22nd Century Stands Ready to Support the Adoption of FDA Proposed Tobacco Product Standard to Mandate Reduced Nicotine Content in Cigarettes with its VLN Cigarettes

Rhea-AI Summary

22nd Century Group (NASDAQ: XXII) announces its readiness to support the FDA's proposed tobacco product standard mandating reduced nicotine content in cigarettes. The proposal, which cleared review by the U.S. Office of Management and Budget on January 3, 2025, aims to drastically reduce nicotine levels in cigarettes.

The company's VLN branded low nicotine cigarettes align with this initiative, being the first and only FDA-authorized reduced nicotine content cigarettes in the market. CEO Larry Firestone emphasizes the policy's potential significant impact on public health and smoking harm reduction.

22nd Century Group has been instrumental in research and development supporting this policy, which has progressed across multiple administrations since 2009. The company plans to launch additional reduced nicotine content products under other brand labels and aims to expand the distribution and awareness of low nicotine cigarettes as a distinct market category.

Positive

• First and only company with FDA-authorized reduced nicotine content cigarettes
• Strategic positioning to benefit from potential FDA mandate on reduced nicotine
• Plans for expansion with additional reduced nicotine products under new brands

Negative

• None.

FDA Reduced Nicotine Content Proposal Indicated to Have Completed OMB Review as of January 3, 2025

FDA Spokesperson Indicates Policy Could Be Among Most Impactful Population-Level Actions in the History of U.S. Tobacco Product Regulation

MOCKSVILLE, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced that it stands ready to support the U.S. Food and Drug Administration’s proposed tobacco product standard to mandate reduced nicotine content in cigarettes, which is indicated to have cleared review by the U.S. Office of Management and Budget on January 3, 2025. The proposal is part of a long-standing effort by the FDA to mandate a drastic reduction in the amount of nicotine in cigarettes, a cornerstone goal of public health experts seeking to reduce the harms of smoking and very much in concert with 22nd Century’s VLN branded low nicotine cigarettes.

“OMB clearance marks a major step in moving this policy forward, and we are excited to see further definitive action by the federal government toward making this scientifically backed, non-partisan smoking harm reduction policy a reality,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “The FDA has openly stated that this could be the most impactful action for the improvement of public health in reducing the widespread and clearly documented harms of smoking.”

“22nd Century has played a pivotal role in the research, development and numerous federally funded clinical studies underpinning this policy, which has been advanced across multiple administrations since 2009, including action under the first Trump administration. We are also the first and only Company to bring an FDA authorized reduced nicotine content cigarette designed specifically to reduce the harms of smoking to market through the commercial launch of our VLN reduced nicotine content cigarettes. We are now working to launch additional products, including additional reduced nicotine content products using our tobacco but under other brand labels and give greater awareness to low nicotine cigarettes as a separate category in the market. This is a key component as part of our drive to expand the distribution of reduced nicotine content cigarettes manufactured by 22nd Century, increase consumer awareness and expand the VLN^® footprint.”

About 22nd Century Group, Inc.

22nd Century Group is the pioneering nicotine harm reduction company in the tobacco industry enabling smokers to take control of their nicotine consumption. 

We created our flagship product, the VLN^® cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to greatly reduce nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 

Our wholly owned subsidiaries include a leading cigarette manufacturer that produces all VLN^® products and provides turnkey contract manufacturing for other tobacco brands both domestically and internationally. The 60,000 square foot facility in Mocksville, North Carolina has the capacity to produce more than 45 million cartons of combusted tobacco products annually with additional space for expansion. 

Our proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets.

VLN^® and Helps You Smoke Less^® are registered trademarks of 22nd Century Limited LLC.

Learn more at xxiicentury.com, on X (formerly 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, including but not limited to our full year business outlook. 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. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives, (ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, (iii) our financial and operating performance and (iv) our expectations for our business interruption insurance claim. 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 28, 2024, and in the Company’s Quarterly Reports filed on May 15, 2024, August 13, 2024, and November 11, 2024. 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
Matt Kreps
Investor Relations
22nd Century Group
mkreps@xxiicentury.com
214-597-8200

FAQ

When did the FDA's reduced nicotine content proposal clear OMB review for XXII?

The FDA's proposed tobacco product standard cleared review by the U.S. Office of Management and Budget on January 3, 2025.

What is 22nd Century Group's (XXII) role in the FDA's nicotine reduction initiative?

22nd Century Group has played a key role in research, development, and federally funded clinical studies supporting the policy, and is the only company with FDA-authorized reduced nicotine content cigarettes through their VLN brand.

What are XXII's expansion plans for VLN cigarettes?

The company plans to launch additional reduced nicotine content products under other brand labels, increase consumer awareness, and expand the VLN footprint in the market.

How long has the FDA's reduced nicotine policy been in development affecting XXII?

The policy has been advancing across multiple administrations since 2009, including action under the first Trump administration.