22nd Century Group Supports Upcoming FDA Action Banning Menthol in Highly Addictive Combustible Cigarettes

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) supports the FDA's intent to ban menthol in combustible cigarettes, emphasizing the need for a non-addictive alternative. The company believes its VLN® Menthol King, with 95% less nicotine, could be exempt, aiding transitions for current menthol smokers. The FDA has authorized the VLN® product line and recognizes its role in reducing nicotine consumption. The tobacco market is significant, estimated at $80 billion.

Positive

• Support for FDA's menthol ban aligns with public health objectives.
• VLN® Menthol King could become the only non-addictive menthol option.
• FDA authorization of VLN® products enhances market position.
• 22nd Century’s innovative approach addresses addiction issues in smoking.

Negative

• None.

VLN® Menthol King Reduced Nicotine Cigarettes Could Be Exempted from Menthol Ban to Help Current Menthol Smokers Transition Away from Highly Addictive Nicotine Cigarettes

BUFFALO, N.Y., Feb. 01, 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, today announced its continued support for a menthol ban in nicotine laden combustible cigarettes following FDA’s expectation to publish proposed rules in April 2022.

On January 27, 2022, the FDA posted an update on its FDA Voices site stating that it “remains on track” with its plans to prohibit menthol in combustible tobacco products.

“We fully support the FDA taking action on menthol cigarettes, in particular due to the disproportionate impact highly addictive traditional menthol cigarettes have on minority communities,” said James A. Mish, Chief Executive Officer. “We believe 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’ is a critical off-ramp for current menthol smokers. By providing a non-addictive menthol option, we believe FDA’s policy can help menthol smokers truly move away from addictive nicotine products rather than merely transitioning to another addictive combustible cigarette or nicotine product,” continued Mish.

The FDA authorized 22nd Century’s VLN^® reduced nicotine content cigarette products on December 23, 2021. In its MRTP authorization press release, the FDA acknowledged its menthol plans, stating “In reaching today’s determination, the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day. The FDA is committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022.” (Emphasis added)

The FDA has also maintained its longer-term interest in requiring all tobacco products to be made non-addictive, a feat already achieved with 22nd Century’s proprietary VLN^® tobacco and MRTP products.

VLN^® is the first cigarette in the world that is 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.

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e88ec02-2a76-4c07-b65a-7ca05df724f5

FAQ

What is 22nd Century Group's response to the FDA's menthol ban?

22nd Century Group supports the FDA's menthol ban and believes their VLN® Menthol King could be exempt due to its reduced nicotine content.

How does VLN® Menthol King compare to traditional menthol cigarettes?

VLN® Menthol King has 95% less nicotine than traditional menthol cigarettes, offering a non-addictive alternative.

What is the market size for tobacco products like VLN®?

The U.S. tobacco market is estimated to be around $80 billion.

When did the FDA authorize VLN® products?

The FDA authorized 22nd Century's VLN® reduced nicotine cigarette products on December 23, 2021.

Why is the FDA focused on banning menthol cigarettes?

The FDA aims to address the disproportionate health impacts of menthol cigarettes, particularly in minority communities.