Fewer than 1% of electronic nicotine delivery system PMTAs remain in active FDA review.
COSTA MESA, CA / ACCESS Newswire / March 4, 2025 / Charlie's Holdings, Inc.(OTCQB:CHUC) ("Charlie's" or the "Company"), an industry leader in the premium vapor products space, today announced that the Center for Tobacco Products of the U.S. Food and Drug Administration ("FDA") informed the Company that eleven (11) of Charlie's best-selling flavored PACHA Disposables Pre-Market Tobacco Applications ("PMTAs") have received Acceptance Filings.
The FDA has received PMTAs for nearly 27 million Electronic Nicotine Delivery System (ENDS1) products and has made determinations on more than 99% of the applications. However, the FDA has authorized fewer than three dozen tobacco- and menthol-flavored e-cigarette products and devices. To date, no company in the world has received an FDA marketing order for a flavored (non-tobacco or non-menthol) disposable vape product.
Ten of eleven of the PMTAs for which Charlie's received FDA Acceptance Filings this week are for Charlie's best-selling flavored PACHA Disposables brand styles:
PACHA Syn - Banana Ice, 8ml 20mg
PACHA Syn - Blue Razz Ice, 8ml 50mg
PACHA Syn - Clear, 8ml 50mg
PACHA Syn - Fuji Apple Strawberry Ice, 8ml 50mg
PACHA Syn - Le Crème, 8ml 50mg
PACHA Syn - Lemon Meringue, 8ml 50mg
PACHA Syn - Mango Ice, 8ml, 50mg
PACHA Syn - Pink Lemonade, 8ml, 50mg
PACHA Syn - Strawberry Kiwi, 8ml 50mg
PACHA Syn - Watermelon Ice, 8ml 50mg
PACHA Syn - White Grape, 8ml 50 mg
At this date, Charlie's has received Acceptance Filings for more than 700 of its PMTA submissions. Since 2020 the Company has invested more than $7MM on a team of more than 200 professionals, including doctors, scientists, biostatisticians, data analysts, and numerous contract research organizations to create Charlie's PMTA submissions. Charlie's believes its applications are among the most robust and comprehensive in the entire industry. As recently as December 2024, Charlie's invested more than $1MM to amend and further strengthen certain of the Company's applications.
1 ENDS are defined as battery-powered devices, also known as an e-cigarettes or "vapes," that deliver nicotine to users through aerosolized solutions. In order for ENDS to be sold legally in the United States, the products must receive marketing authorization through the FDA's PMTA pathway; FDA marketing authorizations require that PMTAs provide sufficient evidence that new products offer greater benefits to population health than risks.
An Important Hedge
While Charlie's continues to push forward, aggressively, with its PMTA-submitted tobacco products, the Company is also pursuing nicotine substitute products that are not subject to the FDA's PMTA review process. Charlie's has invested heavily over the last 30 months on the development and testing of the nicotine substitute category. The Company's nicotine substitute-based vape liquids are not made from or derived from tobacco, nor do they contain nicotine from any source. Accordingly, the Company's proprietary nicotine substitute alkaloid (patented in the United States and in China by the Company's chemical supplier) does not meet the definition of nicotine and therefore Charlie's nicotine substitute products are not subject to Federal regulation as "tobacco products".
After testing nicotine substitutes throughout 2024 in the pod-based SPREE BAR product line, the Company ultimately decided to commercialize "SBX," a more modern disposable device that is very similar to the leading (nicotine) vapes on the market today.
SBX
Featuring a proprietary nicotine substitute alkaloid, in lieu of tobacco-based or synthetically derived nicotine, SBX perfectly replicates the sensation of vaping a traditional nicotine disposable. By combining this proprietary alkaloid with Charlie's award-winning flavors, SBX provides a great way for adults to enjoy the taste and sensation of traditional flavored nicotine products… in a distinctive new product that is legal across most of the United States. SBX represents a very important commercial opportunity - and a highly significant strategic hedge - for Charlie's.
"Charlie's continues to pursue, diligently, FDA's PMTA pathway. As highlighted in today's press release, we have made substantial progress… but the process has taken YEARS and the FDA still has not authorized any flavored vapes (other than menthol) for any company… All the while illegal nicotine products continue to be imported into the U.S. market on a daily basis," explained Henry Sicignano III, Charlie's President. "For 85% of US adults who smoke - and will only vape less harmful non-combustible products IF they are flavored - SBX is the answer."
"We plan is to introduce SBX to mass market convenience chain operators who do not sell illicit flavored nicotine vapes and who desperately seek legal flavored products," explained Ryan Stump, Charlie's Chief Operating Officer. "Though redirecting resources away from the sales of legacy nicotine products in favor of new nicotine substitute technologies has significantly reduced Company revenue over the last two years, we believe the new SBX product line will give Charlie's very significant long term competitive advantages in the vapor products marketplace."
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: 949-570-0691
SOURCE: Charlie's Holdings, Inc.
View the original press release on ACCESS Newswire
