Charlie’s Holdings Says 30 PACHA SKUs May Be Included on FDA Public Webpage
Charlie’s Holdings, a US vape company, announced that the US Food and Drug Administration (FDA) notified the company on June 23, 2026, that 30 of its PACHA vape SKUs, for which it has submitted PMTA (Product Marketing Authorization Act) applications, have been preliminarily identified for inclusion in a public product webpage planned by the FDA.
According to enforcement guidance issued by the FDA in May of this year, this webpage will list certain unauthorized products for which the FDA does not typically intend to prioritize premarket authorization requirements. The company announced this development on August 17, along with a report that second-quarter revenue increased by 116% year-over-year to $3.8 million.
Key Overview of Charlie’s FDA Update
Charlie’s Holdings stated that the FDA notified the company on June 23, 2026. That 30 of its PACHA vape SKUs have been preliminarily identified for inclusion in a public product webpage planned by the FDA.
This webpage stems from the new enforcement guidance issued by the FDA in May 2026, targeting certain ENDS (End-of-Life Devices) and oral nicotine pouch products that have not yet obtained premarket authorization.
Being listed on this webpage does not equate to obtaining PMTA marketing authorization; the relevant products still fall under the category of products that have not yet obtained premarket authorization.
Reuters previously reported that the FDA’s policy adjustment could affect hundreds of vape and nicotine pouch products, with sources estimating that approximately 100 to 200 products might immediately benefit.
Charlie’s second-quarter revenue was $3.8 million, a 116% year-over-year increase; operating loss was $1.2 million, compared to $1 million in the same period last year.
On August 24, 2026, according to Charlie’s Holdings’ second-quarter earnings announcement released on August 17, 2026. The company stated that the U.S. Food and Drug Administration (FDA) had notified it that 30 PACHA vape SKUs that had submitted Premarket Tobacco Product Applications (PMTAs) were preliminarily identified for inclusion in a public product webpage planned by the FDA. This webpage will list products for which the FDA does not typically intend to prioritize premarket authorization requirements.
Charlie’s further disclosed that the company received the relevant notification from the FDA on June 23, 2026.
This development is directly related to the new enforcement guidance issued by the FDA in May of this year regarding certain new tobacco products that have not received premarket authorization. This policy covers certain electronic nicotine delivery systems (ENDS) and oral nicotine pouches.
It’s important to note that the 30 PACHA SKUs mentioned by Charlie’s are currently only tentatively identified for inclusion on this publicly available webpage, and this does not mean that these products have already received PMTA marketing authorization.
30 PACHA SKUs Tentatively Selected for FDA Public Webpage
Charlie’s President and CEO Henry Sicignano stated in the company’s earnings announcement:
“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.”
In other words, the FDA recently notified the company that some of its PACHA products that have submitted PMTAs—a total of 30 SKUs—have been tentatively selected for inclusion on the FDA’s public-facing product webpage. The FDA generally does not intend to prioritize enforcement of PMTA requirements for products listed on the webpage. Sicignano described this as a “highly promising development.”
The company announcement did not disclose the specific product names of these 30 PACHA SKUs, nor did it indicate that these products have received PMTA marketing authorization.
American vape company Charlie’s has announced that 30 of its PACHA brand SKUs have been preliminarily identified for inclusion in the FDA’s “non-priority enforcement” public list. (Image source: Charlie’s Holdings, by Henry Sicignano, President and CEO)
FDA’s May 2026 Enforcement Guidance
This public list stems from the FDA’s May enforcement guidance. In May 2026, the FDA released its final guidance, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization,” which outlines new enforcement policies for certain ENDS and nicotine pouch products that have not yet obtained premarket authorization.
According to this policy, for certain products that meet the conditions outlined in the guidance, the FDA generally does not intend to prioritize enforcement actions related to premarket authorization requirements while their PMTA is still under review.
The FDA also proposed establishing a public website to help retailers, distributors, consumers, and other stakeholders identify products that comply with the relevant enforcement policies.
The 30 PACHA SKUs disclosed by Charlie’s are related to this public website mechanism.
The FDA clarified that its guidance reflects the agency’s current policies and enforcement considerations on related issues and does not establish legally binding liability.
Inclusion on the List Does Not Mean FDA Approval
Being on the list does not equate to obtaining PMTA marketing authorization.
A key regulatory distinction in Charlie’s disclosure is that the FDA’s enforcement priority policy differs from formal PMTA marketing authorization.
Under the current U.S. tobacco regulatory framework, new tobacco products generally require FDA premarket authorization to be legally marketed. The FDA’s decision not to prioritize enforcement action on certain unauthorized products does not grant them market authorization.
Therefore, even if Charlie’s 30 PACHA SKUs eventually appear on the FDA’s planned public website, it cannot be interpreted as the FDA having “approved,” “authorized,” or “recognized” these products.
Charlie’s itself stated in its company risk disclosure that there is still uncertainty regarding whether its nicotine-containing products will ultimately receive FDA PMTA authorization.
Reuters Estimates Hundreds of Products Could Be Affected
Reuters previously reported that hundreds of products may be affected by the new policy.
After the FDA announced its policy in May, Reuters analyzed this regulatory adjustment and its potential market impact.
According to a previous Reuters report cited by 2Firsts. Three current and former U.S. government officials stated at the time that the new policy could affect hundreds of e-cigarette and nicotine pouch products in the coming weeks or months.
One official estimated that approximately 100 to 200 products could immediately benefit from the policy change; another source familiar with the FDA review process stated that around 1,000 applications were already in the scientific review stage at the time.
Reuters also reported at the time that industry players. Including large tobacco companies, could be significant beneficiaries of the policy adjustment, while the policy also drew criticism from some public health officials and organizations.
Charlie’s disclosure provides an update on the number of specific companies and products involved in the implementation of this policy. However, the FDA has not yet made a PMTA marketing authorization decision for the 30 PACHA SKUs disclosed by Charlie’s.
Charlie’s Q2 Revenue Climbs 116% Year Over Year
In addition to the FDA-related developments, Charlie’s also released its second-quarter financial data ending June 30, 2026.
The company’s second-quarter revenue was $3.8 million, a 116% increase from $1.8 million in the same period of 2025. Gross profit increased from $0.5 million to $1.1 million, a 130% year-over-year increase, and gross margin rose from 27.6% to 29.4%.
The company stated that the revenue growth was driven by increased sales of nicotine-containing products and nicotine alternatives. Meanwhile, sales of its nicotine-free disposable e-cigarette product, SBX, also saw significant growth in 2026.
Total operating expenses for the second quarter were $2.4 million, a 63% year-over-year increase. Operating loss was $1.2 million, further widening compared to $1 million in the same period last year.
As of the end of the second quarter, the company held $500,000 in cash, down from $1.3 million at the end of 2025. Total assets were $12.8 million, and shareholders’ equity was $3.1 million.
Company Plans Test of Age-Gated Flavored Disposable Product
Charlie’s also disclosed in the announcement that it plans to test the sale of what it calls the first age-gated flavored disposable e-cigarette in the U.S., and plans to conduct tests in hundreds of compliance-focused retail stores.
Sicignano stated that he believes this product project and its potential regulatory opportunities could have a significant impact on the company’s future business.
However, the company’s announcement classifies statements regarding future market performance and company valuation as forward-looking statements. Actual results may be affected by regulatory decisions, market acceptance, and other factors.
