FDA’s Preparations for the September 9 Submission DeadlineThat is one of the Best Things I have ever heard Mitch Zeller say.
BTW - Do you have a Link to the source?
FDA’s Preparations for the September 9 Submission DeadlineThat is one of the Best Things I have ever heard Mitch Zeller say.
BTW - Do you have a Link to the source?
It seems the "on the market" date is still in force for PMTA applications, so those products that came on the market after 8/8/16 don't qualify for PMTA or any extensions, right? Only "substantial equivalence" to approved products at some future date would apply if I recall correctly.
It seems the "on the market" date is still in force for PMTA applications, so those products that came on the market after 8/8/16 don't qualify for PMTA or any extensions, right? Only "substantial equivalence" to approved products at some future date would apply if I recall correctly.
Actually all US products came onto market in 2016. That's when the first US patent for Ruyan was released
Umm... patents protects the owner from others selling clones. And having a patent means nothing to the FDA's PMTA. All the FDA cares about is when it was first marketed and if a PMTA
That is one of the Best Things I have ever heard Mitch Zeller say.
Any product after 8/8/2016 can't be sold period without a prior PMTA approval (which to date, nothing after 8/8/2016 has been). Prior products can be sold today and must submit a PMTA by the 9th.
I mentioned the patent just to indicate that there are no pre2016 products that we can fall back on.
Sure we can. There are lots of pre 8/8/2016 products still being sold. The DNA60 Billet Box is a huge example. Then there are many others things like from Aspire, like Nautilus, Atlantis, Triton, etc. still being sold. Kanger Subtank OCC coils are still common. I am not up on Smok stuff, but I am sure they still sell a few. Same I bet for iJoy, Joyetech, and for many others. Heck Fasttech even still sells the Vamo v2.
Well knowing how much Big Tobacco and the Government hates vaping, I fully expect the FDA will be mailing millions of Refusal to Accept (RTA) letters on Monday, September 10. My understanding is the FDA doesn't have to state the reason for the refusal. Of course there will be lawsuits, but the Government will get the taxpayers to pay for it all anyway. And then drag it out until the e-cig community is bankrupted.
Then we enter into the new post September 10th era.
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Unfortunately, everything I use now is post-2016. I have tons of older gear in my Vapocalypse box, but not in use any more. Not going back to Vision Spinners with T3 clearomizers.![]()
Sure we can. There are lots of pre 8/8/2016 products still being sold. The DNA60 Billet Box is a huge example. Then there are many others things like from Aspire, like Nautilus, Atlantis, Triton, etc. still being sold. Kanger Subtank OCC coils are still common. I am not up on Smok stuff, but I am sure they still sell a few. Same I bet for iJoy, Joyetech, and for many others. Heck Fasttech even still sells the Vamo v2.
You are right. I typed pre2016 when I meant pre2006. There wont be any resurrection of old technology to save us.I'm confused.
Last I checked a few days ago the grandfather date for PMTA is Feb 15, 2007, not Aug 8, 2016. If the 2007 grandfather date has not changed, that means that virtually every product out on the market today, including 510 and 808 cigalikes and eGo batteries and their tanks/cartomizers all need a PMTA to remain on the market. This would even include CE series clearomizers.
Please prove me wrong because if anything on the US market before 8-8-2016 is allowed to be sold without PMTA then that changes the level of doom I would feel about PMTA and deeming.
You are correct. The "grandfather" date is 2/15/07.I'm confused.
Last I checked a few days ago the grandfather date for PMTA is Feb 15, 2007, not Aug 8, 2016. If the 2007 grandfather date has not changed, that means that virtually every product out on the market today, including 510 and 808 cigalikes and eGo batteries and their tanks/cartomizers all need a PMTA to remain on the market. This would even include CE series clearomizers.
Please correct me if this has been updated because if anything on the US market before 8-8-2016 is allowed to be sold without PMTA then that changes the level of doom I would feel about PMTA and deeming.
I'm confused.
Last I checked a few days ago the grandfather date for PMTA is Feb 15, 2007, not Aug 8, 2016. If the 2007 grandfather date has not changed, that means that virtually every product out on the market today, including 510 and 808 cigalikes and eGo batteries and their tanks/cartomizers all need a PMTA to remain on the market. This would even include CE series clearomizers.
Please correct me if this has been updated because if anything on the US market before 8-8-2016 is allowed to be sold without PMTA then that changes the level of doom I would feel about PMTA and deeming.
No, no! The grandfather date of Feb 15, 2007 is very real and is something else completely. Anything prior to this date is exempt from the PMTA completely.
And anything marketed between Feb 15, 2007 through Aug 8, 2016 can still be sold legally and must file a PMTA by Sep 9, 2020. Anything marketed after Aug 8, 2016 can't be sold legally until a PMTA is filed and approved. Which basically means everything marketed after Aug 8, 2016 and sold in the country is illegal. Because nothing has been approved yet except iQOS and snus.