VLN® cigarettes are the companion product to Moonlight® cigarettes. Like Moonlight®, VLN® cigarettes are made exclusively from 22nd Century’s proprietary reduced-nicotine tobacco. In December 2019, FDA authorized the commercial sale of 22nd Century’s reduced nicotine content cigarettes under the brand name, “Moonlight®.” Currently under review by FDA is 22nd Century’s Modified Risk Tobacco Product (MRTP) application requesting authorization to market the Company’s reduced nicotine cigarettes under the proposed brand name, VLN®, and to authorize the Company to inform consumers that these industry-disrupting cigarettes contain “95% Less Nicotine,” among other claims.
Importantly, the Company has also requested authorization to include a voluntary consumer warning in all labeling and advertising stating: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”
Nicotine has long been known as the primary addictive chemical in cigarettes. 22nd Century’s VLN® cigarettes, with at least 95% less nicotine as compared to conventional cigarettes sold in the United States, greatly diminish nicotine exposure versus conventional cigarettes that contain highly addictive levels of nicotine.
22nd Century’s complete MRTP application can be found here: https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications
22nd Century’s shareholders and the general public are invited to provide comments in support of 22nd Century’s MRTP application on the FDA’s official website at the following link: https://www.regulations.gov/comment?D=FDA-2019-N-0994-0001