The U.S. Food and Drug Administration announced that it has authorized the marketing 22nd Century Group's "VLN King" and "VLN Menthol King" combusted, filtered cigarettes as modified risk tobacco products, which help reduce exposure to, and consumption of, nicotine for smokers who use them.  These are the first combusted cigarettes to be authorized as "modified risk tobacco products." 

The FDA has specifically authorized the manufacturer to market its cigarettes with certain reduced exposure claims regarding nicotine, including: 

  • "95% less nicotine"; 
  • "Helps reduce your nicotine consumption"; and 
  • "Greatly reduces your nicotine consumption." 

When using any reduced exposure claims on the product labeling or other advertising for the product, the manufacturer must also include the statement, "Helps you smoke less."  The FDA also recommends that, in addition to the usual required cigarette warnings, the labeling and advertising include the statement, "Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.” 

In a statement, Mitch Zeller, Director of the FDA's Center for Tobacco Products, said, "Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes."