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TSRC, Tob. Sci. Res. Conf., 2015, 69, abstr. 61

Can US FDA substantially equivalent predicates be developed without knowledge of and a sample of the predicate product?

LAUTERBACH J.H.
Lauterbach & Associates, LLC, Macon, GA USA

The passage in 2009 of the Family Smoking Prevention and Tobacco Act (the Act) has created unexpected problems for many companies in the small business tobacco manufacturing industry. Section 905(j) of the Act dealing with the substantially equivalent (SE) requirement, whereby the predicate product had to be on the market on February 15, 2007, and the FDA guidance on what constitutes SE product has been less than clear. If a company did not market a product on February 15, 2007, or was not even in business at that time, then what do they do for a predicate product? Since SE difficulties will increase as other tobacco products fall under FDA jurisdiction, we have investigated several approaches for recreating predicate products. These will be presented for filter tubes, conventional cigarettes and filtered cigars, and unwrapped tobacco products such as pipe tobacco, roll-your-own tobacco, and chewing tobacco. These approaches involve a combination of analytical and physical testing and reports in the tobacco literature.