22nd Century Group Urges Policymakers and FDA to Enact and Implement the Reduced Nicotine Content Standard, Citing Years Without a Final Rule

22^nd Century Group Calls on HHS Secretary Kennedy, Acting FDA Commissioner Diamantas and CTP Director Koplow to Enact and Implement the Reduced Nicotine Content Standard

Administration’s Reported Move to Accelerate Vape and Nicotine Pouch Authorizations Addresses Only Part of the Continuum of Risk

MOCKSVILLE, N.C., Sept. 24, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company focused on reducing the harms of smoking through nicotine reduction, today called on political leaders and the U.S. Food and Drug Administration (“FDA”) to enact and implement the proposed “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products,” 90 Fed. Reg. 5032 (Jan. 16, 2025) (“Proposed Rule”), which remains pending more than eight years after the FDA first announced its intent to act and more than a year after the public comment period closed.

The Company’s call follows a Wall Street Journal report published Wednesday that the Trump administration plans to change federal rules to speed the authorization of tobacco products such as flavored vapes and nicotine pouches, with the FDA expected to announce in coming days that it will revisit the 2021 rule governing premarket review of new tobacco product applications (“U.S. Regulators Plan Major Move to Speed Authorizations of Vapes, Tobacco Pouches,” WSJ, Sept. 23, 2026). 22nd Century supports those efforts and believes they represent only one component of a comprehensive continuum-of-risk strategy to address the harms of tobacco.

The Proposed Rule would establish a maximum nicotine level of 0.70 milligrams per gram of total tobacco in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco, a level low enough to no longer create or sustain addiction. The FDA first issued an advance notice of proposed rulemaking on the subject on March 16, 2018 (83 Fed. Reg. 11818). The Proposed Rule was issued on January 15, 2025, and the comment period closed on September 15, 2025. To date, there is no final rule, no published timeline and no public update from the agency.

What 22nd Century Is Asking Of Federal Policymakers

1. HHS Secretary Kennedy: Direct FDA to prioritize the pending standard, consistent with your stated commitment to tobacco harm reduction and to delivering results for the American people.
2. Acting FDA Commissioner Diamantas: Place the rule back on the FDA’s entry into the Unified Agenda and establish a clear timeline for transmitting a final rule.
3. CTP Director Koplow: Convene the Tobacco Products Scientific Advisory Committee (TPSAC) to review the standard, as FDA stated it intended to do, and complete that step publicly.
4. The Trump Administration: Clear interagency and OMB review rather than allowing the rule to remain undecided and apply the same acceleration to combusted products that it is applying to non-combusted alternatives and to make mandatory that all retailers that sell combustible cigarettes immediately make available, space on their shelves to carry VLNC products.
5. Congress: Members of the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee, from both parties, should request a status update from FDA and hold the agency to the 180-day review framework Congress established in the Tobacco Control Act of 2009. Senators who have consistently championed tobacco policy, including Senators Durbin and Merkley, have pressed the agency on the youth implications of its recent flavor decisions; that same scrutiny should extend to finishing a standard FDA itself projects would prevent 48 million young Americans from starting to smoke.
   

22nd Century notes that the standard is not a partisan question. The policy has been advanced under multiple administrations in both parties since 2009, and the FDA’s own analysis describes it as among the most consequential public health actions available to the agency.

The Evidence Is Irrefutable and the Tool Already Exists

“The evidence is irrefutable, and it has been for years. The FDA’s own scientists have modeled a standard that would prevent approximately 48 million young Americans from starting to smoke and avert 1.8 million tobacco-related deaths by 2060. That proposal and comment period have now been closed for more than one year, while cigarettes remain the leading cause of preventable death in this country. I am asking Secretary Kennedy, Acting Commissioner Diamantas and Director Koplow to finish the job, and I am asking Republicans and Democrats in Congress to insist on a timeline. A reduced nicotine content standard is not a competing policy to the administration’s vape and nicotine pouch efforts, it is the other half of the same objective. Accelerated authorizations for lower-risk alternatives help adults who want to move away from cigarettes; reducing nicotine in combusted products to non-addictive levels helps the adults who are still smoking make that move or quit altogether. Together, those two policies move people down the continuum of risk at population scale, and separately, neither reaches its potential. This is the single most powerful tool available under existing law to accomplish the objectives Washington says it wants, and it can be implemented with products that are already authorized, already in the market and already proven. The mandate should also include a mandatory allocation of space to allow a wider distribution of VLNC products in the combustible space in retail. The only barrier left is the willingness to move forward.” said Larry Firestone, Chief Executive Officer.

Based on the FDA’s population health model published with the Proposed Rule, adopting the standard would:

• Prevent approximately 48 million U.S. youth and young adults from starting to smoke by 2100;
• Prompt more than 12.9 million people who smoke to stop within one year of the rule taking effect, rising to 19.5 million within five years;
• Avert 1.8 million tobacco-related deaths by 2060, rising to 4.3 million by the end of the century;
• Deliver estimated benefits of more than $1.1 trillion per year over the first four decades.

The Proposed Rule bans no product. It caps nicotine — the substance that creates and sustains addiction — and leaves every product category legal, while expressly excluding e-cigarettes, nicotine pouches, heated tobacco products, smokeless tobacco, waterpipe tobacco and premium cigars.

The Technology Is Commercialized, Authorized and Ready

22nd Century’s proprietary non-GMO reduced nicotine tobacco plants are grown using patented technologies that regulate alkaloid biosynthesis, producing tobacco with 95% less nicotine than traditional tobacco. The Company’s VLN^® cigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States, carrying authorized claims including “95% less nicotine,” “Helps reduce your nicotine consumption” and “Greatly reduces your nicotine consumption.”

As the Company stated in its comments filed in support of the Proposed Rule, the development and FDA authorization of very low nicotine content tobacco makes it entirely feasible to produce conventionally flavored, consumer-acceptable combusted tobacco products that deliver a customary smoking experience with greatly reduced nicotine levels that comply with the proposed standard. 22nd Century’s wholly owned subsidiary, a leading cigarette manufacturer, produces all VLN^® products at its 60,000 square foot facility in Mocksville, North Carolina, which has the capacity to produce more than 45 million cartons of combusted tobacco products annually, with additional space for expansion.

The Company is also the sole holder of an FDA-authorized reduced nicotine content combustible cigarette in the United States, and in May 2026 the FDA filed for scientific review of the Company’s modified risk tobacco product renewal applications for VLN^® King and VLN^® Menthol King cigarettes and opened a public docket.

Media Availability

Larry Firestone, Chairman and Chief Executive Officer, is available for interviews on the reduced nicotine content standard, the continuum of risk, and the Company’s FDA-authorized VLN^® products. To arrange an interview or request data or background materials, contact investorrelations@xxiicentury.com.

About 22nd Century Group, Inc.

22nd Century Group is pioneering the Tobacco Harm Reduction and Nicotine Reduction Movements by enabling smokers to take control of their nicotine consumption.

Our Technology is Tobacco

Our proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant that contains 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio has been developed to ensure that our-high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual property to ensure our ongoing leadership in the tobacco harm reduction movement.

Our Products

We created our flagship product, the VLN^® cigarette using our low nicotine tobacco, 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 compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption.

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 expectations regarding regulatory enforcement, including our ability to receive authorization or approval for new products, and (ii) our financial and operating performance. 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 26, 2026 and Quarterly Reports on Form 10-Q filed May 7, 2026 and August 14, 2026. 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  
Daniel Otto
Chief Financial Officer & Investor Relations
22nd Century Group
investorrelations@xxiicentury.com