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6 results

  1. TSRC, Tob. Sci. Res. Conf., 2021, 74, abstr. 40

    The synthetic nicotine loophole: regulatory issues and technical challenges

    COFFA B.G.(1); GILLILAND S.(2); BURD K.(3); SPROWL E.(4); CAMPBELL P.(2); PLUNKETT S.(1,2)
    (1) Enthalpy Analytical, LLC, Henrico, VA, USA; (2) Consilium Sciences, Richmond, VA, USA; (3) North America Nicotine, Rocklin, CA, USA; (4) Pyxus International, Morrisville, NC, USA
    A significant scientific, regulatory, and economic need exists to distinguish tobacco-derived nicotine (TDN) from synthetic nicotine (SynNic) to assess its use in commercial products. Products containing TDN are regulated by FDA; however those with...
  2. 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    In the electronic nicotine delivery systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the U.S. Food and Drug Administration (FDA) recommends a full assessment of the toxicological profile associated with new tobacco products,...
  3. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 34

    Characterization of an air-liquid-interface (ALI) in vitro exposure system (VITROCELL® VC1/7 and Ames 48) using a prototype e-vapor product

    ZHANG Jingjie(1); DOSHI U.(1); OLDHAM M.J.(1); COFFA B.G.(1); GILLMAN I.G.(2); WOLZ R.L.(2); KOSACHEVSHY P.(2); LEE K.M.(1)
    (1) Altria Client Services LLC, Richmond, VA, U.S.A.; (2) Enthalpy Analytical, Inc., Richmond, VA, U.S.A.
    Direct delivery of aerosol or vapor to the apical surface of cells (ALI) allows more relevant exposure for in vitro toxicological evaluation of inhalable chemicals. In this study, we quantitatively characterized the aerosol delivery in a commercially...
  4. CORESTA Congress, Kunming, 2018, Smoke Science/Product Technology Groups, STPOST 43

    In vitro micronucleus (MN) assay using TK6 cells: review of historical positive and negative control data

    STANKOWSKI L.F. Jr(1); HURTADO S.B.(1); WELLS M.M.(1); KWOK V.Y.(1); DOSHI U.(2); COFFA B.G.(2); LEE K.M.(2)
    (1) Charles River Laboratories, Genetic and In Vitro Toxicology, Skokie, IL, U.S.A.; (2) Altria Client Services LLC, Research, Development & Regulatory Affairs, Richmond, VA, U.S.A.
    TK6 human lymphoblastoid cells are widely used in the in vitro MN assay as a part of regulatory genotoxicity testing for pharmaceuticals, but have seen relatively limited use in testing of other test materials, including tobacco-related products. As...
  5. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 009 (also presented at CORESTA 2018)

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

    COFFA B.G.; DOSHI U.; ZHANG Jingjie; McKINNEY W.J.; LEE K.M.
    Altria Client Services LLC, Richmond, VA, USA
    In the Electronic Nicotine Delivery Systems (ENDS) Premarket Tobacco Application (PMTA; 2016) Draft Guidance, the FDA recommends a full assessment of the toxicological profile associated with new tobacco products, using in vitro toxicology (e.g.,...
  6. TSRC, Tob. Sci. Res. Conf., 2017, 71, abstr. 007

    Neutral red uptake cytotoxicity assay in A549 cells under different culture conditions

    COFFA B.G.(1); DOSHI U.(1); ZHANG Jingjie(1); McKINNEY W.J.(1); LEE K.M.(1); DESAI P.(2)
    (1) Altria Client Services, Richmond, VA, USA; (2) Enthalpy Analytical, Richmond, VA, USA
    The OECD guideline (TG129) recommends mouse fibroblasts (3T3) & normal human epidermal keratinocytes (NHK) for performing in vitro cytotoxicity assays but also mentions limitations of these cells, such as having little to no metabolic capacity or...