Harmful and Potentially Harmful Constituents (HPHCs)
The Food, Drug and Cosmetic Act (FD&C Act) requires tobacco manufacturers and importers to report the levels of harmful and potentially harmful constituents (HPHCs) found in their tobacco products and tobacco smoke. HPHCs are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers.
FDA must publish HPHC quantities in each brand and subbrand of tobacco product, in a way that people find understandable and not misleading. There are several efforts under way at FDA to make progress toward that goal.
Preliminary HPHC List
FDA published a preliminary list of 93 HPHCs in March 2012. This HPHC list focuses on chemicals that are linked to the five most serious health effects of tobacco use (cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction.)
Tobacco Industry Reporting Requirements
FDA issued draft guidance in 2012 that identified a subset of 20 HPHCs for which manufacturers and importers are to test and report to FDA. FDA chose these 20 because testing methods were well established and widely available. This includes reporting on HPHC levels in three categories of tobacco products: cigarettes (including smoke and filler), smokeless tobacco (such as snuff, plug, chew, loose leaf, and snus), and roll-your-own tobacco. FDA is now evaluating the quality and reliability of the data submitted by manufacturers.
Communicating to the Public
Making sure the public can clearly understand the real and potential risks of tobacco use is an important goal. Presently, FDA is conducting research about how best to ensure that the public is made aware of the dangers of the chemicals and chemical compounds in tobacco products and smoke and to communicate the levels of HPHCs in each brand and subbrand of tobacco product. In the meantime, FDA is including messages about HPHCs in its ongoing public health campaigns.