The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents found in tobacco products or tobacco smoke by brand and sub-brand.
Harmful and potentially harmful constituents are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers. All on the list either cause or may cause serious health problems including cancer, lung disease and addiction to tobacco products.
While there are more than 7,000 chemicals in tobacco and tobacco smoke, the FDA established a list of 93 harmful and potentially harmful constituents that tobacco companies will be required to report for every regulated tobacco product sold in the United States.
FDA officials said they recognized the industry may be unable to meet the deadline due to current testing limitations, so the draft guidance identified 20 harmful and potentially harmful constituents that are representative of the full list and for which testing methods are well established and widely available.
The FDA said it plans to make information about the amount of harmful and potentially harmful constituents in specific products available to the public in a consumer-friendly format by April 2013.
The FDA also issued draft guidance on submitting applications to sell modified risk tobacco products -- tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.