FDA Authorized Reduced-Nicotine Cigarette from 22nd Century Group (Nasdaq: XXII) That ‘Helps You Smoke Less’ Obtains Illinois Tobacco Product Listing

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) announced that its VLN^® cigarettes will be listed in the Illinois Directory of Participating Manufacturers effective April 4, 2022. This registration allows distribution of the FDA-authorized reduced nicotine cigarettes as part of a pilot program in Chicagoland. VLN^® cigarettes contain 95% less nicotine and are designed to help adult smokers reduce consumption. A pilot program is set to commence in a market with a smoking rate of 15.5%, above the national average.

Positive

• VLN® cigarettes receive FDA authorization as reduced nicotine content products.
• Pilot program in the high smoking rate market of Illinois, with 15.5% adult smokers.

Negative

• None.

BUFFALO, N.Y., March 28, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), today announced that it has received notification from the Office of the Illinois Attorney General’s Tobacco Enforcement Bureau that its VLN^® cigarettes will be listed in the Illinois Directory of Participating Manufacturers effective April 4, 2022. Registration permits the Company to begin distributing VLN^® – the first and only U.S. Food and Drug Administration (FDA)-authorized reduced nicotine content cigarette that “helps you smoke less” – as part of its Chicagoland pilot program.

“VLN^® cigarettes are scientifically shown to help adult smokers smoke less,” said James A. Mish, CEO of 22nd Century Group. “Chicago’s rich demographic diversity represents an excellent market for our pilot program starting in April, which will include both our VLN^® King and VLN^® Menthol King reduced nicotine content cigarettes containing 95% less nicotine than conventional cigarettes.”

Illinois is the second most expensive cigarette retail market in the United States. The Centers for Disease Control and Prevention estimated that 15.5% of Illinois adults aged 18 years or older smoke cigarettes, higher than the national average of 12.5%, according to 2020 statistics.

After 20 years in development and 10 years in clinical trials, VLN^® received the FDA’s first MRTP authorization granted for a combustible tobacco cigarette. The FDA authorization cited scientific evidence that VLN^® cigarettes can help reduce exposure to and the consumption of nicotine for adult smokers who use the products, leading to the FDA’s requirement to include the phrase “Helps You Smoke Less” on every package.

In the FDA’s December 2021 MRTP authorization press release for 22nd Century’s VLN^® King and VLN^® Menthol King cigarettes, Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, stated, “We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes.”

22nd Century is pursuing registration in all 50 states as it readies for national launch following its Chicagoland pilot program.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury, and on LinkedIn.

Learn more about VLN^® at tryvln.com.

22nd Century Group Investor Relations & Media Contact

Mei Kuo
22nd Century Group, Inc.
Director, Communications & Investor Relations
T: 716-300-1221
mkuo@xxiicentury.com

Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
mkreps@darrowir.com

Illinois Media Contact
Res Publica Group
Kevin Owens
T: 312-755-3512
ko@respublicagroup.com 

FAQ

What is the significance of VLN® cigarettes for 22nd Century Group (XXII)?

VLN® cigarettes are the first FDA-authorized reduced nicotine content cigarettes, designed to help smokers consume less nicotine.

When will 22nd Century Group's VLN® cigarettes be available in Illinois?

VLN® cigarettes will be available in the Illinois market starting April 4, 2022.

What market is 22nd Century Group targeting for the VLN® pilot program?

The pilot program will target the Chicagoland area, which has a higher than average smoking rate.

How does the CDC report on smoking rates in Illinois relate to 22nd Century Group (XXII)?

The CDC reports that 15.5% of adults in Illinois smoke, which presents a significant market opportunity for VLN® cigarettes.

What is the unique proposition of VLN® cigarettes compared to regular cigarettes?

VLN® cigarettes contain 95% less nicotine than conventional cigarettes, helping smokers to potentially reduce their nicotine intake.