The Impact of Exposure to Food and Drug Administration E-cigarette Authorization Messages on Product Perceptions and Interest—An Experiment With Adults Who Smoke and Youth

Abstract

Introduction

In the United States, e-cigarettes have entered a new regulatory era, needing authorizations from the Food and Drug Administration (FDA) to remain on or enter the marketplace. This study explored the impact of e-cigarette authorization messages on product perceptions and interests.

Aims and Methods

We conducted an online experiment in June 2022 with nationally representative samples of adults (≥21) who smoke cigarettes (n = 866) and youth ages 15–20 (n = 859). They were randomized to one of five conditions: Viewing an ad for a fictional e-cigarette brand with no reference to the FDA (control), an ad with an “authorized for sale by FDA” claim in varying presentation styles (plain text, FDA “approved” stamp, FDA logo), or reading a fictional news excerpt about the product’s authorization plus control ad. We compared group differences in product interest, susceptibility, harm perceptions, and message perceptions.

Results

Among adults who smoke, there were no effects on product interest nor susceptibility, but ratings of the product’s harmfulness compared to cigarettes were lower among those in the news versus control condition (β = −0.25, p = .04). Among youth, odds of susceptibility were higher among ever e-cigarette users who viewed the ad with the FDA logo authorization message relative to the control ad (OR = 6.3, 95% CI:1.67 to 23.9, p < .01). About 40% of all participants agreed the authorization claim makes them think the product is safe to use, but fewer (14%–19%) agreed it makes them more interested in trying it.

Conclusions

FDA e-cigarette authorization messages may impact some product harm beliefs. More research is needed to track potential impacts on product use and on ways to promote accurate message understanding.

Implications

This study provides new data about the potential impact of messages about FDA authorization of e-cigarette products (presented as ad claims or a news story) on authorized product perceptions, interest, and susceptibility among adults who smoke cigarettes and youth. Our results suggest that FDA e-cigarette authorization messages may impact harm-related beliefs among adults who smoke and product susceptibility among youth who have ever used e-cigarettes before, though real-world effects are likely to be impacted by message type and format, and perceived message source and credibility. Authorization messages are likely to be misinterpreted as “FDA approval” by some; therefore, providing clarifications about authorization meaning and standards are relevant where possible.

Introduction

In the United States, the 2009 Tobacco Control Act gave the U.S. Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco, which was extended to include e-cigarettes, vaping products, and other nicotine products through the 2016 Deeming Rule.¹ Under the FDA’s authority, any new tobacco products introduced for sale (after February 15, 2007) require a marketing authorization from FDA.² To be considered, manufacturers must file premarket tobacco product applications (PMTAs), providing product information (eg, ingredients) and evidence that, when considering the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, the product would be “appropriate for the protection of public health,” the authorization standard.² This might include, for example, evidence that the new product poses fewer risks than an existing product (eg, cigarettes), and that the likelihood of significant product uptake by non-tobacco users, particularly youth, is relatively low.³

E-cigarettes and nicotine vaping products entered the U.S. marketplace around 2007.⁴ When FDA gained regulatory authority in 2016, FDA did not immediately enforce the PMTA requirement for vaping products already on the marketplace—instead, a PMTA deadline was eventually set for September 2020, by which date any e-cigarette manufacturers wishing to remain on the marketplace needed to apply. During this period with minimal regulation, e-cigarette products proliferated into the millions, with public discourse referencing it as a “wild west.”^5,6 While e-cigarette use increased since their introduction,^4,7 favorable public perceptions, including that they are less harmful than cigarettes, have declined over time.^8,9 This is relevant given that previous studies have found harmful beliefs about e-cigarettes to be associated with e-cigarette interest and use.^10–12

The enforcement of PMTAs will arguably represent a new era for e-cigarettes in the US. Since the PMTA deadline, select products from only three e-cigarette brands have received marketing authorizations as of February 2024, while millions have received denials, signaling a potentially much smaller e-cigarette market in the future. An open research question is whether this authorization process and potential public exposure to FDA authorization messages could impact harm perceptions and interest in authorized e-cigarettes. For example, might some adults who smoke cigarettes be more apt to use e-cigarettes they learn are authorized by FDA? Previous research has found that adults rate FDA as moderately credible on issues related to tobacco products^13,14 and to be among the more trusted sources of health information about e-cigarettes.¹⁵ Research also suggests that a perceived lack of regulations is among the reasons for thinking e-cigarettes are as harmful as cigarettes.¹⁶ Marketing authorization therefore has the potential to change e-cigarette perceptions and interest, depending on how adults who smoke interpret what is meant by authorization. It is also important to consider whether authorization messages could inadvertently lead to misperceptions that those products are “FDA approved” and safe, and unintentionally induce appeal among youth.

