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Miranda A, Patterson J, Lapolt D, Rumano R, Reynoso A, Berman M, Keller-Hamilton B, Roberts M, Ferketich A, Zettler P. A call for regulatory clarity: “switch” and “quit smoking” marketing among online disposable E-cigarette sellers.HPHR. 2022;61. https://doi.org/10.54111/0001/III1
FDA generally regulates products containing nicotine under its tobacco authorities, unless those products are intended for smoking cessation—in which case, they are regulated as drugs that must be FDA-approved as safe and effective. Accordingly, for e-cigarettes, questions arise about where the line is between a tobacco product intended merely for recreational use and a drug product intended for smoking cessation. Against this background, this Research Letter describes a content analysis of certain claims made by 28 online e-cigarette retailers and argues that our findings suggest a need for additional regulatory clarity about when e-cigarettes are appropriately regulated as smoking cessation drug-delivery devices rather than tobacco products.
Since 2016, FDA has generally regulated e-cigarettes intended for recreational use as tobacco products. This means that e-cigarettes are subject to various tobacco product requirements, including that FDA authorize the marketing of an e-cigarette as “appropriate for the protection of the public health” after considering the product’s impact on both tobacco product users and non-users.1 Now that FDA is no longer exercising enforcement discretion for this premarket authorization requirement, it has received premarket tobacco product applications for almost 6.7 million e-cigarette products.2
At the same time, FDA regulates products intended for smoking cessation as drugs (or drug-delivery devices) that must be FDA-approved as safe and effective for that use, even if such products are e-cigarettes.3 Accordingly, whether an e-cigarette is intended for recreational use or for smoking cessation is key for determining the product’s regulatory path. Even with requirements for tobacco product premarket authorization now being enforced, e-cigarette companies likely prefer their products to be regulated as tobacco products, so they can avoid the onerous drug regulatory requirements applied to smoking cessation pharmacotherapies. Indeed, no e-cigarette company has voluntarily sought to have its products approved as a drug-delivery devices; rather, e-cigarette companies have filed lawsuits to avoid having their products categorized as such.4 And to date, no e-cigarette is FDA-approved as a smoking cessation product.
This, in turn, raises important regulatory questions about how to distinguish claims about recreational e-cigarette use from claims about smoking cessation. For example, after JUUL launched a campaign encouraging smokers to “switch” from cigarettes to JUUL,5 public health groups argued that JUUL was being marketed as—and should be regulated as—a smoking cessation drug-delivery device.6 FDA, however, has suggested that “switch” and “quit” claims are distinct, with the latter category more likely to trigger drug regulation.7
Against this background, in June 2020 we conducted a content analysis of websites for 28 online e-cigarette retailers who were selling disposable e-cigarettes directly to US consumers. At the time, disposable e-cigarettes were becoming popular among adolescents and young adults as well as smokers,8,9 and were not subject to an FDA policy limiting the use of flavors.10 Retailers were identified via a systematic Internet search using popular search engines (Google and Bing) and specific search terms: “e-cigarettes,” “ecigs,” and “vape pen.” Two researchers reviewed websites appearing within the first 5 pages of results to assess whether the online retailers sold directly to US consumers. We reviewed and coded all website advertisements, webpage text and images, and blog posts to identify “switch” language (e.g., “switch to e-cigarettes from cigarettes”), “quit smoking” language (e.g., references to “quitting” or stopping smoking), and smoking cessation disclaimers (e.g. “these products are not smoking cessation products and have not been evaluated by the Food and Drug Administration”).
Of the 28 websites examined, 57.1% (n = 16) displayed “switch” language, such as “instrumental in helping smokers switch the habit for good…” (STIG), and 42.9% (n = 12) displayed “quit smoking” language, such as “Flavors like Pina Colada helped me quit smoking” (Uno by Skol) (Table 1). Of sites including quit language, almost all (n = 11, 91.7%) also displayed switch language. Only 21.4% (n = 6) of all websites in the sample displayed smoking cessation disclaimers, such as “These products are not smoking cessation products and have not been tested as such” (PuffBar).
