Guidance for Industry: Reporting harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic act: DRaFT GUIDaNCE

Introduction:
This text is a draft guidance document issued by the Food and Drug administration (FDa) for persons reporting harmful and potentially harmful constituents (hPhCs) in tobacco products and tobacco smoke under section 904(a)(3) of the Federal Food, Drug, and Cosmetic act. The guidance provides information on the statutory requirement for testing and reporting hPhCs, who should test and report hPhCs, when reports should be submitted, what information should be reported, and how reports should be submitted to FDa. The guidance is intended to assist the industry in complying with the hPhC reporting requirements.

Key Points:

* The guidance provides information on the FDa's current thinking on the hPhC list requirement.
* The guidance explains the criteria used to identify hPhCs and lists 96 hPhCs identified by FDa.
* The guidance establishes the list of hPhCs and publishes it in the Federal Register.
* The guidance provides an abbreviated list of hPhCs for industry to test and report, while industry develops laboratory capacity to comply with section 904(a)(3).
* The guidance explains who should test and report hPhCs, when reports should be submitted, and what information should be reported.
* The guidance provides recommendations on how reports should be submitted to FDa.

Main Message:
The main message of the text is that the FDa has established a list of hPhCs that tobacco product manufacturers or importers must report under section 904(a)(3) of the Federal Food, Drug, and Cosmetic act. The guidance provides information on the hPhC list requirement, including the criteria used to identify hPhCs, the abbreviated list of hPhCs for industry to test and report, and the requirements for testing and reporting hPhCs. The guidance also provides recommendations on how reports should be submitted to FDa. Compliance with the hPhC reporting requirements is essential for protecting the public health and reducing tobacco use by minors.

“Guidance for Industry: Reporting harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic act: DRaFT GUIDaNCE.” USDhhS FDa Center for Tobacco products (CTP), March 2012.