FDA TVECA post table of contents for Deeming Final Rule

[squee]

Wait a sec... What???? How did I miss that?

So Kangertech, njoy, joyetech and all the big e-cig and e-juice makers don't have to submit PMTAs??????? The only ones who actually have the resources to do so are exempt? And mom and pop stores are going to do R&D for them and submit PMTAs?

Geez.................

No, no, no. What this means is that for someone like nJoy - they don't have their own manufacturing plant. They contract with a factory to produce their product. That factory, i.e. the manufacturer, is not who will have to submit the PMTA. nJoy, who is the actual "seller" of that product, will.

Like if this were about cell phones. The PMTA for the iphone would not be submitted by FoxConn, it would be done by Apple.

 

[zoiDman]

Many of those in the know have resisted coming to that conclusion.
But it is becoming clearer by the day.

I Haven't. And have seen this Coming for a Long Time.

But was Repeatedly called a "Fear Moger" every time I would Bring it Up. So I just Gave Up Bring it Up.

 

[roxynoodle]

Yes, I was called an idiot yesterday for suggesting people have more than one atty. And told I should have my ECF title taken away, lol! Which is due to my gabby nature rather than any other reason, but whatever. I'll be happily vaping into the future while that guy will be staring at his broken atty or mod.

 

[skoony]

No, no, no. What this means is that for someone like nJoy - they don't have their own manufacturing plant. They contract with a factory to produce their product. That factory, i.e. the manufacturer, is not who will have to submit the PMTA. nJoy, who is the actual "seller" of that product, will.

Like if this were about cell phones. The PMTA for the iphone would not be submitted by FoxConn, it would be done by Apple.

Do you have a different definition of the words wholesaler and retailer?

I Haven't. And have seen this Coming for a Long Time.

But was Repeatedly called a "Fear Moger" every time I would Bring it Up. So I just Gave Up Bring it Up.

You should of heard what they said about me
Regards
Mike

 

[Lessifer]

"Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA." exert from : The Rest of the Story: Tobacco News Analysis and Commentary: FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

???!!!!,what in the is this?
If this was concerning cigarettes it would mean the tobacco company's were exempt and the local
gas station would have to do the filing.
I am understanding this wrong am I not?
I couldn't read anymore.
Regards
Mike

That can't be right... We must be missing something.

Please somebody tell me we're missing something. Please....

That's not how I read it, though I could be wrong of course.

I read that as something that is not intended to be sold directly to a consumer, like nic base(if you don't count DIY) doesn't need a PMTA, but something like a finished product(e-liquid) does. It would be up to the manufacturer of the product, who in this case is actually someone mixing together pre-made products, who would have to submit the PMTA even if they don't sell directly to consumers themselves.

So in the case of atomizers, Youde submits a PMTA for the IGO-Z12 with replaceable heads, but temco doesn't need to submit one for their industrial wire.

 

[roxynoodle]

Yeah, and he's banking it all on a Chinese atty that has no spare parts availability. Well, I did go so far as writing the manufacturer to obtain the specialized o rings for the glass tank for mine, but I can guarantee you he didn't. And I'm not inclined to share with someone who is questioning my IQ.

 

[Katya]

Yes, I was called an idiot yesterday for suggesting people have more than one atty. And told I should have my ECF title taken away, lol!

Seriously? I'm so sorry, Roxy...

 

[skoony]

That's not how I read it, though I could be wrong of course.

I read that as something that is not intended to be sold directly to a consumer, like nic base(if you don't count DIY) doesn't need a PMTA, but something like a finished product(e-liquid) does. It would be up to the manufacturer of the product, who in this case is actually someone mixing together pre-made products, who would have to submit the PMTA even if they don't sell directly to consumers themselves.

So in the case of atomizers, Youde submits a PMTA for the IGO-Z12 with replaceable heads, but temco doesn't need to resubmit one for their industrial wire.

Retailers generally do not assemble the products they sell on site. E-juice may be an
exemption but is not the rule.
Regards
Mike

 

[zoiDman]

Retailers generally do not assemble the products they sell on site. E-juice may be an
exemption but is not the rule.
Regards
Mike

But this is what is So Unique about the e-Liquid Market. And where that 99% Thing comes into play. Because Most of the B&M Shops/Online Retailers make their Profits from the e-Liquids that the Make and then Sell.

Sure, they make a Little off selling Someone Else's product. But the Margins are So Small, without the "House Brand" e-Liquids, they Can't Make It.

