INTRODUCTION
The prevalence of e-cigarette use among US young adults has increased in recent years. E-cigarette use prevalence in the past 30 days among this population was 13.7% in 2017 and soared to 23.7% in 20221. This high prevalence warrants attention given that over half of young adults who reported e-cigarette use in recent years were those who had never smoked cigarettes1. Initiating e-cigarette use in young adulthood increases the risk of nicotine addiction, respiratory issues, and harm to the developing brain from nicotine exposure2. Additionally, e-cigarette initiation may lead to a more harmful form of tobacco use, including smoking cigarettes3. Therefore, young adults who do not use tobacco are a priority population for e-cigarette use prevention. It is important to explore how perceptions of FDA-authorized e-cigarettes for market entry (thereafter, FDA-authorized e-cigarettes), in particular, are perceived by young adults who do not use tobacco and how these authorizations impact e-cigarette use interest.
In 2021, the U.S. Food and Drug Administration (FDA) began authorizing new e-cigarettes for market entry with the purpose of promoting product switching among adults who smoke cigarettes4. E-cigarette companies can receive product authorization for market entry through a pathway called Premarket Tobacco Product Applications (PMTA)5. These applications present data that show whether the proposed e-cigarette product is suitable with respect to the protection of public health. When reviewing the applications, the FDA evaluates the potential risks and benefits of e-cigarette authorization for both those who currently use tobacco and those who do not use tobacco. Specifically, the FDA considers the likelihood that those who use tobacco will switch from their current product to the e-cigarette newly authorized for market entry and the likelihood that those who do not use tobacco will start using the authorized e-cigarette product6. Flavors, product designs, and marketing plans are also evaluated for those applications to understand if young people who do not use tobacco would be more or less likely to begin using the products7. Once an e-cigarette company receives FDA authorization for market entry, the e-cigarette can be marketed and sold in the country, and the FDA will continue to monitor the marketing and sales of the authorized product to see whether they are demonstrating protection to public health5. Since 2021, the FDA has authorized more than 20 e-cigarette products and devices from several brands (Vuse, NJOY, and Logic)8 for market entry and denied authorization to more than 1 million products9. Meanwhile, about 6.7 million new PMTAs were accepted for review as of September 20239.
Despite having a rigorous review process in place, there is limited research regarding whether FDA authorization for market entry may mislead young adults who do not use tobacco to believe that FDA-authorized e-cigarettes are safe to use. This misunderstanding may lead to product experimentation and use, which can increase health risks related to nicotine exposure in young adulthood2. This assessment is crucial because FDA authorization does not imply that the products are deemed safe for use; it only means they are legally permitted to be marketed and sold in the US. Additionally, some researchers raised questions about the FDA’s justification that the benefits of these authorized e-cigarettes for those who smoke outweigh the risk of product initiation among those who do not use tobacco, including young people, asserting that the FDA’s analysis and decision-making for PMTAs should be re-evaluated10,11.
Few studies have assessed awareness, beliefs, and product perceptions surrounding e-cigarette authorization for market entry since the initiation of the PMTA review12-14. Results from two previous studies demonstrate that few participants were aware that e-cigarettes are regulated by the FDA12,14. Additionally, seeing messages or ads for FDA-authorized e-cigarettes was associated with the perception that FDA authorization means product approval or safety among adults who smoke and youth12,14. In contrast, findings from another study, which assessed perceptions of Vuse e-cigarette authorization on Twitter, convey that the general public has more negative than positive views of FDA e-cigarette authorization due to wariness of potential health risks13. In addition to limited research on this topic in general and varying results, there is a need for an in-depth qualitative exploration of FDA-authorized e-cigarette product perceptions and use interest among young adults who do not use tobacco.
To address these research gaps, we conducted one-on-one, in-depth interviews with young adults who do not use tobacco to explore the perceived appeal and use interests of FDA-authorized e-cigarette products. The results from this study can be used to understand the potential unintended consequences of the FDA’s e-cigarette authorization for market entry among young adults who do not use tobacco and inform policy decisions and communication strategies to reduce any such unintended consequences. With potentially more e-cigarettes to be authorized by the FDA through PMTAs in the near future, study results can also be used to help guide the authorization process with the goal of preventing e-cigarette use among young adults who do not use tobacco.
