22nd Century Group Files VLN® MRTP Renewal to Promote Reduced Harm in Smoking
MOCKSVILLE, N.C., Jan. 6, 2026 (GLOBE NEWSWIRE) – 22nd Century Group, Inc. (Nasdaq: XXII), a leader in the tobacco harm reduction sector, has announced the filing of its Modified Risk Tobacco Product (MRTP) renewal application for its VLN® reduced nicotine content products. This groundbreaking initiative is recognized as the only combustible cigarette authorized by the U.S. Food and Drug Administration (FDA) explicitly aimed at mitigating the health risks associated with smoking.
Significance of VLN® Reduced Nicotine Cigarettes
The VLN® cigarettes offer a significant reduction in nicotine levels, boasting claims authorized by the FDA, which include:
- 95% less nicotine
- Helps reduce nicotine consumption
- Greatly reduces nicotine intake
- Encourages lower smoking rates
With approximately 28.8 million smokers in the United States and healthcare costs exceeding $600 billion annually due to tobacco-related harm, 22nd Century’s VLN® products play a crucial role in reducing addiction to nicotine.
Clinical Evidence Supporting VLN® Efficacy
The effectiveness of VLN® reduced nicotine content cigarettes is supported by decades of clinical research. An extensive study in 2024, involving over 400 participants, demonstrated a substantial reduction in daily cigarette consumption—by approximately 40% over 12 weeks. This study further bolstered the evidence of VLN® products' potential to aid in smoking reduction and increase quit attempts among smokers.
Originally authorized in December 2021 for five years, the VLN® cigarette renewal application is due by December 2026. A variety of cigarette brands are now featuring VLN® products, providing smokers with a safer alternative that contains 95% less nicotine than conventional cigarettes.
CEO Larry Firestone Comments on the MRTP Authorization
“With smoker health and wellness as our primary goal, the MRTP authorization for VLN® cigarettes represents a pivotal moment in the tobacco industry,” said Larry Firestone, CEO of 22nd Century Group. “Nicotine is a highly addictive substance, and the FDA’s affirmation of our products’ potential to alter smoking behaviors leads to more quit attempts, thereby promoting better public health outcomes.”
Firestone also noted that VLN® tobacco products are the sole offerings that align with the FDA’s low nicotine guidelines proposed in January 2025. “We anticipate the FDA will support our MRTP renewal for VLN®,” he added.
About 22nd Century Group, Inc.
22nd Century Group is at the forefront of tobacco harm reduction, empowering smokers to control their nicotine intake. Their proprietary non-GMO reduced nicotine tobacco plants are engineered to contain 95% less nicotine compared to traditional tobacco. The company’s commitment to advancing its intellectual property ensures ongoing leadership in the tobacco harm reduction movement.
Through their flagship product, the VLN® cigarette, 22nd Century provides smokers with an authentic alternative that encourages them to manage their nicotine consumption effectively while reducing health risks linked to smoking.
Contact Information
For more information about 22nd Century Group’s innovative VLN® product line, visit xxiicentury.com or connect with them on platforms such as X (formerly Twitter), LinkedIn, and YouTube.
For investor relations, please contact:
Matt Kreps
Investor Relations
22nd Century Group
Email: investorrelations@xxiicentury.com
Phone: (214) 597-8200