 

[Katya]

but temco doesn't need to submit one for their industrial wire.

Why the hell not? They should all be submitting their PTMAs. Temco, Sally's, Joan's, and all those shady cotton balls dealers. Every single one of them. Do you know what's in those cotton balls? Do you?

And don't forget to include

• Consumer perception studies are highly recommended;
• Studies of the potential use of the product by nonsmokers (including youth) and existing smokers is highly recommended. Such studies must be related to the product itself or a similar product. Thus, an open-system vaping device could not submit information on the results of a study involving a first-generation cig-a-like product, and vice versa; and
• Puff topography studies should be included in the application.

What exactly are consumer perception studies, if I may ask????? Puff topography?

Poor Orwell, he didn't have a clue....

 

[skoony]

But this is what is So Unique about the e-Liquid Market. And where that 99% Thing comes into play. Because Most of the B&M Shops/Online Retailers make their Profits from the e-Liquids that the Make and then Sell.

Sure, they make a Little off selling Someone Else's product. But the Margins are So Small, without the "House Brand" e-Liquids, they Can't Make It.

By no stretch of the imagination are all B&M' s making there own juice.
Very many are having their juice out sourced.
Regards
Mike

 

[Katya]

And speaking of Orwell:

• Studies of the potential use of the product by nonsmokers (including youth) and existing smokers is highly recommended.

However,

• E-cigarette companies and businesses will not be allowed to market these products for smoking cessation; and
• Therefore, no smoking cessation claims will be allowed for any of these products.

 

[2coils]

As for the ANTI orgs meeting with the OMB......What could they possibly say???? The FDA gave the ANTI's everything they wanted, what could they possibly have to say to OMB??? Victory Lap Maybe?
EO 12866 Meetings Search Results

 

[zoiDman]

By no stretch of the imagination are all B&M' s making there own juice.
Very many are having their juice out sourced.
Regards
Mike

If I understand what you are referring to when you use the words "Out Sourced", it really Doesn't Matter. They would still need to submit a PMTA if they want to sell them to an End User.

 

[Katya]

As for the ANTI orgs meeting with the OMB......What could they possibly say???? The FDA gave the ANTI's everything they wanted, what could they possibly have to say to OMB??? Victory Lap Maybe?

Having a celebratory cigar, perhaps? And a dry martini.

 

[haleysdadda]

Why the hell not? They should all be submitting their PTMAs. Temco, Sally's, Joan's, and all those shady cotton balls dealers. Every single one of them. Do you know what's in those cotton balls? Do you?

And don't forget to include

• Consumer perception studies are highly recommended;
• Studies of the potential use of the product by nonsmokers (including youth) and existing smokers is highly recommended. Such studies must be related to the product itself or a similar product. Thus, an open-system vaping device could not submit information on the results of a study involving a first-generation cig-a-like product, and vice versa; and
• Puff topography studies should be included in the application.

What exactly are consumer perception studies, if I may ask????? Puff topography?

Poor Orwell, he didn't have a clue....

All that jibberish is exactly why this whole country is in the mess that it's in!!!!!LOL!

 

[Lessifer]

What exactly are consumer perception studies, if I may ask????? Puff topography?

I believe consumer perception studies would be the ones where they have to prove that this product doesn't make people more likely to start vaping, or less likely to quit smoking/vaping altogether, or to believe that this product is less harmful than smoking.

Puff topography is the way in which a device would be used, like a deep lung inhale from 1-10 seconds that results in lung penetration of the aerosol down to x level, etc.

 

[Katya]

I believe consumer perception studies would be the ones where they have to prove that this product doesn't make people more likely to start vaping, or less likely to quit smoking/vaping altogether, or to believe that this product is less harmful than smoking.

Puff topography is the way in which a device would be used, like a deep lung inhale from 1-10 seconds that results in lung penetration of the aerosol down to x level, etc.

I get that, Les. But how is a B&M owner going to conduct "perception studies"?????

 

[zoiDman]

I get that, Les. But how is a B&M owner going to conduct "perception studies"?????

They would Contract a Firm to Conduct one for them.

 

[Lessifer]

I get that, Les. But how is a B&M owner going to conduct "perception studies"?????

What makes you think they actually WANT them to? That's the point, that's why this leads to decimation.

It's not just about the cost of doing these things, it's about having the ability to do them. The tobacco companies have been doing PMTA for a long time, they have specialists on staff. Your local B&M, or your favorite online vendor, or mod maker, is totally outmatched.