | N/A | N/A | 50.9 (33.7–67.9) | ref | N/A | N/A |
| 30–44 | 47.4 (40.8–54.0) | 0.89 (0.46–1.75) | N/A | N/A | 28.2 (22.7–34.5) | 1.06 (0.49–2.27) | N/A | N/A | 19 (14.4–24.5) | 0.82 (0.38–1.78) | N/A | N/A | 41.6 (34.6–48.9) | 0.84 (0.38–1.82) | N/A | N/A |
| 45–59 | 41.9 (35.6–48.4) | 0.77 (0.39–1.51) | N/A | N/A | 27.3 (21.8–33.6) | 1.05 (0.49–2.26) | N/A | N/A | 23.8 (18.8–29.5) | 1.24 (0.58–2.62) | N/A | N/A | 51.4 (44.2–58.5) | 1.27 (0.58–2.76) | N/A | N/A |
| 60+ | 30.9 (25.3–37.1) | 0.55 (0.27–1.09) | N/A | N/A | 20.9 (15.9–27.1) | 0.81 (0.37–1.79) | N/A | N/A | 20.7 (15.8–26.6) | 1.16 (0.55–2.46) | N/A | N/A | 37.0 (30.3–44.3) | 0.80 (0.35–1.70) | N/A | N/A |
| Education | ||||||||||||||||
| No college | 40.5 (35.5–45.8) | ref | N/A | N/A | 26.8 (22.3–31.9) | ref | N/A | N/A | 24 (19.7–28.8) | ref | N/A | N/A | 43.1 (37.4–49.0) | ref | N/A | N/A |
| Any college | 44.9 (39.3–50.6) | 1.17 (0.84–1.63) | N/A | N/A | 25.3 (20.5–30.8) | 0.91 (0.62–1.32) | N/A | N/A | 18.1 (14.3–22.7) | 0.66 (0.44–0.98) | N/A | N/A | 46.3 (40.2–52.5) | 1.09 (0.76–1.55) | N/A | N/A |
| Race/ethnicity | ||||||||||||||||
| White, Non-Hispanic | 41.4 (37.0–46.0) | ref | 43.7 (38.7–48.8) | ref | 24.3 (20.4–28.7) | ref | 27 (22.8–31.8) | ref | 22 (18.3–26.1) | ref | 14.8 (11.7–18.5) | ref | 45.7 (40.6–50.8) | ref | 42 (37.1–47.1) | ref |
| Black, Non-Hispanic | 34.7 (26.2–44.2) | 0.77 (0.48–1.23) | 28.5 (18.2–41.7) | 0.55 (0.29–1.04) | 23.6 (16.7–32.2) | 0.94 (0.57–1.54) | 39 (27.4–52) | 1.84 (1.03–3.29) | 17.5 (11.6–25.6) | 0.78 (0.45–1.35) | 17.2 (9.3–29.7) | 1.24 (0.59–2.59) | 35.0 (25.6–45.6) | 0.63 (0.38–1.04) | 30.2 (20.1–42.8) | 0.63 (0.35–1.11) |
| Hispanic | 50.3 (38.1–62.5) | 1.13 (0.66–1.94) | 36.4 (28.3–45.2) | 0.8 (0.53–1.23) | 29.8 (19.2–43) | 1.08 (0.59–1.97) | 25.2 (18.1–34) | 0.96 (0.59–1.56) | 22.5 (14.1–34) | 0.89 (0.45–1.74) | 15.5 (10.2–23) | 1.09 (0.62–1.92) | 45.7 (33.2–58.7) | 0.90 (0.51–1.60) | 33.8 (25.9–42.8) | 0.74 (0.47–1.15) |
| Other, Non-Hispanic | 50.7 (35.1–66.1) | 1.59 (0.78–3.21) | 46.3 (35.3–57.7) | 1.18 (0.71–1.95) | 40.3 (25.9–56.6) | 2.13 (1.05–4.33) | 27.8 (18.4–39.6) | 1.07 (0.59–1.92) | 23.3 (12.5–39.1) | 1.14 (0.51–2.51) | 19.2 (10.9–31.5) | 1.38 (0.67–2.82) | 47.7 (31.2–64.8) | 1.10 (0.52–2.34) | 41.1 (30.3–52.8) | 1.01 (0.6–1.68) |
| E-cigarette use | ||||||||||||||||
| Never tried | 32.9 (27.8–38.3) | ref | 36.6 (32.4–41.1) | ref | 24.5 (19.8–29.9) | ref | 28.2 (24.1–32.6) | ref | 17.2 (13.6–21.6) | ref | 13.6 (10.7–17.1) | ref | 40.0 (34.0–46.2) | ref | 35.8 (31.6–40.3) | ref |
| Not in past 30 days | 45.8 (39.8–52.0) | 1.6 (1.13–2.27) | 45.2 (34.7–56.1) | 1.38 (0.83–2.28) | 23.3 (18.5–28.9) | 0.96 (0.65–1.43) | 27 (18.5–37.4) | 0.95 (0.55–1.64) | 21.1 (16.5–26.6) | 1.33 (0.89–2.00) | 16.9 (10.5–26.2) | 1.32 (0.72–2.43) | 43.4 (36.9–50.1) | 1.08 (0.74–1.58) | 36.0 (26.5–46.8) | 0.97 (0.6–1.57) |
| Past 30 days | 62. (51.4–72.1) | 2.93 (1.74–4.96) | 59.2 (46.3–70.9) | 2.35 (1.35–4.07) | 39.3 (29–50.7) | 1.99 (1.13–3.5) | 29.7 (19.5–42.4) | 0.99 (0.54–1.84) | 36.4 (26.4–47.6) | 2.99 (1.74–5.11) | 29.2 (19.2–41.8) | 2.69 (1.45–4.99) | 60.7 (48.7–71.5) | 2.24 (1.25–4.00) | 58.6 (46.1–70.1) | 2.35 (1.35–4.09) |
| Smoking Frequency | ||||||||||||||||
