On December 23, 2021 the FDA announced an historic landmark decision in the fight against smoking when it authorized VLN King and VLN Menthol King from 22nd Century Group, Inc. as the first and only reduced nicotine content cigarettes under its Modified Risk Tobacco Product designation. Scientific studies show the company's VLN reduced nicotine content cigarettes help smoke less. 22nd Century is now moving aggressively to bring VLN to market.

A pilot launch will begin in its first major metropolitan market by March 2022 and then marketing and distribution is expected to expand to a full nationwide launch. The FDA decision on VLN is a major event for public health in the fight to reduce the harm caused by smoking. Not only did 22nd Century receive the MRTP authorization based on its application requests, the FDA proactively added an extra and incredibly valuable claim of Helps Smoke Less mandated on every package to educate the consumer about the product's benefit.

VLN King and VLN Menthol King are the only FDA authorized reduced nicotine content combustible cigarettes in the U.S. tobacco products market, estimated at approximately $80 billion in size. 22nd Century intends to commence its pilot market launch in March 2022 in order to test and optimize its marketing mix educating smokers about the benefits of reduced nicotine content VLN King and VLN Menthol King cigarettes. The pilot will help the Company better understand how adult smokers will use this unique and revolutionary product prior to advancing to national distribution, providing an unmatched tool for helping adult smokers find an off-ramp from nicotine addiction.

Additionally, 22nd Century is engaged in ongoing discussions with other potential partners – both retail and strategic – interested in helping to introduce reduced nicotine content products using 22nd Century's proprietary tobacco to adult smokers. While 22nd Century owns or controls the intellectual property that makes VLN® tobacco possible, the company has reiterated its willingness and expectation to license the technology to strategic partners to help ensure availability to the maximum number of adult smokers in the U.S. and worldwide as quickly as possible in support of broader public health goals established by the U.S. FDA and other agencies.