Session: In Vitro Toxicological Assessment Of White Fox Modern Oral Nicotine Pouch Products

Speaker: – Manoj Misra, Ed Carmines, Chris Woodruff and Lise Fraissinet

Date: September 8th, 2024 – Atlanta, GA

About The Poster:

In vitro toxicological assessment of Modern Oral Nicotine Products (MONP) is an essential part of the US FDA’s premarket tobacco product application (PMTA) process. The in vitro toxicological assessment of a MONP pouch product was conducted using a battery of well-established regulatory assays, including the Bacterial Reverse Mutation (Ames), In Vitro Micronucleus (ivMN) and Neutral Red Uptake (NRU) assays to assess mutagenicity, genotoxicity, and cytotoxicity, respectively. The GN Tobacco White Fox Pouches are made by mixing nicotine polacrilex and nicotine in glycerol with inert substrates and adding flavors. The principal difference between the tested products is the amount of nicotine.

The tested products contained different nicotine levels (10-19 mg/pouch). The MONP pouch products were extracted with dimethyl sulfoxide (DMSO) and extracted samples were used for toxicological assessment within the time frame of established extract stability by nicotine analysis. For toxicology assays, the dose-dependent effect of extract was conducted with the product with highest amount of nicotine per pouch and other products with lower amount of nicotine per pouch was tested only at the top dose.

Under the experimental conditions and based on the established criteria for evaluation of various assays, no cytotoxicity, mutagenicity nor genotoxicity was observed for any of the GN Tobacco White Fox pouch MONP products