| Smoke daily | 40.2 (36.1–44.5) | ref | N/A | N/A | 24.4 (20.8–28.4) | ref | N/A | N/A | 21.2 (17.9–24.9) | ref | N/A | N/A | 43.9 (39.3–48.7) | ref | N/A | N/A |
| Smoke some days | 49.1 (40.6–57.6) | 1.2 (0.79–1.82) | N/A | N/A | 31.9 (24.1–40.9) | 1.36 (0.88–2.12) | N/A | N/A | 22.9 (16.3–31.1) | 1.18 (0.72–1.92) | N/A | N/A | 46.5 (37.0–56.3) | 1.08 (0.69–1.68) | N/A | N/A |
Note: Bolding indicates significance at p<.05.
Sample size is lower for this outcome because participants from one of the experimental groups in the broader study were excluded (n=191). Exclusion of this group change the prevalence of agreement from 42.1% to 44.5%, but did not change any statistical inferences from the regression model.
Fewer agreed that FDA e-cigarette regulation helps prevent youth uptake (adults who smoke, 26.2%; youth, 28.3%). Male sex was associated with higher odds of having this belief for both samples (Table 2). Among adults who smoke, current e-cigarette use was also associated with agreement (aOR: 2.13, 95% CI: 1.05–4.33), but prior awareness that FDA regulates e-cigarettes significantly reduced odds of agreement (aOR: 0.55, 95% CI: 0.36–0.84).
Finally, 44.5% of adults who smoke and 38.4% of youth agreed regulation limits the choices of e-cigarettes available – fewer agreed regulation takes away people’s freedom to choose to use e-cigarettes (21.6% and 15.7%, respectively). Odds of agreement for both beliefs were higher among current e-cigarette users in both samples. Among youth, prior FDA regulatory awareness was associated with the belief about fewer available choices (aOR: 1.68, 95% CI: 1.11–2.52) and male sex was associated with the belief about taking away the right to choose (Table 2).
Discussion
This is the first study to report awareness of e-cigarette regulation, authorization, and associated beliefs since the rise of youth vaping and initiation of PMTA reviews. Despite increases in regulation and media attention surrounding PMTAs,25 we found low awareness that FDA regulates e-cigarettes or has authorized any e-cigarette products.
Even given low regulatory awareness prior to the study, about 41% of both samples agreed FDA regulation makes e-cigarettes safer, suggesting the public may assume that regulation makes e-cigarettes safer when hearing about it. This is consistent with previous research finding high agreement (over 80%) that the government should regulate e-cigarettes for safety.10,12 These assumptions are important because the FDA does not regulate e-cigarettes for product safety, and thus such beliefs could constitute misperceptions. However, it could be argued that FDA e-cigarette regulation could indirectly lead to a “safer” e-cigarette market, for example by issuing denial orders for products determined not appropriate for the protection of public health, and/or through new potential standards, such as manufacturing requirements proposed in March 2023 to reduce contaminations and inconsistent constituent labeling.26 Regardless, beliefs about product safety may motivate some adults who smoke to use e-cigarettes but also perpetuate low harm perceptions and e-cigarette use among youth. Efforts to understand how to communicate nuanced information about FDA e-cigarette regulation, product authorization and product safety should be explored.
The prevalence of believing regulation prevents youth initiation was particularly low, although those who had heard of FDA-authorized e-cigarettes had higher odds of agreeing with this belief. This may signal low awareness of, support for, or perceived effectiveness of FDA’s efforts in this area, given years of news coverage about the youth vaping epidemic,27 and continued availability of flavored e-cigarettes, despite millions of marketing denial orders.18 Low agreement that regulation prevents youth initiation may be particularly problematic as it has been associated with e-cigarette policy support in other studies,12 can increase the likelihood of further policy action,28 and is a priority area for FDA.
We also found that agreement that regulation restricts freedom to choose e-cigarettes and e-cigarette options was higher among current e-cigarette users (who clearly have access to products). This could potentially reflect general reactance against government regulations restricting choice/freedom.29 Media coverage discussing the need for policies to restrict flavoring and coverage of local flavor bans27 could also potentially increase perceptions of a constricting marketplace and anti-regulation sentiment.
Study limitations include use of a cross-sectional survey not designed to assess trends or causal relationships. Most of the sample was unaware the FDA regulates e-cigarettes, and therefore likely responded to regulatory belief items on the spot, which could help to explain awareness was significantly associated with regulatory beliefs. Responses about regulatory and authorization awareness may be inflated by recall and social desirability bias, and true awareness may be lower than reported. Additionally, only days after data collection concluded, FDA released its marketing denial order for JUUL, which received significant media attention.30 Although the denial order was stayed, this incident likely increased public awareness to the authorization process, which our data do not reflect.
Overall, awareness of FDA e-cigarette regulation and authorization is low among two priority populations, adults who smoke cigarettes and youth. Adults who smoke might especially benefit from better understanding of how FDA is regulating e-cigarettes given e-cigarettes may be able to act as harm-reduction products. Efforts to increase understanding of the premarket review process may be complicated given it might limit or remove e-cigarette products deemed not appropriate for the protection of public health from the marketplace without specifically assessing product safety. Additional research is needed to identify methods for communicating this nuanced information effectively. Monitoring awareness of and beliefs about e-cigarette regulation, as well as potential changes in product perceptions, intentions, and behaviors should continue as FDA issues more marketing orders and denials of PMTAs.
Supplementary Material
Highlights.
Awareness that FDA regulates e-cigs is low among both adults who smoke and youth.
About 40% agree regulation makes e-cigs “safer”, but limits choices available.
About 27% agree regulation helps prevent youth e-cigarette uptake.
E-cigarette use is positively associated with beliefs about FDA e-cig regulation.
Funding:
This work was supported by the Food and Drug Administration Center for Tobacco Products (CTP) and the National Cancer Institute (NCI) under Award Number U54CA229973. Contributions by JCS, MJ and OW were also supported in by part grants R00CA242589, K01CA242591 and R37CA222002, respectively. The content is solely the responsibility of the authors and does not necessarily represent the views of the NIH or FDA.
Footnotes
Competing interests: The authors have no competing interests to declare
Declarations of interest: none.
Author Agreement Statement
We declare that this manuscript is original, has not been published before and is not currently being considered for publication elsewhere. We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us. We understand that the Corresponding Author is the sole contact for the Editorial process. He/she is responsible for communicating with the other authors about progress, submissions of revisions and final approval of proofs.
CRediT author statement
Caitlin Weiger: Formal analysis, Writing – Original Draft. Julia Chen-Sankey: Conceptualization, Writing – Editing & Reviewing. Michelle Jeong: Conceptualization, Writing – Editing & Reviewing. Cristine Delnevo: Acquired study funding, Conceptualization, Writing – Editing & Reviewing. Olivia Wackowski: Acquired study funding, Conceptualization, Methodology, Writing – Editing & Reviewing, Supervision.
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Data statement:
Study instrument (survey) and data are available upon reasonable request to the study’s Principal Investigator (olivia.wackowski@rutgers.edu).
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Study instrument (survey) and data are available upon reasonable request to the study’s Principal Investigator (olivia.wackowski@rutgers.edu).