https://orcid.org/0000-0002-8574-7263
Abstract
Background: Manufacturers of Puff Bar electronic cigarettes (e-cigarettes) and Fre nicotine pouches claim that their products contain synthetic nicotine. The packages for Puff Bar and Fre have modified versions of the warning labels required by the Food and Drug Administration (FDA) for tobacco products, which specify that Puff Bar and Fre products contain “tobacco free” or “non-tobacco” nicotine, respectively. We evaluated whether exposure to these “tobacco free” warning labels was associated with differing perceptions about the products. Method: N = 239 young adult men who were enrolled in a cohort study completed a short online experiment. Participants were randomly assigned to view either packages of Puff Bar and Fre nicotine pouches with the standard FDA warning or packages with the standard FDA warning + the tobacco free descriptor. We compared harm and addictiveness perceptions and products’ perceived substitutability for cigarettes and smokeless tobacco (SLT) by exposure to a “tobacco free” warning. Results: Viewing a Puff Bar package with a “tobacco free” warning label was associated with increased perceived substitutability of the product for cigarettes and smokeless tobacco (p’s<.05). Viewing a Fre package with a “non-tobacco” warning label was associated with thinking the product was less harmful than SLT (p<.01). Conclusions: “Tobacco free” descriptors in warning labels for e-cigarettes and nicotine pouches affect young adults’ perceptions of the products. To date, it is unclear whether the FDA will continue to permit “tobacco free” descriptors in warning labels. As e-cigarettes and nicotine pouches are increasingly marketed with “tobacco free” language, urgent action is needed.
Introduction
On March 15, 2022, the United States Congress gave the Food and Drug Administration (FDA) authority to regulate tobacco products that contain synthetic nicotine (Consolidated Appropriations Act, Citation2022). This legislation closed a loophole that permitted some electronic cigarette (e-cigarette) and oral nicotine pouch manufacturers to avoid FDA oversight by claiming that their products used synthetic (rather than tobacco-derived) nicotine. The e-cigarette manufacturer, Puff Bar, was perhaps the most notable tobacco company to exploit this synthetic nicotine loophole. After the FDA issued a Warning Letter to Puff Bar citing its disposable e-cigarettes’ lack of premarket authorization, the company re-introduced its products to the market with claims that its products contained tobacco free, synthetic nicotine and thus were not subject to the FDA’s authority (Jordt, Citation2023; Kong & Krishnan-Sarin, Citation2021). Other companies followed suit, such as Fre, which, similar to Puff Bar, claims its pouches contain synthetic nicotine (Kong & Krishnan-Sarin, Citation2021; Robichaud et al., Citation2019).
Although the synthetic nicotine loophole is now closed, an artifact of manufacturers’ actions during this time remains: Prior to falling under the FDA’s purview, Puff Bar and Fre used modified versions of the FDA warning label on their products. The standard FDA warning label states, “This product contains nicotine. Nicotine is an addictive chemical” (U.S. Food & Drug Administration, Citation2018). Puff Bar modified this warning label on their packaging to state, “This product contains tobacco free nicotine. Nicotine is an addictive chemical” (emphasis added). Fre similarly modified the warning label on their packaging to state, “This product contains non-tobacco nicotine. Nicotine is an addictive chemical” (emphasis added). Notably, both products still use these modified versions of the FDA’s standard warning labels.
Because use of synthetic nicotine in tobacco products is so recent, it is unknown what effect these “tobacco free” warning labels have on consumers. It appears that consumers perceive nicotine pouches that contain synthetic nicotine differently from nicotine pouches that contain nicotine derived from tobacco (Morean et al., Citation2023). Compared to people who have never heard of tobacco free or synthetic nicotine, those who are aware of tobacco free nicotine pouches believe that they are less harmful to one’s overall health (Morean et al., Citation2023). Additionally, those who are susceptible to using nicotine pouches are more likely than those who are not susceptible to report that tobacco free nicotine pouches are less harmful to one’s overall health, as well as less addictive (Morean et al., Citation2023). Similar associations hold for perceptions of tobacco free e-cigarettes. Exposure to “tobacco free” language in e-cigarette product descriptions has been associated with reduced harm perceptions (Chen-Sankey et al., Citation2021), and those who are curious about using tobacco free e-cigarettes hold lower perceptions of their addictiveness (Camenga et al., Citation2022).
