Humble Juice Co. announced today that the company had received an acceptance letter for its premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). Humble submitted its application to the FDA on Sept. 3.
“Since starting Humble in 2015, we’ve grown more than I could have ever imagined. During that time, we’ve expanded the business while being mindful of future regulation of the e-liquids industry,” said Humble CEO Daniel Clark. “For the past several months, the Humble team has dedicated time and resources to compiling the necessary materials for our PMTA. We are confident in our submission and look forward to providing our customers with flavor-filled, affordable and compliant e-juice long into the future.”
Humble’s PMTA submission includes product-specific details, consumer survey data, and scientific studies and analyses, as well as risk assessments. Its application specifically pursues marketing orders for 84 e-liquid products in various flavors, nicotine levels and sizes.
“Our long-term strategy will include the release of additional flavors and nicotine levels,” said Clark. “In the near term, we are focused on working with the FDA to obtain marketing orders for the products submitted in our initial PMTA.”
Clark added that the Humble team looks forward to the next step in the PMTA journey: the preliminary scientific review of its application.