Relatedly, persuasion theories posit that communication effects may depend on the perceived message source (and relevant characteristics such as expertise and credibility), characteristics of the message itself and the channel of delivery.¹⁷ As such, potential shifts in e-cigarette perceptions or interest could be influenced by the way and by whom e-cigarette marketing authorizations are communicated. Marketing order letters to authorized manufacturers indicate that marketing materials should not state or imply that the products have been “FDA approved,” but it is unknown how other types of factual statements, for example, that the products have been “authorized for sale by FDA,” may be interpreted. Furthermore, people could potentially hear about authorizations from various sources, including industry ads or press releases. For example, following the FDA’s modified-risk product authorization for General Snus products, ads featuring the modified-risk claim included a preface that it was authorized by FDA.¹⁸ An email to consumers about VLN reduced-nicotine cigarettes described it as “the only FDA-authorized cigarette designed to help you smoke less.”¹⁹ E-cigarette companies could similarly communicate about PMTA authorizations. In fact, prior to any e-cigarette authorizations, business-to-business (B2B) publications had begun carrying e-cigarette advertisements marketing that their “PMTAs were filed and accepted” as unique selling claims, accompanied with graphics resembling stamps and even FDA logos.^20,21 After the e-cigarette brand Logic received an initial set of product authorizations, an email to subscribers announced that: “After five years, many studies and clinical trials and more than 200 000 pages submitted to FDA, we are excited to announce that Logic has received marketing orders for its products.”²² While it has not been proposed to date, it is possible that the FDA could consider allowing authorized e-cigarettes to carry some type of standardized authorization message in the future to distinguish them from e-cigarettes illegally on the market.

The public could also learn about e-cigarette authorizations through the FDA’s own communications, including press releases and subsequent news coverage.^23–25 Previous research has documented the newsworthiness of e-cigarette topics and linked tobacco news coverage with product perceptions among adults and young people.^26–29 Importantly, these communications allow for more detailed information about e-cigarette authorizations, including explanations about the standards met, and that authorization does not mean FDA approval or safety.

This study aimed to examine this emerging research topic with two important populations with regard to assessing the risks and benefits of e-cigarette messaging—adults who smoke and youth.³⁰ We hypothesized that those viewing a news story or ads with messaging about an e-cigarette authorization would have lower product risk perceptions and higher product interest and susceptibility compared to those in a control condition with no authorization messaging. We also explored whether these effects may vary based on prior e-cigarette use given that (1) research has found those with prior use to be more open to and favorable of e-cigarettes^31–34 and (2) it is possible that new FDA claims could nudge interest among those who have been skeptical of trying before. Per our interest in message format and perceived source, we also hypothesized that ads with the FDA claim using an official FDA logo would be perceived as more believable and credible than ads without the FDA logo. Finally, we also aimed to explore people’s interpretation of an “authorized for sale” message.

Materials and Methods

Participant Sample

We conducted an online experiment in June 2022 with a national sample of 866 adults who smoke cigarettes (ages ≥21) and 859 youth (ages 15–20, under legal age to purchase tobacco). Eligibility for adults who smoke (confirmed by screener questions) included having smoked at least 100 cigarettes in their lifetime and now smoking cigarettes every day or some days. There were no criteria for the youth sample other than age (ie, general population sample). Participants were English survey takers recruited from a commercial panel (Ipsos’ KnowledgePanel) designed to be representative of the U.S. population, with panel recruitment through probability-based sampling of U.S. Postal Service addresses (rather than online opt-in membership), and survey weights were used to produce nationally representative estimates.³⁵ Ipsos recruited adults for the current study by inviting a sample of adults ages ≥21 from their panel believed to match the smoking eligibility criteria, and then re-confirming their current smoking status. Youth ages 15–17 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 using a combination of invitations through parents and direct invitations to individuals ages 18–20 in their adult panel. All participants provided informed consent before beginning the survey; consent information described the study as intended to better understand how youth and adults react to different tobacco and e-cigarette ads and messages.

Procedures and Conditions

After completing measures about smoking and e-cigarette history, participants were randomized by the online survey program to one of five study conditions in which they viewed one ad for a fictional e-cigarette brand (named “Legacy”) designed by the study team (to prevent bias from possible preexisting perceptions associated with any existing brands). The control group viewed a simple ad with visuals of pod-style vaping products, a standard nicotine warning label, and ad text that stated “Introducing Legacy. Here to satisfy. Your vape, your way.” The control ad made no reference to the FDA nor FDA authorization. Participants in experimental groups 1, 2, and 3 viewed versions of that ad that included an FDA authorization message at the bottom but which varied in its visual presentation (Figure S1). In experimental group 1 (“plain text claim”), the message stated “Authorized for sale by the FDA” in plain italicized black text. The ad in group 2 (“FDA stamp”) was identical to group 1 but also included an “FDA approved” stamp-style graphic (inspired by ads observed in B2B magazines).^20,21 In group 3 (“FDA logo”), the claim was designed to look more official, and used an FDA logo and a more formal version of the message written out as a full sentence (“This product has been authorized for sale by the U.S. Food and Drug Administration”). Finally, participants in group 4 (“news excerpt”) were asked to read a brief mock news article excerpt (233 words, displayed for minimum of 15 seconds) constructed by our team about Legacy’s authorization (based on FDA’s press release and news coverage of the first e-cigarette authorization,^23–25 see Supplementary Material) before viewing the control ad. The excerpt included an explanation for the authorization (ie, potential reduced exposure benefits for smokers, met “appropriate for the protection of public health” standard) as well as statements indicating that FDA authorization does not mean the product is safe or FDA approved, and that it should not be initiated by nonusers of tobacco.

