The FDA’s authorization for the sale and marketing of Zyn flavored nicotine pouches marks a significant step toward recognizing that alternative tobacco products may be less harmful than cigarettes. Based on the Premarket Tobacco Product Application (PMTA) submitted by Zyn, it was determined that Zyn nicotine pouches are appropriate for the protection of public health (APPH).
The information provided in Zyn’s PMTA included details on product chemistry, microbial profiles, the manufacturing process, shelf-life stability studies, and both non-clinical and clinical data, along with a 10-week consumer perception study.
In this decision, the FDA acknowledged that the risks associated with the sales and marketing of Zyn products, particularly for vulnerable populations, outweighed the benefits for current smokers seeking less harmful tobacco alternatives. This conclusion is supported by recent data from the 2024 National Youth Tobacco Survey, which reported that the prevalence of nicotine pouch use among youth was 1.8%, making it the least used tobacco product. This was followed by cigarettes at 1.4%, cigars at 1.2%, smokeless tobacco at 1.2%, other oral nicotine products at 1.2%, heated tobacco products at 0.8%, hookahs at 0.7%, and pipe tobacco at 0.5%.
In contrast, e-cigarettes emerged as the most commonly reported tobacco product used by youth, with a prevalence of 5.9%, which is 4.1% higher than that of nicotine pouches.
Between 2023 and 2024, the estimated number of students reporting current use of any tobacco product decreased from 2.80 million to 2.25 million. E-cigarette use fell from 2.13 million to 1.63 million, while hookah use dropped from 290,000 to 190,000. Among high school students, the current use of any tobacco product decreased from 12.6% to 10.1%, with e-cigarette use declining from 10.0% to 7.8%. No statistically significant changes occurred among middle school students. Evidence-based strategies can effectively help prevent the initiation and promote the cessation of tobacco product use among youth in the U.S.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review