22nd Century Applauds the American Academy of Family Physicians Comments and Support of the FDA’s Proposed Reduced Nicotine Mandate to Reduce Smoking, Transform Public Health, Save Lives and Reduce Health Costs

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) welcomes the American Academy of Family Physicians' (AAFP) support for the FDA's proposed reduced nicotine mandate. The AAFP, representing over 128,300 family physicians, endorses establishing a maximum nicotine yield of 0.7 milligrams per gram of tobacco in combustible products.

The company's VLN® products, including partner brands Smoker Friendly VLN® and Pinnacle VLN®, are currently the only FDA-authorized reduced nicotine content cigarettes that comply with the proposed standard. According to the release, smoking causes over 480,000 deaths and costs more than $600 billion annually in the United States, while reducing life expectancy by 10 years.

Positive

• Only company with FDA-authorized reduced nicotine content cigarettes compliant with proposed standard
• Commercial viability demonstrated through existing VLN® products and partner brands
• Potential for licensing opportunities with other tobacco industry brands
• Strong support from AAFP representing 128,300 medical professionals

Negative

• Implementation timeline of FDA standard remains uncertain
• Potential competition if other companies develop compliant products

Insights

Tobacco Industry Analyst

22nd Century Group stands to benefit significantly from FDA's proposed nicotine reduction mandate as the only company with compliant cigarettes already approved.

This announcement positions 22nd Century Group (XXII) at a critical regulatory inflection point. The FDA's proposed mandate to limit nicotine in cigarettes to 0.7mg per gram of tobacco would create an enormous competitive advantage for the company, as their VLN® products are currently the only combustible cigarettes authorized by the FDA that already comply with this standard.

The support from the American Academy of Family Physicians, representing over 128,300 family physicians, adds significant credibility to the regulatory push. This endorsement from a major medical organization strengthens the likelihood of the FDA finalizing the proposed mandate.

If implemented, this regulation would fundamentally transform the $600 billion U.S. tobacco market. Every cigarette manufacturer would need to reformulate their products or potentially license 22nd Century's technology. The company's 27 years of experience and intellectual property in reduced nicotine tobacco gives them a substantial first-mover advantage in what would become a completely restructured industry.

The company's partnership strategy, evident in the Smoker Friendly VLN® and Pinnacle VLN® brand extensions, demonstrates a clear commercialization pathway. This positions 22nd Century to potentially become a critical technology provider to the entire tobacco industry if the mandate is finalized.

This regulatory development represents a rare scenario where government action could instantly validate a smaller company's technology and potentially force major industry players to partner with them or license their technology.

22nd Century VLN^® products are the only combustible cigarettes authorized by the FDA as a reduced nicotine content product that comply with the FDA proposed rule

MOCKSVILLE, N.C., July 29, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today commented on responses provided to the U.S. Food and Drug Administration to date as part of its open comment period on the proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.

“In the United States, smoking causes more than 480,000 deaths and costs over $600 billion annually and reduces life expectancy by 10 years. The US government and our federal courts have issued countless warnings concerning nicotine, the effects of nicotine addiction, and the harms caused by smoking since the early 1950’s. Implementation of the proposed FDA standard, which would require that all combusted tobacco products sold in the U.S. contain less than 0.7mg of nicotine per gram of tobacco, would directly combat the public health issues resulting from nicotine and nicotine dependence, as outlined by the American Academy of Family Physicians,” said Larry Firestone, Chief Executive Officer of 22nd Century Group.

Comments published from the American Academy of Family Physicians (AAFP), which represents more than 128,300 family physicians and medical students across the country, recommend the FDA finalize the proposed mandate as the new standard, including:

• Establishing a maximum nicotine yield of 0.7 milligrams per gram of total tobacco in cigarettes and other combusted tobacco products
• Extending the standard to other forms of nicotine consumption, such as e-cigarettes and vapes, as a means to protect children and support quitting. It’s letter states: “Establishing a maximum nicotine yield is a vital step towards curbing nationwide tobacco dependence.”

The full comment submission can be read on the AAFP webpage found here.

“The commercial launch of our low nicotine VLN^® products which include partner brand products such as Smoker Friendly VLN^® and Pinnacle VLN^®, demonstrate the commercial viability for cigarettes which are already compliant with the new standard. If licensed from, or produced by 22^nd Century, VLN^® products can be quickly produced, marketed and sold under the wide array of brands in the tobacco industry,” said Larry Firestone, Chief Executive Officer of 22nd Century Group.

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 in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN^® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers in the form that they are used to, 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 proprietary non-GMO reduced nicotine tobacco blends are made possible by comprehensive and patented technologies and tobacco plants 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^® is a registered trademark 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 20, 2025 and Quarterly Report on Form 10-Q filed on May 13, 2025. 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 FDA's proposed nicotine limit for cigarettes that XXII supports?

The FDA proposes a maximum nicotine yield of 0.7 milligrams per gram of tobacco in cigarettes and other combusted tobacco products.

How many deaths does smoking cause annually in the US according to XXII?

According to the release, smoking causes more than 480,000 deaths and costs over $600 billion annually in the United States.

Which 22nd Century (XXII) products currently meet the FDA's proposed nicotine standards?

22nd Century's VLN® products, including partner brands Smoker Friendly VLN® and Pinnacle VLN®, are the only FDA-authorized reduced nicotine content cigarettes that comply with the proposed standard.

How many medical professionals does the AAFP represent in their support of reduced nicotine standards?

The American Academy of Family Physicians (AAFP) represents more than 128,300 family physicians and medical students across the country.

What is the impact of smoking on life expectancy according to XXII's release?

According to the release, smoking reduces life expectancy by 10 years.