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  1. Rules, Regulations and Guidance

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

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  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. "(rr)
      2. 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).  
      3. 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).  
      4. The products described in paragraph (2) shall be subject to chapter V of this Act.   
      5. 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:  

 

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