22nd Century Group has filed a Premarket Tobacco Application (PMTA) with the US Food and Drug Administration (FDA) for its low nicotine ‘Brand A’ cigarettes, the company said in a press release.

The company is seeking FDA authorisation to commercialise Brand A under the proposed name VLN. Subject to FDA approval, the name VLN references the company’s proprietary Very Low Nicotine (VLN) tobacco, which is produced exclusively by the company and has been used in its Spectrum research cigarettes.
A PMTA is necessary to launch any new tobacco product on the market and the plant biotech company said filing the PMTA was also an important step toward marketing its low nicotine combustible cigarettes as a Modified Risk Tobacco Product.
Henry Sicignano, chief executive officer and president at the company, said an MRTP for Brand A is to follow. “Later this month, 22nd Century will submit to the FDA the company’s highly-anticipated MRTP application. Containing only a tiny fraction of the nicotine found in the 100 leading US cigarette brands, 22nd Century’s proposed VLN cigarettes will demonstrate conclusively that the FDA’s plan to dramatically reduce nicotine in all US cigarettes is immediately feasible,” Sicignano said.