Maker of Tobacco Lozenges Seeks FDA Okay for ’Less Harmful’ Claim

A small Virginia company, Star Scientific, Inc., is seeking approval from the Food and Drug Administration (FDA) to market one of its smokeless tobacco products as less harmful than other tobacco products, the Associated Press reported Jan. 4.

Star Scientific said its new Stonewall Moist-BDL dissovable tobacco lozenge has 90 to 99 percent fewer carcinogens than similar products and should qualify for a new “modified-risk” label being developed by the FDA.

Two similar applications to the agency from Star are still under consideration. 

According to the federal Centers for Disease Control and Prevention, smokeless tobacco is not safer than cigarettes because it has 28 cancer-causing ingredients. The United Kingdom’s Royal College of Physicians has taken a different position. In a 2007 report, the College said that some smokeless tobacco products were less harmful than cigarettes.

Smokeless tobacco products, such as electronic cigarettes and dissolvable lozenges, have divided public health advocates. Some argue that smokeless tobacco presents a lower risk to the public, while others argue that all tobacco use is harmful.

About 3 percent of adults in the United States use smokeless tobacco.