After viewing the ad stimuli (programmed for a 5-second minimum display time), participants completed survey measures about product interest, susceptibility, and risk perceptions (primary outcomes), FDA message recall, and authorization message perceptions. Lastly, participants were directed to a debriefing page that explained the study design and purpose.

Measures

Primary Outcomes. We measured interest in trying Legacy e-cigarettes by asking “How interested, if at all, are you in trying this product in the next 6 months?” (1 = not at all—5 = extremely interested).^11,36 We measured susceptibility to trying Legacy by asking, “If one of your best friends were to offer you this product, would you try it?” (1 = definitely not—4 = definitely yes), and categorized participants as “not susceptible” if they answered “definitely not,” and “susceptible” if they provided any other response.^37,38

We measured absolute product harm perceptions by asking “How harmful to your health do you think using LEGACY e-cigarettes/vapes would be?” (1 = not at all harmful—5 = extremely harmful).³⁹ We also measured perceived harm to health from using Legacy e-cigarettes compared to (1) smoking “regular cigarettes” and (2) using “other brand/types of e-cigarettes” (1 = a lot less harmful—5 = a lot more harmful).³⁹

Secondary Outcomes. Next, we included items about recall of specific terms and statements (eg, “FDA approved”) from some of the experimental ads, which also served for use in a manipulation check. Then, participants in groups 1, 2, and 3 were asked to view their assigned experimental ad again, to notice the FDA message at the bottom of the ad, and to indicate their agreement (1=strongly disagree – 6=strongly agree) with several perception items about the perceived source of the message, its believability and credibility, and its perceived impact on product safety perception and use interest. To maximize sample size, participants in the control group were randomly assigned to view one of the experimental group ads (1, 2, or 3) that they had not seen before and asked to rate the newly viewed ad. Because we were interested in participants’ perceptions of the three different ads themselves for this particular part of the analysis, we excluded responses from those in group 4, as their ad perceptions may have been influenced by the news article they read (separate results from group 4 are available in Supplementary Tables). Lastly, participants also received an open-ended question that asked: “What do you think it means for an e-cigarette to be ‘authorized for sale’ by the FDA?”

Analysis

This study was not preregistered and thus analyses and results are considered exploratory. We ran weighted linear regression analyses (and logistic regression for the susceptibility outcome) with an experimental condition as the predictor variable, and the control condition set as the referent group to examine effects on the primary outcomes and hypotheses. To explore differences by ever e-cigarette use status (never/ever), interaction terms were added to these models. To examine differences in the secondary outcomes (message perceptions of the three experimental ads), we ran linear regression analyses with experimental ad viewed as the predictor variable and the plain-text claim ad (experimental Ad 1) set as the referent group. Because of differences between the two sample groups (adults who smoke and youth), which were drawn and weighted separately, all analyses were run separately for each group, with a complex sampling procedure, and group respective weights applied. Analyses were run using Stata Version 18.0. For the open-ended measure about the meaning of the “authorized for sale” message, responses were coded (by CW) using a coding guide developed by the research team based on our research interests (eg, misinterpretations that it means the product is “safe” or “FDA approved”) as well as themes identified during iterative review of the responses. Approximately 15% of responses (n = 244) were double-coded (by OW) to assess intercoder reliability (average Cohen’s Kappa = 0.86). Discrepancies between coders were resolved and descriptive statistics were used to summarize results.

Results

Sample Description

Among both the adults who smoke and youth samples, most participants were white and approximately 13% were non-Hispanic Black (Table 1). The average age of adult smokers was 48 (range 21–82) and that of youth was 17.5. Most of the adult smoking group smoked daily (76.4%), and 17.4% of youth had ever smoked a cigarette. Over half of the adults who smoke (53.6%) and 24.2% of youth had ever tried an e-cigarette before, while fewer (14.9% and 11.0%, respectively) had used one in the past 30 days.

Table 1.

Participant Demographics, by Sample Group

	Adult smokers (n = 866)		Youth ages, 15–20 (n = 859)
	%	95% CI	%	95% CI
Sex
Male	54.0	50.2 to 57.8	50.4	46.4 to 54.4
Female	46.0	42.2 to 49.8	49.6	45.6 to 53.6
Age categories
18–29	13.8	10.1 to 17.4	—
30–44	30.8	27.4 to 34.3	—
45–59	29.6	26.3 to 32.9	—
≥60	25.8	22.8 to 28.8	—
Average age (SD)	48.4 (14.5)	47.2 to 49.6	17.5 (1.7)	17.3 to 17.6
Race/Ethnicity
White, Non-Hispanic	67.4	63.7 to 71.1	52.1	48.1 to 56.1
Black, Non-Hispanic	13.3	10.9 to 15.7	13.3	10.2 to 16.4
Other, Non-Hispanic	6.8	4.3 to 9.4	4.6	3.0 to 6.2
Hispanic	10.8	8.3 to 13.3	24.5	20.8 to 28.1
2 + Races, Non-Hispanic	1.7	1.1 to 2.3	5.4	3.9 to 7.0
Education
Less than high school	18.9	15.6 to 22.2	—
High school	39.9	36.2 to 43.7	—
Some college	29.8	26.4 to 33.2	—
Cigarette smoking history
Ever smoked cigarette	100	100.0 to 100.0	17.4	14.4 to 20.5
Current established smoker	100	100.0 to 100.0	3.1	1.6 to 4.7
Currently smoke daily	76.4	73.0 to 79.9	0.5	0.1 to 1.0
Currently smoke some days	23.6	20.1 to 27.0	3.7	1.9 to 5.5
E-cigarette use history
Ever tried an e-cigarette	53.6	49.8 to 57.5	24.2	20.8 to 27.7
Used an e-cigarette in the past 30 days	14.9	11.9 to 17.8	11.0	8.4 to 13.6