Table 1. Prevalence and examples of “switch” and “quit” marketing claims on online disposable e-cigarette retailer websites (n = 28)
| n (%) | Examples |
Switch claims | 16 (57.1) | “Posh disposables are making it our mission to help switch adults from the use of cigarettes, as they can be very harmful to your body.” (POSH)
“Our compact pods make switching to cleaner vaping next-gen disposables not just more healthful than cigarettes, but more convenient, too.” (MOJO)
|
Quit claims | 12 (42.9) | “…the STIG disposable pod vaping device is made specifically for smokers to help them quit smoking” (STIG)
“Let’s face it, quitting smoking is hard. Almost everyday, something triggers us to want that cigarette. Crushed Pens were developed to be ready to go, faster than you could light your cigarettes, with a tight draw, satisfying throat hit and that hand to mouth habit we’ve gotten so used to.” (CRUSHED)
|
Cessation disclaimers | 6 (21.4%) | “These products are not smoking cessation products and have not been tested as such.” (PUFFBAR)
“Products sold by Bucephalus Health LLC DBA kJ Laboratories are not smoking cessation products and have not been evaluated by the Food and Drug Administration, nor are they intended to treat, prevent or cure any disease or condition” (THE JONES)
|
Limitations to our study should be noted. For feasibility, we limited our analyses to US e-cigarette retailers identified within the first 5 pages of a systematic internet search, as these sites were most likely to be identified by consumers. However, this approach may have excluded less popular online vendors. We also limited our search to websites selling disposable e-cigarettes, excluding sites selling only cartridge-based e-cigarettes, because of disposable products’ popularity at the time of data collection.8
Study findings suggest a need for FDA to take a clear position on “switch” and “quit smoking” claims emerging in the e-cigarette market. “Switch” and “quit smoking” claims in online e-cigarette marketing are common, likely are not supported by evidence equivalent to that supporting use of FDA-approved smoking cessation drugs, and might mislead people. Additionally, although FDA has suggested that “switch” and “quit” claims are distinct, our research suggests that sellers often make these claims simultaneously and interchangeably. Regulatory clarity on the permissibility of “switch” and “quit” claims in e-cigarette advertising and promotion would be beneficial, and additional research on how consumers understand “switch” claims may be needed to help FDA determine, and clarify, the appropriate regulatory approach for e-cigarettes marketed with such claims.
This study was funded by an Ohio State University Comprehensive Cancer
Center internal grant and supported by the National Cancer Institute of the National
Institutes of Health under award number T32CA229114. The content is solely the
responsibility of the authors and does not necessarily represent the official views of
the National Institutes of Health.
Alexis Miranda is a masters student at the Harvard T.H. Chan School of Public Health at Harvard University. They received their undergraduate degree at The Ohio State University.
Joanne G. Patterson is an NIH NCI-funded Postdoctoral Scholar at The Ohio State University College of Public Health. She previously trained as part of a T32 in Cancer Prevention and Control at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. She received her doctorate degree from University of Tennessee and both of her masters degrees from Boston University.
Devin LaPolt is a masters student at the College of Public Health at The Ohio State University, where she also received her undergraduate degree.
Ruva P. Rumano is a masters student at the College of Public Health at The Ohio State University.
Alexa M. Reynoso is an undergraduate student at the College of Public Health at The Ohio State University.
Micah L. Berman is an associate professor at the Colleges of Public Health and Law at The Ohio State University, and a member of the Cancer Control Program at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. He received his law degree from Stanford University.
Brittney L. Keller-Hamilton is an assistant professor in the Division of Medical Oncology at The Ohio State University, and a member of the Cancer Control Program at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. She received her doctorate and masters degrees from The Ohio State University.
Megan E. Roberts is an assistant professor at the College of Public Health at The Ohio State University, and a member of the Cancer Control Program at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.. She received her doctorate degree at Dartmouth College and completed postdoctoral training at Brown University and The Ohio State University.
Amy K. Ferketich is a professor at the College of Public Health at The Ohio State University, and a member of the Cancer Control Program at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. She received her doctorate and masters degrees at The Ohio State University.
Patricia J. Zettler is an associate professor at the College of Law at The Ohio State University, and a member of the Cancer Control Program at Ohio State’s Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. She received her law degree from Stanford University.
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