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U.S. Department of Health and Human Services

Tobacco Products

FDA to Host a Public Workshop on Modified Risk Tobacco Product Applications

FDA will host a public workshop August 25-26, 2011, to discuss issues pertinent to the scientific evaluation of modified risk tobacco product (MRTP) applications.

The term “modified risk tobacco product” includes any tobacco product that is sold or distributed for use with a claim of reduced harm or reduced risk of tobacco-related disease associated with the commercially marketed tobacco product.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which gave FDA the authority to regulate tobacco products in 2009, requires manufacturers to submit an application to FDA before marketing a tobacco product that makes modified risk claims. In order to approve such an application, FDA must find that use of the product results in reduced harm to individual users as well as the population as a whole.

The two day workshop is designed for FDA to receive input from a variety of experts on what scientific studies the tobacco industry needs to provide to prove reduced harm or risk in tobacco products. According to the Congressional findings listed in the Tobacco Control Act, such proof and review is imperative to protect the public health from unsubstantiated modified risk tobacco products:

“The costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and injuries and huge costs to our health care system.”

The Congressional findings also state:

“It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”

FDA is inviting scientific and medical experts, as well as interested participants from academia, public health organizations, federal, state and local government agencies, consumer groups, and the tobacco industry, to attend the workshop in person or by live webcast.