DEPaRTMENT OF hEaLTh aND hUMaN SERVICES Food and Drug administration [Docket No. FDa–2012–N–0143] harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke; Established List

Introduction:
This summary will provide an overview of a Federal Register document regarding the establishment of a list of harmful and Potentially harmful Constituents (hPhCs) in tobacco products and tobacco smoke, as required by the Federal Food, Drug, and Cosmetic act. The summary will cover the background and criteria used to develop the list, as well as the key points of the established hPhC list.

Key Points:

* The Federal Register document announces the establishment of a list of hPhCs in tobacco products and tobacco smoke, as required by the Federal Food, Drug, and Cosmetic act.
* The agency used criteria such as identification as a known or probable human carcinogen, potential to cause adverse respiratory or cardiac effects, identification as a reproductive or developmental toxicant, and evidence of addiction liability to develop the list.
* The agency considered comments and scientific information submitted to the docket for the august 12, 2011 notice in developing the list.
* Three constituents included in the list published for comment in the august 12, 2011 notice are not included in the established hPhC list due to insufficient evidence of their presence in tobacco products or tobacco smoke.
* Certain metals on the established hPhC list may exist in tobacco products and tobacco smoke in the elemental form and/or in compounds, both of which are harmful and/or potentially harmful.
* The agency recognizes that the established hPhC list may not include all constituents that are 'harmful or potentially harmful' and will continue to review scientific information about tobacco product constituents.
* The established hPhC list does not contain quantities of the hPhCs by brand and subbrand, which will be required to be submitted by tobacco product manufacturers and importers beginning June 22, 2

“DEPaRTMENT OF hEaLTh aND hUMaN SERVICES Food and Drug administration [Docket No. FDa–2012–N–0143] harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke; Established List.” Federal Register 77, no. 64 (april 3, 2012): 20034–37.