TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 03 (Symposium)

Design and implementation of pre- and post-marketing surveillance for tobacco products

SHIFFMAN S.; GERLACH K.K.
Pinney Associates, Inc. Pittsburgh, PA, USA

Under the Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration may require pre- and/or post-market surveillance of tobacco products to assess the expected or actual product impact on population health. This will typically involve data both from users of the product and from potential users. This presentation discusses methods for developing and implementing such surveillance, including the practical and conceptual challenges involved. Surveys are an important tool for surveillance, with both public-use Federal surveys and special-purpose surveys playing a role. Both survey design and sampling considerations are crucial to survey validity. Considerable practical challenges arise when attempting to characterize use of products with a small market share. Significant conceptual challenges arise in linking any one product to potential effects on the population as a whole, especially in a dynamic tobacco/nicotine marketplace. In addition to surveys, surveillance may require retrieval and analysis of data from other sources, such as calls to Poison Control Centers, emergency department visits, traditional media stories, and social media mentions. The presentation will discuss the development of surveillance tools and the challenges of their implementation.