Step one in this crazy process, for any person at all concerned about this Deeming Rule, has to be to go to the source and get some actually information, right? So that would be the FDA website, no problem. Do some basic searches and everything says they are committed to helping people through the process, they have set up videos and special web sites and even put out guidance documents! This seems great! At first glance…
Then you click on one link, looking for an answer, and it takes you to a page you were already at. OK, surely I did something wrong, handy little back arrow puts me back where I was. Click. Nope. OK, back up. Fast forward twenty minutes later. I have my answer! Well, mostly…actually just kinda sorta. They still keep using terms like PMTA, Master List, and user fees but I cannot get any concrete answers about this. Surely they know exactly what has to go into this process. Why isn’t there just a check list?
An hour later I finally find an outline of dates! I’m doing a happy dance through my house as my dogs look on at me like I’m crazy – maybe I am since I am looking at the FDA website for hours. Then I really look at the document. One form claims it is due February 8, 2017 OR August 8, 2017. What does that mean? How do I know which date to use?
Deep breath. Surely I can figure this out. I am an Attorney (hear the bells and whistles). FDA said, somewhere in the labyrinth I got stuck in (that didn’t even have a talking worm with a British accent, mind you) that they would help, that this process would be laid out for me. There I sat, hours later, still unsure of where to start.
That is why we are here to help. We have already gone through the frustration that is the FDA web site, along with the actual regulations, and lived to tell the tale. We have answers for your questions, at least the answers that are available. The truth of the matter is the FDA has only updated ONE, yes I said, ONE, form that is tailored for vape and ENDS products. The more you muddle through their web site you get the feeling maybe this whole thing was rolled out a little too quickly, but here we are. They hold the keys to the castle and they are trying to hide the fact that the castle isn’t even fully built.
Still the first real deadline, with the only document tailored to this unique and specialized product, is fast approaching. December 31, 2016 is the first deadline, with the only form we are sure about. This is not the type of form you sit down during your copious amounts of down time as a small business owner and fill out. (Could you feel the sarcasm?) There are attachments and DUNS numbers that have to be attached. Let us help and let you actually enjoy the limited free time you have. As more information becomes available we will keep you up to date and and as in the know as possible.