For adult smokers—there was no significant association between experimental group and age, gender, race/ethnicity, education, ever e-cigarette use, past 30-day e-cigarette use. For youth: Also no difference by age, race/ethnicity, youth, ever e-cigarette use, past 30-day e-cigarette use. Education data was not provided for youth—only parental education was available.

FDA Message Recall

As expected, recall of any reference to “FDA” in the stimuli ads viewed was high (78%–87%) among those in the three FDA authorization ad claim groups and lower among those viewing the control ads (News Excerpt and Control Groups, 26%–28%). Among those in the three FDA authorization ad claim groups, recall of the specific FDA message(s) pertaining to their ad condition was significantly associated with their corresponding conditions (Supplementary Table 1).

Product Interest and Susceptibility

There were no main effects of the experimental group in either sample on interest in trying the advertised e-cigarette, nor on susceptibility to trying it (Table 2). However, among youth, susceptibility varied by ever e-cigarette use status (p = .02). Among youth who were ever e-cigarette users, those in the FDA logo group had significantly higher odds of susceptibility (OR = 6.3, 95% CI: 1.67 to 23.9, p < .01) compared to those in the control group. There were no group differences among youth never e-cigarette users.

Table 2.

Product Interest, Susceptibility, and Harm Perceptions by Experimental Condition and Sample

	Adults who smoke				Youth
	%	OR	(95% CI)	p-value	%	OR	(95% CI)	p-value
Susceptible to product trial (susceptible vs. not susceptible)
Grp 1 (plain text claim)	57.6	1.17	(0.72 to 1.91)	.53	35.8	1.41	(0.82 to 2.44)	.13
Grp 2 (w/ FDA stamp)	52.3	0.94	(0.58 to 1.53)	.81	31.2	1.15	(0.67 to 2.01)	.55
Grp 3 (w/ FDA logo)	58.7	1.22	(0.76 to 1.98)	.41	31.9	1.19	(0.68 to 2.08)	.47
Grp 4 (news excerpt)	60.3	1.31	(0.79 to 2.17)	.30	32.1	1.2	(0.69 to 2.08)	.44
Control	53.7	ref			28.3	ref
Group × ever e-cigarette use interaction				.77				.02
Among ever e-cigarette users
Grp 1 (plain text claim)					76.2	1.70	(0.59 to 4.86)	.33
Grp 2 (w/ FDA stamp)					57.9	0.73	(0.26 to 2.03)	.54
Grp 3 (w/ FDA logo)					92.3	6.32	(1.67 to 23.90)	<.01
Grp 4 (news excerpt)					73.9	1.50	(0.48 to 4.70)	.49
Control					65.4	ref
Among never-e-cigarette users
Grp 1 (plain text claim)					25.1	2.03	(0.96 to 4.29)	.06
Grp 2 (w/ FDA stamp)					21.6	1.67	(0.86 to 3.67)	.20
Grp 3 (w/ FDA logo)					14.4	1.02	(0.45 to 2.31)	.96
Grp 4 (news excerpt)					18.6	1.38	(0.65 to 2.93)	.40
Control					14.2	ref
	Mean (SD)	Beta	(95% CI)	p-value	Mean (SD)	Beta	(95% CI)	p-value
Interest in product (1 = not at all to—5 = extremely interested)
Grp 1 (plain text claim)	1.44 (0.85)	0.02	(−0.21to 0.25)	.85	1.35 (0.81)	0.08	(−0.13 to 0.29)	.47
Grp 2 (w/ FDA stamp)	1.51 (0.93)	0.09	(−0.13 to 0.31)	.42	1.32 (0.69)	0.04	(−0.13 to 0.22)	.64
Grp 3 (w/ FDA logo)	1.48 (0.83)	0.06	(−0.14 to 0.26)	.56	1.31 (0.69)	0.04	(−0.15 to 0.22)	.70
Grp 4 (news excerpt)	1.57 (0.93)	0.15	(−0.07 to 0.36)	.19	1.25 (0.62)	−0.02	(−0.19 to 0.15)	.78
Control	1.42 (0.88)	ref			1.27 (0.65)	ref
Group × ever e-cigarette use				.37				.93
Absolute harm (1 = not at all—5 = extremely harmful)
Grp 1 (plain text claim)	3.60 (0.80)	0.07	(−0.14 to 0.28)	.50	3.86 (1.03)	−0.26	(−0.52 to 0.01)	.06
Grp 2 (w/ FDA stamp)	3.60 (0.91)	0.08	(−0.14 to 0.30)	.49	4.00 (0.92)	−0.11	(−0.35 to 0.13)	.36
Grp 3 (w/ FDA logo)	3.37 (1.05)	−0.15	(−0.39 to 0.08)	.20	4.04 (0.96)	−0.07	(−0.33 to 0.18)	.56
Grp 4 (news excerpt)	3.49 (0.97)	−0.04	(−0.27 to 0.20)	.77	3.99 (1.00)	−0.12	(−0.36 to 0.13)	.35
Control	3.52 (0.96)	ref			4.11 (0.96)	ref
Group × ever e-cigarette use				.58				.29
Relative harm of Legacy vs. cigarettes (1 = much less harmful—5 = much more harmful)
Grp 1 (plain text claim)	3.14 (0.85)	0.05	(−0.17 to 0.26)	.67	3.17 (1.07)	−0.04	(−0.31 to 0.22)	.75
Grp 2 (w/ FDA stamp)	3.10 (1.00)	0.01	(−0.23 to 00.25)	.93	3.10 (0.98)	−0.11	(−0.36 to 0.14)	.39
Grp 3 (w/ FDA logo)	3.02 (1.06)	−0.08	(−0.32 to 0.17)	.53	3.13 (1.01)	−0.08	(−0.33 to 0.18)	.54
Grp 4 (news excerpt)	2.85 (0.97)	−0.24 a	(−0.47 to −0.02)	.04	3.01 (1.09)	−0.20	(−0.46 to 0.06)	.13
Control	3.09 (0.97)	ref			3.21 (0.98)	ref
Group × ever e-cigarette use				.45				.56
Relative harm of Legacy vs. other e-cigarettes (1 = much less harmful—5 = much more harmful)
Grp 1 (plain text claim)	3.14 (0.62)	0.04	(−0.12 to 0.19)	.62	3.26 (0.77)	0.06	(−0.15 to 0.27)	.60
Grp 2 (w/ FDA stamp)	3.11 (0.63)	0.02	(−0.13 to 0.17)	.82	3.22 (0.75)	0.02	(−0.18 to 0.22)	.86
Grp 3 (w/ FDA logo)	3.14 (0.77)	0.05	(−0.12 to 0.21)	.60	3.19 (0.75)	−0.01	(−0.21 to 0.19)	.90
Grp 4 (news excerpt)	3.09 (0.67)	−0.01	(−0.17 to 0.15)	.93	3.20 (.78)	0.00	(−0.20 to 0.20)	.99
Control	3.10 (0.71)	ref			3.20 (0.75)	ref
Group × ever e-cigarette use				.17				.98

