Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop

Abstract

Since 2009, the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. On August 3–4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: 1) approaches to evaluating and selecting biomarkers; 2) biomarkers of exposure and relationship to disease risk; 3) currently-used biomarkers of exposure and biomarkers in development; and 4) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems (ENDS). This paper synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation.

Atomic force microscopy and Raman spectra profile of blood components associated with exposure to cigarette smoking

“…102,103 The exposure to tobacco smoke presents an ideal environment to nd, characterize, and rene biological markers, especially for those carcinogens found in tobacco. 29,30,93 Changes in secondary and tertiary structures of Hb in cigarette smokers and impaired function have been described previously 104 Additionally, the nding subtle changes in proteins as amino acid residues moved toward or behind more hydrophobic region in biomarkers, in addition to impaired amino acid interaction with each other and their environment, could be a sign of an increased susceptibility to disease or risk. In the preventive medicine, to nd this kind of biomarkers is mandatory.…”

“…Quantitative and qualitative changes of these molecules are related to numerous pathologies. [26][27][28] There is a need to identify early biomarkers of exposure for cigarettes 29,30 and the AFM and Raman spectroscopy presents great potential in identifying the proles of different stress conditions and diseases that can be used for differentiation. 31,32 Additionally, analysis of RBC by Raman spectroscopy and AFM compared with other biological samples has signicant advantages, especially in the cases when we need repeatedly sample collection.…”

Tobacco toxicant exposure in cigarette smokers who use or do not use other tobacco products

“…The study did not obtain information on depth of inhalation, which could provide a potential explanation for the lower tobacco toxicant levels of Cig-OTP users. Other biomarkers of toxicant exposure exist (e.g., N′-nitrosonornicotine [NNN], metabolites of polycyclic aromatic hydrocarbons and volatile organic compounds, carbon monoxide), and should be examined in future studies to better understand the relative harm of Cig-OTP versus Cig-Only use (Chang et al, 2017). The study was not designed to examine differences in biomarker concentrations between different types of OTP, although the product mix of the current sample generalizes well to the majority of multiple tobacco product users.…”

Comparison of Liquid Chromatography Mass Spectrometry and Enzyme-Linked Immunosorbent Assay Methods to Measure Salivary Cotinine Levels in Ill Children

“…Biochemical verification is the gold standard used to validate levels of tobacco smoke exposure (TSE) in children and the tobacco use status of smokers in clinical trials [1][2][3][4][5][6]. Since pediatric TSE…”