Vapor products and Heated Tobacco Products (HTPs); Tobacco, tobacco products and related equipment (ICS 65.160)

Procedure for Pre-market Application for Vapor Products and Heated Tobacco Products seeking Registration under the Center for Cosmetics Regulation and Research (5 page(s), in English)

This Circular provides the procedural guidelines and documentary requirements for the Pre-Market Application pathway for FDA registration of Heated Tobacco Products and vapor products that have health claims and permissible concentrations above 20mg/mL but less than 65 mg/ml. This circular shall cover all manufacturers, traders, and importers of vapor products with health claims or with nicotine concentrations between 20 and 65 mg/ml and shall also apply to Heated Tobacco Products.