Session: Hphc Analysis 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:

FDA guidance is intended to assist in submitting premarket tobacco product applications (PMTAs) under section 910 of the FD&C Act which include reporting of HPHCs in tobacco and nicotine products and tobacco smoke under section 904(a)(3) of the FD&C Act. The GN Tobacco White Fox Pouches are made by mixing synthetic nicotine with polacrilex and glycerol with inert substrates and adding flavors. The use of these products is similar to snus, the consumer places the product between the cheek and gum. The product belongs to the Category Other and subcategory Other. The FDA has not defined an appropriate list of HPHCs for products of this type. In the absence of guidance, GN Tobacco has chosen to follow the required list for portioned smokeless tobacco products. FDA recommends that companies analyze nine (9) chemicals.

The HPHC analysis was conducted on per pouch and estimated daily consumption basis. Among tested HPHCs, acetaldehyde, crotonaldehyde, cadmium, NNK or NNN levels were either not detected or below quantitative limits. Non-significant levels of formaldehyde and arsenic was found in White Fox products. The estimated daily use levels of formaldehyde and arsenic was compared with the oral no significant risk levels (NSRL) by OEHHA-Cal-EPA and minimum risk level (MRL) by ASTDR. For all White Fox pouch products, the potential daily formaldehyde and arsenic exposure are significantly lower than the NSRL and MRL values thus presents minimal risk to the consumers.