Harmful and Potentially Harmful Constituents (HPHCs)
Harmful and potentially harmful constituents (HPHCs) are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers.
The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of HPHCs found in tobacco products or tobacco smoke by brand and sub-brand.
While there are more than 7,000 chemicals in tobacco and tobacco smoke, FDA established a list of 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S. All HPHCs included on the list cause or may cause serious health problems including cancer, lung disease, and addiction to tobacco products.
- Read the HPHC draft guidance released March 2012. FDA recognizes that industry may be unable to meet the deadline due to current testing limitations. In recognition of this, the draft guidance identifies 20 HPHCs that are representative of the full list and for which testing methods are well established and widely available. FDA intends to focus reporting enforcement on these 20 HPHCs during 2012.