Abstract

Summary On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a Final Rule that extended its regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (Deemed Products). Effective August 8, 2016, this decision greatly expanded the scope of tobacco products being regulated by FDA and introduced significant testing challenges that need to be addressed. The major challenge for cigars in particular is testing as well as generation of accurate and reliable data, in the absence of certified reference products and standardized methodology for a product category with significant complexity and high inherent variability. In this article, we provide an overview of recent studies as well as active opportunities and on-going challenges associated with regulating and testing cigars. To the best of our knowledge, this is the first comprehensive review of non-clinical research for this product category (cigars). We are therefore convinced that, tobacco scientists and farmers, analytical chemists, cigar consumers, tobacco legal counsels, state and federal regulatory authorities will find this review beneficial and insightful.

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