Lauterbach & Associates, LLC (L&ALLC) was founded in October 2004 with the primary business objective of providing scientific and regulatory affairs (S&RA) services to the tobacco industry and its suppliers.  While we are a small company, our scientists are very active in tobacco-related matters. They have over forty years experience in tobacco and closely related industries.  L&ALLC is a corporate member of CORESTA (Cooperation Centre for Scientific Research Relative to Tobacco) and the US Technical Advisory Group (TAG) to ISO Technical Committee 126 on Tobacco and Tobacco Products.  Our scientists make presentations of our research at the annual Tobacco Science Research Conference and at the meetings of Division of Chemical Toxicology of the American Chemical Society.  We are also frequent contributors to the prestigious, peer-reviewed journal, Regulatory Toxicology and Pharmacology.

Our principal scientist for our work on FDA regulation of tobacco products is Dr. John H. Lauterbach.  Dr. Lauterbach has almost thirty years of experience working in the tobacco industry first with Brown & Williamson Tobacco Corporation and then with L&ALLC, a company he founded in October 2004.  While at Brown and Williamson, Dr Lauterbach served in leadership positions in the Research and Development Department including Division Head, Analytical Research; Director, Research Services; and Principal Scientist, Scientific & Regulatory Affairs.  While at Brown & Williamson, Dr. Lauterbach was active in tobacco industry scientific committees.  From 1993 to 1998, he was Chairman of the Board of Directors of the Tobacco Industry Testing Laboratory, the organization that provided tar, nicotine, and carbon monoxide data on domestically sold cigarettes to the US Federal Trade Commission.  Dr. Lauterbach also served from 1993 to 1998 as Chair of the US Technical Advisory Group (TAG) to ISO Technical Committee 126 on Tobacco and Tobacco Products.  The TAG formulates and recommends to ANSI (American National Standards Institute) the US positions on the approval and modification of international standards related to tobacco products.  Dr. Lauterbach also has been a participant and frequent speaker at annual Tobacco Science Research Conference (TSRC formerly known as the Tobacco Chemists’ Research Conference or TCRC).  Dr. Lauterbach was Program Chair for the 2002 TSRC, and the lead-off speaker in that conference’s symposium, Toxicological Evaluation of Tobacco Products, with his presentation, Smoke chemistry: a useful predictor of smoke toxicology.  Click on the corresponding pages on the left of this page to get listings of Dr. Lauterbach’s tobacco-related publications, presentations, and US patents.

Governmental regulation of tobacco products both here the United Sates and in other countries is not new.  In the US, we had FTC mandated reporting of tar and nicotine deliveries from 1967 until late 2008.  The Alcohol and Tobacco Tax and Trade Bureau is responsible for determining the tax classifications for different types of tobacco products.  For over two decades, Germany, England, and other countries have had lists of permitted and forbidden lists of compounds that could or could not be used in cigarettes and other tobacco products.  There are also European Union directives.  In addition, both Canada and Brazil have tobacco regulations, but they are focused on reporting of tobacco and smoke constituents.  We are keeping informed of developments in FDA regulations and will report them on this web site.

In March 2010, Dr. Lauterbach was appointed as the Representative for the Interest of Small Business Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee (TPSAC) for the Food and Drug Administration (FDA).  Since then, the FDA has required the tobacco product manufacturers to file 905(j) Substantial Equivalence Reports showing substantial equivalence to a product made before February 15, 2007.  The FDA has also stated that they are going to regulate cigars.  The FDA have started visiting factories to confirm that manufacturers are producing what matches on their 905(j) Reports.