In a groundbreaking move, FDA has kicked off the year with its very first marketing authorization for an oral nicotine pouch product. On January 16, 2025, FDA authorized twenty ZYN nicotine pouch products, marketed by Swedish Match (a subsidiary of Philip Morris International), in two nicotine strengths, 3 mg and 6 mg. The newly authorized pouches come in the following flavor varieties, none of which are tobacco-flavored: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen. Prior to this, FDA had issued marketing granted orders (“MGOs”) for other flavored oral tobacco products such as Swedish Match’s snus (mint smokeless tobacco) in 2015, and VERVE nicotine mints and chews in 2021 (which is not currently being marketed).

Section 910 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, requires that for a product to receive a MGO, FDA must determine that permitting the product to be marketed would be appropriate for the protection of the public health (“APPH”). In making this determination, FDA is required to consider the risks and benefits to the population as a whole, including users and nonusers of tobacco products, and taking into account, among other things, the likelihood that those who do not use tobacco products will start using them. In doing so, FDA weighs any potential negative public health impacts (e.g., harm from initiation and use among nonusers, particularly youth) against the potential positive public health impacts (e.g., benefit from adult smokers completely switching or significantly reducing combustible cigarette use). For the APPH standard to be met, the benefits must outweigh the risks.

Actual use/switching, along with consumer perception and intentions study data, were, as FDA puts it, “key considerations” for issuing the marketing authorization for the Zyn pouches. Specifically, the Zyn Premarket Tobacco Product Application (PMTA) provided data from a 10-week prospective patterns of use study, in which participants recorded their daily tobacco product use, as well as a retrospective survey. The patterns of use data showed that nearly one-quarter of study participants using Zyn (i.e., 83 of 346) had completely switched from other tobacco product use to exclusive use of Zyn by the end of the study. These data were not differentially affected by characterizing flavor. In addition, data from the retrospective survey showed that prevalence of cigarette and moist snuff use declined after study participants began using the new products. Another key line of evidence supporting FDA’s APPH finding came from the applicant’s consumer perception and intentions study. The likelihood of use study sought to characterize participants’ perceptions and intentions towards using and purchasing Zyn. These study data supported that adults over the age of 24 who smoke cigarettes and intend to quit exhibited the highest intentions to purchase Zyn and that, by comparison, intentions to purchase Zyn was low among former and never tobacco users. Specifically, former and never-tobacco users reported low to no intention to purchase the products, and the majority found the products “not at all appealing.” Study data also demonstrated that nearly half of the adults who currently smoke cigarettes with intentions to quit found the new products’ variety of flavors to be “very or extremely appealing.”

Notably, the Zyn marketing authorization demonstrates that oral pouch applicants can make an APPH finding without having to assess comparative efficacy of their flavored products relative to a tobacco-flavored version of that product. Thus, despite FDA’s contentions in litigation, where it recently argued before the Supreme Court that the so-called “comparative efficacy” study was a statutory requirement (and thus, would apply to all flavored nicotine products, not just ENDS), FDA did not require a comparative efficacy study here, based on the published Order Letters and Decision Summaries.

With respect to flavors, FDA noted that the majority of the new products include characterizing flavors that are common in smokeless tobacco products (e.g., Cool Mint, Peppermint, Spearmint, and Wintergreen) and are not novel flavors likely to increase appeal to youth. Specifically, FDA stated that the new products include flavors that are common to the flavor varieties of smokeless tobacco products, as well as nicotine gum products authorized as nicotine replacement therapy (NRT). FDA concluded that the availability of the new products with these characterizing flavors contributes to the overall likelihood that users of more harmful products like cigarettes and moist snuff may be interested in trying and potentially switching to Zyn. FDA also stated that it expected youth initiation of Zyn to be relatively low based on the totality of the evidence related to appeal and intentions to use the new products. Further, FDA concluded that, while it views non-tobacco flavored tobacco products as being more appealing to youth than tobacco-flavored tobacco products, the concern about the appeal of flavors to youth is currently “partially alleviated” by the low overall nicotine pouch use rates by youth (which again indicates that the comparative efficacy study is not rooted in the statute). As part of its evaluation, FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches. This was further supported by the consumer perceptions and intention study, in which roughly half the respondents who currently smoke with intention to quit found the variety of flavors to be “very or extremely appealing,” leading FDA to conclude that “[t]e fact that the new products come in a variety of characterizing flavors is appealing to current tobacco product users.”

Lower toxicological risk was another significant consideration in FDA’s APPH finding. The overall toxicological risk to the users of Zyn was found to be lower compared to cigarettes due to significantly lower harmful and potentially harmful constituents (HPHCs) of the new products compared to moist snuff and snus products, including the General Snus products for which FDA has issued marketing orders. Overall, among the 42 HPHCs analyzed in the Zyn pouches, levels of 36 were too low to be quantified. FDA’s toxicology review also concluded that adults who smoke and switch completely to Zyn are expected to experience a reduced risk of cancer, respiratory toxicity, and cardiovascular toxicity. In addition, based on evidence suggesting the potential for reduction in lung cancer risk following significant reduction in cigarettes-per-day (CPD), FDA concluded that Zyn may also pose a benefit to adults who switch and significantly reduce their cigarette use. Despite these reduced harm implications, FDA was careful to caution in its MGO announcement that the authorization does not allow the company to make reduced risk claims, which would require a separate modified risk tobacco product (“MRTP”) authorization. 

Finally, FDA also found the abuse liability (i.e., the ability of the new tobacco product to promote continued use, addiction, or dependence) of the Zyn pouches to be lower than combusted cigarettes and similar to smokeless tobacco products.

Through the studies and assessments described above, PMI was able to demonstrate that through use of Zyn a substantial proportion of adult tobacco users were able to completely switch away from more harmful tobacco products to Zyn and that current tobacco users showed the highest intention to purchase Zyn. Collectively, findings from these studies, NYTS results, and other factors, such as lower-levels of HPHCs, helped to inform FDA in weighing the population-level benefits of Zyn against the potential risks of the product, leading to an APPH determination.