Research has focused on the effects of “tobacco free” language in product descriptions, but it is unknown what effect viewing warning labels that describe a product’s nicotine as “tobacco free” might have on consumer perceptions. To our knowledge, the FDA has not warned Puff Bar or Fre against using these warning labels that include “tobacco free” language. Accordingly, we evaluated whether “tobacco free” language in warning labels on Puff Bar and Fre nicotine pouch packages affected young adults’ perceptions of the respective products. Using a randomized experiment, we hypothesized that viewing “tobacco free” language in the warning (vs. the FDA’s standard nicotine warning) would be associated with reduced harm and addiction perceptions.
Materials and methods
Setting and participants
In July and August 2021, 239 young adult men who were enrolled in a cohort study completed an online survey (N = 688 invited; 34.7% response rate) (Friedman et al., Citation2018). Only males were included in the parent study because it focused on smokeless tobacco (SLT) use (Gentzke et al., Citation2020). Participants were enrolled into the cohort using in-person interviews in 2015-2016, were between the ages of 11 and 16 years at baseline, and lived in a non-Appalachian urban Ohio county or one of nine Appalachian Ohio counties. Participants who were at least 18-years-old were recruited via email for the current study. All methods were approved by The Ohio State University’s Institutional Review Board.
Procedures
After providing informed consent, participants completed an online survey. All participants viewed one image of a Puff Bar package and one image of a Fre nicotine pouch package. For the Puff Bar package (viewed first), participants were randomly assigned to view either an image with Puff Bar’s “tobacco free” warning label or an image with FDA’s standard nicotine warning. For the Fre package (viewed second), participants were randomly assigned to view either an image with Fre’s “non-tobacco” warning label or an image with FDA’s standard nicotine warning. The FDA’s standard nicotine warning states: “This product contains nicotine. Nicotine is an addictive chemical.” After viewing the product image for at least 10 s, participants completed self-report measures.
Measures
Exposure variables were viewing a “tobacco free” message in a Puff Bar or Fre warning label (yes vs. no for each product).
Outcome measures included perceived substitutability for other tobacco products and harm and addiction perceptions. Substitutability for cigarettes and SLT was assessed by asking participants if they thought the e-cigarette/nicotine pouch could be used as a substitute for cigarettes/SLT for people who smoke/use SLT (1: Definitely not to 7: Definitely yes) (Mays et al., Citation2023). Several harm and addiction perceptions items were assessed. Participants reported their perceived chance of becoming addicted to nicotine if they used the product (1: No chance to 7: Certain to happen). Participants reported how harmful they thought the product would be to their health and how addictive the product would be, respectively. Responses were collapsed to “Not at all to somewhat” and “Very” harmful/addictive categories due to skewed distributions. Finally, participants reported perceptions of the relative harm and addictiveness of e-cigarettes/nicotine pouches to cigarettes and SLT. Responses were collapsed to “less,” “about the same,” and “more.”
Covariates included age (years); past 30 day use of tobacco, including cigarettes, e-cigarettes, cigars/cigarillos, SLT, snus, nicotine pouches, hookah, and other (yes vs. no); peer tobacco use (“none” vs. “a few or more”); race and ethnicity (non-Hispanic white vs. all other), parental education (less than Bachelor’s degree vs. Bachelor’s degree or higher), household tobacco use (lived with an adult tobacco user during adolescence vs. did not), and region of Ohio (Appalachian vs. non-Appalachian urban).
Statistical analysis
We calculated descriptive statistics for all variables, both overall and by e-cigarette and nicotine pouch exposure groups. We additionally compared distribution of covariates between the full invited sample and the survey respondents. Next, we checked for balance in covariates according to randomization using Wilcoxon rank sum tests and chi-square tests. Finally, we used Wilcoxon rank sum tests, chi-square tests, or Fisher’s exact tests to evaluate whether distributions of outcomes differed by exposure to “tobacco free” language in the warning label. An alpha of 0.05 indicated statistical significance. Stata/SE version 17 was used for analyses.
Results
Participant characteristics
Participants were 20.2 (SD = 1.3) years-old on average, 81.2% were non-Hispanic white, and 36.8% lived in Appalachian Ohio (). Over 20% used tobacco or nicotine products in the past 30 days, including 13.7% who used e-cigarettes and 2.6% who used nicotine pouches in the past 30 days. All characteristics were balanced by randomization.
Table 1. Participant characteristics and perceptions of Puff Bar e-cigarettes and Fre nicotine pouches according to warning label contents, Ohio, 2021.a
Overall, characteristics of survey respondents were similar to the full invited sample, with the exception of parental education and household tobacco use (). Descriptively, survey respondents were more likely than the full invited sample to have parents with a Bachelor’s degree or higher (72.8% vs. 58.9%, respectively) and less likely to have lived with an adult tobacco user during adolescence (21.8% vs. 29.4%, respectively).
