"harmful and Potentially harmful Constituents" in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic act (Revised)

Introduction:
This document is a guidance for industry and FDa staff regarding the definition of "harmful and Potentially harmful Constituents" (hPhC) in tobacco products, as used in Section 904(e) of the Federal Food, Drug, and Cosmetic act. The guidance discusses the meaning of hPhC in the context of the hPhC list requirement and is a revision of the guidance from January 2011. The guidance provides recommendations and does not establish legally enforceable responsibilities.

Key Points:

* The guidance applies to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, as well as other kinds of tobacco products subject to FDa's authority.
* hPhC includes any chemical or chemical compound in a tobacco product or in tobacco smoke that is inhaled, ingested, or absorbed into the body and causes or has the potential to cause direct or indirect harm to users or non-users of tobacco products.
* Examples of constituents that have the potential to cause direct harm include toxicants, carcinogens, and addictive chemicals.
* Examples of constituents that have the potential to cause indirect harm include those that facilitate initiation of tobacco product use, impede cessation, increase the intensity of use, or enhance the harmful effects of tobacco product constituents.
* The guidance was updated in august 2016 to reflect the issuance of the deeming rule and the current range of tobacco products subject to FDa's authority.
* The phrase "including as an aerosol (vapor) or any other emission" was added to the text to reflect the current range of tobacco products.
* The guidance is not legally binding and does not establish any rights for any person or binding on FDa or the public.

Main Message:
The guidance provides recommendations for defining hPhC in tobacco products and is applicable to a wide range of tobacco products subject to FDa's authority. The guidance emphasizes that hPhC includes not only direct harm-causing constituents but also those that have the potential to cause indirect harm, such as facilitating initiation or impeding cessation of tobacco product use. The guidance was updated in august 2016 to reflect the current range of tobacco products subject to FDa's authority, including those that emit aerosol or vapor. Overall, the guidance is an important tool for regulating tobacco products and protecting public health.

“‘harmful and Potentially harmful Constituents’ in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic act (Revised).” FDa Center for Tobacco Products (CTP), august 2016.