The Food and Drug Administration will review the public-health benefits of making cigarettes with very low levels of nicotine available to smokers.
The FDA said Friday it will study two modified-risk tobacco product applications from 22nd Century Group Inc.
A modified-risk tobacco product application seeks authorization to advertise products as reduced harm or reduced risk compared to cigarettes.
The company, based in Clarence, N.Y., operates a tobacco-manufacturing plant in Mocksville, where it had 70 of its 79 employees at last count.
22nd Century filed applications in December for its “Brand A” product, which has been the subject of more than 50 global studies. Some of those studies have been funded all or in part by the FDA and National Institutes of Health.
The products initially would go by the brand VLNTM King and VLNTM Menthol King. The FDA has authority over product names.
The FDA plans to open today a Federal Register notice establishing a docket on www.regulations.gov to receive public comments on the 22nd Century applications. The notice allows the public to submit research, data or comments to docket FDA-2019-N-0994 on the website.
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.
22nd Century bases the claim of 95% less nicotine on its VLNTM products containing just 0.5 milligrams of nicotine per gram of tobacco, compared to an average of 20 milligrams, or 0.71 ounces, for many of the top-selling traditional cigarette brands.
The Federal Register will publish a notice establishing a formal docket for public comments on www.regulations.gov at a later date.