From: US FDA
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft concept paper entitled “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.” FDA seeks public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. This draft concept paper is offered to stimulate dialogue around the subject of possible illicit trade in connection with tobacco product standards.
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FDA faces a complex task when assessing the potential for an illicit trade market to develop in response to a tobacco product standard. While it remains difficult to measure existing illicit trade markets and use existing data to reliably predict future illicit markets, it may be possible to isolate some of the key factors that may encourage or discourage illicit trade in tobacco products. This draft concept paper assists that effort by breaking down the potential mechanics of an illicit trade market into various components, and examining the factors that could support or hinder the establishment of a persistent illicit trade market in the face of an FDA tobacco product standard. This paper first discusses the legal authority and general approach to establishing tobacco product standards, and then discusses the different components of illicit trade markets, followed by relevant research in consumer behavior and potentially applicable economic research.
