Smoktech has a PMTA page, but doesn't mention any devices specifically.
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PMTAs - who is doing what?
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Fasttech listed the tarot nano months after 8/8/16. I know you can't go by fastech's listing dates as market dates, but it's possible even the Taro Nano kit might not be a pre 8/8/16 product..
I think someone got a little Zero Happy when they wrote Zeller's statement.
That, or they were Vape'n something other than Nicotine.
If I'm thinking correctly, they can file a PMTA application for post 08/08/2016 product(s), but come 09/09/2020 that product would become illegal to sell in the USA. If PMTA is approved then that product would again be able to be sold.
An item where PMTA has been filed and Accepted (basically no obvious defects in the application), I believe, is permitted to continue sales until an Approve/Deny decision is made. (Looking at one of the FDA FAQs for vendors yesterday).
If after review they Approve an application, all is well for that product.
If they get to it earlier than their nominal year timeline, and Deny (rather than Approve), that would stop things, no litre sales. If they are swamped, can't complete in a year, I'd expect them to allow the items whose applications have not yet been adjudicated to be sold until a final decision.
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I think that is correct for Pre 08/08/2016 products but I don't think anything Post 08/08/2016 will be allowed until they receive an Approval letter to be sold. That's my understanding and I could be completely wrong....
"...Tobacco companies and manufacturers have until Sept. 9 to file PMTAs for products included in the 2016 deeming rule, among them vapor products. Any product that does not have PMTA must be removed from the market as of Sept. 10.
Without a listing from the FDA, retailers would have to rely on their suppliers, wholesalers and distributors to inform them which products are no longer available — a concern that drew retailer groups, including NACS, to urge the agency to provide an account of the PMTAs, as Convenience Store News previously reported.
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Once an application is submitted and accepted by the agency, the FDA has a 12-month timeline to review and approve the PMTA...."
FDA Agrees to Release List of PMTA Product Applicants
Without a listing from the FDA, retailers would have to rely on their suppliers, wholesalers and distributors to inform them which products are no longer available — a concern that drew retailer groups, including NACS, to urge the agency to provide an account of the PMTAs, as Convenience Store News previously reported.
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Once an application is submitted and accepted by the agency, the FDA has a 12-month timeline to review and approve the PMTA...."
FDA Agrees to Release List of PMTA Product Applicants
I'm guessing that they included all the various liquids, nic levels, sizes and PG/VG ratios across the industry to come up with that number. It's not as if that number of products will be submitted but it sure makes it sound like they're working hard.
Here's How it Works. Or, at least, was supposed to Work Date-wise.
If your Tobacco Product was sold in a US Market On or Before Feb 15th 2007, it is Grandfathered. Nothing is Needed. Legal to Sell. Feb 15th 2007 is called the "Predicate Date".
If your Tobacco Product was sold in a US Market between Feb 16th 2007 and Aug. 8th 2016, then you were given 2 Years to Prepare/File a PMTA (or a SE or a MRT) for it. And you were Allowed to continue to Sell your Product while the FDA reviewed your application. This 2 Year "Grace Period" was extended by the former FDA Commissionaire. And then later rolled back in Court to what is now be Sept 9th 2020. Products sold between Feb 16th 2007 and Aug. 8th 2016 are referred to as "Existing Products".
If your Tobacco Product was Not Sold in a US Market On or Before Aug. 8th 2016, then it is considered to be a "New Product". And it Can Not Be Sold in a US Market UNTIL you receive a PMTA (or an SE or MRT) from the FDA.
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Where there is much Confusion is the FDA did Not Enforce the requirement for "New Products" that were Released after Aug. 8th 2016. They took a "Look the Other Way" approach.
So Technically, most of what the Average Vaper uses Today wasn't even supposed to have been Legal to Sell. Since Most of what people use Today came into the Market after Aug. 8th, 2016.
But the Long and the Short of it is Now we are about done with the Grace Period. And on Sept 9th your are going to have to have a PMTA (or Se or MRT) on file with the FDA to keep selling your Tobacco Product.
And you can Keep selling your PMTA-ed (or SE-ed or MRT-ed) Product for up to 1 Year. Or until the FDA either Approves your Product (Yah!) or Denies it (then it must be Removed from the Market).
Zeller's statement says "400 million".
FDA’s Preparations for the September 9 Submission Deadline
Good luck.
Zeller's statement wsn't really geared so much as to Us or to Retailers/OEM's. It was Meant more as a message to Congress.
That we at the FDA/CTP are doing Everything we can with what we have. And maybe if we had More Money, we could Do More.
And you should Keep Me around if the Leadership Changes. Because I'm such a Good Guy. And a Team Player.
That number includes all tobacco products, including cigarettes, cigars, and such. Those such products were obviously sold prior to 2006 and are grandfathered in and do not require PMTAs.
I saw it when I posted the Link to it Earlier in this Thread.
Like I said, IMO, someone either Fat Fingered that stat. Or they were on some Bootleg Carts at the time.
That or Maybe they are Counting Individual Cigarettes in a Pack and Individual Cigars in a Box?
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