1. 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...
  2. 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...
  3. 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...
  4. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 41

    Sharing and reusing data: toxicology assessment meta-analysis of various e-liquids and heat-not-burn platforms with INTERVALS datasets

    STAN A.; BOUÉ S.; HOENG J.; PEITSCH M.C.
    PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland
    Extensive scientific studies are conducted to assess the relative risks of various candidate modified risk tobacco products compared with those of smoking cigarettes. As the scientific community conducts such assessments for diverse products and in a...
  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. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 57

    Cross-cultural equivalence of the ABOUT™–Perceived Risk instrument in seven languages

    CHREA C.(1); CANO S.(2); SALZBERGER T.(3); MAINY N.(1); ACQUADRO C.(4); POPIELNICKI A.(5); WEITKUNAT R.(1)
    (1) PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland; (2) Modus Outcomes, Letchworth Garden City, U.K.; (3) University of Economics and Business, Vienna, Austria; (4) Mapi Research Trust, ICON plc, Lyon, France; (5) TransPerfect, Linguistic Validation Group, Boston, MA, U.S.A.
    The risk of smoking has long been well understood by consumers. However, it is important to measure the perceived risks by consumers of novel smoke-free alternatives to cigarettes. The ABOUT™–Perceived Risk instrument was developed to allow the...
  7. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 58

    A consortium approach for consumer-reported outcome measures to assess tobacco- and nicotine-containing products

    ACQUADRO C.(1) on behalf of the CORESTA CROM Task Force: AYALA-FIERRO F.(2); BLACK R.(3); CAHOURS X.(4); CHREA C.(5); CURTIN G.(6); GILES L.(7); McCAFFREY S.(3); PARK C.H.(8); PRASAD K.(9); SHERWOOD N.(10); SHIFFMAN S.(11); SMITH J.(6); SPIES E.(5)
    (1) Mapi Research Trust, Lyon, France; (2) ITG Brands, Greensboro, NC, U.S.A.; (3) Altria Client Services, Richmond, VA, U.S.A.; (4) SEITA - Imperial Brands, Paris, France; (5) Philip Morris Products S.A., Neûchatel, Switzerland; (6) RAIS, Winston-Salem, NC, U.S.A.; (7) JT Int'l SA, Genève, Switzerland; (8) KT&G Research Institute, Daejeon, Republic of Korea; (9) British American Tobacco, Southampton, U.K.; (10) Neil Sherwood Consulting, Commugny, Switzerland; (11) Pinney Associates, Pittsburgh, PA, U.S.A.
    In the tobacco space, consumer-reported outcome measures (CROM) are essential for understanding motivations, subjective effects, and behavior. Such measures have become particularly important with the advent of candidate modified risk tobacco...
  8. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 59

    A novel repository for consumer reported outcome measures in tobacco research: development, implementation and evolution from 2016 to date

    CLERC E.(1); MAINY N.(1); PERRET C.(2); ACQUADRO C.(3); BACSO A.(1); BINGGELI P.(1); CHREA C.(1)
    (1) PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland; (2) Mapi Research Trust, Lyon, France; (3) ICON plc, Lyon, France
    The consumer reported outcome measures Repository is a measurement instrument knowledge base developed by Mapi Research Trust (MRT) for Philip Morris International (PMI) in June 2016. It enables PMI researchers to identify and select measures to...
  9. CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, STPOST 63 (also presented at TSRC 2019)

    Comparison of methods for measuring the particle size distribution of smokeless tobacco products

    JACKSON C.; DILL K.; PLATT S.; RUSYNIAK M.
    Altria Client Services LLC, Regulatory Affairs, Richmond, VA, U.S.A.
    Tobacco cut size is one of the product properties for smokeless tobacco products, which the Food and Drug Administration has proposed as a requirement for a Substantial Equivalence (SE) submission, (21 CFR Parts 16 and 1107). However, no guidance has...
  10. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 005

    Incorporating analytical variance into a comparative quantitative risk assessment (QRA) approach for tobacco products

    ANDERSON C.A.; HAASE V.; EHMAN K.D.; WIECINSKI P.N.; SMITH D.C.
    Altria Client Services, Richmond, VA, USA
    The US Food and Drug Administration (FDA) draft guidance for industry (2012) provides abbreviated lists of harmful and potentially harmful constituents (HPHCs) found in tobacco and cigarette smoke. As FDA considers the abbreviated HPHC list to be...