Deeming Regulations have been released!!!!

Mazinny

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Post them on their European site if not otherwise restricted by the TPD. Just because a US user chooses to visit a site hosted in Italy does not imply the FDA has jurisdictional reach regarding that site or those claims. If any vendor in the US chooses to publish those results in connection with FA products, that could trigger a response. Still, there's nothing I can recall in the deeming regs (like I could possibly remember all that :censored:), but posting a test result WITHOUT any additional statements like "See? It's really safe!" might very well be allowed as it is simply an objective third party certificate of analysis up to the end user to interpret. It might very well not run afoul of the regs. however, not sure I'd want to be the test case for that.
Yeah, that's the bottom line, isn't it ? No one really knows how all this will work out. Mr. eliquid went on the advice of their lawyers it seems. Other vendors still have their test results up.
 

Eskie

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Yeah, that's the bottom line, isn't it ? No one really knows how all this will work out. Mr. eliquid went on the advice of their lawyers it seems. Other vendors still have their test results up.

Which is just another indication of how poorly thought out these regs are. They are so vague, nonspecific, and open to interpretation that compliance will very well be impossible. I can't blame their lawyers counseling them to take the C of A down, but that is a very conservative opinion which might be unnecessary. But who wants to be the test subject?
 

Rossum

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One consequence of the Deeming I hadn't thought of is whether posting test results or even saying your eliquid doesn't contain diketones would be considered a modified risk claim. Picked this up from the diketone free tested vendor thread.

mel-png.586197

https://cdn2.bigcommerce.com/server...loaded_images/testresults-1-.png?t=1468341322

Now how about that for irony, FDA just took away consumers ability to make what they feel are safer choices unless someone besides a vendor does independent lab testing and publishes the results. The voluntary testing and publishing by vendors was driven by a free market and consumers and (at least in this vendors eyes) the FDA has just created what might well be a less safe market by regulating it.
Test results are not a claim. They are just data.

Too many people in this industry are folding without putting up any kind of fight at all.
 

kbeam418

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Flavourart is an Italian company. Their vape line is all diketone free. They aren't allowed to publish their test results !? How would that work ? Keep test results up for their European customers and stop selling to U.S. vendors, or remove test results, so Europeans don't have access to them either ?

One word; VPN. I'll use a VPN to view those sites. Then the government will ban the use of VPN.
 

eww245

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It's finally here thank god the children are safe! I officially use a tobacco product today and should probably start saying I smoke because if I say vape then I might be implying that it's MRTP. Right now I am using an END that has 21 parts so I'd better pay at least 6. 3 million if I expect it to stay on the market, and more if I want to use E-Liquid.

Does anyone think the FDA will knock on my door today and request to see my basement tobacco manufacturing facility? It probably won't pass inspection, though it might if they found some rat droppings.
 

skoony

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Flavourart is an Italian company. Their vape line is all diketone free. They aren't allowed to publish their test results !? How would that work ? Keep test results up for their European customers and stop selling to U.S. vendors, or remove test results, so Europeans don't have access to them either ?

@Mazinny This raises a very interesting scenario.
I am certain Flavourarts can pretty much publish anything on their web
site they want. On the other hand any US based e-liquid manufacturer
would be prohibited from saying our juice is diketone free as it is
a modified risk claim. I wouldn't be surprised if even a statement such
as "We exclusively use only Flavourart flavors in our products" Would
be claimed by the FDA as a modified risk statement under the new intended
use definition.

We will be finding out real soon what the FDA's boots on the ground will
be up to shortly. Things may start to get very interesting.
:2c:
Regards
Mike
 

Kent C

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@Mazinny This raises a very interesting scenario.
I am certain Flavourarts can pretty much publish anything on their web
site they want. On the other hand any US based e-liquid manufacturer
would be prohibited from saying our juice is diketone free as it is
a modified risk claim. I wouldn't be surprised if even a statement such
as "We exclusively use only Flavourart flavors in our products" Would
be claimed by the FDA as a modified risk statement under the new intended
use definition.

We will be finding out real soon what the FDA's boots on the ground will
be up to shortly. Things may start to get very interesting.
:2c:
Regards
Mike

For one, and I've pointed this out before, FA full line is not diketone free. See the FA FAQ regarding that and the listings it has for flavor ingredients - esp. Yogurt flavor. So any reference to FA by a US vendor would be disingenuous anyway.
 

subwayaznm

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We will be finding out real soon what the FDA's boots on the ground will
be up to shortly. Things may start to get very interesting.

Well if it's anything like the US Food Inspectors or Cosmetology Inspectors, or Barber Inspectors; the chances of too many seeing those Boots are slim.:):thumbs: Your food isn't but about 25% at best being Inspected and most often it's by the Company themselves.
Cosmos and Barbers even less; for the entire state of AZ they had two Barber Inspectors. You have to have out in writing/law so when those few complain there will be grounds for those powers/FDA to stand on. And hopefully the topic will Police itself.:lol:

And I will venture to say that the aspect of this entire thing that we will see or hear about the most. Is the effect on Minors; Sale, possession of under the age. Convince Stores, Vape Shops checked to make sure they're not selling to Minors.
 

