The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents to help fight the tobacco epidemic and prevent children from using tobacco.
The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act that will ultimately provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products.
The first document provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products. The second document provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.
The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) found in tobacco products or tobacco smoke by brand and sub-brand. HPHCs are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers.
While there are more than 7,000 chemicals in tobacco and tobacco smoke, the FDA has now established a list of 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S.
The FDA also issued draft guidance on submitting applications to sell modified risk tobacco products, tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the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. The draft guidance describes scientific studies and analyses an applicant should submit to demonstrate its product will, or is expected to, significantly reduce harm or exposure to individuals and benefit the health of the population as a whole.
The draft guidance document and a December 2011 report from the Institute of Medicine titled "Scientific Standards for Studies on Modified Risk Tobacco Products" are open for comments from the public until June 4, 2012.
