# 1100.202 Definitions.
For the purposes of this subpart:
*Commercially marketed* means selling or offering for sale a tobacco product in the United States to consumers or to any person for the eventual purchase by consumers in the United States.
*Pre-Existing Tobacco Product* means a tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. A Pre-Existing Tobacco Product is not subject to the premarket requirements of section 910 of the Federal Food, Drug, and Cosmetic Act.
*Tobacco product* means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term “tobacco product” does not mean an article that under the Federal Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device (section 201(h)); a combination product (section 503(g)); or a food (section 201(f)) if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine.
*Tobacco product manufacturer* means any person, including any repacker or relabeler, who—
(1) Manufactures, fabricates, assembles, processes, or labels a tobacco product; or
(2) Imports a finished tobacco product for sale or distribution in the United States.
[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]