22nd Century VP of Regulatory Science to Present on Health Disparities Caused by Cigarette Addiction at FDLI Annual Conference

Research Shows Cigarette Addiction Disproportionately Harms Minority and Vulnerable Communities; Mandating Reduced Nicotine Content in Cigarettes Would Help Counteract Years of Targeted Marketing of Addictive and Deadly Products by Big Tobacco

BUFFALO, N.Y., May 18, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and hemp/cannabis research, announced today that the Company’s Vice President of Regulatory Science, John Pritchard, will present at the Food and Drug Law Institute (FDLI) Annual Conference as part of the event’s session, “Tobacco and Nicotine Use and Health Disparities: How to Address Equity Issues through FDA Actions,” on Wednesday, May 19, 2021, at 3:00 p.m. ET. The session will focus on the health disparities caused by tobacco and nicotine products among different groups within society, including a review of the use of mentholated products and their disproportionately high impact on African Americans. Pritchard and the other invited panelists will also make recommendations on how the U.S. Food and Drug Administration (FDA) can accelerate and improve health outcomes through public education and regulation, such as a nicotine cap to make all cigarettes “minimally or non-addictive.”

“We are proud to partner with leading organizations like FDLI and work together to get the important message out that the time is now for the FDA to act decisively to stop the negative health effects caused by nicotine and cigarette addiction,” said James A. Mish, chief executive officer of 22nd Century Group. “FDA action is long overdue. Four years have passed since the FDA issued its Comprehensive Plan for Tobacco and Nicotine Regulation, including the Agency’s advance notice of proposed rulemaking (ANRPM) to reduce the amount of nicotine allowed in cigarettes to ‘minimally or non-addictive’ levels. While there have been some positive developments recently, including reports that the White House is considering taking action on nicotine in cigarettes, it is imperative that industry leaders continue to encourage the government to take the necessary and proportionate action through nicotine regulation in order to save the lives of millions of Americans and to help prevent younger generations from ever becoming addicted to cigarettes.”

“Our Company has a solution, and we are prepared to move into action immediately. With our VLN® King and VLN® Menthol King reduced nicotine content (RNC) cigarettes, 22nd Century provides the only combustible tobacco products able to meet the nicotine level in the FDA’s proposed mandate. The FDA must move quickly to authorize 22nd Century’s MRTP (Modified Risk Tobacco Product) application for VLN® so that while the Agency continues its work towards establishing a nicotine cap for all cigarettes, adult smokers can have the choice of a non-addictive cigarette and take action to improve their health.”

Pritchard will present data on the disproportionate impact of cigarette addiction within society, as well as highlighting research on the potential role of a “minimally or non-addictive” nicotine product standard to help tackle the root causes of health disparities for various minority segments of the population, including African Americans, Hispanics, people with mental illness and those living with HIV, among others.

Joining Pritchard on the panel are public health experts, Aruni Bhatnagar, professor of medicine and distinguished university scholar with the University of Louisville; and Darlene Huang, legislative and policy counsel for The Campaign for Tobacco-Free Kids. The panel will be moderated by Jasjit S. Ahluwalia, Professor, Behavioral and Social Sciences, Brown University School of Public Health; Professor of Medicine, Alpert School of Medicine; and Associate Director (Populations Sciences), Brown Cancer Center. Acting FDA Commissioner Dr. Janet Woodcock will provide the keynote address for the conference, which will also be attended by high-ranking public health and policy figures, including FDA’s Center for Tobacco Products Director, Mitch Zeller, and Mark J. Raza, acting chief counsel for the FDA. Former FDA Commissioner, Dr. Robert Califf, is also scheduled to speak at the conference.

“The FDA’s recently announced intention to remove menthol from cigarettes is a welcome step forward to addressing the health disparities caused by cigarette smoking – sadly, it’s far from enough. With around half a million Americans dying from cigarette addiction each, and every year, it’s time for the FDA to fully deploy the substantial authority that Congress provided the Agency in 2009. The feasibility of a low nicotine product standard is clear, the science is clear, and the benefits to our society are clear. Public health can and must be advanced and we must ensure that no one in our society is left behind,” said John Pritchard. Speaking further on the menthol ban, he added, “Independent clinical research shows that consumption of menthol reduced nicotine content cigarettes leads to reduced cigarette consumption, increased quit attempts, and would play an important role in the FDA comprehensive plan, by providing existing menthol smokers with a product to enable them to reduce their nicotine consumption compared to non-menthol conventional cigarettes that would remain on the market.”

Pritchard represents 22nd Century in the FDLI as a member of its Tobacco Nicotine Products Committee. The Committee brings together a diverse group of expert stakeholders, including public health researchers, leaders of non-governmental organizations, and members of the FDA’s Center for Tobacco Products to discuss tobacco regulation and policy. Following his session at the FDLI Annual Conference, Pritchard’s presentation will be available on the Events section of 22nd Century’s website.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century’s primary mission in tobacco is to reduce the harm caused by smoking through the Company’s reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company’s primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury, and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com