Charlie's Holdings (OTCQB: CHUC) Applauds the Trump Administration’s Plans to Re-vamp the FDA Authorization Process for Flavored Vapes
Charlie’s retains 678 timely-filed PMTA assets while the reported FDA rule review remains prospective.
Rhea-AI Summary
Charlie’s Holdings (CHUC) welcomed reported plans to revisit FDA application rules for new tobacco products on September 24, 2026. Charlie’s said the FDA is expected to announce a review of a 2021 rule governing premarket tobacco applications, or PMTAs, in the coming days. The reported review is prospective; it is not an FDA authorization for Charlie’s products.
Charlie’s has sought FDA marketing authorization for certain tobacco-derived nicotine e-liquids since September 2020 and for hundreds of synthetic nicotine products since May 2022. It sold 16 PACHA-brand PMTA products in 2025 and retains 678 timely-filed PMTA assets. The company believes a streamlined authorization process would make its PACHA portfolio one of the industry’s most valuable. Charlie’s is scheduled to launch flavored disposable vapes this year and says they cannot be activated by underage consumers.
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“The Trump administration is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets, and providing safer alternatives for adults who want to quit smoking cigarettes.”
“A Streamlined pathway for FDA authorization will make Charlie’s PACHA™ product line one of the most valuable PMTA portfolios in the industry.”
COSTA MESA, CA, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Charlie’s Holdings, Inc. (OTCQB: CHUC) (“Charlie’s” or the “Company”), an industry leader in the premium vapor products space, applauds the Trump administration’s new plans to revise U.S. Food and Drug Administration (“FDA”) rules governing applications for new tobacco products, likely making it easier and faster for products such as Charlie’s flavored vapes to win regulatory approval.
As reported yesterday in The Wall Street Journal, the FDA is expected to announce in coming days that it will revisit a 2021 rule that outlined requirements for new tobacco products as governed by the Agency’s Premarket Tobacco Application (“PMTA”) review process. Tobacco companies have long complained that this FDA review process is essentially a regulatory gauntlet that takes much longer than the six month time-frame mandated by Congress.
As a point of reference, since September 2020 Charlie’s has been attempting to obtain FDA marketing authorization for certain of its tobacco-derived nicotine e-liquid products. Further, since May 2022, Charlie’s has been attempting to obtain FDA marketing authorization for hundreds of synthetic nicotine products that are subject to the same FDA rules as tobacco-derived nicotine products.
“The unwieldy PMTA review process has punished hundreds of small American businesses that have spent years and untold millions of dollars attempting to comply with the FDA’s tobacco product authorization process,” explained Henry Sicignano, Charlie’s President and Chief Executive Officer. “Meanwhile billions of dollars of illicit product – made by Chinese manufacturers who thumbed their noses at the FDA – have flooded American streets. Charlie’s is thrilled that the US regulatory landscape is, at last, changing.”
As reported by The Wall Street Journal, “the Trump administration is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets, and providing safer alternatives for adults who want to quit smoking cigarettes.”
Reportedly, the Trump administration hopes to see tobacco products it considers less harmful for smokers, such as flavored vapes, enter the market more easily, people familiar with the matter said. This refreshing perspective aligns squarely with Charlie’s corporate mission: to provide adult smokers with better alternatives to combustible cigarettes. What’s more, Charlie’s is scheduled to launch, this year, America’s first flavored disposable vapes – that cannot be activated by underage consumers.
Charlie’s commitments to regulatory compliance and youth access prevention are what distinguish the company.
“After selling 16 PACHA™ brand PMTA Products in 2025 to one of the world’s largest tobacco companies, Charlie’s retains 678 timely-filed PMTA assets,” Mr. Sicignano explained. “We believe the Trump Administration’s streamlined pathway for FDA authorization of timely-filed PMTAs will make Charlie’s PACHA product line one of the most valuable PMTA portfolios in the industry.”
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
FAQ
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What FDA rule change is Charlie’s Holdings (CHUC) responding to?
Charlie’s is responding to reported plans for the FDA to revisit a 2021 rule governing premarket tobacco applications. Charlie’s said an announcement is expected in the coming days; it did not report a completed rule change.
How many PACHA PMTA assets does Charlie’s Holdings (CHUC) retain?
Charlie’s retains 678 timely-filed PMTA assets. It sold 16 PACHA-brand PMTA products in 2025.