Charlie's Holdings (OTCQB: CHUC) Issues Letter to Shareholders
Charlie’s is refocusing on age-gated PACHA disposables as legal and regulatory shifts increase the potential value of its 678‑SKU PMTA portfolio.
Rhea-AI Summary
Charlie's Holdings (CHUC) issued a shareholder letter outlining major U.S. vapor regulatory shifts and the company’s plan to exploit new opportunities.
The NicQuid v. FDA decision in the Fifth Circuit requires FDA to revisit its flavored ENDS denial standard, while FDA has authorized age-gated flavored Glas pods and the JUUL2 device, validating technology-based youth-access controls. FDA has identified 30 PACHA disposable products from Charlie’s PMTA portfolio for a proposed public webpage of ENDS products it generally does not prioritize for enforcement. Charlie’s retains 678 timely filed PMTA assets after selling 16 PMTA products in 2025 for up to $11.7 million, with at least 200 applications still in Filing Review and all MDO’d products under administrative stays. The company is pivoting resources to launch a test pilot of age-gated flavored PACHA disposables this year, backed by tens of thousands of finished units and purchase commitments from a leading U.S. vapor retailer, while actively managing liquidity as cash remains tight.
Positive
- 30 PACHA SKUs selected for FDA’s proposed non-priority PMTA enforcement webpage
- Company retains 678 timely filed PMTA assets after prior monetizations
- Sold 16 PMTA products in 2025 for up to $11.7 million
- At least 200 PMTA products remain active in Filing Review without MDOs
- All Charlie’s products that received MDOs have administrative stays from the Fifth Circuit
- Tens of thousands of age-gated PACHA units produced with test-market commitments from a leading U.S. vapor retailer
Negative
- Management states that cash is tight while executing the strategic pivot toward PACHA disposables
- Shift of priorities away from PACHAMAMA and SBX sales may pressure legacy revenue streams
AI-generated analysis. How Rhea-AI works. Not financial advice.
US Regulatory Landscape Has Improved Dramatically in Recent Months; Charlie’s is Positioned to Capitalize.
- In NicQuid v. FDA, the Fifth Circuit issued what could be the most important legal development for Charlie's Premarket Tobacco Application (“PMTA”) portfolio in years;
- The FDA identified 30 of Charlie’s PMTA-pending products for inclusion on a proposed public-facing webpage that identifies products for which the FDA generally does not intend to prioritize enforcement;
- Most importantly, the FDA has now validated “age-gating” as a pathway for flavored electronic nicotine delivery (“ENDS”) products; Charlie’s is on pace to launch America’s first age-gated flavored disposable vapes this year.
COSTA MESA, CA, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Charlie’s Holdings, Inc. (OTCQB: CHUC) (“Charlie’s” or the “Company”), an industry leader in the premium vapor products space, today released the following letter to shareholders:
Dear Fellow Shareholders,
The US vapor products regulatory landscape has undergone titanic shifts in recent months. I am writing to explain these developments, how they powerfully benefit Charlie’s, and what we are doing to capitalize on this changing landscape.
First, consider the market opportunity. Adult consumers overwhelmingly prefer flavored vapor products, yet there are currently zero FDA-authorized flavored vapor products broadly available to U.S. consumers. As a result,
How can this be possible? Why are 7 out of 10 vapes sold in the US illicit or unauthorized products? The reason is straightforward: Over the last six years the FDA received more than 27 million Premarket Tobacco Applications (“PMTAs”) for electronic nicotine delivery systems (“ENDS”) and, even though the vast majority of these applications were for flavored products, the FDA authorized only two non-menthol flavored SKUS… and these two authorized SKUs (out of 27,000,000) were granted only this year – in May of 2026.
The two authorized Glas Inc. SKUs (the mango flavor is called “Gold” and the blueberry flavor is called “Sapphire”) are not yet on the market (for reasons separate from the FDA authorization process; Glas is fighting a third-party patent dispute related to its “pod system”). Both Glas products are described as “youth access restricted” flavored pods. Though these products are not yet on the market, the simple fact that they are FDA-authorized now validates “age-gating” as a legitimate pathway for flavored ENDS products to be sold legally in the United States.
