22nd Century claims its cigarette brands with very low nicotine levels have shown in studies to: lower exposure to toxins across time; contribute to smokers consuming fewer cigarettes per day; greater reduction in nicotine dependence; and more days in which participants had cigarette-free days.

Anti-smoking advocates have expressed concern that reducing nicotine levels too much could lead smokers to consume more cigarettes to get the same amount of nicotine, thereby increasing their exposure to carcinogens from the burning of the tobacco leaves.

Weighing benefits and risks

22nd Century also filed in December a premarket tobacco application for the Brand A product.

The premarket standard requires the FDA to consider products’ risks and benefits to the population as a whole, including users and non-users.

“Together, these important applications seek the FDA’s authorization to commercialize the company’s VLNTM cigarettes and to advertise that the VLNTM cigarettes contain 95% less nicotine as compared to the 100 leading cigarette brands in the United States,” the company said in December.