So what exactly is going to happen?what will happen to the current products that were released before August? Are they like grandfathered in? If say a website has a mod on there now and it's still in Stock past august is it still able to be purchased? I'm just not getting what exactly is going to happen.
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Question about the fda reg's
- Thread starter Trusty_vapor
- Start date
Simplified version here: https://www.dropbox.com/s/85k3f5tqm... Deeming Compliance Calendar - FINAL.pdf?dl=0
Only for two years, until August of 2018.
The way I read the regs, yes.
What will happen in 2018?
If the manufacturer of the "tobacco product" in question hasn't filed a PMTA (something which costs 6 or maybe even 7 figures per product to prepare) that product will no longer be legal to sell.
By that point whatever is on the market will most likely be old anyway I feel. I'm just gonna have to stock up soon I guess!
There's a number of moving parts to the regulations, the grandfather date and the need for pre-market approval. One of the things that people have overlooked is that there's a generous amount of time for companies to either come into compliance or make as much money as they can and then exit the industry. Manufacturer's have 24 months to start the compliance process and then have an additional 36 months to complete the required steps needed to become cGMP. There's also a good chance the FDA will amend the grandfather date if there's enough traction or the regulations will be tied up in lawsuits for a long time. tl;dr: there is still hope!
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Shameless self-promotion: if you're a manufacturer, distributor, or knows someone who falls into those categories, we make a software that will help you come into compliance with these new regulations. Information can be found here.
