Characterization of on!® nicotine pouches – Part 1: HPHCs
on!® is an oral tobacco-derived nicotine pouch product that does not contain cut, ground, powdered or leaf tobacco. In order to issue market authorization, the U.S. Food and Drug Administration (FDA) must determine whether the on!® nicotine pouches are appropriate for the protection of public health (APPH). We characterize the levels of harmful and potentially harmful constituents (HPHCs) for the portfolio of on!® nicotine pouches to inform the determination of APPH.
FDA has not issued specific guidance for reporting HPHCs for oral tobacco-derived nicotine products, such as on!® nicotine pouches. Absent specific guidance from FDA, the abbreviated list of HPHCs in on!® nicotine pouches was measured according to the guidance for smokeless tobacco products, recognizing that these products do not meet the statutory definition of a smokeless tobacco product. The HPHCs evaluated included nicotine, NNN, NNK, B[a]P, acetaldehyde, formaldehyde, crotonaldehyde, cadmium and arsenic. The objective of this work was to determine HPHCs in on!® nicotine pouches and compare those results to commercially available tobacco products such as cigarettes, smokeless tobacco including snus, and an oral nicotine replacement therapy (NRT) product. Except for nicotine, it was observed that there were either no detectable levels or significant reductions in HPHCs when compared to traditional combustible and smokeless tobacco products, including snus, and comparable results relative to the NRT.