Note: The definition of “tobacco product,” where included in the text of FDA regulations, has been updated to reflect the statutory amendments to include products that contain nicotine from any source. FDA has made these conforming changes to its regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022 (the Appropriations Act), which amended the term “tobacco product” in the FD&C Act. Revisions to FDA’s guidances to reflect the updates are ongoing.
Related Resources for Section 101
- Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the FD&C Act
- Definition of Tobacco Products. Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
- The term 'tobacco product' means any product made or derived from tobacco 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 is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
- The products described in paragraph (2) shall be subject to chapter V of this Act.
- A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement)."
- FDA Authority over Tobacco Products. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended
- by redesignating chapter IX as chapter X;
- by redesignating sections 901 through 910 as sections 1001 through 1010; and
- by inserting after chapter VIII the following: