A Call for Regulatory Clarity: “Switch” and “Quit Smoking” Marketing among Online Disposable E-Cigarette Sellers

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).