In its latest shareholder letter, Charlie’s Holdings announced that, following the FDA’s adjustment of enforcement priorities for unauthorized ENDS products this year, the company is resuming the commercialization of its PACHA products. It is realigning its strategy around age-verification technology, PMTA assets, and partnerships with major tobacco companies. Thirty PACHA products were previously identified by the FDA for potential inclusion on a public webpage listing products subject to “non-priority enforcement,” and the company is preparing to launch test sales of flavored disposable vapes featuring age-verification capabilities. Charlie’s currently reports holding 678 PMTA-related assets and plans to continue pursuing strategic transactions and partnerships.
Key Highlights
- Charlie’s stated that 30 PACHA products were preliminarily identified by the FDA for inclusion on a public “non-priority enforcement” webpage; however, this status does not equate to FDA marketing authorization.
- The company has prepared tens of thousands of PACHA disposable vapes equipped with age-verification technology and has secured a commitment for a test-market purchase from a major U.S. vape retailer.
- Charlie’s currently reports holding 678 PMTA-related product assets and plans to continue enhancing their commercial value through supplemental regulatory filings, partnerships, and transactions.
- Reynolds’ advancement of the Vuse Pro—which lacks FDA marketing authorization—marks another corporate move by a major tobacco company under the new enforcement priority framework; the FDA is simultaneously incorporating this framework into its import enforcement processes.
September 11, 2026. According to a shareholder letter released by Charlie’s Holdings on September 9, 2026, the company is resuming the commercialization of its PACHA vape products and related PMTA assets. It has prioritized age-verification technology, test sales, and strategic partnerships with major tobacco companies for the next phase of its operations.
These moves follow the U.S. Food and Drug Administration’s (FDA) recent adjustment of enforcement priorities regarding unauthorized vape products. For Charlie’s, these regulatory changes are translating from policy-level shifts into concrete plans involving products, regulatory assets, and commercial partnerships.
FDA Identifies 30 PACHA Products for Potential Non-Priority Enforcement Listing
Charlie’s stated that the FDA previously notified the company that 30 PACHA products had been preliminarily identified for inclusion on a webpage slated for public release.
This webpage is intended to list certain products currently under review for which the FDA does not generally intend to prioritize the enforcement of pre-market authorization requirements. In regulatory filings, Charlie’s clarified that this status does not constitute FDA marketing authorization, nor does it imply that the products will ultimately be approved; the FDA retains the right to take enforcement action based on specific circumstances.
The enforcement guidance issued by the FDA in May of this year targets certain ENDS (Electronic Nicotine Delivery Systems) and nicotine pouch products that lack pre-market authorization, further clarifying enforcement priorities. For products with pending PMTAs (Premarket Tobacco Product Applications) that have reached a specific stage of review, the FDA stated it generally would not prioritize enforcement action.
For non-tobacco-flavored ENDS, applications must also contain sufficient information for the FDA to assess whether the products meet public health standards.
Charlie’s Prepares Age-Verified PACHA Disposable Vapes for Test Sales
Charlie’s is also incorporating age-verification technology directly into its commercialization plan for PACHA products.
The company stated it has received tens of thousands of finished PACHA disposable vapes equipped with age-verification capabilities and has secured a purchase commitment for a test market launch from a major U.S. vape retailer.
Charlie’s plans to begin shipments once final testing of the associated consumer application is complete.
The company previously indicated plans to use the IKE age-verification technology to collect real-world compliance data and to supplement existing PACHA PMTA filings with age-verification-related information.
This approach extends age verification beyond a mere retail-level check to encompass product design, market testing, and regulatory applications.
When the FDA authorized non-tobacco, non-menthol flavored Glas vape products for the first time this year, the devices also featured app-based age and identity verification capabilities.
Consequently, Charlie’s views age verification as a key component of its future regulatory and commercialization strategy for flavored ENDS products.
678 PMTA Assets Become a Key Part of Charlie’s Partnership Strategy
Charlie’s has disclosed that it holds 678 PMTA-related product assets.
Of these, the company states that at least 200 remain in the “Filing Review” stage and have not received a Marketing Denial Order (MDO).
These applications cover a range of disposable vapes and e-liquids, featuring various liquid capacities and product configurations.
In a letter to shareholders, the company clearly stated its intention to continue seeking partnerships with major global tobacco companies to enhance the value of and monetize these regulatory assets.
Charlie’s has previously executed similar transactions. In 2025, the company sold 16 PACHA synthetic nicotine products and related PMTA assets to R.J. Reynolds Vapor Company for a total cash consideration of $7.5 million, plus contingent payments of up to $4.2 million.
