Washington Post Story Featuring 22nd Century VLN Products Highlights Proposed FDA Reduced Nicotine Content Policy Could Initially Benefit An Estimated 13 Million Smokers

Rhea-AI Summary

22nd Century Group (NASDAQ: XXII) was featured in a Washington Post article discussing the FDA's proposed policy to mandate reduced nicotine content in cigarettes. The policy, which cleared U.S. Office of Management and Budget review on January 3, 2025, could benefit an estimated 13 million smokers in its first five years.

The company's VLN branded low nicotine cigarettes are the first and only combustible tobacco products with FDA Modified Risk Tobacco Product designation, available in over 5,000 stores nationwide. The products are manufactured using proprietary tobacco strains that can be licensed to other brands, potentially creating a new market category similar to non-alcoholic beverages.

The policy initiative, started in 2017 during the Trump administration, is supported by decades of clinical research using 22nd Century's reduced nicotine content cigarettes, demonstrating that adult smokers can effectively control their smoking habits with these products.

Positive

• First and only FDA-authorized reduced nicotine cigarettes in the market
• Present in over 5,000 stores across the country
• Potential to license proprietary tobacco strains to other brands
• FDA policy implementation could benefit 13 million smokers
• Cleared important regulatory hurdle with OMB review

Negative

• Faces competition from larger tobacco companies ('David-and-Goliath' situation)
• Success depends on pending FDA policy implementation
• Potential resistance from major tobacco companies questioning policy viability

News Market Reaction

+5.83%

1 alert

+5.83% News Effect

On the day this news was published, XXII gained 5.83%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

VLN Reduced Nicotine Content Cigarettes from 22nd Century Is the Only Authorized Combustible Solution to Support the FDA’s War on Smoking

MOCKSVILLE, N.C., Jan. 14, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, was featured today in a Washington Post news story (https://www.washingtonpost.com/health/2025/01/14/cigarettes-low-nicotine-regulation-biden/) addressing new federal policy activities that could reduce the health harms of smoking. The article focuses on a recent U.S. Food and Drug Administration policy proposal to mandate reduced nicotine content in cigarettes, which recently cleared review by the U.S. Office of Management and Budget on January 3, 2025.

“While we are in the final days of the Biden administration, this policy – which may be the most ambitious and impactful smoking harm reduction policy in a generation – was originally jumpstarted in 2017 during the first Trump administration by then FDA Commissioner Scott Gottlieb, a major proponent of smoking harm reduction,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We are excited to see federal policy continue to progress even as we continue to roll out the first reduced nicotine cigarettes commercially across the U.S., demonstrating that adult smokers who want this product can use it effectively to control their nicotine intake.”

The proposal is based on decades of clinical research underpinned by reduced nicotine content cigarettes manufactured by 22nd Century showing that adult smokers can control their smoking when using a reduced nicotine content cigarette in place of conventional nicotine cigarettes currently sold by the major tobacco companies. 22nd Century’s VLN branded low nicotine cigarettes are the first and only combustible tobacco products to receive authorization by the FDA under its Modified Risk Tobacco Product designation and available at more than 5,000 stores across the country.

“While this may be a David-and-Goliath story, we are quickly moving ahead with an increasing number of retailers who are interested in not only putting our VLN products on the shelf, but also stocking their own or other brands of reduced nicotine cigarettes that we can manufacture or license using our proprietary tobacco strains, creating a new category in the market. Using VLN products mirrors the growing non-alcoholic beer and spirits segments in adult beverage as consumers seek alternatives to traditional products in those categories.”

“The FDA originally estimated in the first five years alone that 13 million smokers could benefit under this policy, a tremendous figure for public health across the country. Big Tobacco has tried to question whether this policy could be achieved on a commercial basis or suggest contraband cigarettes would be a major issue. 22nd Century has demonstrated that not only is this policy commercially viable, it is also effective at the primary goal – controlling nicotine intake and cutting smoking activity,” said Firestone.
About 22nd Century Group, Inc.

22nd Century Group is the pioneering nicotine harm reduction company in the tobacco industry enabling smokers to take control of their nicotine consumption. 

We created our flagship product, the VLN^® cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to greatly reduce nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 

Our wholly owned subsidiaries include a leading cigarette manufacturer that produces all VLN® products and provides turnkey contract manufacturing for other tobacco brands both domestically and internationally. The 60,000 square foot facility in Mocksville, North Carolina has the capacity to produce more than 45 million cartons of combusted tobacco products annually with additional space for expansion. 

Our proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets.

VLN^® and Helps You Smoke Less^® are registered trademarks of 22nd Century Limited LLC.

Learn more at xxiicentury.com, on X (formerly Twitter), on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

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, including but not limited to our full year business outlook. 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. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives, (ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, (iii) our financial and operating performance and (iv) our expectations for our business interruption insurance claim. 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 28, 2024, and in the Company’s Quarterly Reports filed on May 15, 2024, August 13, 2024, and November 11, 2024. 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.

Investor Relations & Media Contact
Matt Kreps
Investor Relations
22nd Century Group
mkreps@xxiicentury.com
214-597-8200

FAQ

What is the potential market impact of FDA's reduced nicotine policy for XXII?

The FDA estimates that 13 million smokers could benefit from this policy in the first five years, representing a significant market opportunity for XXII as the only authorized manufacturer of reduced nicotine cigarettes.

How many stores currently sell XXII's VLN cigarettes?

VLN cigarettes are available in more than 5,000 stores across the United States.

When did the FDA's reduced nicotine content proposal clear OMB review?

The proposal cleared review by the U.S. Office of Management and Budget on January 3, 2025.

What regulatory approval does XXII have for its VLN cigarettes?

VLN cigarettes are the first and only combustible tobacco products to receive FDA authorization under its Modified Risk Tobacco Product designation.

How does XXII plan to expand its reduced nicotine cigarette business?

XXII plans to manufacture or license its proprietary tobacco strains to other brands, creating a new category in the market similar to non-alcoholic beverages.