PMTA Tracking Tool

Thousands of manufacturers and importers submitted premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) by the Sept. 9 deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.

In the absence of an official database, Vapor Voice decided to create its own tracker. As a news outlet, we already receive many press releases relating to PMTA submissions. In addition, we continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.

Of course, this approach has its limits. The data is self-reported, and at present, we cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches us also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per our protocol, these issues are noted in the list. While we cannot present our dataset as a representative sample, we believe that, after capturing information on 180 companies, it paints as coherent a picture as possible.

Our tracker lists company, brand family, brand styles and PMTA stage. We view it as a “living document” that will be updated as new information becomes available. To that end, the tracker also includes a tool for user input. If the status of your application has changed or if you notice inaccuracies, we invite you to share that information with our editors, who will be pleased to make the required updates. 

Keeping in mind the limitations of our tracker, we recommend using this tool to gain directional understanding of the volume of submissions for which the FDA’s Center for Tobacco Products is processing and as a starting point in a comprehensive due diligence search regarding products. We also strongly recommend that any retailer gain certification of products in their inventory from the manufacturer and rely upon advice of counsel as to appropriate due diligence and safe harbor.