In recent months there have been a series of additional developments that, when considered in conjunction with the FDA’s authorization of the Glas Inc. age-gated flavored products, show that the vapor products regulatory landscape has indeed changed dramatically. Here is a brief overview of recent events that have substantially increased the value of Charlie’s long-time commitment to regulatory compliance… and the value of Charlie’s 678-SKU PMTA portfolio:
1 | 30 of Charlie’s PMTA Products have been identified for FDA’s new, non-priority enforcement framework.
FDA's May 2026 guidance states that the Agency generally does not intend to prioritize enforcement against qualifying ENDS products with pending, accepted-and-filed PMTAs, subject to specified conditions.
- Charlie’s subsequently received direct FDA correspondence identifying certain PACHA products for inclusion on FDA's proposed public-facing webpage and requesting consent to publish the PACHA product information.
- Charlie’s has since publicly identified the PACHA “Green List” as the 30 disposables planned for inclusion on the FDA’s webpage.
2 | FDA has validated age-gating as a pathway for the legal sale of flavored ENDS products.
In May 2026, FDA granted marketing orders for four Glas Inc. pod products, including “Gold” (mango) and “Sapphire” (blueberry) flavored, age-gated pods. This landmark development validates “age-gating” as a legitimate pathway for the legal sale of flavored ENDS products in the United States.
3 | JUUL2 further validates device-level age verification.
On August 28, FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods. JUUL2 incorporates optional age-verification technology designed to restrict underage access. Together with Glas, the decision provides further evidence that technology-based youth-access restrictions have become a critical component of the regulated ENDS market.
4| Fifth Circuit vacates flavored ENDS Marketing Denial Order.
On August 19, 2026, the Fifth Circuit issued what we believe is the most important legal development for Charlie's PMTA portfolio in years.
- The court ruled in NicQuid v. FDA that the FDA's comparative-efficacy denial standard was unlawfully applied without notice-and-comment rulemaking, requiring the Agency to rethink or properly re-adopt its denial standard in compliance with the Administrative Procedure Act.
- Charlie’s own MDO litigation related to certain of our PMTA products2 presents closely related issues, creating a potentially significant pathway for additional Charlie’s assets to return to FDA review.3
5 | R.J. Reynolds (BTI) signals a major change in commercial risk tolerance.
In recent weeks, Reynolds' Vuse business began publicly advertising four new fruit flavors (berry, fresh mint, peach, and watermelon) as “Coming Soon.” FDA previously issued MDOs covering flavored Vuse Alto products, including menthol and mixed berry products. The strategic implication is significant for the vapor products industry and for Charlie’s: a major tobacco company appears increasingly willing to pursue flavored ENDS commercialization strategies before final FDA authorization, materially changing the strategic calculus for its competitors and for Charlie’s potential strategic partners.
6 | Charlie’s set to launch test pilot of age-gated flavored disposables.
By collecting real-world market data in a test pilot of America's first age-gated flavored disposable vape, Charlie’s intends to demonstrate to public health advocates and Big Tobacco competitors alike that (i) Charlie’s is committed to providing the US market with the flavored vapor products that adult consumers overwhelmingly prefer (by a 4:1 margin), and (ii) unlike illicit Chinese flavored disposable products or outdated Big Tobacco pod systems, age-gated PACHA products cannot be activated by underage consumers. We believe this launch, and the potential regulatory upside it represents, could revolutionize the non-combustible nicotine industry and unlock extraordinary value for Charlie’s shareholders.
7 | Charlie’s boasts a robust PMTA portfolio.
After selling 16 PMTA Products in 2025 for up to
When 4 out of 5 adult consumers prefer flavored vapes, while there are zero FDA-authorized flavored vapor products available to adult consumers, illicit Chinese products have continued to flood the US market… But, by all measures, the regulatory landscape has finally begun to improve. Dramatically.
In this new environment, Charlie’s has established two new, near-term strategic priorities:
- We have shifted our priorities from sales of our PACHAMAMA and SBX product lines to a laser focus on our test pilot of PACHA age-gated flavored disposables. While cash is tight, management is actively managing liquidity through this strategic pivot. Over the last 30 days we have received tens of thousands of finished age-gated PACHA products in our warehouse. We have secured test-market purchase commitments from one of the leading US vapor products retailers. As soon as IKE’s software developers complete their final tests of the consumer app, we will begin shipping the age-gated PACHA product to stores.
