Evaluation of novel, oral tobacco-derived nicotine products for HPHCs
VERVE® Discs and Chews are oral, non-dissolvable, tobacco-derived nicotine products. 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, including VERVE® 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 tobacco products, such as VERVE®, as they have for certain other regulated tobacco products. Absent specific guidance from FDA, we measured HPHCs in VERVE® 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 measure HPHCs in VERVE® Discs and Chews products and compare those results 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 other oral tobacco products and comparable HPHC results to the NRT.