22nd Century Group Provides Business Update Letter from CEO - Seite 2

The political changes now in place will likely be highly favorable to our business prospects from a policy priority and regulatory view. What’s more, we believe we have made an impact on the timing of our MRTP application based on a positive and relentless approach with the FDA through multiple channels. With the Biden Administration in the White House and Democrats in control of both the Senate and House of Representatives in the 117^th United States Congress, we believe that government agencies will be much more focused on improving public health in 2021. And we have already begun working to align completely with the new administration and to encourage their support.

We also believe that, under the new administration, the FDA will now be re-energized in implementing its ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to cap the amount of nicotine in combustible cigarettes. At just 0.5 milligrams of nicotine per gram of tobacco, VLN is the only combustible tobacco product today that meets the FDA’s proposed product standard for nicotine levels that are “minimally or non-addictive.” 22nd Century’s MRTP authorization and the launch of VLN will serve as a vanguard for the FDA’s proposed mandate. We believe the tide is, at last, turning and have a bullish outlook on the implementation of such a mandate that will, according to public health researchers, help more than five million adult smokers quit smoking, prevent hundreds of children from becoming addicted to smoking every day, and save more than eight million American lives by the end of the century³. This is the grand slam that will drive our revenue and market capitalization orders of magnitude higher.

Commercial Launch Ready

As previously discussed, we are fully prepared for the commercial launch of VLN King and VLN Menthol King cigarettes within 90 days of receiving authorization from the FDA. The launch of VLN will be paired with a compelling marketing campaign to introduce adult smokers to the world’s lowest nicotine content cigarette. Based on early sales projections and to meet the expected demand from adult smokers, we have significantly expanded the growing program for VLN reduced nicotine content tobacco.