22nd Century Ready to Provide Full Commercial Support to New Zealand’s Plan to Reduce Nicotine Content of All Cigarettes

• New Zealand Ministry of Health announced aggressive measures to reduce smoking, including a reduced nicotine mandate by 2025

• 22nd Century fully engaged and ready to support New Zealand’s government as it takes bold steps to make country smokefree by 2025

BUFFALO, N.Y., Dec. 10, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through plant science, announced today that it is fully engaged and ready to provide commercial support to the New Zealand Ministry of Health’s Smokefree Aotearoa 2025 Action Plan, including supplying reduced nicotine content combustible cigarettes able to meet New Zealand’s proposed standards.

The final version of the Plan introduced on December 9^th details comprehensive measures to reduce smoking, including legislation to implement a reduced nicotine mandate. 22nd Century has been an active supporter of New Zealand’s smoke-free efforts throughout the plan’s development process.

“We applaud the bold plans in New Zealand, which is now leading the world in introducing novel and highly effective tobacco control strategies to end cigarette addiction. This is an ambitious plan, and reduced nicotine content (RNC) cigarettes such as our VLN^® products will be critical to its success. We are fully prepared to support New Zealand and its Smokefree Plan as it blazes a trail for other health agencies around the world to follow, including the United States FDA and the World Health Organization,” said James A. Mish, chief executive officer of 22nd Century Group.

New Zealand’s plan details six key focus areas, the fourth of which is: “Making it easier to quit and harder to become addicted by only having low-level nicotine smoked tobacco products for sale and restricting product design features that increase their appeal and addictiveness.”

22nd Century’s VLN^® cigarettes would enable New Zealand to authorize a reduced nicotine content cigarette for sale immediately.

With just 0.5 mg of nicotine per gram of tobacco, 22nd Century’s VLN^® reduced nicotine content cigarettes contain 95% less nicotine than conventional cigarettes, but they taste, smell and smoke the same. An extensive body of independent, clinical science shows that this innovative alternative to addictive, conventional cigarettes will help adult smokers reduce their exposure to nicotine, smoke fewer cigarettes and support their efforts to quit smoking.

22nd Century is already advancing to international VLN^® sales commencing in the first quarter of 2022 in select international markets in Asia and Europe and has established a branch in New Zealand. The Company is fully prepared to produce VLN^® reduced nicotine content cigarettes for export to New Zealand.

“Almost half a million New Zealanders still smoke, and the smoking prevalence in the Māori and Pacific Islander communities is disturbingly high. There is an urgent need for new tobacco regulatory policies in Aotearoa and throughout the world to address cigarette addiction in general, while also ensuring that minority communities and vulnerable groups are not left behind from public health advances. The New Zealand Smokefree Plan and reduced nicotine content mandate exemplify the very best of modern public health thinking, providing a roadmap for other countries to deploy similar public health policies,” said John Pritchard, vice president of regulatory science at 22nd Century Group.

The U.S. is exploring similar policy changes designed to improve public health and reduce smoking. 22nd Century’s reduced nicotine tobacco products are the cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, which includes a reduced nicotine standard similar to that proposed by New Zealand’s government.

22nd Century’s MRTP application is currently in the final stage with the FDA, and the company remains highly confident of a positive outcome given recent dialogue with FDA. Upon receipt, the Company will begin pilot sales of its VLN^® products within 90 days in the U.S.

VLN^® and Reduced Nicotine Content Cigarettes
An extensive body of available scientific evidence demonstrates VLN^® and RNC cigarettes can benefit the health of the population as a whole. The science includes dozens of emerging independent scientific studies using 22nd Century’s RNC tobacco cigarettes funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies.

These studies show that smokers who used RNC cigarettes reduced their nicotine exposure and dependence, smoked fewer cigarettes per day, increased their number of smoke-free days, and doubled their quit attempts – all with minimal or no evidence of nicotine withdrawal symptoms or compensatory smoking.

22nd Century is ready to supply the market with RNC tobacco and finished products such as VLN^® to enable both 22nd Century and other manufacturers to comply with the mandate in New Zealand and other countries that adopt such policies in the future.

The plant-based technology and products from 22nd Century are superior to costly extraction and similar de-nicotinization technologies because those technologies typically use chemicals that strip out not just nicotine but also flavor and aroma compounds, resulting in a product that has been found unacceptable to smokers because it delivers no smoking satisfaction.

In contrast, 22nd Century’s reduced nicotine tobacco naturally grows with very low levels of nicotine resulting in products that smoke, taste and smell like conventional cigarettes but contain 95% less nicotine than conventional, highly addictive cigarettes. This is critical to creating an acceptable solution and “off-ramp” for current smokers.

22nd Century remains committed to licensing its technology and products to every manufacturer to enable industry wide compliance with the mandate in New Zealand and elsewhere in the world, including the U.S.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed its proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable 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