22nd Century Group Regulatory Science VP Joins FDLI Tobacco and Nicotine Products Committee
BUFFALO, N.Y., April 08, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company’s Vice President of Regulatory Science, John Pritchard, will represent 22nd Century as a new member of the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Committee. The Committee brings together a diverse group of stakeholders, including public health researchers, leaders of non-governmental organizations, and members of the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to discuss tobacco product regulation and policy.
“We are proud that John has been invited to serve on the highly regarded FDLI Tobacco and Nicotine Product Committee and to represent 22nd Century in this forum,” said James A. Mish, chief executive officer of 22nd Century Group. “Our organization is fortunate to have a number of experts on our leadership team, and it is important that we play an active role in moving the tobacco industry forward to reduce the harm caused by smoking. The status quo of cigarette addiction must end, and we are delighted that John will serve on this committee to educate the industry about 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application for our VLN® reduced nicotine content cigarettes, which we are highly confident is in the final stages of review by the FDA. John will also spend this year supporting the committee’s programs and advocating for the FDA to implement the Agency’s proposed mandate to set a maximum level of nicotine in cigarettes of 0.5 milligrams of nicotine per gram of tobacco, a level already achieved in our VLN® cigarettes, and previously deemed by the FDA to ‘minimize addictiveness’.”
The FDA’s proposed tobacco product standard for nicotine level of combustible cigarettes, which was published in March 2018 as an Advance Notice of Proposed Rulemaking (ANRPM), is the cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation. The FDA’s plan seeks to lower the nicotine content of all cigarettes to a “minimally or non-addictive” level. The creation of a proposed nicotine cap could decreasethe chances that future generations become addicted to cigarettes and could make it easier for currently addicted smokers to quit. Public health researchers project that the enactment of a nicotine cap would help more than five million people to quit smoking within the first year of implementation and save more than eight million American lives by the end of the century. A recent survey reported by the Centers for Disease Control and Prevention (CDC) found that 80% of adults in the United States are in favor of lowering nicotine levels in cigarettes to make them less addictive.
“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.
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