FDA Lists HPHC Reporting Requirements for Tobacco Manufacturers, Importers
The Food and Drug Administration released two draft guidance documents that implement the provisions of the Family Smoking Prevention and Tobacco Control Act that aims to provide the public with previously unknown information about chemicals in tobacco products and helps…
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prevent misleading marketing about the risks associated with tobacco products. The Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) found in tobacco smoke by brand and sub-brand. The new FDA documents list 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S. But realizing that industry may be unable to meet the reporting deadline because of current testing limitations, the agency identified 20 HPHCs that are "representative of the full list and for which testing methods are well established and widely available." The FDA said it intends to focus reporting enforcement on these 20 HPHCs in 2012. The first document provides guidance on how companies will comply with the reporting requirement and the second provides guidance on advertising or marketing a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.