^aStandardized Beta (β) = −0.25 (CI −0.47 to −0.02). Bolded values are significant results at p < .05.

Product Harm Perceptions

There were no main effects (nor interactions with ever e-cigarette use) of experimental group on absolute harm perception ratings of the e-cigarette product viewed among either sample group. In terms of relative harm perceptions (of Legacy e-cigarettes compared to regular cigarettes), there were no differences by experimental group for youth. However, among adults who smoke, those in the news excerpt group had significantly lower ratings of the harm of Legacy e-cigarettes versus cigarettes, compared to those in the control group (standardized beta [β] = −0.25, p = .04).

Lastly, there were no significant experimental group differences (nor interactions with ever e-cigarette use) among either sample group in terms of perceptions that Legacy e-cigarettes are less harmful than other e-cigarettes.

FDA Authorization Message Perceptions

Table 3 describes participant ratings of the FDA authorization message in the three experimental ad versions (plain text claim, FDA stamp, and FDA logo). Among both adults who smoke and youth, most agreed that the message looks like it is coming from the e-cigarette company. However, among both sample groups, the FDA logo message received lower agreement that it “looks like it is coming from the e-cigarette company” relative to the plain text claim (β = −0.39 for adults who smoke; β = −0.36 for youth), and, among the adult group, received higher agreement that it “looks like it is coming from the FDA” (β = 0.35, p = .03).

Table 3.

Message Perceptions About the Food and Drug Administration (FDA) Authorization Claim Included on Experimental Ads by Ad Version and Sample Type

