Star Scientific s approach for FDA s OK flawed

Yesterday brought news that smokeless tobacco manufacturer Star Scientific had issued a press release saying that they would ask the FDA to formally acknowledge that their new moist smokeless tobacco product, called Stonewall Moist-BDL, was 90-99 percent lower in carcinogens than those offered by their competitors. The tobacco lozenge maker is asking the government for “modified risk” approval.

While the need for tobacco harm reduction products is desperate, ACSH's Dr. Elizabeth Whelan believes that Star Scientific is heading in the wrong direction. “The reason smokeless tobacco is less harmful than cigarettes is not because it has fewer chemicals but because of the absence of the combustion associated with smoking tobacco.”

ACSH's Dr. Gilbert Ross agrees and worries that the company will do more injury than good to the harm reduction movement. “There is no evidence we know of as to which chemicals (or combinations of chemicals) in cigarettes or in tobacco causes cancer in humans. There are many animal carcinogens in tobacco smoke. But to simply assert that a particular product, having less of certain chemicals, is therefore ‘safer’ is not a valid hypothesis. Such a claim would need to be proven with clinical studies, which unfortunately would take years. I am convinced that Star’s products are much safer than cigarettes, but I believe the FDA will want more evidence before giving them the ‘Seal of Approval’ as a reduced-risk tobacco product. I admire the company for at least trying to get the FDA to pay more attention to less harmful tobacco products, but their position is not backed by the available evidence.”