22nd Century Group, Inc. Highlights FDA Filing of VLN® MRTP Renewal Applications for Scientific Review
Rhea-AI Summary
22nd Century Group (Nasdaq: XXII) announced that the FDA has filed for scientific review renewal applications for its VLN King and VLN Menthol King Modified Risk Tobacco Products. These combusted cigarettes currently carry exposure‑modification orders that expire in December 2026 unless renewed.
The renewal seeks to preserve VLN’s authorized reduced‑nicotine claims, including “95% less nicotine” and related reduced consumption statements, and is supported by prior FDA findings and new marketplace data, including a 2024 study showing a 40% reduction in daily cigarette consumption over 12 weeks.
Positive
- FDA filing of MRTP renewal applications for VLN King and VLN Menthol King
- Current MRTP orders authorize reduced‑nicotine marketing claims such as “95% less nicotine”
- FDA previously found VLN nicotine levels at least 95% lower than most conventional brands
- FDA stated VLN‑like products could reduce nicotine exposure by ~95% and dependence likelihood
- 2024 study of 400+ participants showed 40% lower daily cigarette use over 12 weeks with VLN
Negative
- Existing MRTP exposure‑modification orders are set to expire in December 2026 unless renewed
- Outcome and timing of the FDA MRTP renewal review remain uncertain
- No renewal approval has been granted; future modified‑risk marketing status is not assured
News Market Reaction – XXII
In the May 12 session, XXII declined 2.22%, reflecting a moderate negative market reaction. Argus tracked a peak move of +33.2% during that session. Argus tracked a trough of -5.3% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 07 | Q1 2026 earnings | Negative | -16.4% | Reported Q1 2026 net revenues, losses, and limited cash position. |
| May 04 | Earnings date set | Neutral | -27.6% | Announced schedule for Q1 2026 results and webcast details. |
| Apr 29 | VLN growth plan | Positive | -3.1% | Outlined 2026 VLN® scaling priorities and addressable smoker market. |
| Apr 23 | Testing agreement | Positive | -16.6% | Signed NC State testing pact to validate reduced-nicotine tobacco varieties. |
| Apr 07 | New VLN product | Positive | +0.5% | Advanced 100mm VLN® cigarette and second PMTA toward large U.S. market. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent VLN®-focused and financial updates often coincided with negative next-day moves, including sizeable drops on earnings and strategy updates.
Over the past two months, 22nd Century has repeatedly emphasized its VLN® reduced-nicotine platform. On April 7, it advanced a 100mm VLN® product and broader PMTA portfolio. Subsequent news on testing collaborations, 2026 VLN® growth plans, and its Q1 2026 results highlighted ongoing losses and a shift to proprietary products. Despite these strategic updates, shares often fell after announcements, with moves of -16.59%, -3.11%, -27.59%, and -16.35%, indicating a pattern of weak price response to positive-sounding VLN® news.
Key Terms
modified risk tobacco product regulatory
mrtp regulatory
scientific review regulatory
modified risk claims regulatory
public comment regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway for continued modified risk marketing status
MOCKSVILLE, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco harm reduction company focused on reduced nicotine innovation, today highlighted that the U.S. Food and Drug Administration has filed for scientific review two Modified Risk Tobacco Product, or MRTP, renewal applications for the Company’s VLN® King and VLN® Menthol King combusted, filtered cigarettes. The FDA filing marks an important step in the regulatory process for the continued marketing of these products with authorized modified risk claims.
VLN® King and VLN® Menthol King were originally granted MRTP exposure modification orders by the FDA in December 2021, making them the first combusted cigarettes ever authorized as MRTPs. Those orders are set to expire in December 2026 unless renewed, and the current review process is intended to support continued modified risk marketing status beyond that date.
“We are pleased that the FDA has filed our VLN® MRTP renewal applications for scientific review, an important procedural step in the renewal process for the first and only combustible cigarettes authorized as modified risk tobacco products,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We believe this development reflects the strength of the scientific and regulatory foundation supporting VLN®, and we remain focused on working through the FDA review process responsibly, transparently and in full compliance with all applicable requirements as we continue advancing our reduced-nicotine platform for adult smokers.”
Under the existing FDA orders, 22nd Century is authorized to market VLN® King and VLN® Menthol King with specific reduced-exposure nicotine claims, including “
In connection with the renewal process, the FDA has begun releasing redacted application materials for public access and opened a docket for public comment, enabling stakeholders to submit data and feedback as part of the scientific review. 22nd Century believes this process further underscores the rigor of the FDA’s modified risk framework and the significance of maintaining a robust evidence base for its VLN® franchise.
In its original MRTP review, the FDA found that nicotine levels in the tobacco and mainstream smoke of VLN cigarettes are at least
22nd Century previously announced that its renewal submission was supported by additional marketplace data, including a 2024 study involving more than 400 participants, which the Company said demonstrated a
This release does not announce renewal approval, and no assurance can be given regarding the outcome of the FDA’s review. The original publication can be found on the FDA website here:https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications?utm_campaign=ctp-mrtp&utm_content=landingpage&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms
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
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
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. 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
investorrelations@xxiicentury.com
214-597-8200
