As many of you are aware, the FDA is requiring that all manufacturers of ENDS products (electronic nicotine delivery systems) including e-liquids to file a (PTMA) premarket tobacco application for each individual product to remain on the market legally after September 9th, 2020. Gothic Vapor has created our PTMAs to include 300 flavors with varying nicotine and pg/vg levels. This equated 62,000+ skus. We did complete that task and it was received by the FDA at 7:58am on September 9th.
Some of our under performing flavors, nicotine levels and pg/vg levels had to be removed to make this task happen. You will notice that some of our product offerings have changed just a bit, but not much. We apologize that we could not register them all. The data the FDA required per variation was just too great. We had to take our SKUS from 329,000 to 64,000 to make their deadline.
If you need assistance selecting an alternate mixture that we now have available please give us a call at 817-473-3600 and we will be happy to assist you.
Thank you to all of our loyal customers, we greatly look forward to providing you with delicious, responsibly marketed, adult flavors for many years to come.
Gothic Vapor LLC
Learn more from the FDA here