METHODS
Participant recruitment, eligibility, and screening
In-depth interviews (n=25) were conducted between February and July 2023 with young adults, aged 18–29 years, who do not use tobacco in Bethesda, Maryland, USA. Participants were recruited through various online channels, including social media sites (Facebook, LinkedIn, and Instagram) and Craigslist (a website that allows users to post classified advertisements). Participant eligibility criteria were: 1) aged 18–29 years; 2) reporting never experimenting with any tobacco products or never regularly using any tobacco products before and not having used any tobacco products in the past 30 days15; 3) being susceptible to using e-cigarettes (defined as the absence of a firm commitment to not use e-cigarettes)15; and 4) being proficient in reading and speaking English. Those who reported eye movement or alignment abnormalities were deemed ineligible due to an eye-tracking research task unrelated to this study. Eligible individuals were contacted by the study coordinator to schedule an in-person visit to the National Institutes of Health campus in Bethesda, Maryland, USA.
Study procedure and in-depth interviews
Participants provided informed consent at the beginning of the study. Following this, they completed an online survey with questions related to their demographic information and tobacco use history. They then participated in one-on-one, in-depth interviews with a trained interviewer. The interviewer first showed participants an image of several e-cigarette products and their packages (all with tobacco or original flavors) that were authorized for market entry by the FDA at the time of the interview (Vuse Solo, NJOY ACE, Logic Pro, and Logic Power)8. The products and packages were directly obtained from e-cigarette brands’ official websites (Figure 1).
Using a semi-structured in-depth interview guide developed by the research team (Table 1), the interviewer asked questions to gather information on participants’ perceptions of and interest in using FDA-authorized e-cigarette products. The interviewer first asked participants to share what came to their mind when they first heard the phrase ‘FDA-authorized e-cigarettes’. They then asked the participants to make general comparisons between these FDA-authorized products and other e-cigarette products that they had seen in stores and advertisements. They also asked participants to discuss the harms of using FDA-authorized e-cigarettes compared to using other e-cigarette products. Participants were then asked about their interest in using FDA-authorized e-cigarettes in general and how they would compare their levels of interest in using authorized versus other e-cigarettes. Lastly, the interviewer inquired about participants’ interests in using these authorized e-cigarette products and if these products come in other flavors besides tobacco (e.g. fruit, candy, beverages). The interviewer also asked probing questions to gain a comprehensive understanding of participants’ thoughts and perceptions.
Table 1
In-depth interview questions used for current analysis
The interviews were audio-recorded (about 30 minutes) with participants’ consent. After the interview, participants viewed health education materials about the harm of tobacco use and were compensated and dismissed. This study was reviewed by the Institutional Review Board of the National Institutes of Health and determined as exempted research.
Interview data interpretation
This analysis includes interview data from 25 participants. Data saturation was reached around the 25th interview because no additional information emerged from the last few interviews16. Interview audio recordings were transcribed verbatim by a professional transcription company (Ubiqus.com). The transcripts were cross-checked against the recordings by the research team for accuracy. The transcripts were de-identified and imported to Dedoose17, a qualitative data management and analysis tool to prepare for the coding process. The research team used the Braun and Clarke18 6-phase approach to thematic analysis, which was designed based on a constructionist epistemology, to guide the data coding and interpretation process.
Specifically, all members of the research team first familiarized themselves with the data by reading through the transcripts. Three trained coders from the research team first read through five transcripts multiple times to become familiar with the data and to develop an initial codebook consisting of thematic and content codes with definitions. The research team then met to discuss and confirm the completion of the codebook. Two coders then used the final codebook to double-code ten transcripts, reaching a satisfactory average coding agreement across codes (Krippendorff ’s alpha=0.76, percent agreement=89%). After a high coding agreement was established, the two coders separately coded the remaining 15 transcripts. Any coding disagreements were discussed and resolved by the third coder.
All members of the research team then independently identified patterns in the coded data and grouped the data into broad categories. The entire team then met to construct the themes based on the coded data and appropriately addressed the research questions. During this process, the team also named the themes, identified supporting participant quotes that accurately represented each theme, and presented them as a narrative to convey participants’ perceptions of and interests in using FDA-authorized e-cigarettes. All generated themes, their narratives, and their represented quotes were reviewed and agreed upon by the research team before final reporting.
