1. CORESTA Congress, Online, 2020, Smoke Science/Product Technology Groups, STPOST 16

    Comparison of in vitro cytotoxicity and genotoxicity of condensates derived from electronic-cigarettes and reference combustible cigarette

    DOSHI U.; GARDNER W.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In recent years, electronic nicotine delivery systems (ENDS) including electronic cigarettes (e-cigarettes) have emerged as potential reduced-risk alternatives to conventional cigarettes for adult smokers. The U.S. Food and Drug Administration (FDA),...
  2. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 36

    Use of ex vivo precision-cut lung slices as a screening tool for potential respiratory toxicity of e-liquids

    BEHRSING H.P.(1); SHEEHAN D.(1); AMIN K.(2); LEE K.M.(3); OLDHAM M.(4); RAABE H.(1)
    (1) Institute for In Vitro Sciences, Inc., Gaithersburg, MD, U.S.A.; (2) University of Minnesota, Minneapolis, MN, U.S.A.; (3) Altria Client Services, Richmond, VA, U.S.A.; (4) former Altria Client Services employee
    The Family Smoking Prevention and Tobacco Control Act gave the FDA regulatory authority over next generation tobacco products (NGTP) such as e-vapor products. E-vapor product liquids contain a variety of ingredient combinations that should be...
  3. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 38

    In vitro cytotoxicity and genotoxicity of representative e-liquid flavor mixtures

    DOSHI U.; ZHANG J.; KUMAR A.; LEE K.M.
    Altria Client Services LLC, Richmond, VA 23219, U.S.A.
    Flavor compounds “generally recognized as safe” for oral consumption are commonly used in inhalable e-vapor products for which insufficient safety data exists. The hazard characterization of each flavor and various flavor mixtures is resource and...
  4. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 40 (also presented at TSRC 2019)

    A seven-month systems toxicology inhalation study in C57BL/6 mice demonstrates reduced pulmonary inflammation and emphysema following smoking cessation or switching to e-vapor aerosol exposures

    KUMAR A.(1); KOGEL U.(2); TALIKKA M.(2); SKOWRONEK A.(3); HOENG J.(2); PEITSCH M.C.(2); LEE K.M.(1)
    (1) Altria Client Services LLC, Richmond, VA, U.S.A.; (2) Philip Morris Products S.A., R&D, Neuchâtel, Switzerland; (3) Battelle, West Jefferson, OH, U.S.A.
    Cigarette smoking causes lung cancer, emphysema, and other serious diseases. While cessation remains the most effective approach to minimize smoking-related diseases, alternative nicotine delivery products that limit the generation of combustion...
  5. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 49

    The CORESTA in vitro test battery for combustible tobacco products: update from the 2004 Rationale and Strategy Report

    LEE K.M.(1); JORDAN K.G.(2); WIECZOREK R.(3); MOENNIKES O.(4); CLEMENTS J.(5); CROOKS I.(6); HASHIZUME T.(7); MILLER J.(8); WEBER E.(9); YOSHINO K.(7)
    (1) Altria Client Services, Richmond, VA, U.S.A.; (2) RAI Services Company, Winston-Salem, NC, U.S.A.; (3) Imperial Brands, Reemtsma Cigarettenfabriken GmbH, Hamburg, Germany; (4) PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland; (5) Covance Laboratories Ltd, Harrogate, U.K.; (6) British American Tobacco (Investments) Ltd, R&D, Southampton, U.K.; (7) Japan Tobacco Inc., Yokohama, Kanagawa, Japan; (8) JT International SA, Geneva, Switzerland; (9) Ökolab, Vienna, Austria
    In 2004, the CORESTA In Vitro Toxicity Task Force issued a rationale and strategy report, commonly known as “the CORESTA in vitro test battery guideline”. The goals of this guideline were to: 1) develop the rationale and strategy for conducting in...
  6. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 022 (also presented at CORESTA SSPT2019)

    A seven-month systems toxicology inhalation study in C57BL/6 mice demonstrates reduced pulmonary inflammation and emphysema following smoking cessation or switching to e-vapor aerosol exposures

    KUMAR A.(1); KOGEL U.(2); TALIKKA M.(2); HOENG J.(2); PEITSCH M.(2); SKOWRONEK A.(3); LEE K.M.(1)
    (1) Altria Client Services, Richmond, VA, USA; (2) Philip Morris International, Neuchâtel, Switzerland; (3) Battelle, West Jefferson, OH, USA
    Cigarette smoking causes lung cancer, emphysema, and other serious diseases. While cessation remains the most effective approach to minimize smoking-related diseases, alternative nicotine delivery products that limit the generation of combustion...
  7. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 067

    Characterization of smokeless tobacco products extracted with different solvents for in vitro testing

    ZHANG JINGJIE (1); DOSHI U.(1); THAIKOOTTATHIL J.(1); LEE K.M.(1); WOLZ R.L.(2)
    (1) Altria Client Services, Richmond, VA, USA; (2) Enthalpy Analytical, Richmond, VA, USA
    Unlike cigarettes, there are no standardized methods available for preparing extracts from smokeless tobacco (SLT) products for in vitro toxicological evaluation. Methods are available for Harmful and Potentially Harmful constituents (HPHCs)...
  8. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 29 (also presented at TSRC 2018)

    Toxicological assessment of e-liquid formulations using in vitro genotoxicity and cytotoxicity assays

    COFFA B.G.; DOSHI U.; ZHANG J.; McKINNEY W.J.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, U.S.A.
    In the electronic nicotine delivery systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the U.S. Food and Drug Administration (FDA) recommends a full assessment of the toxicological profile associated with new tobacco products,...
  9. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 30

    Effects of exposure to e-cigarette aerosols compared with cigarette smoke on 3D human buccal and small airway cultures: a systems toxicology assessment

    ISKANDER A.(1); STEINER S.(1); MAJEED S.(1); KONDYLIS A.(1); XIANG Yang(1); ZANETTI F.(1); FRENTZEL S.(1); MARTIN F.(1); PEITSCH M.C.(1); DOSHI U.(2); McKINNEY W.J.(2); LEE K.M.(2); HOENG J.(1)
    (1) Philip Morris Products S.A. (part of Philip Morris International group of companies), PMI R&D, Neuchâtel, Switzerland; (2) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond VA, U.S.A.
    Considerable attention has been given toward the reduced risk potential of e-cigarettes (e-cigs). Most in vitro studies have focused on testing e-liquid formulations directly on submerged 2D cultures. Here, we examined the effects of exposure to the...
  10. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 32

    Characterization and in vitro testing of whole smoke condensates from combustible cigarettes

    DOSHI U.(1); GARDNER W.P.(1); GILLMAN I.G.(2); LEE K.M.(1)
    (1) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond, VA, U.S.A.; (2) Enthalpy Analytical, Inc., Richmond, VA, U.S.A.
    Health Canada recommends in vitro testing of separately collected gas and particulate phases of cigarette smoke for cytotoxicity and genotoxicity assessment. While these test materials have shown cytotoxicity and genotoxicity in literature, there has...