	Adult					Youth
Agree that “this FDA message...”	% agree	Mean (SD)	Beta	(95% CI)	p-value	%	Mean (SD)	Beta	(95% CI)	p-value
“looks like it is coming from the e-cigarette company”
Ad 1 (plain text claim)	78.4	4.27 (1.33)	ref			77.3	4.24 (1.39)	ref
Ad 2 (w/ FDA stamp)	77.8	4.29 (1.29)	0.02	(−0.25 to 0.30)	.88	76.5	4.21 (1.31)	−0.03	(−0.35 to 0.28)	.83
Ad 3 (w/ FDA logo)	59.6	3.73 (1.47)	−0.54 a	(−0.84 to −0.24)	<.001	58.2	3.72 (1.61)	−0.52 b	(−0.85 to −0.19)	<.01
Total	72.0	4.10 (1.38)				71.0	4.07 (1.45)
“looks like it is coming from the FDA”
Ad 1 (plain text claim)	42.1	3.21 (1.36)	ref			37.7	3.15 (1.44)	ref
Ad 2 (w/ FDA stamp)	36.6	3.00 (1.46)	−0.21	(−0.50 to 0.08)	.15	40.8	3.11 (1.39)	−0.04	(−0.36 to 0.28)	.81
Ad 3 (w/ FDA logo)	57.0	3.56 (1.56)	0.35 c	(0.04 to 0.66)	.03	50.3	3.39 (1.50)	0.24	(−0.08 to 0.55)	.14
Total	45.2	3.26 (1.48)				42.6	3.21 (1.44)
“is believable to me”
Ad 1 (plain text claim)	46.1	3.21 (1.31)	ref			40.5	3.06 (1.42)	ref
Ad 2 (w/ FDA stamp)	32.8	2.74 (1.40)	−0.47 d	(−0.75 to −0.19)	<.01	25.8	2.52 (1.39)	−0.54 e	(−0.86 to −0.21)	<.01
Ad 3 (w/ FDA logo)	44.7	3.13 (1.40)	−0.08	(−0.36 to 0.21)	.60	43.5	3.07 (1.49)	0.01	(−0.31 to 0.33)	.95
Total	41.3	3.03 (1.38)				36.7	2.88 (1.45)
“is credible to me”
Ad 1 (plain text claim)	38.1	2.94 (1.26)	ref			36.2	2.91 (1.44)	ref
Ad 2 (w/ FDA stamp)	27.2	2.59 (1.35)	−0.36 f	(−0.62 to −0.09)	<.01	21.7	2.43 (1.31)	−0.48 g	(−0.80 to −0.17)	<.01
Ad 3 (w/ FDA logo)	37.0	2.96 (1.38)	0.02	(−0.26 to 0.29)	.91	32.5	2.78 (1.48)	−0.13	(−0.45 to 0.19)	.43
Total	34.2	2.83 (1.34)				30.4	2.72 (1.42)
“makes me think this product is safe to use”
Ad 1 (plain text claim)	41.2	3.01 (1.29)	ref			43.7	2.90 (1.47)	ref
Ad 2 (w/ FDA stamp)	38.6	2.85 (1.51)	−0.17	(−0.45 to 0.11)	.24	37.4	2.79 (1.41)	−0.11	(−0.43 to 0.21)	.51
Ad 3 (w/ FDA logo)	41.7	2.99 (1.47)	−0.03	(−0.31 to 0.26)	.86	42.2	2.89 (1.52)	−0.01	(−0.33 to 0.30)	.94
Total	40.5	2.95 (1.42)				41.2	2.86 (1.47)
“makes me think this product would be safer to use than other ecigs/vapes”
Ad 1 (plain text claim)	44.2	3.07 (1.37)	ref			37.3	2.83 (1.42)	ref
Ad 2 (w/ FDA stamp)	36.5	2.83 (1.45)	−0.24	(−0.53 to 0.05)	.10	35.1	2.78 (1.32)	−0.05	(−0.36 to 0.26)	.75
Ad 3 (w/ FDA logo)	39.7	2.92 (1.41)	−0.15	(−0.45 to 0.14)	.31	37.1	2.77 (1.53)	−0.06	(−0.38 to 0.26)	.71
Total	40.2	2.94 (1.41)				36.5	2.80 (1.42)
“makes me more interested in trying this product”
Ad 1 (plain text claim)	18.5	2.19 (1.24)	ref			14.6	1.96 (1.13)	ref
Ad 2 (w/ FDA stamp)	21.4	2.18 (1.36)	−0.01	(−0.29 to 0.27)	.94	14.6	1.96 (1.13)	0.00	(−0.26 to 0.25)	.97
Ad 3 (w/ FDA logo)	16.6	2.18 (1.32)	−0.01	(−0.29 to 0.27)	.95	11.7	1.83 (1.15)	−0.13	(−0.37 to 0.11)	.29
Total	18.8	2.19 (1.31)				13.7	1.92 (1.14)
“would make me think seriously about completely switching to this product”
Ad 1 (plain text claim)	15.8	2.12 (1.22)	ref
Ad 2 (w/ FDA stamp)	15.7	2.05 (1.28)	−0.06	(−0.34 to .21)	.65
Ad 3 (w/ FDA logo)	14.3	2.10 (1.22)	−0.02	(−0.29 to 0.26)	.89
Total	15.3	2.09 (1.24)

% agreement columns based on dichotomizing of “agreement” (ie, somewhat agree, agree, or strongly agree response) versus disagreement (somewhat disagree, disagree or strongly disagree response). Responses are limited to those in experimental groups 1, 2, 3, and control (n = 1378); results from those in experimental group 4 (news group) are presented in a separate Supplementary Table.

Bolded values are significant results at p < .05. Corresponding standardized beta levels were: ^a β= −0.39 (CI: −0.60 to −0.18); ^b β= −0.36 (CI: −0.59 to −0.13); ^c β=.23 (CI:0.027 to 0.44); ^d β= −.34 (CI: −0.54 to −0.14); ^e β= −0.37 (CI:−0.60 to −0.15); ^f β= −0.26 (CI: −0.46 to −0.07); ^g β= −0.34 (CI: −0.56 to −0.12).

