22nd Century Group Validates Nicotine Reduction Initiative

MOCKSVILLE, N.C., Sept. 28, 2026 /CourierPR/ -- 22nd Century Group, Inc., the only low nicotine tobacco company in the world, has 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. The report, titled "Referral No. 2025-AST-0038 - Nicotine," was commissioned by France's Directorate General of Health (DGS) and validated on December 5, 2025. The report 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, including conventional cigarettes, rolling tobacco, and cigars, 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 ANSES report raises the question of how reduced nicotine products would fit within French and European rules on genetically modified organisms (GMOs). 22nd Century has expanded its technology platform to include reduced-nicotine tobacco produced without genetic modification. The company's non-GMO low nicotine tobacco has been sourced at commercial scale and is now 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.

The ANSES report aligns with the WHO Framework Convention on Tobacco Control (WHO FCTC), which France and all EU Member States are parties to. 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.

The ANSES report, after a critical review of the global evidence, has identified the approach pioneered by 22nd Century as the one currently available at commercial scale. The report further documents the Company's regulatory record, including FDA authorization of the VLN product line in December 2019 and 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 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. In May 2026, the FDA filed the Company's MRTP renewal applications for VLN King and VLN Menthol King for scientific review.

Under a nicotine-cap rule of the kind recommended by ANSES, 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 identified in the report, 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.

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.

Under the leadership of CEO Larry Firestone, 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.

22nd Century Group, Inc. (Nasdaq: XXII), the only low nicotine tobacco company in the world, is pioneering the Tobacco Harm Reduction and Nicotine Reduction Movements by enabling smokers to take control of their nicotine consumption. The Company's proprietary non-GMO reduced nicotine tobacco plants were developed using its patented technologies that regulate alkaloid biosynthesis activities, resulting in a tobacco plant that contains 95% less nicotine than traditional tobacco plants. The Company's extensive patent portfolio has been developed to ensure that its high-quality tobacco can be grown commercially at scale. The Company continues to develop its intellectual property to ensure its ongoing leadership in the tobacco harm reduction movement.