FDA Takes Action under the Tobacco Control Act of 2009
On March 29, the Food and Drug Administration (FDA) released two draft guidance documents intended to provide the public with accurate information about the chemicals in tobacco products and to help prevent misleading marketing by the tobacco industry. The documents are part of the FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act of 2009.
“We are committed to stopping…practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death,” said FDA Commissioner Dr. Margaret Hamburg in a press release.
The first document provides guidance on how tobacco companies will comply with the requirement to report the amount of harmful and potentially harmful constituents (HPHCs) found in their products. There are more than 7,000 chemicals in tobacco and tobacco smoke. The guidance document establishes a list of 93 HPHCs in tobacco and tobacco smoke and identifies 20 representative HPHCs for which testing methods are well established and widely available. The FDA intends to focus reporting enforcement on these 20 HPHCs during 2012 and to make information about the HPHCs in specific tobacco products available to the public in a consumer-friendly format by April 2013.
The Tobacco Control Act establishes rigorous scientific criteria that must be met before the FDA can allow a tobacco company to market a product with a claim of “reduced harm.” With this in mind, the second draft guidance document describes the scientific studies and analyses an applicant should submit to the FDA to demonstrate that its product will, or is expected to, significantly reduce harm or exposure to individuals and benefit the health of the population as whole. The “modified risk tobacco product” draft guidance is open for public comment until June 4, 2012.