The storm had brewing for a couple of years, gaining traction when in late November 2022, Philip Morris acquired Swedish Match for its popular NP brand, Zyn. Last January Tobacco Insider questioned whether Swedish Match would be for Philip Morris International (PMI) what Juul was for Altria. Fast forward two months, and PMI is facing a significant legal challenge in the US for its ZYN nicotine pouches, with the first major lawsuit alleging addiction and harmful effects.
Is this history repeating itself?
The plaintiff claims that ZYN delivers more nicotine than cigarettes, causing addiction, dental issues, cognitive problems, cardiovascular injuries, gastrointestinal problems, and gum disease. The lawsuit seeks class-action status, accusing PMI and Swedish Match of failing to warn about these risks. The case draws parallels with the legal actions against Juul Labs, which eventually led to Altria’s settlement of $235 million.
Moreover, following complaints about the high number of young influencers marketing the NPs on social media, the US Senate Majority Leader is calling for investigations into ZYN’s marketing practices and health effects. If things are to proceed according to plan, PMI expects significant revenue from ZYN, projecting a threefold increase in the US nicotine pouch category by 2030, at an estimated $3.5 billion. However, uncertainties related to regulatory approval and potential litigation pose risks to PMI’s ambitious plans.
What does science tell us?
The study, “A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products,” is a randomized crossover clinical study, where researchers assessed the nicotine pharmacokinetics of an oral nicotine pouch (NP) compared to traditional nicotine replacement therapy (NRT) products, specifically nicotine gum and lozenge.
The study involved 34 healthy adult smokers, who had their nicotine levels measured following a specific administration schedule of the tested products. The participants were also given a questionnaire to rate their satisfaction with the three different products.
The study found that the NP, gum, and lozenge all had mean Cmax (maximum concentration) values of 8.5, 4.4, and 8.3 ng/mL, respectively. The AUC0-T (area under the concentration-time curve) values were 30.6, 14.3, and 31.5 ng*h/mL for NP, gum, and lozenge, respectively. These results indicated that the NPs showed similar nicotine bioavailability to the lozenge and superior bioavailability compared to the gum.
Moreover, NPs demonstrated greater product satisfaction compared to the lozenge, as evidenced by more positive responses to subjective satisfaction questions. All three products were considered well-tolerated, with the incidence of minor adverse events being lower for the NP (18.2%) than for the lozenge (33.3%) or gum (18.8%). In conclusion, the study suggests that nicotine pouches may offer smokers an equally safe, yet more satisfying alternative nicotine source compared to traditional NRTs.
Meanwhile, the legal challenges and regulatory uncertainties surrounding ZYN raise questions about PMI’s acquisition of Swedish Match and its foray into the smokeless category. The comparison with Altria’s association with Juul suggests potential risks associated with marketing practices and regulatory environments. PMI’s growth projections for ZYN beyond 2026 may face obstacles, especially if unfavorable regulatory conditions emerge internationally.
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