• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Tobacco Products

  • Print
  • Share
  • E-mail
  • en Español en Español

Section 101 of the Tobacco Control Act - Amendment of Federal Food, Drug, and Cosmetic Act (FDCA)

Return to Tobacco Control Act Main Page


Table of Contents



Related Resources for Section 101


Draft Guidance





  1. 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:

      1. 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).
      2. 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).
      3. The products described in paragraph (2) shall be subject to chapter V of this Act. 
      4. 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)."
  2. FDA Authority over Tobacco Products. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended
    1. by redesignating chapter IX as chapter X;
    2. by redesignating sections 901 through 910 as sections 1001 through 1010; and

    3. by inserting after chapter VIII the following: