- Email: [email protected]
Tobacco harm reduction and e-cigarettes
Abstracts / Toxicology Letters 280S (2017) S58–S59
S24-03 Pathway to regulatory submission: The Swedish Match story Jim Solyst Swedish Match, Severna Park, United States Swedish Match is the only company to have received a Premarket Tobacco Application (PMTA) order from the US Food and Drug Administration (FDA). Swedish Match is also the only company to have a pending Modified Risk Tobacco Product application (MRTPA). The PMTA decision and the pending MRTPA decisions are for the Company’s line of General snus products sold in the US. The statutory standard that must be met for both pathways is a demonstration that the products are protective of the public health. Swedish Match submitted an abundance of scientific evidence, including human health data derived from Swedish studies, and a detailed description of how the product is manufactured and the levels of Harmful and Potentially Harmful Constituents. In addition to providing evidence, maneuvering through the two regulatory pathways (PMTA and MRTPA) was a challenging experience requiring insight into the statutory language and intent (Section 910 and 911 of the Tobacco Control Act) and deciphering guidance documents issued by FDA. The presentation will include a description of FDA’s reasoning for issuing the PMTA order and the decision process to date for the MRTPA. http://dx.doi.org/10.1016/j.toxlet.2017.07.147 S24-04 Tobacco harm reduction and e-cigarettes Riccardo Polosa 1,2 1
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy 2 Institute of Internal Medicine and Clinical Immunology, University Hospital “Policlinico-V. Emanuele”, Catania, Italy Tobacco harm reduction seeks to decrease the net damage to health associated with the use of combustible tobacco products. It is based on the concept that “smokers smoke for nicotine but die from tar,” expressed by British tobacco addiction researcher Michael A.H. Russell, referring to combustion products and toxins other than nicotine, which are present in smoke. Although nicotine itself may not be absolutely harmless, several studies evaluating the effects of non-combustible nicotine products have shown that it is highly unlikely to contribute significantly to smoking-related cancer and
S59
cardio-respiratory disease. Reducing health risks and reversing harm associated with cigarette smoke is now a reality. Alternative sources of nicotine to smokers who are unable or unwilling to quit tobacco and nicotine entirely are now available and many more are being introduced on the market. This talk will review biomarkers of exposure which have been widely used to monitor human uptake of tobacco smoke constituents in relation to studies presenting data on current and emerging THR tools (e.g. e-Cigarettes, Tobacco Heated Products, smokeless tobacco and NRT). Biomarkers of physiological/biological effect will also be reviewed and their applicability to regulatory pathways discussed. http://dx.doi.org/10.1016/j.toxlet.2017.07.148 S24-05 Building pathways for regulatory acceptance of alternative methods for tobacco product assessment Erin Hill, Holger Behrsing Institute for In Vitro Sciences, Gaithersburg, United States The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 gave the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) regulatory authority over the manufacture, marketing and distribution of tobacco products in the United States. Estimates of the potentially large number of animals that could be used to meet toxicology requirements of this regulation are concerning to industry and animal protection organizations alike. However, following guidance set forth in the 2007 NAS report “Toxicity Testing in the 21st Century: A Vision and Strategy”, U.S. regulatory authorities and industry are actively looking for ways to incorporate more predictive, mechanistic, non-animal models to replace the traditional use of animals in toxicology testing. Therefore, these new regulations may offer opportunities to bring forth optimized and standardized in vitro testing approaches to be considered for regulatory decision making. In 2015 the Institute for In Vitro Sciences, Inc. initiated a collaborative, multi-laboratory Proof of Concept study to standardize testing approaches commonly used by industry for product stewardship purposes. Three commonly used endpoints – ciliary beat frequency, goblet cell hyperplasia and mucus production – were assessed under standardized protocols using two commercially available human reconstructed airway models (EpiAirway, MatTek Corporation and Mucilair, EpiThelix). Preliminary results of the study along with strategies to approach the regulatory agency will be presented as an example of collaborative efforts to gain regulatory acceptance of in vitro methods. http://dx.doi.org/10.1016/j.toxlet.2017.07.149
