22nd Century Group Welcomes Dr. Califf as FDA Commissioner, Urges Action on Menthol and Nicotine in Combustible Cigarettes

Rhea-AI Summary

The FDA's rulemaking could position 22nd Century Group's VLN^® Menthol King as the only menthol cigarette available, following the FDA's commitment to ban menthol cigarettes. The VLN^® brand offers reduced nicotine content, with 95% less nicotine than leading brands, aligning with the FDA's push to lower nicotine levels in cigarettes. CEO James A. Mish highlighted the potential of VLN^® to help smokers transition away from addiction. Authorized by the FDA as a modified risk tobacco product, VLN^® aims to provide a healthier alternative in a $80 billion industry.

Positive

• FDA's potential ban on menthol cigarettes could lead to VLN® Menthol King being the only product in the category.
• VLN® products have received FDA MRTP authorization, making them the first cigarettes designed not to create or sustain nicotine addiction.
• VLN® cigarettes contain 95% less nicotine compared to leading brands, supporting public health initiatives.

Negative

• None.

FDA’s Rulemaking Process Could Make VLN^® Menthol King Reduced Nicotine Cigarettes the Only Menthol Cigarette on the Market

Opportunity to Accelerate FDA’s Plan to Cap Nicotine in Cigarettes at Levels Already Achieved in 22nd Century’s VLN^® Products

BUFFALO, N.Y., Feb. 25, 2022 (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 modern plant science, congratulates Dr. Robert Califf on his confirmation as FDA Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf is known to be a longtime proponent of innovative tobacco control programs and strong supporter of the Agency’s Comprehensive Plan for Tobacco and Nicotine Regulation. The FDA’s commitment to moving forward with the rulemaking process to ban menthol in cigarettes signifies the Agency’s intent to take significant action toward dramatically reducing tobacco-related disease and death in the U.S.

“Cigarette smoking kills nearly half a million Americans every year. With Dr. Califf’s background, we are confident he will use the power the FDA was given by the 2009 Tobacco Control Act to protect and improve public health by introducing regulations that will help smokers break their addiction to cigarettes,” says James A. Mish, chief executive officer of 22nd Century Group. “The FDA has already taken great strides to improve public health by granting 22nd Century MRTP authorization for our VLN^® cigarettes and by announcing that they are on track with the rulemaking process that could ban menthol in cigarettes. It is crucial that the FDA now accelerate implementation of its Comprehensive plan to reduce the amount of nicotine allowed in combustible cigarettes to levels that render them ‘minimally or non-addictive.’ Our VLN^® reduced nicotine content cigarette – the only combustible that FDA has ever granted modified risk orders to – is the only cigarette that meets the nicotine levels proposed in FDA’s nicotine mandate, and we stand ready to support the Agency on this critical public health initiative.”

Dr. Califf previously served briefly as FDA commissioner under the Obama administration, from 2016-2017. After leaving the role, Dr. Califf continued to demonstrate his commitment to tobacco control, outlining his strategy to regulate tobacco products in a 2019 blog post for the Association of American Medical Colleges. Dr. Califf’s strategy included requiring the tobacco industry to lower the amount of nicotine in its products to non-addictive levels using selective breeding – technology and intellectual property that 22nd Century has already developed for its VLN^® brand of cigarettes.

Today’s appointment of long-time FDA regulator and former acting FDA Commissioner Dr. Janet Woodcock as principal deputy commissioner will further help to quickly advance these regulatory efforts.

In March of last year, Dr. Califf used his platform on a panel discussion organized by STAT to urge the Biden administration to get tough on tobacco companies, saying: “Tobacco use is becoming one of the most important markers of disparities in our economy and our health care system. I hope that this administration will have the courage to fight what will be tough battles.”

Senator Richard Burr of North Carolina echoed these concerns during Dr. Califf’s December nomination hearing, stating: “More than a decade after receiving authority from Congress, FDA just recently issued the foundational rules to provide a regulatory roadmap for new, and potentially less harmful, tobacco products. CTP is charged with the regulation of tobacco products, which includes a mission to regulate these products for the protection of public health.”

The FDA subsequently authorized 22nd Century’s VLN^® reduced nicotine content cigarette products on December 23, 2021. VLN^® King and Menthol King are the first cigarettes in the world that are not designed to create or sustain nicotine addiction. VLN^® smokes, smells, and tastes like a conventional cigarette, but uses 22nd Century Group’s proprietary tobacco to deliver America’s lowest nicotine content cigarette with 95% less nicotine than America’s leading brands.

22nd Century believes FDA’s reduced harm commitment and rule-making process could leave VLN^® Menthol King as the only menthol cigarette on the market due to its 95% reduction in nicotine. Maintaining access to a non-addictive menthol cigarette such as VLN^® Menthol King that “Helps You Smoke Less” will be a critical off-ramp for menthol smokers. By providing a non-addictive menthol option, 22nd Century believes FDA’s policy can better help menthol smokers move away from addictive nicotine products altogether rather than merely transitioning them to another addictive nicotine product.

VLN^® King and VLN^® Menthol King are the only FDA authorized reduced nicotine content combustible cigarettes in the U.S. tobacco products market, estimated at approximately $80 billion in size.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco 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 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. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. 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.

Learn more about VLN^® at tryvln.com.

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
22nd Century Group, Inc.
Director, Communications & Investor Relations
T: 716-300-1221
mkuo@xxiicentury.com

Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
mkreps@darrowir.com

FAQ

What is the significance of the FDA's rulemaking process for XXII?

The FDA's rulemaking may position XXII's VLN® Menthol King as the sole menthol cigarette on the market, following a potential ban on menthol cigarettes.

How does XXII's VLN® cigarette differ from traditional cigarettes?

XXII's VLN® cigarettes contain 95% less nicotine than leading brands, which aims to reduce addiction and support public health.

What recent FDA action affected XXII's VLN® products?

The FDA granted MRTP authorization to XXII's VLN® cigarettes, marking them as the first cigarettes not designed to create or sustain nicotine addiction.

What market opportunity does XXII see with the FDA's plan to cap nicotine levels?

XXII believes the FDA's plan to lower nicotine levels aligns with its VLN® products, potentially increasing market share in a $80 billion tobacco market.