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Under the Food, Drug and Cosmetic Act (FD&C Act) all tobacco manufacturers and importers are required to report the levels of harmful and potentially harmful constituents (HPHCs) found in their tobacco products and tobacco smoke. In 2012, the Food and Drug Administration (FDA) included in the Federal Register a list of 93 HPHCs suspected to be found in tobacco products and tobacco smoke.  To support the Family Smoking Prevention and Tobacco Control Act, the National Institute of Standard and Technology (NIST) has recently developed a new cigarette tobacco filler standard reference material (SRM) 3222, at the request of the FDA Center for Tobacco Products (CTP).  The focus of the tobacco filler SRM was to provide the FDA with a material with certified and reference concentration values of nicotine and several nitrosamines in tobacco, to support enforcement of existing regulations and future legislation.


Recently, NIST efforts have focused on the development of a new candidate Reference Material (RM) 8112 (Tobacco Smoke Condensate Solution). Analytical laboratories continuously measure targeted analytes in their cigarette smoke. Candidate RM 8112 is under development for use as a cigarette smoke condensate control material. Because analyte levels are associated to the solution material and not a specific tobacco or smoking regime, measurement issues can be isolated to either the analytical method or smoking machine. Additionally, the new reference material will have the capability to easily be adopted for method development studies. RM 8112 will include smoke condensate samples including two ampoules of a low-nicotine and two ampoules of a high-nicotine smoke condensate solution.

Created June 26, 2020, Updated August 17, 2020