22nd Century Group Regulatory Science VP Joins FDLI Tobacco and Nicotine Products Committee - Seite 2

“With respiratory health front and center in everyone’s minds, there has never been a more critical time to advance effective public health policy and regulation in the area of tobacco control. Cigarette addiction is the leading cause of preventable death in the United States and having the opportunity for multi-stakeholder dialogue is an essential part of achieving this,” said Pritchard. “I have a tremendous amount of respect for the FDLI, and I look forward to contributing my experience to the organization.”

Pritchard started in his regulatory role at 22nd Century in 2019 and brings more than 20 years of scientific and regulatory experience in the tobacco and pharmaceutical industries, as well as public health experience, to the committee. At 22nd Century, he oversees global regulatory and compliance activities, which includes stewardship of the Company’s MRTP application for its VLN cigarettes.

Made from proprietary tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN is the only combustible tobacco product that complies with the FDA’s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company is highly confident that it is in the final stages of the FDA’s application process to obtain a MRTP designation for VLN. The designation will allow 22nd Century to communicate key features of VLN King and VLN Menthol King, including a headline claim of “95% less nicotine.” Although VLN contains just 0.5 milligrams of nicotine per gram of tobacco, VLN tastes, smells, and smokes like a conventional cigarette. This disruptive product is an innovative alternative to addictive, conventional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN brand and tobacco franchise. The Company remains willing to license its technology to enable every cigarette manufacturer to comply with the FDA’s proposed nicotine cap that will significantly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.