Deeming Regulations have been released!!!!

mikepetro

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But Mike, 2009 aint gonna to get you anywhere with the FDA.

The Predicate Date is February 15, 2007.
I am working my way there, just trying to find documentation to prove it. They existed.

The FDA quotes a 5 May 2008 date for one advertisement, surely the company existed prior to then. I guess the question is "when did they set up shop in Las Vegas".
 

mikepetro

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Anyway, I am done for the night. These guys existed back then, and still exist today. There have got to be digital breadcrumbs to prove it somewhere.

BTW, Ruyan, was around back then too, they have been bought out several times, but they still exist too.
 
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Kent C

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If this Foreign company has No US Presence, I don't believe that selling to US Individuals would be considered Engaged in a US Market. I believe that is considered Exporting from a Foreign Market. And what the Individuals are doing is Buying an Imported Product.

Here's the FDA's pdf on that subject....

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

...and a list of things it would consider valid as 'commercially marketed':

B. Evidence Demonstrating the Grandfathered Status of the tobacco Product


FDA recommends that you provide adequate information to demonstrate that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of
February 15, 2007. As stated in section II.D, we interpret "as of" to mean "on." Accordingly, the information submitted should demonstrate (individually or collectively) that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States on February 15, 2007. If you cannot provide documentation specifically dated on February 15, 2007, FDA suggests you provide documentation of commercial marketing for a reasonable period of time before and after February 15, 2007.


Examples of such information may include, but are not limited to, the following:

  • dated copies of advertisements
  • dated catalog pages
  • dated promotional material
  • dated trade publications
  • dated bills of lading
  • dated freight bills
  • dated waybills
  • dated invoices
  • dated purchase orders
  • dated customer receipts
  • dated manufacturing documents
  • dated distributor or retailer inventory lists
  • any other document you believe demonstrates that the tobacco product was commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007
FDA will consider and evaluate all of the information provided on a case-by-case basis. • • • • • • • • • • • • •
 

mikepetro

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Well, this was taken from the E-Cig.com website in January 2007.
upload_2017-7-27_8-35-59.png


I am sure there is more to be mined as I also know they sold pure nic as well.

There are also e-cigars and other hardware that we wouldnt care about today.

If E-Liq so chose, I am sure they could come up with
  • dated bills of lading
  • dated freight bills
  • dated waybills
  • dated invoices
  • dated purchase orders
  • dated customer receipts
  • dated manufacturing documents

I also found this:
Together with Hon, Dr. Sam Han, chief executive at Cixi E-Cig Technology Inc. Ltd., also undertook research projects with the goal to find new ways to reduce smoking and adopting only a vapor based e-cig, with the minimum intake of nicotine.

This led to four patents in the U.S., together with other two awarded by China. Dr. Han continues his research and development activities related to modern technology.

I am searching for these patents, but so far have come up blank. I would think Cixi E-Cig can produce them if they exist. In any event it would be up to E-Liq to pursue any SE. The only thing they had back then that we would still want is the juice, nothing else would be worth filing a SE over.


 

Eskie

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Maybe I'm mistaken, but isn't it a product sold before whatever, 2007, in the US, not just limited to retail consumers? After all, even today if I buy a Pico on MVS, it's not like Eleaf sold it directly to me. As such, what about all that liquid nicotine sold prior to 2007 to BP to manufacture NRT products? BP didn't go out and set up a tobacco farm and extract the nicotine themselves, they bought the active ingredient from some supplier, so it's been sold way earlier than 2007.
 

zoiDman

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Well, this was taken from the E-Cig.com website in January 2007.
View attachment 674825

I am sure there is more to be mined as I also know they sold pure nic as well.

There are also e-cigars and other hardware that we wouldnt care about today.

If E-Liq so chose, I am sure they could come up with
  • dated bills of lading
  • dated freight bills
  • dated waybills
  • dated invoices
  • dated purchase orders
  • dated customer receipts
  • dated manufacturing documents

I also found this:


I am searching for these patents, but so far have come up blank. I would think Cixi E-Cig can produce them if they exist. In any event it would be up to E-Liq to pursue any SE. The only thing they had back then that we would still want is the juice, nothing else would be worth filing a SE over.


Can you Imagine if E-Cig.com does have an FDA Acceptable Grandfathered e-Liquid?

