Charlie’s Holdings, parent to the Charlie’s Chalk Dust e-liquid brand, has submitted its initial premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA).
“Today’s submission marks the first of multiple applications that Charlie’s Chalk Dust (CCD) intends to take through FDA’s approval process as it seeks to create a long-term, robust product portfolio. This is a day we’ve long awaited for in our industry,” stated Charlie’s Holdings’ Chief Operating Officer Ryan Stump in a press release. “After spending nearly $5 million over the past two years on our PMTA preparation and submission, we are extremely excited about the application we filed with the FDA.”
The release states that Stump believes “that a significant amount of our competitors will not have the resources, desire, and/or expertise to complete the extensive and costly PMTA process.” However, once approved, CCD’s marketing orders would allow the company “to benefit from being one of only a select group of companies responsibly operating in the flavored nicotine product space.”
The company also announced that it was performing human clinical trials on its products to help detect the biomarkers of exposure associated with smoking combustible cigarettes and determine the nicotine delivery efficiency of CCD products via pharmacokinetic studies.
“A large team of doctors, scientists, biostatisticians, and data analysts are conducting these time intensive clinical trials,” the release states. “We believe that this kind of study will significantly set our application apart from those that are relying solely on the literature-based approach to this critical ‘in human’ assessment of product performance.”