Modification of standardized methods for the measurement of nicotine in very low nicotine content cigarettes
In March 2018, the U.S. Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking (ANPRM) for a nicotine product standard that would limit the amount of nicotine in combusted tobacco products. FDA requested comments regarding setting maximum nicotine levels in tobacco filler at 0.3 to 0.5 mg/g. FDA is also considering if this proposed product standard should specify a method for manufacturers to use for the determination of nicotine in very low nicotine content (VLNC) tobacco fillers. The ANPRM states that CORESTA developed a standardized method for the analysis of nicotine in unburned tobacco and tobacco products (CRM 62). However, CRM 62 has not been demonstrated to be fit-for-purpose for the analysis of tobacco fillers with nicotine levels in the range of 0.3 to 0.5 mg/g. Similarly, the ANPRM mentions that ISO 10315 is a standardized method that was developed for the analysis of nicotine in mainstream smoke, but as is the case with CRM 62, ISO 10315 has not been demonstrated to be fit-for-purpose for the analysis of VLNC smoke condensates. Our efforts were focused on lowering the limit of quantitation (LOQ) for these two methods. We will present the method modifications and validation results for CRM 62 and ISO 10315 for the determination of nicotine in VLNC tobacco filler and smoke condensate. The limit of quantitation for the modified methods was determined to be 0.02 mg/g and 0.01 mg/cigarette for CRM 62 and ISO 10315, respectively.