Mister-E-Liquid Enters PMTA Substantive Review Phase
Mister-E-Liquid, LLC has been notified by the U.S. Food and Drug Administration (FDA) that our Premarket Tobacco Product Application (PMTA) submission has been filed, moving our applications on to the Substantive Review phase of the PMTA process.
Under the Filing Review, the Center for Tobacco Products conducted a preliminary review and determined that Mister-E-Liquid’s applications for all 13 flavors in the MEL Brand Collection line of e-liquid possessed the filing requirements for new tobacco products seeking a marketing order. The requirements for these products are defined under Section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act – Application for Review of Certain Tobacco Products.
This means our PMTA submission is now in the Substantive Review phase, the most extensive and time-consuming stage. The FDA now conducts an in-depth analysis of all data in each of the applications. Depending on the situation, the FDA may release an environmental information request letter or a deficiency letter.
“We understand the importance of manufacturing products that follow all regulatory compliance, upholding a long-time commitment that will continue long into the future.”
If our submission moves on to the final stage of the PMTA review process, the FDA then determines approval of our application with the release of a marketing order letter, or denial with a no marketing order letter.
Mister-E-Liquid spent multiple years and thousands of hours preparing these applications, following all guidelines set forth by the FDA, including studies showing the effect of the products on public health, testing for scientific data on every component or ingredient included in their products, in-depth description of all production processes, and a detailed review and plan of marketing efforts. We understand the importance of manufacturing products that follow all regulatory compliance, upholding a long-time commitment that will continue long into the future.