Charlie’s Holdings, Inc., parent to Charlie’s Chalk Dust and Pacha brands, announced today that the FDA’s Center for Tobacco Products has issued premarket tobacco product application (PMTA) acceptance letters for 11 of its best-selling flavored PACHA Disposable products.

The regulatory achievement marks a major step forward for the company, which has invested heavily in building a robust submission portfolio, according to a press release.

The FDA has received PMTAs for nearly 27 million Electronic Nicotine Delivery Systems (ENDS) products, making determinations on more than 99% of the applications. However, fewer than three dozen tobacco- and menthol-flavored e-cigarette products and devices have been authorized for marketing.

Notably, no company to date has secured an FDA marketing order for a flavored (non-tobacco or non-menthol) disposable vape product.

According to the release, 10 of the 11 PMTAs accepted cover the “PACHA Syn” line of products, which include popular flavors such as “Banana Ice” (8ml 20mg), “Blue Razz Ice” (8ml 50mg), “Clear” (8ml 50mg), “Fuji Apple Strawberry Ice” (8ml 50mg), “Le Crème” (8ml 50mg), “Lemon Meringue” (8ml 50mg), “Mango Ice” (8ml 50mg), “Pink Lemonade” (8ml 50mg), “Strawberry Kiwi” (8ml 50mg), “Watermelon Ice” (8ml 50mg), and “White Grape” (8ml 50mg).

“These flavors represent some of the most sought-after options in the premium disposable vape market,” the release states.

To date, Charlie’s has secured acceptance letters for over 700 PMTA submissions. Since 2020, the company has invested more than $7 million and built a dedicated team of over 200 professionals—including doctors, scientists, biostatisticians, and data analysts—to develop its comprehensive PMTA submissions, according to the release.

“We believe our applications are among the most robust and comprehensive in the entire industry,” a company spokesperson said. Charlie’s invested over $1 million as recently as December 2024 to amend and further strengthen certain submissions.