By Timothy S. Donahue

Top Takeaways:

• 22nd Century says VLN distribution expanded to nearly 2,000 retail stores across 20+ states in 2025.
• In 2021, the FDA authorized VLN King and VLN Menthol King as MRTPs, allowing “95% less nicotine” reduced-exposure claims.
• Firestone said the company exited 2025 with no debt and is targeting scale-driven progress toward EBITDA breakeven in 2026.

22nd Century Group, Inc. said it expanded distribution of its U.S. Food and Drug Administration-authorized VLN reduced-nicotine cigarettes in 2025 and ended the year debt-free, as the company pivots from a multi-year restructuring into a commercial growth phase tied to its tobacco harm reduction strategy.

In a 2025 year-in-review letter to stockholders, CEO and Chairman Larry Firestone said 2025 marked the company’s exit from restructuring and the start of a push toward higher-margin branded products, anchored by VLN, its reduced-nicotine combustible cigarette platform.

Firestone said VLN products are now sold in nearly 2,000 retail locations across more than 20 states, and distribution growth is tied to rising consumer awareness of reduced-nicotine options.

“The core of this strategy is our proprietary VLN reduced-nicotine cigarette platform, the market-leading, first and only combustible cigarette authorized by the U.S. Food and Drug Administration as a Modified Risk Tobacco Product (MRTP),” Firestone wrote.

The company’s VLN cigarettes were authorized by the FDA in December 2021 as MRTPs under “exposure modification” orders, allowing the company to market certain reduced-exposure claims regarding nicotine. In early January, the company filed a renewal application.

FDA’s authorization permits marketing claims such as “95% less nicotine” and statements that VLN helps reduce nicotine consumption. In announcing the decision, FDA said nicotine levels in the tobacco and mainstream smoke of VLN cigarettes were at least 95% lower than those of the majority of marketed conventional cigarette brands evaluated.

In the letter, Firestone reiterated the company’s position that while the cigarettes have less nicotine than conventional cigarettes, they maintain a familiar smoking experience, which the company argues may support reduced nicotine exposure and dependence.

22nd Century said it relaunched VLN and its partner VLN-branded products in 2025 and has begun receiving early consumer feedback. Firestone reported that the company is “encouraged by initial testimonials,” including one example of a consumer reporting a reduction in cigarette consumption of about 66% over 12 weeks.

The letter did not present those testimonials as clinical outcomes and stated that the company expects to share additional insights “responsibly” as it evaluates consumer engagement and outcomes.

Firestone also said that 22nd Century continued shifting its business toward proprietary branded products, maintained cost-reduction and operational streamlining efforts initiated during its restructuring period, and exited 2025 with “the elimination of debt” and improved liquidity.

The shareholder letter also referenced the FDA’s January 2025 proposed rule establishing a maximum nicotine level in cigarettes. Firestone said 22nd Century views the proposal as strategically relevant because VLN was designed to meet very low nicotine thresholds, while acknowledging that the timing and final form of any rule remain uncertain. The FDA has not finalized the nicotine proposal.

Looking ahead, Firestone said 22nd Century’s 2026 priorities include further expansion of VLN distribution, continued cost discipline, progress toward EBITDA breakeven, and continued engagement with the FDA and public health stakeholders.