22nd Century Group is accelerating commercial partnerships for its VLN reduced-nicotine cigarettes as the tobacco industry prepares for the FDA's proposed nicotine reduction mandate. The company announced new brand partnerships including Smoker Friendly VLN and Pinnacle VLN, expanding market availability of the only FDA-authorized combustible cigarette products that meet the proposed federal standard.
The FDA's proposed Tobacco Product Standard for Nicotine Yield, announced in January 2025, would establish a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products. The rule would take effect two years from final approval, expected by 2026.
VLN Platform Meets Regulatory Requirements
22nd Century's VLN cigarettes contain an average of 0.5 mg of nicotine per gram of tobacco, already complying with the proposed standard. The products incorporate proprietary and patented tobacco with 95% less nicotine than conventional cigarettes while maintaining full flavor and high yield through comprehensive technologies that regulate nicotine biosynthesis in tobacco plants.
"The FDA recognizes that nicotine is a highly addictive substance and that to achieve true tobacco harm reduction, nicotine consumption must be addressed," said Larry Firestone, Chief Executive Officer of 22nd Century Group. "The FDA's new product standard proposed in January is one of many factors that are driving early commercial interest in our VLN reduced nicotine content tobacco products."
The company's VLN cigarette received FDA Modified Risk Tobacco Product (MRTP) authorization in 2020, providing two years of commercial experience before competitors can develop compliant products. The MRTP authorization expires in 2026, with renewal expected given the product's proven safety and efficacy profile.
Clinical Evidence Supports Efficacy
Clinical validation demonstrates VLN's effectiveness in reducing nicotine addiction. A 2023 trial showed smokers of VLN cigarettes experienced 33% lower cravings and 50% higher cessation success compared to conventional cigarettes. Long-term data revealed no compensatory smoking behavior, such as increased puff counts, to maintain nicotine levels—addressing a key industry concern.
These results stem from 22nd Century's 15+ years of research and development, protected by more than 80 patents on nicotine reduction and tobacco plant genetics. The extensive patent portfolio ensures the company maintains the only low nicotine combustible cigarette in the United States and critical international markets.
Public Health Impact Projections
The FDA's population health model estimates significant long-term benefits from the proposed standard. By 2100, approximately 48 million youth and young adults who would have otherwise initiated smoking would not start as a result of the nicotine reduction requirement. The agency projects $1.1 trillion in economic benefits by 2060.
Former FDA Commissioner Robert M. Califf stated: "Today's proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability."
Market Expansion Strategy
Beyond the initial 100mm VLN cigarette launched in 2023, 22nd Century is developing heat-not-burn and vapor products with reduced nicotine, leveraging its core intellectual property. The company is also pursuing international opportunities as the EU and Canada prepare similar nicotine reduction policies.
The global expansion strategy includes potential licensing agreements with major tobacco companies. Competitors like Philip Morris may license 22nd Century's technology to avoid FDA penalties, creating recurring revenue streams for the company.
22nd Century is monitoring comment submissions under the proposed rule and plans to submit its own comments before the period closes. The company's previous 2018 comment letter influenced the current proposal, including the 0.7mg/g standard based on 22nd Century's 0.5mg/g recommendation and feasibility data demonstrating adequate tobacco supply capacity.
The commercial partnerships and regulatory positioning establish 22nd Century as the primary beneficiary of the tobacco industry's transition to reduced-nicotine products, with the company's CEO noting that "there need not be any commercial barriers to adopting this FDA policy, which could be the most impactful health decision in a generation."