They would be Immediately Elevated to Dominance in the US Market after August 2018.
 

zoiDman

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Maybe I'm mistaken, but isn't it a product sold before whatever, 2007, in the US, not just limited to retail consumers? After all, even today if I buy a Pico on MVS, it's not like Eleaf sold it directly to me. As such, what about all that liquid nicotine sold prior to 2007 to BP to manufacture NRT products? BP didn't go out and set up a tobacco farm and extract the nicotine themselves, they bought the active ingredient from some supplier, so it's been sold way earlier than 2007.

But as soon as you Make Any Modifications, what you have becomes a "New" Tobacco Product.

As per Kent's Link...


B. What is a new tobacco product?

A new tobacco product is defined in section 910(a)(1) of the FD&C Act 3 as:


(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf
 

mikepetro

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If they were still in business.
They still are, today anyway.
e-liq.com (US website since 2013)
e-cig.com (original China website since 2004)

Both belong to Cixi E-Cig Technology Inc
 
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Eskie

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But as soon as you Make Any Modifications, what you have becomes a "New" Tobacco Product.

As per Kent's Link...


B. What is a new tobacco product?

A new tobacco product is defined in section 910(a)(1) of the FD&C Act 3 as:


(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

But as long as it's not modified, I can keep buying it? I mean, yes, it still sucks for the 97% of vapers unprepared to mix their own juice and build stuff themselves, but for the other 3% of us, the spigot will remain on. In light of the whole justification for the regulations to save the children and protect others from seeing a wisp of vapor out of someone's mouth, they sure have that loophole in place. We'll still have to wait and see if they catch it.

Given the allowance that all those brands of cigarettes sold before 2007 were allowed to stay on the market in the first place, why not pre 2007 nicotine solution as well? Can't be any worse for public health.
 

zoiDman

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...

Given the allowance that all those brands of cigarettes sold before 2007 were allowed to stay on the market in the first place, why not pre 2007 nicotine solution as well? Can't be any worse for public health.

In a Sensible World with a Reasonable FDA who believes in THR, I'm not sure why they wouldn't? I'm just Not sure we live that world? If the FDA Grandfathers a Flavored e-Liquid(s) or Grandfathers an Unflavored e-Liquid(s), that would be Huge.

100mg/ml (probably 50mg/ml+) Nicotine Base(s) I Don't think would have a chance. Because I believe the FDA/Courts would say that it was Not Meant for Human Consumption.

But a 50mg/ml or less Unflavored would for the Most Part preserve the e-Liquid Market.

Only a Small Percentage of Vapers do DIY right now. But come August 2018, when Almost Every Flavored e-Liquid is going to Fall Off the Edge of the Cliff, those Non-DIY vapers might have enough motivation to learn.

IF an Unflavored is Grandfathered.
 

Eskie

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100mg/ml (probably 50mg/ml+) Nicotine Base(s) I Don't think would have a chance. Because I believe the FDA/Courts would say that it was Not Meant for Human Consumption.

But if 100 mg/ml was on the market prior to 2007, regardless of fit or not fit for human consumption, that would have to be allowed to stay on the market. They would have to somehow reclassify it in a manner that prevents sales to retail customers, but under the deeming regs I'm not sure they can do it. Then of course they could come up with some other method to restrict access.
 

zoiDman

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Funny how the FDA requires no modification yet they required the tobacco industry to modify cigarettes to be 'fire safe' which in turn created a more toxic product. :blink: :grr:

And if those Flame ......ants are found to be Toxic (which they probably were Known to be so Already) they Can't be Removed because that would make the Cigarette a "New" Tobacco Product. And you would Lose the Grandfathered Status.

:facepalm:
 

Rickb119

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Funny how the FDA requires no modification yet they required the tobacco industry to modify cigarettes to be 'fire safe' which in turn created a more toxic product. :blink: :grr:
Which in turn feeds BP, which in turn feeds the FDA.

It's a mutually parasitic relationship, with the consumer being the host.

Other terms come to mind, but they're not allowed here. :blush:
 

zoiDman

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But if 100 mg/ml was on the market prior to 2007, regardless of fit or not fit for human consumption, that would have to be allowed to stay on the market. They would have to somehow reclassify it in a manner that prevents sales to retail customers, but under the deeming regs I'm not sure they can do it. Then of course they could come up with some other method to restrict access.

I'm Not sure the FDA needs to.

Because if Nicotine is Not Used for Human Consumption as a "Tobacco Product", then I believe that Courts would agree that it is a Drug.

That's kinda the Road we went down in the NJOY Lawsuit circa 2010.
 
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