First Cigarette Authorized by FDA to “Help You Smoke Less” Now Available Across Colorado

Rhea-AI Summary

22nd Century Group has launched VLN® cigarettes in Colorado, the first FDA-approved Modified Risk Tobacco Product, featuring 95% less nicotine than regular cigarettes. This initiative aims to help smokers reduce consumption and quit smoking. VLN® King and Menthol King are now available at Smoker Friendly locations and will soon be in Circle K stores. Clinical trials show switching to VLN® can reduce cigarettes per day by 50% after 20 weeks. The rollout aligns with public health goals and aims to reduce smoking-related deaths, particularly among Colorado's adult smokers.

Positive

• Launch of VLN® cigarettes in Colorado supports public health goals.
• FDA's MRTP designation enhances product credibility.
• Clinical trials show potential for significant reduction in smoking rates.

Negative

• None.

VLN^® cigarettes from 22nd Century Group contain 95% less nicotine than conventional cigarettes, greatly reducing nicotine consumption to help smokers smoke less; support State and FDA goals of reducing tobacco harm

DENVER, Oct. 06, 2022 (GLOBE NEWSWIRE) -- There’s a revolutionary new option available for the more than 680,000 adult smokers in Colorado — many of whom are trying to cut back or quit. VLN^® brand cigarettes are the first and only combustible tobacco cigarettes to receive a Modified Risk Tobacco Product designation by the FDA and contain minimal to non-addictive levels of nicotine. VLN^® cigarettes are now available at all Smoker Friendly locations in the state via a partnership with Creager Mercantile and will be available in Colorado Circle K stores by next week. VLN^® is also rolling out to retail locations throughout the state, through a partnership with Eagle Rock Distributing Company, a wholesale partner of Anheuser-Busch.

The VLN^® King and VLN^® Menthol King cigarettes are substantially lower in nicotine content — 95 percent less — than any other cigarettes currently available to smokers in the United States. These uniquely low levels of nicotine were developed using proprietary modern tobacco breeding techniques from 22nd Century Group, Inc. (Nasdaq: XXII), a leading agriculture biotechnology company focused on tobacco harm reduction and plant technology/science.

More than 50 government-funded, independent clinical trials under grants from federal organizations including the FDA and National Institutes of Health (NIH) conducted at Johns Hopkins University, Mayo Clinic and other leading U.S. institutions over the past 12 years have reported that adult smokers who switch to greatly-reduced nicotine content cigarettes:

• Reduce their cigarettes per day (CDP) by 50 percent after 20 weeks
• Have more smoke-free days and quit attempts as a group
• Experience a reduction in cravings and withdrawal symptoms
  

In June 2022, the Biden-Harris Administration expressed support for the FDA’s plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes and other combustible tobacco products. While no cigarette is safe and VLN^® must still include the Surgeon General’s warning language on its packaging and marketing materials, 22nd Century is at the forefront of aligning with the FDA’s goal of promoting public health and reducing nicotine use.

“According to the CDC, almost half of the Colorado adult smoking population tried to quit in 2019; our VLN^® King and VLN^® Menthol King cigarettes are proven to help adults smoke less,” said John Miller, president of 22nd Century Group's Tobacco Business. “Reducing cigarette consumption is important, though challenging, and we are hopeful many smokers will transition away from smoking cigarettes entirely.”

Colorado is the first state where VLN^® cigarettes will be fully rolled out, following an exceptionally successful pilot in the Chicago area earlier this year. Despite continually ranking as one of the healthiest states in the country, more than 12% of adult Coloradans still smoke and more than 5,000 people in the state continue to die each year from smoking highly addictive cigarettes. 22nd Century Group chose Colorado for the first statewide rollout due to Colorado’s rapid progress in permitting and facilitating the sale of VLN^® products, as evidenced by being one of the first states in the country to produce an MRTP stamp for VLN^® and the second Master Settlement Agreement state to approve listing VLN^® for sale in their state.

VLN^® King and VLN^® Menthol King reduced nicotine content cigarettes can be purchased at all Smoker Friendly locations throughout the state and will be available at all Colorado Circle K stores by next week. The cigarettes will also soon be available at almost any location alcoholic beverages are sold, through the Eagle Rock Distributing Company partnership. VLN^® will be competitively priced in-line with other major brands at $9 to $9.25 a pack, depending on tax.

Learn more about VLN^®’s revolutionary approach to reducing tobacco harm at tryVLN.com and click on the ‘Store Locator’ to find the nearest location selling VLN^® King and VLN^® Menthol King.

About VLN^®
VLN^® is the first and only FDA MRTP authorized combustible cigarette. Utilizing 22nd Century Group’s proprietary tobacco plant lines, VLN^® cigarettes smoke, smell and taste just like a conventional cigarette but contain 95% less nicotine. Numerous independent scientific studies, funded largely by the U.S. Food and Drug Administration, the National Institutes of Health, and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes like VLN^® helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no nicotine withdrawal symptoms or compensatory smoking behavior. VLN^® helps you smoke less. Learn more at tryVLN.com. 

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 modified risk tobacco product (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, on LinkedIn, and on YouTube.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Media Contact:
Paul Raab
Linhart Public Relations
303-951-2551
praab@linhartpr.com

FAQ

What is the significance of VLN® cigarettes from 22nd Century Group?

VLN® cigarettes are the first FDA-authorized Modified Risk Tobacco Product, designed to reduce nicotine consumption by 95%, helping smokers to smoke less.

Where can I buy VLN® cigarettes in Colorado?

VLN® cigarettes are available at all Smoker Friendly locations and will be at Circle K stores soon.

What are the benefits of switching to VLN® cigarettes?

Clinical studies indicate that switching to VLN® can lead to a 50% reduction in daily cigarette use over 20 weeks.

How does the rollout of VLN® align with public health initiatives?

The rollout of VLN® supports FDA goals to reduce tobacco harm, aligning with national efforts to decrease smoking rates and related health issues.