Charlie's Holdings (OTCQB:CHUC) Receives FDA PMTA Acceptance Filings for Eleven PACHA(TM) Flavored Disposables
Charlie's Holdings (CHUC) announced FDA acceptance filings for eleven PACHA Disposables Pre-Market Tobacco Applications (PMTAs). Ten of these are for flavored PACHA Syn products, including varieties like Banana Ice, Blue Razz Ice, and Mango Ice. The company has invested over $7 million since 2020 on a team of 200+ professionals for PMTA submissions, with an additional $1 million investment in December 2024 to strengthen applications.
Notably, while pursuing PMTA approval, Charlie's is hedging with nicotine substitute products through their new SBX product line, which uses a proprietary alkaloid not subject to FDA tobacco regulations. The company acknowledges revenue reduction over the past two years due to resource redirection but sees SBX as a strategic opportunity in the vapor products marketplace.
Charlie's Holdings (CHUC) ha annunciato l'accettazione da parte della FDA di undici domande di autorizzazione per i prodotti usa e getta PACHA (PMTA). Dieci di queste riguardano prodotti PACHA Syn aromatizzati, tra cui varietà come Banana Ice, Blue Razz Ice e Mango Ice. L'azienda ha investito oltre 7 milioni di dollari dal 2020 in un team di oltre 200 professionisti per le presentazioni PMTA, con un ulteriore investimento di 1 milione di dollari a dicembre 2024 per rafforzare le domande.
È importante notare che, mentre persegue l'approvazione PMTA, Charlie's sta diversificando con prodotti sostitutivi della nicotina attraverso la sua nuova linea di prodotti SBX, che utilizza un alcaloide proprietario non soggetto alle normative sul tabacco della FDA. L'azienda riconosce una riduzione dei ricavi negli ultimi due anni a causa della riallocazione delle risorse, ma vede SBX come un'opportunità strategica nel mercato dei prodotti per vaporizzazione.
Charlie's Holdings (CHUC) anunció la aceptación por parte de la FDA de once solicitudes de productos desechables PACHA (PMTA). Diez de ellas son para productos PACHA Syn con sabor, incluyendo variedades como Banana Ice, Blue Razz Ice y Mango Ice. La empresa ha invertido más de 7 millones de dólares desde 2020 en un equipo de más de 200 profesionales para las presentaciones de PMTA, con una inversión adicional de 1 millón de dólares en diciembre de 2024 para fortalecer las solicitudes.
Es notable que, mientras busca la aprobación de PMTA, Charlie's está diversificando con productos sustitutos de nicotina a través de su nueva línea de productos SBX, que utiliza un alcaloide propietario no sujeto a las regulaciones de tabaco de la FDA. La empresa reconoce una reducción de ingresos en los últimos dos años debido a la re-dirección de recursos, pero ve a SBX como una oportunidad estratégica en el mercado de productos de vapor.
Charlie's Holdings (CHUC)는 FDA가 11개의 PACHA 일회용 제품에 대한 사전 시장 담배 신청서(PMTA)를 수락했다고 발표했습니다. 이 중 10개는 Banana Ice, Blue Razz Ice, Mango Ice와 같은 다양한 맛의 PACHA Syn 제품에 해당합니다. 이 회사는 2020년 이후 PMTA 제출을 위해 200명 이상의 전문가 팀에 700만 달러 이상을 투자했으며, 2024년 12월에는 신청서를 강화하기 위해 추가로 100만 달러를 투자할 예정입니다.
특히 PMTA 승인을 추구하는 동안 Charlie's는 FDA 담배 규제의 적용을 받지 않는 독점 알칼로이드를 사용하는 새로운 SBX 제품 라인을 통해 니코틴 대체 제품으로 헤지하고 있습니다. 이 회사는 자원 재배치로 인해 지난 2년 동안 수익 감소를 인정하고 있지만, SBX를 증기 제품 시장에서의 전략적 기회로 보고 있습니다.
Charlie's Holdings (CHUC) a annoncé l'acceptation par la FDA de onze demandes de produits jetables PACHA (PMTA). Dix d'entre elles concernent des produits PACHA Syn aromatisés, y compris des variétés telles que Banana Ice, Blue Razz Ice et Mango Ice. L'entreprise a investi plus de 7 millions de dollars depuis 2020 dans une équipe de plus de 200 professionnels pour les soumissions PMTA, avec un investissement supplémentaire de 1 million de dollars en décembre 2024 pour renforcer les demandes.
Il est à noter que, tout en poursuivant l'approbation de la PMTA, Charlie's se diversifie avec des produits de substitution à la nicotine grâce à sa nouvelle gamme de produits SBX, qui utilise un alcaloïde propriétaire non soumis aux réglementations sur le tabac de la FDA. L'entreprise reconnaît une réduction des revenus au cours des deux dernières années en raison de la réallocation des ressources, mais considère SBX comme une opportunité stratégique sur le marché des produits de vaporisation.
Charlie's Holdings (CHUC) hat die Annahme von FDA-Anträgen für elf PACHA Einwegprodukte (PMTAs) bekannt gegeben. Zehn davon betreffen aromatisierte PACHA Syn Produkte, darunter Sorten wie Banana Ice, Blue Razz Ice und Mango Ice. Das Unternehmen hat seit 2020 über 7 Millionen Dollar in ein Team von über 200 Fachleuten für die PMTA-Einreichungen investiert, mit einer zusätzlichen Investition von 1 Million Dollar im Dezember 2024 zur Stärkung der Anträge.
Bemerkenswert ist, dass Charlie's während der Verfolgung der PMTA-Zulassung mit Nikotinersatzprodukten durch ihre neue SBX Produktlinie absichert, die ein proprietäres Alkaloid verwendet, das nicht den FDA-Tabakvorschriften unterliegt. Das Unternehmen erkennt einen Rückgang der Einnahmen in den letzten zwei Jahren aufgrund der Umverteilung von Ressourcen an, sieht jedoch SBX als strategische Gelegenheit im Markt für Verdampferprodukte.
- FDA acceptance of 11 PACHA Disposables PMTAs
- Development of SBX product line bypassing FDA tobacco regulations
- Patents secured in US and China for nicotine substitute alkaloid
- Strategic positioning in legal flavored vape market
- Significant revenue decline over past 2 years
- Heavy investment costs ($7M+ since 2020)
- No FDA marketing authorization received yet
- Uncertainty in PMTA approval timeline
Fewer than
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
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
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
"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
FAQ
How many PACHA Disposables PMTAs did CHUC receive acceptance filings for in March 2025?
What is the total investment CHUC made in PMTA submissions since 2020?
What is CHUC's SBX product line and why is it significant?
How has CHUC's revenue been affected by their focus on nicotine substitutes?
