22nd Century Stands Fully Prepared to Enable New Zealand Proposal to Advance Nationwide Smoke-Free Action Plan

New Zealand Ministry of Health Proposal Calls for Reducing Nicotine Content in Cigarettes to “Minimal Levels” to Help Smokers Quit, Prevent Addiction

BUFFALO, N.Y., April 15, 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 it is fully prepared to support New Zealand in its efforts to become a smoke-free nation by 2025. This follows the release of a new proposal by the New Zealand Ministry of Health Manatū Hauora that calls for reducing the amount of nicotine allowed in smoked tobacco products to “minimal levels.” When enacted, the proposal will help existing adult smokers to reduce their consumption or switch to alternative products and would protect young people from cigarette addiction.

“We applaud the New Zealand government for the proactive approach they are taking to help their citizens break their cigarette addiction. We were expecting this proposal and are fully prepared to help New Zealand to reach its goal,” said James A. Mish, chief executive officer of 22nd Century Group. “New Zealand has made great progress since announcing their goal of becoming smoke-free by 2025, but in order for the country to finally achieve success it is imperative that the amount of nicotine in cigarettes is reduced 95% to ‘minimal levels.’ We are pleased to see that the New Zealand government recognizes the technical feasibility of this approach.”

22nd Century initially engaged with public health researchers in New Zealand in 2016, when the country announced its goal of becoming smoke-free, leading the New Zealand Medical Journal to publish a letter recommending 22nd Century’s reduced nicotine content (RNC) cigarettes as an “important smoking reduction tool.” Given its position as the sole supplier of RNC cigarettes used in public health research, the authorization by FDA of its Premarket Tobacco Application (PMTA) for RNC cigarettes, and its readiness to commercialize RNC cigarettes at commercial scale, 22nd Century is well-positioned to supply RNC cigarettes to the New Zealand market in support of the implementation of its 2025 initiative.

New Zealand has played a key role in past smoking reduction initiatives that have eventually been adopted globally. 22nd Century also expects other countries, including Australia and Canada as well as the World Health Organization (WHO), will call to reduce the amount of nicotine allowed in cigarettes sold in their countries and around the world. “New Zealand has so often been at the vanguard of the right policy for a just and thriving society, being the first self-governing nation to give women the vote in 1893, and it continues to this day to provide inspirational leadership. We recognize the disproportionate burden that cigarette addiction has on minority and vulnerable communities in New Zealand, as it does in the U.S., and stand ready to play our part in addressing this key societal and health issue,” added John Pritchard, vice president of regulatory science at 22nd Century Group.

“We know other countries and the WHO will be further encouraged by New Zealand, and 22nd Century has already advanced dialogue with a number of these interested parties. With the U.S. Food and Drug Administration [FDA] continuing its review of the ANPRM, to see another country putting forward such proposals is a significant development for global public health and our commercial interest. I am confident that the FDA will move quickly to enact its mandate to reduce the nicotine content in all cigarettes sold in the U.S. to ‘minimally or non-addictive levels,’ as it proposed in its 2017 Comprehensive Plan for Tobacco and Nicotine Regulation,” said Mish.

22nd Century’s VLN^® RNC cigarettes contain just 0.5 milligrams of nicotine per gram of tobacco, 95% less nicotine than conventional cigarette brands, which is exactly in line with the New Zealand proposal. It is the only combustible tobacco product that complies with the FDA’s proposed nicotine rule and has already been authorized to be sold in the U.S. through the FDA’s PMTA pathway. Numerous independent scientific studies, funded largely by the FDA, the (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 believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for its RNC cigarette, 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 it 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 alternative to addictive, traditional 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 RNC tobacco technology to every cigarette manufacturer, including Altria, Reynolds American, and other Big Tobacco companies, so that the entire industry can join 22nd Century’s effort to reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

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 proprietary 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