Yes — FDA CTP treats heated tobacco products as tobacco products subject to premarket authorization requirements. Importers of these products must ensure the relevant marketing authorization (such as a Premarket Tobacco Product Application approval) is in place before commercial importation, or the products may be refused entry.

Foreign tobacco product manufacturers must register with FDA and submit product listings annually. If a manufacturer is not registered or is out of compliance, CBP can detain or refuse the shipment at the port of entry regardless of whether the products otherwise meet tariff classification requirements.