There were also significant associations between experimental ad and perceptions that the FDA authorization message looks like it is (1) believable and (2) credible. For both sample groups, agreement that the FDA authorization message was believable and credible was significantly lower for the ad with the FDA stamp message relative to the plain text claim (β =−0.26 - β =−0.37, p < .01; Table 3).

Notably, approximately 40% of both adults who smoke and youth across the three ad claim versions agreed that the FDA authorization ad message they saw makes them think that: (1) the product is safe to use, and (2) the product would be safer to use than other e-cigarettes, with no significant mean differences by ad version for either perception (Table 3). However, fewer participants (18.8% of adult smokers, and 13.7% of youth) agreed the message makes them more interested in trying the product (with no significant mean differences by ad version).

Message Interpretation

Approximately 97% of participants provided a response to the open-ended question about the meaning of an e-cigarette being authorized for sale by the FDA (n = 1668 responses). About 32% of adults who smoke and 38% of youth made some reference in their response to the idea that the product and/or its ingredients are okay/acceptable to use, safe or “safer” than other products, or not harmful or not very harmful (Table 4). About 23% of all participants provided some explanation that the message means the product can be sold/distributed, about 16% made reference to the product being “approved” in their response (or some other expression of FDA endorsement) and about 12% thought it meant that the product has been tested, evaluated, or reviewed by the FDA in some way. Some participants (11%) expressed skepticism about the message (eg, untrue, just a marketing gimmick) and a minority of participants’ responses (6%) included a more accurate interpretation, indicating that they understood the message did not mean the product was “approved” or safe. About 18% indicated that they did not know what the message meant.

Table 4.

Interpretations of “Authorized for Sale” Message Based on Coded Open-Ended Responses

	Adults who smoke (n = 835)	Youth (n = 833)	All participants (n = 1668)
Safe/safer/okay to use (eg, responses refer to idea that the product and/or its ingredients or risks are “okay,” acceptable to use, safe, not harmful, not very harmful, safer or not worse than other products)	32.4%	38.2% 2	35.3%
Authorized/sale/legal (eg, means product can be sold, allowed to be sold, sale is authorized, can be widely available/distributed; it’s allowed, legal, not prohibited, means “exactly what it says”)	19.8% 1	26.2%	23.0%
Approved/Endorsed (response makes reference to “approval,” eg, FDA approved, approved by FDA, FDA “approved” the sale, or use of other words that suggest FDA endorsement, such as FDA “agrees” with the sale of this product)	15.8%	16.0%	15.9%
Tested/evaluated/regulated (response makes reference to the idea that the product and or its ingredients (including chemicals) have been “reviewed,” “tested,” “evaluated,” or “studied” by the FDA. May also include references to being “regulated” by FDA)	13.8%	11.0%	12.4%
Untrue/Skeptical (response suggests skepticism, including that the authorization claim is not true and/or just a marketing tactic)	13.2%	9.4%3	11.3%
Not Approved/not safe (response makes any reference to product not being or necessarily being “approved” or endorsed, or to not necessarily being safe)	4.9%	6.7%	5.8%
Means nothing (responses that the message “means nothing” or “almost nothing”)	4.8%	1.2%	3.0%
Don’t know/not sure (response indicates person is not sure what the message means)	18.1%	17.8%	18.0%
Other (responses not fitting into any of the categories above, eg, “politics,” “user-friendly”)	8.6%	7.8%	8.2%

Responses could receive all codes that applied (more than one).

Frequency of responses was not significantly associated (p < .05) with experimental conditions except in three instances:

¹Authorized/sale/legal code among adult smokers: Grp 1 (28.0%), Grp 2 (22.2%), Grp 3 (20.4%), Grp 4 (14.5%), Control (12.3%).

²Safe/Okay to Use code among youth: Grp 1 (27.3%), Grp 2 (36.4%), Grp 3 (48.0%), Grp 4 (37.7%), Control (43.2%).

³Skeptical code among youth: Grp 1 (5.3%), Grp 2 (10.4%), Grp 3 (10.7%), Grp 4 (14.4%), Control (6.9%).

Discussion

This study observed some mixed results with respect to a new research topic—the potential effects of exposure to messages about FDA authorization of e-cigarette products. The results of our experiment showed no effects of exposure to an authorization message about a hypothetical new e-cigarette on product susceptibility and interest in trying the product among adults who smoke cigarettes, the primary intended audience for authorized e-cigarettes. However, we did observe an effect on susceptibility among a subset of youth—among youth ever e-cigarette users, exposure to a more official version of the authorization message (including an FDA logo) had a large effect (OR = 6.3)⁴⁰ on product susceptibility. We found no effects of the authorization ad claims themselves on harm perception outcomes in our experimental analyses (only the more in-depth “news” condition impacted relative harm perceptions among adults who smoke). However, upon re-exposure to the stimuli ads and forced attention to the authorization claim, approximately 40% of both adults who smoke and youth agreed that the authorization message (regardless of message style) makes them think that the product is safe to use and would be safer to use than other e-cigarettes. Responses to an open-ended item about the interpretation of the “authorized for sale” message also suggest that at least some people (though not the majority) may take this to mean FDA approval and that certain safety or testing standards have been met.

