In May 2016, the U.S. Food and Drug Administration (FDA) issued a final rule to deem e cigarettes, cigars and all other tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Manufacturers of regulated tobacco products are required to report to FDA quantities of harmful and potentially harmful constituents (HPHCs) by November 8, 2019. FDA has not issued specific guidance for reporting HPHCs for novel oral tobacco products, such as those containing tobacco derived nicotine, as they have for certain other regulated tobacco products. In the absence of specific guidance from FDA, we measured HPHCs in VERVE^® (oral, non-dissolvable, tobacco derived nicotine products) according to the requirements for smokeless tobacco, recognizing that these products do not meet the statutory definition of a smokeless tobacco product. The objective of this work was to modify and validate existing analytical methods to measure HPHCs in two product variants. An overview of the challenges and solutions that transpired during method development and validation for these unique matrices is provided. Also, the HPHC results are compared to other commercially available oral tobacco products and an oral nicotine replacement therapy (NRT) product. Results show the absence of detectable levels or significant reductions in HPHCs compared to traditional oral tobacco products and comparable HPHC results to the NRT.