Tobacco product manufacturing; Cigars, cheroots, cigarillos and cigarettes of tobacco or of tobacco substitutes (HS code(s): 2402); Product and company certification. Conformity assessment (ICS code(s): 03.120.20); Domestic safety (ICS code(s): 13.120); Tobacco, tobacco products and related equipment (ICS code(s): 65.160)

Requirements for Tobacco Product Manufacturing Practice; (90 page(s), in English)

Proposed rule - The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).