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

• Date: June 14, 2010
• Source: www.fda.gov

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.

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