The U.S. Food and Drug Administration Centerfor Tobacco Products (CTP) recently published a list of research priorities deemed most relevant to its responsibility for the regulation of tobacco products. The first priority listed is """"""""understandng the diversity of tobacco products."""""""" While extensive data are available on the chemical composition and human exposure to tobacco toxicants for conventional cigarettes, much less is known about new and emerging tobacco products such as snus, electronic cigarettes, and hookah, that users may perceive as less harmful than conventional cigarettes. Our funded PSO, DA012393, provides analytical chemistry support to numerous investigators carrying out behavioral and toxicological studies of tobacco, including some relevant to the mission of CTP. Our PSO also develops new biomarkers of exposure, and improved analytical chemistry methods for assessment of exposure to tobacco toxins. In this Revision Application, we are proposing to develop new biomarkers of exposure: (1) the tobacco alkaloid nicotelline as a biomarker for tobacco smoke particulate matter (TPM, """"""""tar""""""""), and (2) pseudooxynicotine, the chemical precursor to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(S-pyridyl)-1-butanone (NNK). In developing these biomarkers, we will analyze urine samples from subjects using new and emerging products: hookah, snus, and electronic cigarettes. We will also analyze urine samples from users of conventional tobacco products: cigarettes, cigars, and oral snuff. We will also analyze new and conventional tobacco products for toxic substances and their precursors. Our application addresses four FDA research priorities (2-5) listed in the FOA for the present program. If funded, we expect that the new biomarkers that we develop will aid the FDA in evaluation of new and emerging tobacco products, enhance the ability of our PSO to support studies relevant to the FDA CTP's mission, as well as advance the field of tobacco exposure assessment. We expect that our analytical chemistry methods will identify substances in tobacco that predict human toxicity, and thus represent possible targets for regulation or development of reduced harm products.

Public Health Relevance

Tobacco companies are putting considerable effort into developing new products that might reduce human exposure to tobacco toxins. Evaluation of claims of reduced exposure will be an important part of the FDA's regulatory process. We expect that our research will aid the FDA in the evaluation of the risks of new and emerging tobacco products and in their regulation.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Center Core Grants (P30)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Chiang, Nora
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California San Francisco
Schools of Medicine
San Francisco
United States
Zip Code
Pulvers, Kim; Emami, Ashley S; Nollen, Nicole L et al. (2018) Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes. Nicotine Tob Res 20:206-214
Panzer, Ariane R; Lynch, Susan V; Langelier, Chaz et al. (2018) Lung Microbiota Is Related to Smoking Status and to Development of Acute Respiratory Distress Syndrome in Critically Ill Trauma Patients. Am J Respir Crit Care Med 197:621-631
Benowitz, Neal L; Flanagan, Christie A; Thomas, Timothy K et al. (2018) Urine 4-(methylnitrosamino)-1-(3) pyridyl-1-butanol and cotinine in Alaska native postpartum women and neonates comparing smokers and smokeless tobacco users. Int J Circumpolar Health 77:1528125
Vogel, Erin A; Ramo, Danielle E; Rubinstein, Mark L (2018) Prevalence and correlates of adolescents' e-cigarette use frequency and dependence. Drug Alcohol Depend 188:109-112
Rubinstein, Mark L; Delucchi, Kevin; Benowitz, Neal L et al. (2018) Adolescent Exposure to Toxic Volatile Organic Chemicals From E-Cigarettes. Pediatrics 141:
Benowitz, Neal L; Nardone, Natalie; Jain, Shonul et al. (2018) Comparison of Urine 4-(Methylnitrosamino)-1-(3)Pyridyl-1-Butanol and Cotinine for Assessment of Active and Passive Smoke Exposure in Urban Adolescents. Cancer Epidemiol Biomarkers Prev 27:254-261
St Helen, Gideon; Shahid, Marian; Chu, Sherman et al. (2018) Impact of e-liquid flavors on e-cigarette vaping behavior. Drug Alcohol Depend 189:42-48
Nabavizadeh, Pooneh; Liu, Jiangtao; Havel, Christopher M et al. (2018) Vascular endothelial function is impaired by aerosol from a single IQOS HeatStick to the same extent as by cigarette smoke. Tob Control 27:s13-s19
St Helen, Gideon; Jacob Iii, Peyton; Nardone, Natalie et al. (2018) IQOS: examination of Philip Morris International's claim of reduced exposure. Tob Control 27:s30-s36
Hang, Bo; Snijders, Antoine M; Huang, Yurong et al. (2017) Early exposure to thirdhand cigarette smoke affects body mass and the development of immunity in mice. Sci Rep 7:41915

Showing the most recent 10 out of 187 publications