Comparison of Nicotine and Selected Flavorings Content Between Tobacco-Free and Tobacco-Containing Oral Pouches.

Introduction: Flavored oral tobacco-free pouches (ONPs) are novel products that resemble traditional oral tobacco-containing pouches (OTPs) in design and route of administration. However, ONPs contain nicotine, various additives, and a filler material rather than tobacco leaves. Our study compares nicotine content, release, and form, along with selected flavorings content, between brands of ONPs and OTPs.

Methods: A convenience sample of flavored ONPs (n=10 brands) and OTPs (n=7 brands) were purchased between 2021 and 2023. Total nicotine content in the pouches, nicotine released over 1 hour, isomer ratio (R:S-nicotine), and 33 flavoring chemicals were measured using chromatography methods. Nicotine form (the proportion of nicotine in the protonated versus freebase forms) was calculated after measuring the pH.

Results: Although ONPs contained, on average, 50% less nicotine than OTPs (6.4±3.5 vs. 12.3±8.2mg/pouch, p<0.001), they released similar amounts of nicotine within 5 minutes (ONPs 6.5±3.9 vs OTPs 7.6±3.9 mg/pouch, p=0.422). The nicotine used in ONPs compared to OTPs was primarily freebase (63.4%±25.2% vs. 47.2%±34.4%, p=0.223). Two ONPs contained racemic nicotine, suggesting its synthetic source. Menthol was the most frequently used flavoring chemical in both ONPs and OTPs. Triacetin was the most concentrated flavoring in ONPs (12.7±12.7mg/pouch) and methyl salicylate the most in OTPs (25.1±1.8mg/pouch).

Conclusions: ONPs have a similar nicotine release profile as OTPs but contain a high fraction of the freebase nicotine and a wide range of flavorings. The presence of freebase nicotine and flavorings in ONPs may contribute to differential abuse liability of those novel products compared to OTPs.

Implications: This is the first non-industry study to compare nicotine content, release, form, and select flavoring composition between multiple ONPs and OTPs. These findings have implications if any future modified risk claims for ONPs are considered. Although nicotine content was significantly higher in OTPs than in ONPs, the amount of nicotine released from the pouch was very similar between ONPs and OTPs. While many flavoring chemicals present in ONPs and OTPs are generally recognized as safe (GRAS) for oral consumption, their potential oral health risk in ONP and OTP users has not been evaluated and therefore must be monitored and assessed.