Key Points
- Charlie’s said FDA notified the company on June 23, 2026, that 30 PACHA vape SKUs had been tentatively identified for inclusion on a planned public-facing FDA webpage.
- The webpage stems from FDA’s May 2026 enforcement guidance covering certain unauthorized ENDS and oral nicotine pouch products.
- Inclusion on the webpage does not constitute PMTA marketing authorization; the products remain unauthorized unless FDA grants marketing orders.
- Reuters previously reported that hundreds of vape and nicotine pouch products could be affected by the policy, with one official estimating that around 100 to 200 products could benefit immediately.
- Charlie’s reported Q2 revenue of $3.8 million, up 116% year over year, while its operating loss widened to $1.2 million.
2Firsts
August 24, 2026
Charlie’s Holdings said in its second-quarter results released on August 17 that the U.S. Food and Drug Administration (FDA) had notified the company that 30 PACHA vape SKUs with submitted premarket tobacco product applications (PMTAs) had been tentatively identified for inclusion on a planned public-facing FDA webpage of products for which the agency generally does not intend to prioritize enforcement of premarket authorization requirements.
The company said it received the FDA notification on June 23, 2026.
The development is directly related to FDA enforcement guidance issued in May covering certain new tobacco products marketed without premarket authorization, including certain electronic nicotine delivery systems (ENDS) and oral nicotine pouch products.
Charlie’s 30 PACHA SKUs have only been “tentatively identified for inclusion” on the planned webpage. The development does not mean the products have received PMTA marketing authorization from FDA.
30 PACHA SKUs Tentatively Identified for Public Webpage
Charlie’s President and CEO Henry Sicignano said:
“We are pleased to announce that the FDA recently notified us that certain of our PACHA products - 30 SKUs - for which PMTAs have been submitted have been tentatively identified for inclusion on the FDA's public-facing webpage of products for which the FDA generally does not intend to prioritize enforcement of PMTA requirements. This is a highly promising development.”
The company did not identify the individual PACHA products covered by the notification and did not state that any of the 30 SKUs had received PMTA marketing authorization.
Public List Stems From FDA’s May Enforcement Guidance
In May 2026, FDA issued its final guidance, Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization, setting out enforcement policies for certain unauthorized ENDS and oral nicotine pouch products.
Under the policy, FDA generally does not intend to prioritize enforcement of premarket authorization requirements against certain products that meet conditions described in the guidance while their applications remain under review.
FDA also outlined plans for a public-facing webpage intended to help retailers, distributors, consumers and other stakeholders identify products covered by the relevant enforcement policy.
The 30 PACHA SKUs disclosed by Charlie’s are tied to that planned webpage mechanism.
FDA has also stressed that its guidance documents describe the agency’s current thinking and do not themselves establish legally enforceable responsibilities.
Inclusion Does Not Equal PMTA Marketing Authorization
A key regulatory distinction in Charlie’s disclosure is the difference between FDA’s enforcement priorities and formal PMTA marketing authorization.
Under the U.S. tobacco regulatory framework, new tobacco products generally require premarket authorization from FDA to be legally marketed. FDA’s decision not to prioritize enforcement against certain unauthorized products does not grant those products marketing authorization.
As a result, even if the 30 PACHA SKUs are ultimately included on FDA’s public-facing webpage, their inclusion should not be characterized as FDA “approval,” “authorization” or “endorsement.”
Charlie’s itself notes in its risk disclosures that there remains uncertainty over whether PMTAs for its nicotine-containing products will ultimately be authorized by FDA.
Reuters Previously Reported Hundreds of Products Could Be Affected
Following the May policy change, Reuters examined the potential impact of FDA’s new enforcement approach.
As previously reported by 2Firsts citing Reuters, three current and former U.S. administration officials said the policy could affect hundreds of vape and nicotine pouch products in the following weeks and months.
One official estimated that around 100 to 200 products could immediately benefit from the policy shift. Another source familiar with FDA’s review process said approximately 1,000 applications had reached scientific review, indicating that manufacturers had submitted sufficient information to potentially qualify under the new policy.
Reuters also reported that major tobacco companies could emerge as significant beneficiaries of the regulatory shift, while public health experts and groups raised concerns about its potential consequences.
Charlie’s latest disclosure provides a specific company- and SKU-level development under the policy. FDA has not granted PMTA marketing authorization to the 30 PACHA SKUs based on the information disclosed by the company.
Charlie’s Q2 Revenue Rises to $3.8 Million, Operating Loss Widens
Charlie’s also reported financial results for the three months ended June 30, 2026.
Second-quarter revenue increased 116% to $3.8 million from $1.8 million a year earlier. Gross profit increased 130% to $1.1 million, while gross margin improved to 29.4% from 27.6%.
The company attributed the revenue increase to higher sales of nicotine-based products and nicotine alternative products. It also said sales of SBX, a non-nicotine disposable vapor product, increased significantly in 2026.
Total operating expenses increased 63% to $2.4 million. The company recorded an operating loss of $1.2 million, compared with a $1.0 million operating loss a year earlier.
Charlie’s ended the quarter with $0.5 million in cash, compared with $1.3 million at the end of 2025. Total assets stood at $12.8 million and shareholders’ equity at $3.1 million.
Company Plans Test Market for Age-Gated Flavored Disposable Vape
Charlie’s also said it is preparing to test-market what it describes as America’s first age-gated flavored disposable vape at hundreds of what it called compliance-minded retail stores.
Sicignano said the company views the initiative and its potential regulatory implications as a significant future opportunity. Statements regarding future market performance and company valuation were identified in the announcement as forward-looking statements and remain subject to regulatory decisions, market acceptance and other risks.
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Cover Image Source: Charlie’s Holdings
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