I know it's really early for this question(as most people will start this process as close to the deadline as possible because once you start it, if it's rejected your product is illegal until accepted as far as I understand), but I'm really interested what the actual skinny on the PMTA process is. I've heard so many conflicting stories from basically armageddon (class 4 medical device level requirements which I don't think is true) all the way to pretty tame, and basically you have to have MSDS sheets and quality controlled facilites - meaning you'll need to have your line manufactured in a clean room from one of the big manufacturers like E-Pure, or the others.
I think this one piece is the biggest boogeyman around these regulations, as the age compliance piece is pretty straightforward for brick and mortars, and is just a bit more costly and more of a pain for the consumers for online sellers, depending on how much risk the etailer is willing to take on.
I think this one piece is the biggest boogeyman around these regulations, as the age compliance piece is pretty straightforward for brick and mortars, and is just a bit more costly and more of a pain for the consumers for online sellers, depending on how much risk the etailer is willing to take on.