- We have redeployed the priorities of one of Charlie’s largest shareholders. As previously announced, Ryan Stump, Charlie’s co-founder and former COO, will identify and pursue strategic transactions, and/or partnerships with leading global tobacco companies to significantly enhance long-term value for Charlie’s shareholders.
With these priorities in mind, and in order to appreciate the market opportunity we envision, it is important to understand the competitive landscape:
- More than
90% of Chinese disposables are not FDA authorized. - Big Tobacco “pod systems” are outdated, provide very low puff counts, and offer few flavor choices
- Charlie’s age-gated PACHA products provide the flavors that adult consumers overwhelmingly prefer… In the form of modern, convenient disposable products… With age-gating technology that reliably prevents youth access.
Our commitments to regulatory compliance, youth access prevention, and the creation of simply great products are what have always set Charlie’s apart. Now we are ready to launch America’s first age-gated flavored disposable vape. Neither Juul, nor Reynolds (BTI) , nor Altria (MO), nor Philip Morris International (PM), nor Japan Tobacco, nor any illicit Chinese manufacturers have flavored disposables in the US market that incorporate underage access prevention.
Ryan Stump’s exciting new initiative to monetize Charlie’s 678-SKU PMTA portfolio through partnership with one of the world’s largest tobacco companies represents a massive opportunity for Charlie’s.
On behalf of the Board of Directors and Charlie’s Management Team, thank you for being a part of our family of shareholders. We look forward to launching a pilot test of America’s first age-gated, flavored disposable this fall… to collecting invaluable consumer market data for the game-changing product, and to sharing additional Company developments in the weeks and months to come.
Sincerely,
Henry Sicignano III
President & Chief Executive Officer
About Charlie’s Holdings, Inc.
Charlie's Holdings, Inc. (OTCQB: CHUC) is an industry leader in the premium vapor products space. The Company's products are sold around the world to select distributors, specialty retailers, and third-party online resellers through subsidiary company Charlie's Chalk Dust, LLC has developed an extensive portfolio of brand styles, flavor profiles, and innovative product formats.
For additional information, please visit Charlie’s corporate website at: Chuc.com and the Company’s branded online websites: sbxvape.com, CharliesChalkDust.com, enjoypachamama.com, and Pacha.co.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the Company's overall business, existing and anticipated markets and expectations regarding future sales and expenses. Words such as "expect," "anticipate," "should," "believe," "target," "project," "goals," "estimate," "potential," "predict," "may," "will," "could," "intend," variations of these terms or the negative of these terms, and similar expressions, are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the Company's ongoing ability to quote its shares on the OTCQB; whether the Company will meet the requirements to up-list to a national securities exchange in the future; the Company’s ability to successfully increase sales and enter new markets; whether the Company’s PMTA’s for its nicotine-containing products will be authorized by the FDA, and the FDA’s decisions with respect to the Company’s future PMTA’s for nicotine products; the Company's ability to manufacture and produce products for its customers; the Company's ability to formulate new products; the acceptance of existing and future products; the complexity, expense and time associated with compliance with government rules and regulations affecting nicotine, synthetic nicotine, products containing nicotine substitutes, and products containing cannabidiol; litigation risks from the use of the Company's products; risks of government regulations; the impact of competitive products; and the Company's ability to maintain and enhance its brands, as well as other risk factors included in the Company's most recent quarterly report on Form 10-Q, annual report on Form 10-K, and other SEC filings. These forward-looking statements are made as of the date of this press release and are based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
Investors Contact:
IR@charliesholdings.com
Phone: 949-570-069
1 Analysis published in NEJM Evidence utilizing retail scanner data found that unauthorized disposable vape products constitute
2 At this date, 200 of the Company’s PMTA products have not received MDOs.
3 On December 24, 2025, the U.S. Court of Appeals for the Fifth Circuit granted the Company’s motion to stay an MDO from the FDA with respect to certain of our timely-submitted 2022 PMTAs. On June 8, 2026, the U.S. Court of Appeals for the Fifth Circuit granted the Company’s motion to stay an MDO from the FDA with respect to certain SKUs of our timely-submitted 2020 PMTAs.