RESULTS
Participant characteristics
Table 2 presents participant characteristics. For biological sex, over half of the participants were female (60%), and less than half were male (40%). Additionally, 16% were aged 18–21 years, 44% were 22–25 years, and 40% were 26–29 years. Self-identified race and ethnicity varied, as 32% of participants were White, 25% were Black, 32% were Asian, and 12% were Hispanic (any race) young adults. Over half of the participants had ever used an e-cigarette before (60%).
Table 2
Participant characteristics (N=25)
| Characteristics | Percent |
|---|---|
| Age (years) | |
| 18–21 | 16 |
| 22–25 | 44 |
| 26–29 | 40 |
| Biological sex | |
| Male | 40 |
| Female | 60 |
| Sexual orientation | |
| Heterosexual | 60 |
| Non-heterosexuala | 40 |
| Race/ethnicity | |
| Hispanic | 12 |
| Non-Hispanic White | 32 |
| Non-Hispanic Black | 24 |
| Non-Hispanic Asian | 32 |
| Non-Hispanic Otherb | 0 |
| Education level | |
| Lower than Bachelor’s degree | 24 |
| Bachelor’s degree | 48 |
| Higher than Bachelor’s degree | 28 |
| Subjective financial status | |
| Comfortable | 56 |
| Meet needs | 44 |
| Just meet needs | 0 |
| Do not meet needs | 0 |
| E-cigarette ever use | |
| Yes | 60 |
| No | 40 |
| E-cigarette marketing exposurec | |
| Never/rarely | 20 |
| Sometimes | 52 |
| Often | 28 |
Interview themes
Detailed interview themes are described below. Table 3 provides representative quotes for each theme labeled with participants’ biological sex and age.
Table 3
Themes and sample responses regarding reactions and perceptions toward FDA-authorized e-cigarettes
Low interest in using FDA-authorized e-cigarettes
Low interest in using FDA-authorized e-cigarettes and e-cigarettes in general
Almost all participants expressed that they were not interested in trying FDA-authorized e-cigarettes mainly because they had no interest in using any type of e-cigarette in general. Some believe that all e-cigarettes, authorized or not, are meant to be used by those who smoke cigarettes. Some participants mentioned that they did not intend to use any e-cigarettes, including FDA-authorized e-cigarettes, because they contain nicotine and are harmful to health. Additional reasons for low use interest, specific to FDA-authorized e-cigarettes, included the unappealing tobacco flavors and product designs, which are discussed in greater detail in later themes. Although the majority shared no interest in using e-cigarette products in general, there were a few participants who expressed interest in trying FDA-authorized e-cigarettes because of perceived low harm and curiosity about what they taste like. The few who expressed more interest mentioned that they believed FDA-authorized e-cigarettes are less harmful to health compared to other e-cigarettes.
Low interest in using hypothetical FDA-authorized e-cigarettes with other flavors
When asked about their interest in using FDA-authorized e-cigarettes if they were to come with other flavors, such as fruit and candy, almost all participants mentioned they would not be interested in using the hypothetical flavored products. Many mentioned again that this is because they simply were not interested in using any e-cigarette products and that there are many harmful chemicals in e-cigarette flavors that may lead to negative health consequences. Many also mentioned that the hypothetical flavored products may be attractive to youth or individuals younger than them because of the strong appeal of flavors. This dampened the interest of these participants because they believed that they would not be a part of the intended target audience and also felt that adding flavors to the products is a trap by the tobacco industry to make young people addicted.
FDA-authorized e-cigarettes are unappealing due to tobacco flavors and product design
Tobacco flavors reduce the appeal of FDA-authorized e-cigarettes
Although participants were not asked specific questions about product flavors in the images during the initial part of the interview, most brought up flavors when describing their first impressions of the FDA-authorized e-cigarettes. Many participants specifically said that the FDA-authorized e-cigarette products in the stimuli ‘seem bland in terms of flavor’. They further explained that these products differ from other e-cigarettes that they have seen people use, which come in ‘a variety of fun flavors’ and are ‘more wildly flavored and pleasant’ compared to the tobacco flavor of these FDA-authorized e-cigarettes. Many participants specifically said that flavors like banana, strawberry, mango, and other fruity flavors sound more appealing than tobacco flavors. Some also mentioned that e-cigarette products with other flavors are more socially acceptable than FDA-authorized e-cigarettes because ‘those don’t smell bad’. Additionally, some stated that the tobacco flavors made it clear to them that FDA-authorized e-cigarettes are primarily meant to target older people and those who smoke, not themselves. A few specified that FDA-authorized e-cigarettes may be favored among and beneficial for those who smoke cigarettes because of the familiar tobacco flavors.
