U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Rules, Regulations, and Guidance Related to Tobacco Products
  5. Section 902 of the Federal Food, Drug, and Cosmetic Act - Adulterated Tobacco Products
  1. Rules, Regulations, and Guidance Related to Tobacco Products

Section 902 of the Federal Food, Drug, and Cosmetic Act - Adulterated Tobacco Products

Return to Tobacco Control Act Main Page

A tobacco product shall be deemed to be adulterated if

  1. it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;  
  2. it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;  
  3. its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;  
  4. the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
  5. it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 907 unless such tobacco product is in all respects in conformity with such standard;  
    1. it is required by section 910(a) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i); or
    2. it is in violation of an order under section 910(c)(1)(A);  
  7. the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 906(e)(1) or an applicable condition prescribed by an order under section 906(e)(2); or  
  8. it is in violation of section 911.
Back to Top