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A Regulatory Framework for Substantial Equivalence Product Applications under the FSPTCA

Principal Investigator: Gregory Connolly

Funding Mechanism: National Institutes of Health- Grant

ID number: 1 R21 DA036485-01

Award Date: 9/30/2013

Institution: Harvard School of Public Health

The Family Smoking Prevention and Tobacco Control Act of 2009 grants FDA the authority to conduct a pre-market review of new, revised and modified tobacco products. Under the law, tobacco product sponsors may file an application for exemption from pre-market review if they believe that a new product is "substantially equivalent" (SE) to an existing product. The FDA may grant an SE marketing order if it determines that the new product either has the same characteristics (i.e., materials, ingredients, design, composition, heating source, or other features) as a product on the market as of February 15, 2007, or has different characteristics but does not raise different questions of public health. The goal of this project is to establish a foundation for SE regulatory science by harnessing the science of product equivalence from other realms, understanding the economics and incentives facing tobacco product sponsors when submitting an SE application versus other types of applications, generating a body of research that can inform rigorous evaluation of product applications, and generating a body of research to inform and advance the study of tobacco product equivalence and potential health outcomes. Investigators will demonstrate potential effects on the cigarette market of a relatively low threshold for SE and develop a theoretical model of population outcomes depending on the stringency of research requirements for SE applications. Specific aims are: (1) to analyze the statutory, legislative, and regulatory history and the scientific methods for determining equivalence in FDA-regulated product arenas other than tobacco products as well as internal tobacco industry research on product modification and SE; (2) to conduct a preliminary investigation of the tobacco market and population effects of industry response to the ban on "light" descriptors under a permissive versus restrictive SE approach; and (3) to develop and empirically test a mathematical model of SE review, possible tobacco market incentives, and population health outcomes. This research will provide both a theoretical framework and an empirical basis for FDA's SE pre-market review criteria.

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