Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007." This guidance provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. The guidance includes a description of the types of evidence recommended to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007.