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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 77

Stability evaluations of tobacco-free nicotine-containing pouch products

HUBBARD S.; CUNNINGHAM C.K.; SPANN N.D.
Reynolds American, Winston-Salem, NC, USA

Regarding the stability endpoints to support a PMTA submission, Tobacco-Free Nicotine-Containing Pouch Products (TFNCPPs) are generally grouped with other smokeless tobacco products - the same stability endpoints are required by the FDA to support a company’s proposed shelf life. The objective of this presentation is to demonstrate, using different TFNCPPs and packaging types, that the stability endpoints required by the FDA for smokeless tobacco products are specific to products that contain tobacco leaf and may be less relevant for TFNCPPs. Four distinct packages and four styles of Velo-branded products were tested for aerobic microbial count, yeast count, mold count, TSNA, and water activity across several stability studies. The results will be presented, and statistical comparisons made, where possible, to demonstrate, for TFNCPPs specifically, the endpoints required by FDA for evaluating stability over time are unaffected by different packaging styles.