DEPaRTMENT OF hEaLTh aND hUMaN SERVICES: Food and Drug administration [Docket No. FDa–2012–D–0049] Draft Guidance for Industry: Reporting harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic act; availability

Introduction:
This text discusses the Food and Drug administration's (FDa) draft guidance for industry regarding the reporting of harmful and Potentially harmful Constituents (hPhCs) in tobacco products and tobacco smoke. The guidance aims to assist persons reporting to FDa the quantities of hPhCs in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic act.

Key Points:

* The FDa has identified 96 hPhCs in tobacco products and tobacco smoke.
* Manufacturers or importers are required to report the quantities of these hPhCs in their products to the FDa.
* The draft guidance provides an abbreviated list of hPhCs on which FDa intends to focus enforcement at this time.
* The FDa has developed forms in both paper and electronic formats to facilitate the submission of hPhC information.
* at this time, the FDa does not intend to enforce the requirement to submit quantities of all hPhCs on FDa’s established list where manufacturers or importers complete testing and reporting for an abbreviated list of hPhCs.
* The FDa intends to enforce the hPhC reporting requirements with respect to manufacturers of finished tobacco products for consumer use, such as cigarettes, smokeless tobacco, and roll-your-own tobacco.
* The FDa will use the information submitted under sections 904(a)(3) and 904(c)(1) of the FD&C act to meet the requirements of section 904(e) of the FD&C act regarding a list of hPhCs in each tobacco product by brand and by quantity in each brand and subbrand.

Main Message:
The FDa's draft guidance for industry emphasizes the importance of reporting the quantities of hPhCs in tobacco products and tobacco smoke. The guidance outlines the procedures for reporting and the abbreviated list of hPhCs on which the FDa intends to focus enforcement. The FDa's goal is to protect public health and reduce tobacco use by minors by regulating the manufacture, marketing, and distribution of tobacco products.

“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): 20030–34.