LAUTERBACH & ASSOCIATES, LLC

Research

Lauterbach & Associates, LLC (L&ALLC) has had its own research program since 2008. The main purpose of our program is to provide the information our clients need to meet current and expected FDA regulations. With conventional tobacco products our main focus as been on the constituents that affect product performance, not on trace-level toxicants (FDA HPHC). This approach is far less costly and provides far more useful information, especially when comparing products as if often required when dealing with the FDA's Substantial Equivalence process. Moreover, our focus, with the exception of the research we have sponsored on FSC cigarette paper, has been on the tobacco not the smoke, and the products we have studies include the so-called filtered cigars and pipe tobaccos. Our presentations on cigars and pipe tobaccos have provided data that were not previously available to the public. The research we sponsored on FSC cigarette and presented has explained why some types of FSC paper perform differently from other types of FSC paper.

Our e-vapor research program began in 2011 with the collaboration with clients who had early e-vapor devices tested at a major tobacco research laboratory. Our analyses of the data were given in two poster presentations at the 2012 Society of Toxicology (SOT) national meeting. By the end of 2014, we had expanded our research to include experimental work on cytotoxicity and composition of e-liquids, pyrolysis products of glycerol in e-liquids, pH-values of e-liquids, and a presentation at regulatory strategies for e-cigarettes at the December 2014 FDA E-Cigarette Workshop. Beginning in 2015, we focused our efforts of determining pH-values of aerosols generated by e-cigarettes. This involved development of an e-cigarette vaping machine and use of a glassmouth with special pH-electrodes. Additional research has focused on comparison of aerosol pH-values with those determined by other techniques, absorption of nicotine in the aerosol by artificial saliva, estimation of unprotonated nicotine in e-cigarette aerosols, and evaluation of novel devices and e-liquids including those with nicotine salts.