FDA's Center for Tobacco Products (CTP) has authority over imported tobacco products under the Family Smoking Prevention and Tobacco Control Act. Foreign manufacturers must be registered with FDA, and products must comply with applicable US tobacco product standards before they can be legally imported and sold.

Cigars and cigarettes carry different federal excise tax rates, different HTS tariff classifications, and different FDA regulatory pathways. A product misclassified as a cigar when it meets the definition of a cigarette — based on tobacco filler, wrapper composition, and weight thresholds — can result in substantial back-tax liability and potential seizure.