FDA to review application to modify health warning on Altria subsidiary’s smokeless tobacco product

Source: www.richmond.com
Author: staff

The U.S. Food and Drug Administration will review a request from an Altria Group Inc. subsidiary that wants to make the claim that a smokeless tobacco product is less dangerous than cigarettes. U.S. Smokeless Tobacco Co. said Friday that the FDA has agreed to do a substantive review of its “modified risk” application for Copenhagen Snuff Fine Cut. The company submitted the request for review earlier this year.

The snuff company wants to be able to use the claim “If you smoke consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

The FDA requires smokeless tobacco products to carry statements that warn about the risk of mouth cancer, gum disease, tooth loss and addiction and that the product is not a safe alternative to cigarettes. The warnings are to be randomly rotated on packaging.

“We filed this application because we think adult smokers looking for potential reduced risk alternatives to cigarettes should have accurate information about the relative risks of Copenhagen Snuff,” Joe Murillo, Altria Client Services senior vice president for regulatory affairs, said in a statement.

The FDA defines modified risk tobacco products as tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
In the review process, the FDA’s Tobacco Products Scientific Advisory Committee vets the scientific claims and makes a recommendation.

The FDA has reviewed more than 30 modified risk applications from tobacco companies since 2011, but none has been approved. Some remain under review, while others were denied by the agency or withdrawn by the companies that submitted them.