The passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in 2009 granted the U.S. Food and Drug Administration (FDA) regulatory authority over the manufacture, distribution and marketing of tobacco products. Before tobacco manufacturers may market new products, they must obtain authorization from FDA. The Tobacco Control Act describes multiple pathways for introducing new products on the market, including Substantial Equivalence and Premarket Review. In addition, a manufacturer may submit a modified risk tobacco product application if seeking to market a product to reduce the harm of tobacco-related disease. Tobacco manufacturers must submit scientific data and information so that FDA can evaluate whether the products meet the statutory standards allowing the marketing of these products.

This presentation will provide an overview of the population health standards related to each of the pathways and examples of the types of scientific information that could be used to demonstrate whether products meet those standards, with a primary focus on the role of the social and behavioral sciences for assessing impacts on the population as a whole and modified risk tobacco products. Because of the complexity of tobacco products and the population health standards against which modified risk tobacco products must be assessed, manufacturers provide FDA a broad range of scientific information to enable evaluation of products. A multi-faceted scientific review carefully considers the risks and benefits to the population as a whole including the health risk to the individual users of the products and the impacts on non-users, including the likely impact on initiation and cessation of tobacco use.