Independent French health agency ANSES recommends a maximum nicotine limit for all combustible tobacco product; the Company's supply now includes non-GMO reduced-nicotine tobacco, addressing a key feasibility question for France and the EU

MOCKSVILLE, N.C., Sept. 28, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only low nicotine tobacco company in the world, today highlighted the findings of a scientific assessment published by ANSES, France's National Agency for Food, Environmental and Occupational Health Safety, which identifies nicotine reduction in combustible tobacco products as a promising public health initiative and points to 22nd Century's technology as the only commercially available production path for reduced nicotine content combustible cigarettes.

The ANSES report (Referral No. 2025-AST-0038 - Nicotine), commissioned by France's Directorate General of Health (DGS) and validated on December 5, 2025, concludes that reducing the nicotine content of cigarettes could be an effective tool in the fight against smoking, citing randomized controlled trials showing that reduced-nicotine cigarettes limit addiction and cigarette consumption and can facilitate abstinence when combined with nicotine replacement therapy and professional support. The report recommends that any maximum nicotine limit be applied to all combustible tobacco products, conventional cigarettes, rolling tobacco and cigars alike, and that the measure be considered at the European Union level, including through the ongoing revision of Directive 2014/40/EU on tobacco products.

The report's reference standard for very-low-nicotine production

In its assessment of international experience, the report notes that the only very low nicotine cigarettes (VLNC’s) currently available rely on low-nicotine tobacco produced through plant science and describes 22nd Century's approach as the only currently in commercial use in its VLN^® and Pinnacle VLN^® cigarettes. The report further documents the Company's regulatory record: FDA authorization of the VLN product line in December 2019, and in December 2021 the first-ever Modified Risk Tobacco Product (MRTP) designation for combustible cigarettes, authorizing 22nd Century as the first cigarette manufacturer to use the claim "Helps reduce nicotine consumption." The Company has also supplied the Spectrum research cigarette line to the U.S. scientific community in partnership with FDA, the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) since 2011, and in May 2026 the FDA filed the Company's MRTP renewal applications for VLN King and VLN Menthol King for scientific review.

Non-GMO reduced-nicotine tobacco now available for France and the EU

The ANSES report raises the question of how reduced nicotine products would fit within French and European rules on genetically modified organisms. 22nd Century has expanded its technology platform to include reduced-nicotine tobacco produced without genetic modification. 22^nd Century’s non-GMO low nicotine tobacco has been sourced at commercial scale and is available to support an initiative like the one contemplated in France or across the broader European Union. This means the nicotine-cap scenario described in the report could be supplied without reliance on genetically modified tobacco, removing a perceived key implementation barrier of the reduced nicotine standard.

Alignment with the WHO Framework Convention on Tobacco Control

A maximum nicotine standard for combustible products, as recommended by ANSES, would operate squarely within the framework of the WHO Framework Convention on Tobacco Control (WHO FCTC), to which France and all EU Member States are parties. Regulation of the product itself, reducing the addictive potential of combustible tobacco, complements the demand-reduction and supply measures the Convention establishes and advances the goal of protecting public health policies from commercial influences on consumption.

A multi-billion-euro market would convert to reduced-nicotine products

Under a nicotine-cap rule of the kind ANSES recommends, the standard would apply to all combustible tobacco products sold in France, converting what is today an estimated to be over €20 billion annual retail market into a very-low-nicotine market. Accounting for the transition dynamics the ANSES report itself identifies, displacement to illicit trade, substitution to other nicotine products such as e-cigarettes, and reduced cigarettes-per-day among remaining smokers, the Company estimates the sustainable legal market at approximately €8-13 billion at retail over the first three to five years following implementation. However, as only a small fraction of the retail price reaches manufacturers after French excise duties and VAT, success under this scenario depends on the supply of reduced-nicotine tobacco at scale, a role 22nd Century's expanded platform, including non-GMO reduced-nicotine tobacco, is positioned to fulfill.

European policy window

The European Commission launched a call for evidence on May 18, 2026 as part of the announced revision of the EU tobacco control framework, with legislative proposals widely expected to be put forward before the end of 2026. The ANSES report explicitly frames this revision as the opportunity to create a legal framework for reduced-nicotine tobacco products across the EU single market, harmonized to limit cross-border circumvention.

"The ANSES report is a significant validation of the work our Company has pursued for almost three decades. A sovereign public health agency, after a critical review of the global evidence , has concluded that reducing nicotine in combustible products is among the best-supported interventions in the scientific literature, and has identified the approach we pioneered as the one currently available at commercial scale. With reduced-nicotine tobacco now also sourced and available without genetic modification, we are prepared to supply an initiative like France's in France or across the European Union." said Larry Firestone, Chief Executive Officer of 22nd Century Group.

"With VLN^® products now commercially available in 23 U.S. states, we are seeing a growing number of consumers adopt the platform and purchase through our retail channels, with sales growing month over month. Our reduced nicotine VLN^® cigarette solution is now gaining recognition in Europe as well. Interested parties and prospective partners across multiple European countries have reached out to the Company, and we are actively evaluating these markets and how we can best serve them,” Firestone continued.

22nd Century Group remains focused on advancing tobacco harm reduction through its FDA-authorized VLN^® product platform and its reduced-nicotine tobacco supply, and looks forward to contributing constructively and transparently to the policy discussions ahead in France and the wider European Union.

About 22nd Century Group, Inc.

22nd Century Group is pioneering the Tobacco Harm Reduction and Nicotine Reduction Movements by enabling smokers to take control of their nicotine consumption. 

Our Technology is Tobacco

Our proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant that contains 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio has been developed to ensure that our-high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual property to ensure our ongoing leadership in the tobacco harm reduction movement. 

Our Products 

We created our flagship product, the VLN^® cigarette using our low nicotine tobacco, to give traditional cigarette smokers an authentic and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption. 

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 expectations regarding regulatory enforcement, including our ability to receive authorization or approval for new products, and (ii) our financial and operating performance. 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 26, 2026 and Quarterly Reports on Form 10-Q filed May 7, 2026 and August 14, 2026. 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 
Daniel Otto
Chief Financial Officer & Investor Relations 
22nd Century Group 
investorrelations@xxiicentury.com