Month: September 2026

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

TORONTO, Sept. 24, 2026 (GLOBE NEWSWIRE) — Euro Sun Mining Inc. (TSX: ESM) (“Euro Sun” or the “Company”) is pleased to announce that it has closed its previously announced non-brokered US$3 million strategic equity investment by Urion Investments Holdings Limited (“Urion”), a Trafigura Group company (the “Investment”). For more information about the Investment, please see the Company’s press release dated September 3, 2026, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca.

Pursuant to the Investment, Euro Sun issued 21,974,210 units (each, a “Unit”) at a price of C$0.19 per Unit for gross proceeds of US$3,000,000 (approximately C$4,175,100). Each Unit consists of one common share of the Company (each, a “Common Share”) and one-half of one common share purchase warrant (each whole warrant, a “Warrant”). Each Warrant shall be exercisable to acquire one Common Share at a price of C$0.40 per share until September 24, 2030.

The Units were issued pursuant to Ontario Securities Commission Rule 72-503 Distributions Outside Canada and are not subject to a hold period. The listing of the Common Shares and Warrants issued pursuant to the Investment remains subject to the final approval of the Toronto Stock Exchange. No finder’s fees were paid in connection with the Investment. The net proceeds of the Investment are expected to be used for the Rovina Valley Project and general corporate purposes.

In connection with the Investment, Euro Sun and Trafigura Pte Ltd. also entered into an amendment to the binding offtake agreement dated July 10, 2025, as amended and restated December 15, 2025 (the “Offtake Agreement”) to (among other things) provide for an offtake volume of 40% effective upon closing of the Investment. For more information about the Offtake Agreement, please see the Company’s press release dated July 10, 2025, a copy of which is also available under the Company’s SEDAR+ profile at www.sedarplus.ca.

About Euro Sun Mining Inc.

Euro Sun is a Toronto Stock Exchange-listed mining company focused on the exploration and development of its 100%-owned Rovina Valley Project located in west-central Romania, which hosts the second largest copper & gold deposit in Europe. Already granted European strategic status, the Rovina Valley Project is expected to unlock much needed investment and job creation in Hunedoara County and will deliver critical minerals necessary for Europe’s green energy transition.

Further information:

For further information about Euro Sun, or the contents of this press release, please contact Investor Relations at info@eurosunmining.com.

Caution regarding forward-looking information:

This press release contains statements which constitute “forward-looking information” within the meaning of applicable securities laws, including statements regarding the Investment, such as in respect of the Company’s intended use of net proceeds, receipt of final approval of the Toronto Stock Exchange, and other matters related thereto. Forward-looking information is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions. Investors are cautioned that forward-looking information is not based on historical facts but instead reflect management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, including: the risk that necessary approvals, including Toronto Stock Exchange approval, may not be obtained; general business, economic, competitive, political and social uncertainties in Romania and the European Union; future commodity prices and market demand; accidents, labour disputes and shortages; risks inherent in the mining industry; and other risks described in the Company’s public disclosure. Undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in filings made by the Company with the Canadian securities regulators, including the Company’s annual information form, financial statements and related MD&A for the financial year ended December 31, 2025, filed with the securities regulatory authorities in certain provinces of Canada and available at www.sedarplus.ca.

Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward-looking information except as otherwise required by applicable law.

MONTREAL, Sept. 24, 2026 (GLOBE NEWSWIRE) — Prime Drink Group Corp. (CSE: PRME) (“Prime” or the “Company”) announces that further to its news releases dated July 30, August 14, August 27 and September 10, 2026, the Company voluntarily applied for and the Company’s principal regulator, the British Columbia Securities Commission (the “BCSC”) granted a management cease trade order (the “MCTO”) dated July 30, 2026, under National Policy 12-203 Management Cease Trade Orders (“NP 12-203”) and provided the Company with an extension to file its annual financial statements for the year ended March 31, 2026, including the related management’s discussion and analysis, and Chief Executive Officer and Chief Financial certifications on or before July 29, 2026 (collectively the “Annual Financial Filings”). The deadline has been extended to on or before September 28, 2026.

Pursuant to the MCTO, the Chief Executive Officer and the Chief Financial Officer of the Company may not trade in securities of the Company until such time as the Company files its Annual Financial Filings on or before September 28, 2026, and the Executive Director of the BCSC revokes the MCTO. The MCTO does not affect the ability of shareholders to trade their securities.

The Company expects to file on or before September 28, 2026.

The Company confirms that it will continue to satisfy the provisions of the alternative information guidelines under NP 12-203 by issuing bi-weekly default status reports in the form of news releases until the time it has filed the Annual Financial Filings. The Company confirms that there is no other material information relating to its affairs that has not been generally disclosed.

For further information, please contact:
Jean Gosselin, CFO
Phone: (514) 394-7717
Email: info@prime-group.ca

Forward-Looking Information
This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations (including negative and grammatical variations) of such words and phrases or statements that certain acts, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved”. These statements are based upon assumptions that are subject to significant risks and uncertainties, including risks regarding market conditions, general economic factors and the equity markets generally. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance of Prime may differ materially from those anticipated and indicated by these forward-looking statements. Any number of factors could cause actual results to differ materially from these forward-looking statements as well as future results. Although Prime believes that the expectations reflected in forward-looking statements are reasonable, they can give no assurances that the expectations of any forward-looking statements will prove to be correct. Except as required by law, Prime disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.