This transaction demonstrates that for small-to-medium-sized vape companies like Charlie’s. PMTAs serve not only as a pathway to market entry for their own products but also as assets that can be sold, licensed, or utilized in strategic partnerships.
FDA Enforcement Priorities Begin to Shape Vape Company Strategies
Charlie’s latest moves indicate that adjustments to FDA enforcement priorities are eliciting responses from the business sector.
For a long time, U.S. vape regulation was often viewed simply as a binary distinction between products with marketing authorization and those without.
While this year’s enforcement guidance did not alter the legal status of unauthorized products, it further refined the prioritization of the FDA’s limited enforcement resources.
This has created a more complex market landscape: products still undergoing PMTA review may fall under lower enforcement priority, whereas products that lack PMTA submissions, are counterfeit, involve false declarations, or hold obvious appeal to youth face higher enforcement risks.
For companies, factors such as “pending PMTA” status. The application stage, age verification measures, and capabilities for mitigating youth-related risks are—alongside the prospect of final marketing authorization—shaping business decisions.
Reynolds Advances Vuse Pro Despite Pending FDA Authorization
Major tobacco companies are also taking action within this regulatory environment.
R.J. Reynolds Vapor Company has begun selling Vuse Pro devices and associated pods—in flavors such as Peach, Berry, Watermelon, and Fresh Mint—in select U.S. markets.
These products have not yet received FDA marketing authorization.
The Vuse Pro features age-verification technology, and Reynolds has implemented supporting measures including ID scanning, purchase quantity limits, and retailer compliance protocols.
Reynolds had previously submitted a PMTA for the Vuse Pro age-verification platform in 2024.
BAT has subsequently cited U.S. regulatory and enforcement actions in investor materials as factors supporting the growth of its new product business in the United States.
While Charlie’s and Reynolds differ significantly in terms of product scale and resource capabilities, both are advancing commercialization plans for products lacking final marketing authorization within the framework of the FDA’s new enforcement priorities.
FDA Extends Enforcement Framework to Unauthorized Vape Imports
“Non-prioritized enforcement” also implies a reprioritization of enforcement resources.
When the FDA issued its guidance in May of this year, it clarified that it would continue to focus on products that failed to submit a Premarket Tobacco Product Application (PMTA), as well as counterfeit goods, false declarations, serious violations, and products with obvious appeal to youth.
This strategic direction subsequently began to be integrated into actual enforcement procedures.
Following the FDA’s update to Import Alert 98-07 in September, field enforcement officers must now determine—in conjunction with the May 2026 enforcement guidance—whether unauthorized Electronic Nicotine Delivery Systems (ENDS) should be subject to detention without physical inspection.
If a product potentially falls within the “non-prioritized enforcement” category. The assessment can be submitted to the FDA’s Center for Tobacco Products for further review.
This indicates that the new enforcement priorities are transitioning from policy documents into border and import enforcement mechanisms.
Consequently, the new framework brings changes in two directions for the U.S. vape market: some products still under review gain a degree of enforcement “breathing room,” while the FDA can simultaneously concentrate its resources on high-priority products that fail to meet the relevant criteria.
Charlie’s Financial Position Makes PMTA Commercialization More Significant
Charlie’s serves as a case study of how regulatory changes impact individual companies.
Remains a relatively small-scale vape company.
The company’s revenue for the second quarter of 2026 was approximately $3.8 million, a year-over-year increase of 116%; revenue for the first half of the year was approximately $8.61 million, though it still recorded an operating loss and a net loss from continuing operations for the period.
Against this financial backdrop, the ability to continue commercializing its PMTA assets or monetize them through strategic transactions holds direct operational significance for the company.
FDA Enforcement Changes Are Moving From Policy to Business Decisions
The developments reflected in Charlie’s recent shareholder letter go beyond mere optimism regarding the regulatory environment.
From reactivating its PACHA PMTA assets and advancing test sales of age-verified products to seeking partnerships with major tobacco companies, the firm is translating the FDA’s shift in enforcement priorities into concrete business actions.
Meanwhile, Reynolds’ advancement of the Vuse Pro offers another corporate example.
U.S. vape companies are responding to the new enforcement priority framework in various ways; regulatory changes are already filtering down from the policy level to impact product launches and compliance technologies. PMTA assets, and corporate partnerships. Looking ahead, beyond the question of which products qualify for lower enforcement priority, a key area to watch in the U.S. vape market will be whether the FDA further concentrates its enforcement resources on unauthorized products that fall outside this framework.
