The Humble Juice Co. is moving on to the scientific review stage of its premarket tobacco product application (PMTA). The leading e-liquid company with a humble beginning, announced that it had received a filing letter from the U.S. Food and Drug Administration (FDA). The letter indicates the FDA has completed its preliminary review of Humble’s PMTA, advancing the brand’s application forward in the review process.
Humble submitted its PMTA to the FDA on Sept. 3.
“We were excited to receive a filing letter from the FDA just days after being notified of our PMTA’s acceptance,” said Humble CEO Daniel Clark. “To my knowledge, there are a limited number of e-liquid companies that have moved forward to this phase of the PMTA process thus far. We hope our application continues to advance in a timely manner and we remain committed to working with the FDA in order to achieve this.”
A filing letter from the FDA is a result of a preliminary scientific review of a PMTA. This review ensures an application includes the necessary components and scientific analyses. FDA will now conduct a Substantive Review of Humble’s application to evaluate the scientific information and data submitted within its PMTA. If successful, this phase will result in the FDA granting marketing orders, authorizing the continued marketing and sale of Humble’s products.”