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15 results

  1. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 049

    Assessment of in vitro toxicity/genotoxicity of ends and combustible products

    JORDAN K.(1); BOMBICK B.(1); COOPER B.(1); LEVERETTE R.(1); SHUTSKY T.(1); WEST C.(1); STRASSER J.(1); ROUND E.(1); MARANO K.M.(1); MOMIN R.(2); TRIVEDI A.(2); WAGSTAFF W.(2); BRUCE S.(3); DAKOULAS E.(3); ROY S.(3)
    (1) RAI Services Company, Winston-Salem, NC, USA; (2) Labstat International ULC, Kitchener, ON, Canada; (3) BioReliance Corp, Rockville, MD, USA
    In May 2016, the U.S. Food and Drug Administration Center for Tobacco Products (CTP) issued draft guidance for Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS), which recommends inclusion of in vitro...
  2. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 076

    Do levels of menthol in mainstream cigarette smoke influence dependence? Data from NHANES 2007-2014

    PARMS T.(1); VAN LANDINGHAM C.(2); MARANO K.M.(1)
    (1) RAI Services Company, Winston-Salem, NC, USA; (2) Ramboll, Monroe, LA, USA
    A 2013 preliminary scientific evaluation by the U.S. Food and Drug Administration (FDA) concluded that menthol in cigarettes is likely associated with increased initiation and progression to regular cigarette smoking, increased dependence, and...
  3. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 108

    Toxicity value selection for quantitative risk assessment of harmful and potentially harmful constituents in smokeless tobacco products

    AMANTANA A.; SAWANT S.G.; XIE Wei; LIU Shuang; MARANO K.M.; SZABO D.T.
    RAI Services Company, Winston-Salem, NC, USA
    The United States Food and Drug Administration (FDA) established a list of 93 harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke, as required by the Family Smoking Prevention and Tobacco Control Act. These...
  4. CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, ST 40

    FDA’s proposed NNN product standard: review of the scientific evidence

    MARANO K.M.(1); BACHAND A.(2); LIU C.(1); SULSKY S.(2); MARIANO G.(2); CURTIN G.M.(1); PARMS T.(1); GREEN T.(3); GENTRY P.R.(3)
    (1) RAI Services Co., Winston-Salem, NC, U.S.A.; (2) Ramboll Environ US Corp., Amherst, MA, U.S.A.; (3) Ramboll Environ, Monroe, LA, U.S.A.
    The U.S. Food and Drug Administration (FDA) has published a proposed standard of 1 µg/g (dry weight) N-nitrosonornicotine (NNN) in finished smokeless tobacco products. FDA’s rationale for the standard is that NNN is a potent carcinogen, NNN is a...
  5. CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, STPOST 24

    FDA’s proposed N-nitrosonornicotine (NNN) Standard: epidemiological evidence

    PARMS T.(1); SULSKY S.(2); MARIANO G.(2); MARANO K.M.(1)
    RAI Services Co., Winston-Salem, NC, U.S.A.
    The U.S. Food and Drug Administration (FDA) has advanced a proposed product standard of 1 µg/g N-nitrosonornicotine (NNN) content in finished smokeless tobacco (ST) products, citing selected findings from epidemiology to support the proposed limit....
  6. CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, STPOST 37

    FDA’s proposed NNN product standard: quantitative risk assessment

    MARANO K.M.(1); GENTRY P.R.(2); LIU C.(1)
    (1) RAI Services Co., Winston-Salem, NC, U.S.A.; (2) Ramboll Environ, Monroe, LA, U.S.A.
    The U.S. Food and Drug Administration (FDA) has published a proposed standard for N-nitrosonornicotine (NNN) content in finished smokeless tobacco products. The proposed NNN limit of 1 part per million (ppm) dry weight was derived based on a target...
  7. CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, STPOST 38

    FDA’s proposed NNN product standard: toxicological evidence review

    MARANO K.M.(1); GREEN T.(2) GENTRY P.R.(2)
    (1) RAI Services Co., Winston-Salem, NC, U.S.A.; (2) Ramboll Environ, Monroe, LA, U.S.A.
    The U.S. Food and Drug Administration (FDA) has published a proposed standard for N-nitrosonornicotine (NNN) in smokeless tobacco products. An independent review of the toxicological evidence was conducted, and results of this review suggested that...