FDA – TPSAC – June 8-9, 2010 Preliminary Information Concerning the Establishment of a List of Harmful and Potentially Harmful Tobacco Product Constituents: small tobacco product manufacturer and importer perspectives Council of Independent Tobacco Manufacturers of America (CITMA) David M Johnson, PhD., CITMA Consultant

Key Issues ‘List of harmful’ constituents should not be used as a way to grab market share and market power. TPSAC recommendations should be based upon relative risk evaluated by sound, peer reviewed science and not influenced by “agendas”. ‘List of harmful’ constituents should be adequately explained to the public as to not create confusion. Any list must be reasonable based on the fact small manufacturers generally do not make reduced risk or modified risk claims.

Market Share Reality Companies with fewer than 350 employees represent less than 4%* of total cigarette market. * Estimated

Big Tobacco has long history of Big Science PMUSA, RJRT, Lorillard, and Liggett/Vector have long history of cigarette/tobacco R&D More recent entrants such as Swedish Match, Imperial Tobacco U.K./Commonwealth, and Japan Tobacco also R&D heavyweights They can do the Hoffmann analytes and more, but you don’t need high-priced scientists and expensive testing facilities to make good, consistent quality, conventional tobacco products

Small Tobacco Product Manufacturers (STPM) STPM generally make conventional products by purchasing generic components and tobacco leaf – Manufacture without the use of high-tech science – Operate without scientists – Follow the science from big tobacco Small companies have very limited in-house resources to test for complex constituents Small companies must rely on third party testing facilities for product evaluation Use of third-party testing laboratories for determining product conformance not supported by current test methods

The Reality: STPM’s STPM’s make conventional and traditional products STPM’s have relatively high cost of testing compared to scale and profitability of big tobacco STPM’s are limited in their ability to have control points in leaf selection STPM testing is currently likely generally limited what is needed to stay in business

Defining List of Harmful Constituents Must be based on rational scientific review. Must be based on current industry capabilities and publicly available methodology and technology, and not using big tobacco proprietary methods or technology that is not generally available to small companies. Must be justified in terms of the final use of the data collected and potential consumer understanding of any proposed ‘harmful list’. Constituent tests must be reproducible and priced to reflect economies of small business. Constituent testing must take into account total global capacity available of certified tobacco testing facilities.

Recommendations Convene a permanent industry advisory panel of scientists to work with FDA scientists on constituent evaluation and identification. Apply Federal Data Quality Act (DQA) standards to inclusion of a constituent in any ‘list of harmful constituents’. Limit testing to top constituents based on FDA’s assessment of high relative risk to humans. Allow small companies to test only those primary constituents that can provide a basis for extrapolated reporting of other constituents. If primary components of STPM manufactured products are essentially the same, allow STPM manufacturers to report based on ‘substantial equivalence’ benchmark and within tolerances for similar products produced by large manufacturers.