Njoy response to FDA

[Our House]

Yes--take a look at Nicolite nicotine water--they went though the application and approval process after first getting banned--took a few years to get though the approval process---as a matter of fact they just got approved yesterday.

Interesting. I stand corrected (as of yesterday ).

Nicotine was deemed to be a drug subject to FDA regulations---how the SE and njoy think they are going to get around what Counsel for Nicolite could not is beyond me.

They'd probably just argue that their products are tobacco products -- like they have been since day one of the case.

 

[Sar]

... And of course a comparison to tobacco cigarettes was not and will not be done. These aren't tobacco products in the FDA's eyes. They are drug products, no different that the current NRT products that are FDA approved after rigorous testing and review. Who cares how an e-cig stacks up against a tobacco cigarette if the comparison has no worth; it's apples-to-oranges to regulators. We can stop calling for comparisons. ...

TBob, I don't understand why this would be the case. The FDA would consider other NRT devices only if PVs were derived from their design. Why would it be important for FDA to be comparing PVs to current NRT products? I mean, the PV has to be deemed safe compared to established health hazard criteria and not compared to safety of other NRT products. The PV doesn't need to be safer than other NRT products, it doesn't even need to be better. It just needs to be safe. Sorry, I just don't understand why are the other NRTs relevant.

 

[Sun Vaporer]

Interesting. I stand corrected (as of yesterday ).

They'd probably just argue that their products are tobacco products -- like they have been since day one of the case.

Our House--that is the problem--it did not work for Nicolite water (they even put tobacco shavings in the water)--LOL

So I do not see it flying here with the e-cig.

Sun

 

[eric]

I am legally responsible for the product I sell.

It is intended to be used as an alternative to tobacco cigarettes, not as cessation, and is absolutely a tobacco product.

You all heard it first.

Does that cut it, Sun?

 

[Sun Vaporer]

I am legally responsible for the product I sell.

It is intended to be used as an alternative to tobacco cigarettes, not as cessation, and is absolutely a tobacco product.

You all heard it first.

Does that cut it, Sun?

The reason it does not cut it Eric is because the ultimate end user intent sets the standard of what its indented use will be using an objective standard and it is not a tobacco product----SE and NJOY can argue it till the cows come home, but it has already been litigated and the argument failed in the Nicotine water case---we have the exact same fact pattern here.

Sun

 

[Vapinginmyboots]

@ Vapinginmyboots and others answering him: please don't mix up Ruyan with Ruyan-direct. The companies are different; most-sold liquid by Ruyan-Direct is different. Please keep this clear in posts, else somewhere down the line it is certain to cause misinformation (someone presenting DeKang's liquid-reports as Ruyan's liquid-reports or v.v., for instance; or the Ruyan NZ-studies as Direct-Ruyan studies - if that happens toward an important organisation or media, it can have really bad repercussions for us, we will be accused of lying...)

I didnt really think about it that way, but that does make sense. To clarify, its from Ruyan Direct aka Heavens Gifts. I had no idea Ruyan is a different company, but I shoulda educated myself before asking.

 

[TropicalBob]

Newer members forget the history of Favor, a precursor of our products. The FDA told the company to cease manufacture and marketing in 1987. A copy of the FDA letter is here:

http://www.health.gov.bc.ca/guildford/pdf/059/00006023.pdf

In that letter, just substitute "electronic cigarettes" for "Favor" and you'll see that nothing has changed from a regulatory standpoint.

 

[thewomenfolk]

When you say..."its" from Ruyan Direct aka Heavens Gifts, what does "its" mean? Can someone put Runyan and Runyan Direct into context here. Did one of them make the juice for Njoy? I can't tell from the comments here.

 

[katink]

When you say..."its" from Ruyan Direct aka Heavens Gifts, what does "its" mean? Can someone put Runyan and Runyan Direct into context here. Did one of them make the juice for Njoy? I can't tell from the comments here.

This was about where the liquid was coming from, that these companies sell.
Ruyan is one company. Ruyan-Direct is another (luckily, meanwhile there won't be so much mixing up of those two anymore, because Ruyan-Direct has renamed itself back to an earlier name they used: HeavenGifts).

Ruyan has the original inventor of the e-cig in it's house. They make devices, and either make their own liquid, or have that made by a manufacturer (of which no-one here knows the name, but it's not DeKang). Ruyan also had a lot of testing done, including the new-zealand reports by Dr. Laugeson.

HeavenGifts a.k.a. Ruyan-Direct is a company run by 'Wayne' (sometimes you will see just the name-referal instead of the company's name). Wayne sells a mix of things: some are from Ruyan, and some are from other manufacturers. That goes for the liquid he sells also: he sells original Ruyan-cartridges (so those are filled with original ruyan-liquid) - and he also sells bottles of liquid meant to be used with his non-Ruyan devices - and that liquid (= most of what he sells, and all that he sells in bottles) is made by the manufacturer DeKang.
And to make it all a bit harder to understand: DeKang sells liquids that have gotten the names RY(1 to 4) - clearly refering to the Ruyan name of course - but these liquids are NOT made by Ruyan and are NOT the original Ruyan-liquid: just attempts to copy it I guess, with some variations in taste (hence RY1, RY2, RY3, RY4)...

I hope this is an answer that can answer your questions; and is a bit clearer then mud... sorry if it isn't, it's the best I can do.

 

[thewomenfolk]

katink, thanks for that. I think you did a good job. What I'd like to get at is who makes the juice for the Njoy cartridges and what the recipe is....

Thanks again!