Taken together, our results suggest that FDA e-cigarette authorization messages may impact harm-related beliefs and interests among some people. If real-world exposure to e-cigarette authorization messages were to result in perceptions that those products were less harmful than cigarettes, this could be considered accurate given that the reduced chemical exposure and potential harm-reduction benefits for adults who smoke have been the underlying rationale for the authorizations thus far.⁴¹ However, any resulting perceptions that such products are “safe” and “approved by FDA” are more likely to be potentially concerning misperceptions, particularly when these perceptions exist among e-cigarette-naïve youth. As such, FDA’s communications should continue to explain the standards used for authorization, which do not follow the same product safety standards used for other drugs and consumer goods.² When conducting PMTA reviews, the FDA may also consider that any potential e-cigarette ad claims referencing FDA authorization may indeed be misinterpreted by some as FDA approval.

Our results also suggest that the effects of FDA e-cigarette authorization messages may be influenced to some extent by the presentation and perceived source of the messages. Indeed, across the three different ad claim conditions, most perceived the claim as coming from the e-cigarette company and the perceived credibility of the claim was fairly low, which may partially explain some of our null experimental findings. This is consistent with previous studies finding health-related messages (eg, cessation ads and modified risk claims) perceived as coming from the tobacco industry to be less credible among audiences than those coming from a government or public health source (based on content or design).^42–44 Only the FDA logo ad claim condition that was designed to look more official resulted in greater product susceptibility among some participants (ie, youth ever e-cigarette users only). A previous cigarette communication study found that inclusion of a FDA logo enhanced the source credibility of a message about cigarette constituents.⁴⁵ The news excerpt condition, which was the only condition that provided a detailed rationale for the authorization, including lower chemical exposure and harm-reduction benefits, was also the only experimental condition that prompted lower relative harm ratings about Legacy e-cigarettes compared to cigarette smoking (a small significant effect, β = −0.25, was observed among adults who smoke). This is consistent with previous research findings that exposure to news about non-cigarette tobacco products can impact beliefs about how harmful those products are compared to cigarettes.^26–28

Real-world effects would also likely depend on the frequency of exposure to e-cigarette authorization messages. To date, we have observed only one instance of marketing materials for an authorized e-cigarette making references to FDA authorization,²² and while the first e-cigarette authorization received news coverage from national news outlets, each subsequent authorization is unlikely to be similarly newsworthy. In our survey, we also asked participants if they had heard of any e-cigarettes being authorized for sale prior to the study, and only 11% of adult smokers and 13% of youth indicated that they had.⁴⁶ Broader awareness that FDA regulates e-cigarettes was also low (25% among adults who smoke).⁴⁶

Study strengths include the use of two important sample groups recruited from a national panel while limitations include a small sample size of ever e-cigarette users among youth (which may have led to limited power in detecting other potentially different effects in this subgroup), as well as the use of a point-in-time exposure to one stimulus ad in each condition from one “brand” (such that findings may be specific to particular stimuli used and be vulnerable to case-category confound bias). Future studies may benefit from using multiple, different message exposures per condition, examining additional types of message wording, detail, and presentation styles, different brands, additional analyses of the impact of media messaging about authorizations, and designs with brief follow-ups after message exposure to allow greater time for message processing. This study also did not measure existing perceived FDA credibility, which may moderate the impact of FDA e-cigarette authorization messages.⁴⁵ Future studies could also consider effects of authorization messages on other potentially relevant audiences such as physicians, who are a trusted source of e-cigarette information^47,48 and who might be more comfortable in discussing e-cigarette products that they know are FDA-authorized with their smoking patients.^49,50

Overall, exposure to messages and claims about FDA authorization of e-cigarettes may impact some beliefs about the harm and safety of these products, as well as susceptibility to try authorized e-cigarettes among some youth. Continued research on ways to communicate the meaning of these authorizations so as to prevent misperceptions, particularly among youth, while promoting accurate interpretations among adults who smoke, may inform FDA communications about past and future product authorizations.

Supplementary material

Supplementary material is available at Nicotine and Tobacco Research online.

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 OAW 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.

Declaration of Interests

The authors have no conflicts or interests to disclose.

Author Contributions

Olivia Wackowski (Conceptualization [lead], Formal analysis [lead], Funding acquisition [equal], Methodology [lead], Project administration [equal], Writing—original draft [lead], Writing—review & editing [equal]), Michelle Jeong (Conceptualization [supporting], Investigation [supporting], Methodology [supporting], Writing—original draft [supporting], Writing—review & editing [equal]), Stefanie K Gratale (Conceptualization [supporting], Methodology [supporting], Writing—review & editing [equal]), Caitlin V Weiger (Conceptualization [supporting], Methodology [supporting], Writing—review & editing [equal]), Julia Chen-Sankey (Conceptualization [supporting], Methodology [supporting], Writing—review & editing [equal]), Andrew Strasser (Funding acquisition [lead], Writing—review & editing [equal]), and Cristine Delnevo (Conceptualization [equal], Funding acquisition [lead], Methodology [supporting], Writing—review & editing [equal]).

Data Availability

Study instrument (survey) and data are available upon reasonable request to the corresponding author.