• 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

“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act

 

January 2011 

 

PDF

 

 

 

 

 

Section 904(e) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) (21 U.S.C. 387d(e)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) requires FDA to establish a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand (the HPHC list).  This guidance document discusses the meaning of “harmful and potentially harmful constituent” in the context of implementing the HPHC list requirement. 


 

 

 

 

Contact FDA

1-877-CTP-1373
1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov

Center for Tobacco Products Food and Drug Administration

9200 Corporate Boulevard

Rockville, MD 20850-3229