Mazinny

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For one, and I've pointed this out before, FA full line is not diketone free. See the FA FAQ regarding that and the listings it has for flavor ingredients - esp. Yogurt flavor. So any reference to FA by a US vendor would be disingenuous anyway.
I thought their " vape " line is all diketone free ( even yoghurt has been reformulated according to the Flavourart UK site) . Their " Kitchen Magic " line is not diketone free, i know.

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Mazinny

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@Mazinny This raises a very interesting scenario.
I am certain Flavourarts can pretty much publish anything on their web
site they want. On the other hand any US based e-liquid manufacturer
would be prohibited from saying our juice is diketone free as it is
a modified risk claim. I wouldn't be surprised if even a statement such
as "We exclusively use only Flavourart flavors in our products" Would
be claimed by the FDA as a modified risk statement under the new intended
use definition.

We will be finding out real soon what the FDA's boots on the ground will
be up to shortly. Things may start to get very interesting.
:2c:
Regards
Mike
If that's the case, as of today there are many vendors making " modified risk " claims. I am not aware of any vendor taking down their test results besides Mr. E liquid. We will see i suppose.
 

bigdancehawk

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One consequence of the Deeming I hadn't thought of is whether posting test results or even saying your eliquid doesn't contain diketones would be considered a modified risk claim. Picked this up from the diketone free tested vendor thread.

mel-png.586197

https://cdn2.bigcommerce.com/server...loaded_images/testresults-1-.png?t=1468341322

Now how about that for irony, FDA just took away consumers ability to make what they feel are safer choices unless someone besides a vendor does independent lab testing and publishes the results. The voluntary testing and publishing by vendors was driven by a free market and consumers and (at least in this vendors eyes) the FDA has just created what might well be a less safe market by regulating it.
If the FDA went after a manufacturer for simply posting an independent chemical analysis, that would make a good First Amendment test case. But I'm guessing the FDA won't do that. They'll have their hands full trying to stop KangerTech, etc., from sending us a newly designed tank or mod every week or so, raiding thousands of vape shops to catch kids in mixing rooms adding more banana flavoring than they did before, and monitoring mom and pop drip tip makers to make sure that every drip tip is identical to one they made previously.
ETA: As a taxpayer, it's a great comfort knowing that our fine federal government has ample financial and human resources to devote to this vital work.
 
Last edited:

jmur

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Well if it's anything like the US Food Inspectors or Cosmetology Inspectors, or Barber Inspectors; the chances of too many seeing those Boots are slim.:):thumbs:

IDK. But I'm sure time will tell. My thoughts though, are in the case of Cosmetologists or barbers that they are not a direct threat to a highly profitable, highly monopolized and deeply entrenched industry. To the powers that be there's just not much of a monetary incentive to shut down individual barbers...
 

grandmato5

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Anyone else watching the FDA slowly update their web pages (yesterday and today) dealing with the newly deemed tobacco products ? Small tweaks, nothing earthshaking, just interesting to me to watch. Still haven't updated all of them.

You can tell by looking at the updated date on the bottom left of the pages.
 

Bob Chill

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Something I find pretty comical is how hard the FDA and ANTZ tried since 2009 to find the real "smoking gun" to seal the deal against vaping. They couldn't do it. Nobody could find anything bad enough to pull it from the shelves like what happens to drugs, food, and other products that are found to be dangerous.

7 years and nothing concrete. Plenty of time, energy, and money was spent searching. Every time they thought they had something it ended up being scientifically unsound or inconclusive. They did a good job spinning things of course. But that type of effort can't get things off the shelves.

In the end all they could do was smear campaign and release 499 pages of something that doesn't even make logical sense. Instead of proof ecigs are dangerous (which was tried and failed by our government and health agencies) we're now stuck with proof they're safe but the FDA or health agencies won't help there. Nope, not a chance. It's up to the manufacturer and the impossible process of doing so.

The obvious but very real irony here that everybody knows that smoking is a significant bane on the health of America and the world. But not one single US governmental agency wants to even entertain the idea of actually assisting in determining the actual benefits vaping. Not one single health org either. All they've done is dig under rocks trying to find bad stuff and skew the #s.

We've rehashed this same stuff for years here on ECF. But I still have a hard time wrapping my head around it sometimes. Yes, follow the money and all that but still you would think that we would have had at least an ounce of concession in the deeming regs. We didn't even get that. We just got a giant lead anvil dropped on our heads.

What if the alcohol manufacturers developed beer, wine, and liquor that was 95% less toxic to the human body? Would they be stonewalled too? I highly doubt it. That would most likely be embraced across the board.
 

Bob Chill

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Anyone else watching the FDA slowly update their web pages (yesterday and today) dealing with the newly deemed tobacco products ? Small tweaks, nothing earthshaking, just interesting to me to watch. Still haven't updated all of them.

You can tell by looking at the updated date on the bottom left of the pages.

This banner makes me laugh. Grounded in science? Really? It should say "completely ignored science".

ucm434958.png
 

grandmato5

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Anyone else watching the FDA slowly update their web pages (yesterday and today) dealing with the newly deemed tobacco products ? Small tweaks, nothing earthshaking, just interesting to me to watch. Still haven't updated all of them.

You can tell by looking at the updated date on the bottom left of the pages.

I've already found one statement on an updated page that contradicts what's in their own compliance charts on their website. :facepalm: They say that being an importer makes you a manufacturer BUT what they conveniently leave out on the updated page is that an importer is only a manufacturer IF the importer changes packaging or otherwise changes the container, wrappers or labeling.
 

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