FDA Rejects Claim That Smokeless Tobacco is Safer Than Cigarettes

FDA Rejects Claim That Smokeless Tobacco is Safer Than Cigarettes
FDA Rejects Claim That Smokeless Tobacco is Safer Than Cigarettes

The Food and Drug Administration (FDA) has denied a Citizen Petition requesting the initiation of a rulemaking to change a tobacco warning statement required on smokeless tobacco products.

The petition from R.J. Reynolds Tobacco Company and American Snuff Company, LLC was received on July 29, 2011 and asked the FDA to change the current statement “WARNING: This product is not a safe alternative to cigarettes.” to “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” The warning is one of four statements currently required by the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009.

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Manufacturers may submit a modified risk tobacco product application along with supporting scientific evidence to seek to claim that its product poses fewer risks than other tobacco products. The Citizen Petition was denied by the FDA following a thorough review of the available scientific evidence and public comments, in which it was determined that there was insufficient evidence to demonstrate that a change in the warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products.

For more information call (888) 463-6332 or visit FDA.gov.

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