FDA guidance is intended to assist in submitting PMTA 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 Nic Nac Naturals (NNN) lozenges contain synthetic nicotine, xylitol, natural flavors, and binders and are made by mixing all of the ingredients and compressing the lozenge using a tablet press. The use of NNN lozenge products is similar to typical NRT lozenges. In the absence of FDA HPHC guidance for this type of products, NNN has chosen to follow the required HPHC list for portioned smokeless tobacco products. Among tested HPHCs, acetaldehyde, crotonaldehyde, TSNAs, metals and BaP were not detected or below quantitative limits. An insignificant level of formaldehyde was found in a few of the products. Based on the measured daily product consumption, the estimated daily formaldehyde exposure was compared with the oral no significant risk levels (NSRL) by OEHHA-Cal-EPA, minimum risk level (MRL) by ASTDR and the Derived No Effect Level (DNEL) by ECHA. The calculated potential daily exposure of formaldehyde for the NNN lozenge products was 15-27 fold below Cal EPA NSRL value, 5224-9525 fold below ASTDR-MRL and 107-195 fold below DNEL exposure limit. The HPHC excess lifetime cancer risks (ELCR) of the NNN 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 NNN products do not pose a significant risk to the consumers.