Event name:

HPHC ANALYSIS OF SIBERIA AND BULL DOG MODERN ORAL NICOTINE POUCH PRODUCTS

Session Date:

Session Speakers:

Manoj Misra
Ed Carmines
Lise Fraissinet

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 Swedish Smokeless Solutions AB (SSS) product brands, Siberia and Bulldog Pouches, are made by mixing synthetic nicotine with flavors, sweetener, carriers, and pH modifiers. The use of these products is similar to snus. The FDA has not defined an appropriate list of HPHCs for products of this type (belong to Category Other and Subcategory Other). In the absence of guidance, SSS has chosen to follow the required list for portioned smokeless tobacco products. Among tested HPHCs, acetaldehyde, crotonaldehyde, metals, TSNAs levels were either not detected or below quantitative limits. A non-significant level of formaldehyde was found in Siberia and Bulldog products. The estimated daily exposure 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 and the Derived No Effect Level (DNEL) by ECHA. The calculated potential daily exposure of formaldehyde for the SSA products was 2.3-8.6 fold below Cal EPA NSRL, 806-2998 fold below ASTDR-MRL and 17-61 fold below DNEL exposure limit. The HPHC excess lifetime cancer risks (ELCR) of the SSA products were zero for all of the products compared to currently FDA authorized Marketing Granted Order products of 118 for ENDS products and 10,000 for Kentucky 1R6F reference cigarette. In conclusion, insignificant HPHC yields, significant lower exposure potential and negligible lifetime cancer risk, indicate that the SSS products do not pose a significant risk to the consumers.