Effects of “tobacco free” language in the warning label on product perceptions
Viewing the Puff Bar package with the “tobacco free” warning (vs. the standard FDA nicotine warning) was associated with considering the product more substitutable for cigarettes and SLT (). There were no statistically significant associations between viewing the Puff Bar “tobacco free” warning and harm and addiction perceptions.
Table 2. Perceptions of Puff Bar e-cigarettes and Fre nicotine pouches according to warning label contents, Ohio, 2021.Table Footnotea
Viewing the Fre package with the “non-tobacco” warning label (vs. the standard FDA nicotine warning) was associated with being more likely to perceive nicotine pouches as less harmful than SLT (). There were no statistically significant associations between viewing the Fre “non-tobacco” warning and substitutability or other harm and addiction perceptions.
Discussion
We examined the effects of “tobacco free” language in a warning label for e-cigarettes and nicotine pouches on perceptions of each product in a sample of young adult men. Viewing a Puff Bar package with a “tobacco free” warning label was associated with increased perceptions of Puff Bar’s substitutability for cigarettes and SLT. Although the long-term health effects of e-cigarettes are unknown, e-cigarette aerosols contain lower levels of known irritants and toxicants than cigarettes (Goniewicz et al., Citation2014), and exclusive e-cigarette users have lower levels of biomarkers of toxicant exposure than cigarette smokers (Hecht et al., Citation2015). Thus, increasing perceived substitutability of e-cigarettes for cigarettes or SLT could be a public health benefit if such changes in perceptions can be accomplished without misleadingly suggesting synthetic nicotine e-cigarettes are known to be less harmful than e-cigarettes containing tobacco-derived nicotine—and if the changes in perception translate to complete switching from cigarettes or SLT to e-cigarettes. We did not directly assess whether participants thought of substitutability in the same way as cigarette or SLT cessation, however, so further research could contextualize our findings.
Viewing a Fre nicotine pouch package with a “non-tobacco” warning label was associated with being more likely to think that Fre is less harmful than SLT. These results align with other work describing reduced harm perceptions of tobacco free nicotine pouches (Morean et al., Citation2023). With a similar toxicant profile to nicotine replacement therapy, nicotine pouches carry a much lower toxicant burden than SLT (Azzopardi et al., Citation2021). Our results suggest that the “non-tobacco” qualifier in the Fre warning label helped participants correctly place nicotine pouches at the reduced-harm end of the tobacco products harm continuum. Among adults, reduced harm perceptions are associated with tobacco product initiation (Elton-Marshall et al., 2020), and thus Fre’s modified warning labels could potentially increase Fre use. As SLT users are among the most likely to use nicotine pouches (Hrywna et al., Citation2022), the use of “non-tobacco” in Fre’s warning label could help improve public health if the “non-tobacco” messaging can be provided without misleadingly implying synthetic nicotine pouches are known to be less harmful than tobacco-derived nicotine pouches—and a substantial portion of SLT users switch to using nicotine pouches. Testing the role of “tobacco free” descriptors in warning labels on switching from SLT to nicotine pouches would clarify the public health effects and appropriate regulatory action related to these warnings.
Limitations of this study include having an exclusively male, Ohio, and young adult sample, which limit generalizability of findings. The low response rate might have led to bias in our estimates. Additionally, as all participants saw the Puff Bar package before the Fre package, it is possible that order effects influenced how participants responded to the Fre package. Finally, a one-time, brief exposure to the “tobacco free” warnings might not have been enough to influence participants’ perceptions about the products.
Conclusion
Puff Bar and Fre products are marketed as containing synthetic, rather than tobacco-derived, nicotine. We identified that viewing these products’ packages with “tobacco free” language added to the standard FDA nicotine warning label was associated with differences in perceptions about the products. Given the continued popularity of e-cigarettes and the rapidly-increasing popularity of nicotine pouches (Ali et al., Citation2020; Delnevo et al., Citation2021; Marynak et al., Citation2021), as well as the effects of “tobacco free” marketing, the FDA and other regulators should clarify their approaches to synthetic nicotine products. Such clarifications could specify if or when “tobacco free” language is truthful and non-misleading in a warning label, what exact language is acceptable, and in what circumstances FDA considers such language to be modified risk claims that FDA must authorize.
Declaration of interest
The authors declare that they have no conflict of interest. The authors alone are responsible for the content and writing of the article.
Data availability statement
The data that support the findings of this study are available from the corresponding author, BKH, upon reasonable request.
Additional information
Funding
References
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