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[Accessed February 18, 2016];

however, sales of machine-manufactured, mass-merchandised little cigars and cigarillos have been on the rise, especially since flavored cigarettes were banned (with the exception of menthol) as part of the 2009 Family Smoking Prevention and Tobacco Control Act [1,2]

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The manuscript presents a brief overview of regulations and examples of feedback from regulatory agencies whilst highlighting NAMs that have been successfully applied, or could be used, in a regulatory setting, either as stand-alone methods or as part of a weight-of-evidence approach to address selected endpoints