The product design of FDA-authorized e-cigarettes is not visually appealing
Many participants also quickly noticed the differences between the design of the FDA-authorized products in the stimuli compared to other e-cigarettes that they saw in daily life. A majority specifically said that FDA-authorized e-cigarettes are not as ‘visually appealing’ or ‘stylish’ compared to other e-cigarettes due to their ‘limited color range’ and ‘bulky shapes’. Participants also said these FDA-authorized e-cigarettes look similar to ‘office supplies’, ‘computer parts’, ‘thumb drives or flash drives’, and ‘pens and pencils’. Some also mentioned that they did not find FDA-authorized e-cigarettes attractive because they are shaped like traditional cigarettes and believed these products are for those who smoke or older people.
FDA authorization means the authorized products are safe to use
FDA authorization means quality control and a stamp of approval
Many participants interpreted FDA authorization to mean ‘product approval’. Specifically, participants used phrases such as ‘quality control’, ‘vetting process’, and ‘lab testing’ to describe what the FDA authorization process means to them. Some mentioned that from their understanding, the FDA regulates what chemicals and other ingredients go into the approved products and their effects on consumers’ health and safety. Many also expressed that they associated the FDA authorization process with approval and reassurance, especially because people are familiar with the FDA as a credible regulator of commercial products (i.e. drugs and medical devices). Some participants also mentioned that FDA authorization makes the products legal to use, and these authorized products are, therefore, not ‘sold illegally’. However, many participants also stated that they had never heard of the FDA authorizing e-cigarette products, expressed confusion and uncertainty about the authorization process, and mentioned they would like to know more about it. Additionally, a few shared that they were skeptical of the FDA or its authorization process and were surprised that e-cigarettes are being authorized because they believe that all tobacco and nicotine products are harmful to health.
FDA-authorized e-cigarettes are less harmful than other (unauthorized) e-cigarettes
When comparing the FDA-authorized e-cigarettes with other e-cigarettes that they saw in daily life (mostly unauthorized), most participants reported that they perceived FDA-authorized e-cigarettes to be less harmful to health. When asked why, participants often described that authorized products had undergone rigorous testing and review so the FDA could ‘track what’s in the products’ and make sure that there are no ‘harmful chemicals that have long-term health effects’. Participants also perceived FDA-authorized e-cigarettes to be less harmful because they do not have a variety of flavors or are ‘less addictive’. Some also explained that the lack of flavorings made the authorized products less appealing to young people, which may help prevent kids from using the products. Some expressed that FDA-authorized e-cigarettes are less harmful because they are authorized to help smokers quit.
DISCUSSION
To our knowledge, this is one of the first studies to examine perceptions and use interests of FDA-authorized e-cigarettes among young adults who do not use tobacco. Our main finding suggests that the non-tobacco-using young adults in our study have low interest in using FDA-authorized e-cigarette products because they are not interested in using e-cigarettes or any tobacco product. Our results indicate that young adults may have little interest in using FDA-authorized e-cigarettes, especially due to their flavors and product design. Specifically, tobacco flavors and product designs of the authorized products were perceived as unappealing to the participants and contributed to their lack of interest in the products. This is unsurprising considering that sweet flavorings19,20 and colorful packaging21,22 of e-cigarette products are among the most important reasons for e-cigarette initiation and use among young people in the extant literature23. Therefore, based on the study results, the FDA is recommended to continue to evaluate the impact of flavorings and packages on e-cigarette product appeal through PMTAs and post-market surveillance to eventually reduce e-cigarette product use among young people who are new to tobacco products.
We found that many participants lacked knowledge about the FDA’s authorization process for market entry, expressed confusion, and raised questions about what FDA authorization means. Most participants believed that FDA authorization means product approval. Many participants also believed that FDA authorization means that the products were rigorously reviewed and do not contain chemical ingredients (e.g. flavorings, carcinogens) that pose a threat to human health. These findings suggest that FDA authorization may unintentionally miscommunicate approval for product use, which is inaccurate. FDA approval means that the FDA has decided that a product is safe and effective for use24 while authorization for market entry is granted to a product during urgent circumstances and if the benefits of its use outweigh the potential risks25. Therefore, public policy and communication efforts through effective messaging are greatly needed to correct this inaccurate belief because equating these two terms may contribute to misperceptions about the purpose of e-cigarette authorization and the health risks of FDA-authorized e-cigarettes.