S24-03 Pathway to regulatory submission: The Swedish Match story Jim Solyst Swedish Match, Severna Park, United States Swedish Match is the only company to have received a Premarket Tobacco Application (PMTA) order from the US Food and Drug Administration (FDA). Swedish Match is also the only company to have a pending Modified Risk Tobacco Product application (MRTPA). The PMTA decision and the pending MRTPA decisions are for the Company’s line of General snus products sold in the US. The statutory standard that must be met for both pathways is a demonstration that the products are protective of the public health. Swedish Match submitted an abundance of scientific evidence, including human health data derived from Swedish studies, and a detailed description of how the product is manufactured and the levels of Harmful and Potentially Harmful Constituents. In addition to providing evidence, maneuvering through the two regulatory pathways (PMTA and MRTPA) was a challenging experience requiring insight into the statutory language and intent (Section 910 and 911 of the Tobacco Control Act) and deciphering guidance documents issued by FDA. The presentation will include a description of FDA’s reasoning for issuing the PMTA order and the decision process to date for the MRTPA. http://dx.doi.org/10.1016/j.toxlet.2017.07.147 S24-04 Tobacco harm reduction and e-cigarettes Riccardo Polosa 1,2 1
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy 2 Institute of Internal Medicine and Clinical Immunology, University Hospital “Policlinico-V. Emanuele”, Catania, Italy Tobacco harm reduction seeks to decrease the net damage to health associated with the use of combustible tobacco products. It is based on the concept that “smokers smoke for nicotine but die from tar,” expressed by British tobacco addiction researcher Michael A.H. Russell, referring to combustion products and toxins other than nicotine, which are present in smoke. Although nicotine itself may not be absolutely harmless, several studies evaluating the effects of non-combustible nicotine products have shown that it is highly unlikely to contribute significantly to smoking-related cancer and
S59
cardio-respiratory disease. Reducing health risks and reversing harm associated with cigarette smoke is now a reality. Alternative sources of nicotine to smokers who are unable or unwilling to quit tobacco and nicotine entirely are now available and many more are being introduced on the market. This talk will review biomarkers of exposure which have been widely used to monitor human uptake of tobacco smoke constituents in relation to studies presenting data on current and emerging THR tools (e.g. e-Cigarettes, Tobacco Heated Products, smokeless tobacco and NRT). Biomarkers of physiological/biological effect will also be reviewed and their applicability to regulatory pathways discussed. http://dx.doi.org/10.1016/j.toxlet.2017.07.148 S24-05 Building pathways for regulatory acceptance of alternative methods for tobacco product assessment Erin Hill, Holger Behrsing Institute for In Vitro Sciences, Gaithersburg, United States The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 gave the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) regulatory authority over the manufacture, marketing and distribution of tobacco products in the United States. Estimates of the potentially large number of animals that could be used to meet toxicology requirements of this regulation are concerning to industry and animal protection organizations alike. However, following guidance set forth in the 2007 NAS report “Toxicity Testing in the 21st Century: A Vision and Strategy”, U.S. regulatory authorities and industry are actively looking for ways to incorporate more predictive, mechanistic, non-animal models to replace the traditional use of animals in toxicology testing. Therefore, these new regulations may offer opportunities to bring forth optimized and standardized in vitro testing approaches to be considered for regulatory decision making. In 2015 the Institute for In Vitro Sciences, Inc. initiated a collaborative, multi-laboratory Proof of Concept study to standardize testing approaches commonly used by industry for product stewardship purposes. Three commonly used endpoints – ciliary beat frequency, goblet cell hyperplasia and mucus production – were assessed under standardized protocols using two commercially available human reconstructed airway models (EpiAirway, MatTek Corporation and Mucilair, EpiThelix). Preliminary results of the study along with strategies to approach the regulatory agency will be presented as an example of collaborative efforts to gain regulatory acceptance of in vitro methods. http://dx.doi.org/10.1016/j.toxlet.2017.07.149