Pond Technologies

FDA's Proposed Menthol Ban Advances to Final Rule Status, Greatly Benefits 22nd Century (XXII) by Affirming the Need for VLN(R) Menthol King as a Critical Off-Ramp for Adult Menthol Smokers

17 January 2023
  • Proposed Menthol Ban Could Leave 22nd Century's VLN® Menthol King as the Only Menthol Cigarette in the $26 Billion U.S. Menthol Market
  • FDA to Advance Reduced Nicotine Content Standards for All Combustible Cigarettes in Q4 2023
  • Paradigm Shift in Tobacco Health Policy and Regulation Expected to Generate Major Gains for Public Health

Buffalo, New York--(Newsfile Corp. - January 17, 2023) - 22nd Century Group, Inc. (NASDAQ: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced that the Company is poised to greatly benefit from the recent advancement of the U.S. Food and Drug Administration's (FDA) proposed ban on menthol as a flavoring agent in combustible cigarettes to final rule status, with expectations of a final decision in August 2023.

"The most recent updates to the Biden administration's Unified Agenda on Regulatory and Deregulatory Actions (Unified Agenda) include major advancements in the FDA's proposed tobacco harm reduction policies in 2023," stated John Miller, president of tobacco products for 22nd Century Group. "Advancement of FDA's proposed menthol ban could position VLN® Menthol King as the only combustible menthol tobacco cigarette on the market, providing a critical off-ramp to the estimated more than 15 million menthol smokers in the U.S."

Menthol cigarettes account for an estimated $26 billion in retail sales. Menthol is also known to enhance nicotine's addictive effects, making it more difficult to quit, and a disproportionate amount of menthol smokers are members of minority groups, particularly African American.

"FDA's proposed menthol policy specifically contemplates exempting certain products from the ban, such as our MRTP authorized VLN® cigarettes, providing a critical off-ramp opportunity for adult menthol smokers," stated John Pritchard, vice president of regulatory science for 22nd Century Group. "Without an off-ramp product, both research and real-world experience show the vast majority of menthol smokers would simply transition to traditional combusted cigarettes. 22nd Century's MRTP authorization documents how VLN® products can help people to smoke less, leading to a true reduction in smoking in line with FDA's important public health goals."

The Unified Agenda also indicates that the FDA intends to advance its transformative reduced nicotine content standards later in 2023, which seeks to limit the nicotine levels in all cigarettes to a level considered "minimally or non-addictive." Both of these standards are considered game changers for public health and could be extremely favorable for 22nd Century Group due to VLN®'s 95% reduced nicotine content.

The 22nd Century VLN® expansion is going well, with VLN®'s availability already expanding across five states with anchor partners including Circle K and Smoker Friendly. Following the Company's stated growth strategy to expand to 12-15 states during 2023, 22nd Century is actively engaged with multiple industry leading distribution partners and retail store chains wanting to introduce the Company's transformative VLN® products to adult smokers in both existing and new markets.

Mr. Miller concluded, "The proactive and forward-thinking policies of the FDA have the power to reduce the harms of smoking and save millions of lives. 22nd Century Group continues to fully support these policies, and VLN® reduced nicotine content products demonstrate that these programs are 100% achievable."

22nd Century Group's VLN® brand cigarettes are the only combustible cigarettes that the FDA has authorized as Modified Risk Tobacco Products (MRTP). The Company's VLN® King and VLN® Menthol King contain 95% less nicotine than traditional addictive cigarettes, a level considered to be minimally or non-addictive. Reduced nicotine content cigarettes, such as VLN®, have been studied extensively by federal health agencies, documenting their ability to help smokers smoke less. To inform adult smokers of the product's distinctive purpose, the FDA requires 22nd Century to include the statement "Helps You Smoke Less" on every package of VLN® sold.

As demonstrated by leading independent scientists, reducing the nicotine level in cigarettes has the potential to substantially reduce the enormous burden of smoking-related death and disease. It is estimated that a nicotine product standard to a level that is 95% less than the level of nicotine contained in U.S. conventional cigarettes could save millions of lives and tens of millions of life-years over the next several decades.

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 Modified Risk Tobacco Product (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, on LinkedIn, and on YouTube.

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 1, 2022, and in the Company's Quarterly Report filed on November 8, 2022. 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
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Matt Kreps
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