Cigarettes Containing Tobacco

Under the Family Smoking Prevention and Tobacco Control Act, cigarettes not commercially marketed in the US before February 15, 2007 require FDA premarket authorization — either a Premarket Tobacco Application (PMTA) or a Substantial Equivalence (SE) order — before they can be legally imported and sold. Importers introducing new cigarette products or new variants of existing products must confirm that the appropriate FDA authorization is in place prior to entry.

The Prevent All Cigarette Trafficking Act imposes registration, reporting, and tax-collection obligations on sellers and shippers of cigarettes, particularly those sold through mail-order or online channels. Importers who distribute through non-traditional retail channels should assess their PACT Act obligations carefully, as violations can result in significant civil and criminal penalties.