Although some participants expressed confusion about the authorization for the market entry process, most claimed that they trusted the FDA in authorizing e-cigarette products and felt that the process was legitimate. Our findings, along with those from previous research, highlight that the public is accepting of the FDA as a tobacco regulator26-28. Relevantly, based on our results, the messages that e-cigarette products are for those who smoke cigarettes to quit may be an effective communication strategy to further reduce the interest in using the authorized products among young adults who do not use tobacco. Therefore, the FDA’s communications on those issues may help the public to further gain trust in the FDA’s authorization of e-cigarette products, reduce use interest among those who do not use tobacco, and promote complete product switching among those who smoke cigarettes.
Despite having trust in the FDA and the authorization for the market entry process, many participants had low interest in using FDA-authorized e-cigarettes because of their firm beliefs about the harms of e-cigarette products, in general. Thus, participants’ high harm perceptions towards e-cigarette products may directly serve to minimize their interest in using e-cigarette products under various hypothetical regulatory contexts. Specifically, although many participants thought that authorized e-cigarette products are less harmful than other (unauthorized) e-cigarette products, these reduced harm perceptions did not transfer to higher interest in using the authorized products. A similar lack of interest was found when asking participants to discuss their interest in using hypothetical authorized e-cigarette products that come with appealing flavors such as fruit and candy. Participants communicated their firm belief that e-cigarettes with flavoring chemicals are particularly harmful to health, even if they are authorized by the FDA. Additionally, we speculate that these harmful perceptions about e-cigarettes in general might be partially attributed to the widespread dissemination of campaigns (e.g. Truth Campaign and Real Cost Campaign) highlighting the harm and addictive potential of e-cigarette use among young people29,30. Further dissemination of these public education messages may reinforce the harmful perceptions of using e-cigarettes among young people who do not use tobacco.
Limitations
The following limitations should be considered when interpreting the study results. First, we recruited a diverse rather than representative sample, although sample representation is not a goal of qualitative work31. In particular, we recruited our study participants from Maryland, a state with the lowest rate of e-cigarette use in the US32. Our study’s sample and their general lack of interest in using e-cigarettes generally may not be reflective of e-cigarette use interests among US young adults overall. It is also possible that participants’ responses about having no interest in using the products were influenced by social desirability bias33 as this was a face-to-face interview on the campus of the National Institutes of Health. Participants may have presented responses that they perceived to be viewed more favorably by the interviewer rather than their actual opinions. Second, the stimuli used in the study only included packages and product images and the fact that those e-cigarettes are authorized by the FDA. Participants’ responses may differ if they received more information that FDA authorization means the products are permitted to be marketed and sold in the US but not approved for use. This lack of mention may have confused the participants between ‘authorization’ and ‘approval’. However, in the real world, it is very likely that young adults will not be given the full information, especially when FDA authorization appears in the news or in commercial marketing materials. Third, participants’ reactions might have been different if the product images were to appear in commercial advertisements with other appealing marketing features, such as human models, nicotine warnings, and price promotions15,34. Lastly, the study did not include a youth sample whose perceptions of FDA authorization of e-cigarettes are also important to assess. Youth may show differential responses to the visual stimuli and the concept of FDA authorization compared to young adult participants.
CONCLUSIONS
Currently, FDA-authorized e-cigarette products may not instigate increased e-cigarette use interests mainly because young adults who do not use tobacco have no interest in using any e-cigarette product in general. Additionally, participants may especially not be interested in using FDA-authorized e-cigarettes because of their unattractive tobacco flavors and designs. Therefore, the FDA is recommended to continue to evaluate the impact of flavorings and product design on e-cigarette product appeal through PMTAs and post-market surveillance to ensure that product authorization for market entry does not instigate use among young people. Additionally, we found that FDA authorization may unintentionally communicate product approval and safety to young adults in our study, but this did not change participants’ interest levels in using any type of e-cigarette product. The FDA should consider public education and communication about the purpose of FDA authorization, including the potential benefits of switching to these products for those who smoke and the potential harms of using e-cigarettes for those who do not use tobacco. More research is also greatly needed to understand whether and how perceptions related to the FDA authorization of e-cigarette products can promote complete product switching among those who smoke cigarettes.
