FDA RJ Reynolds (RAI) files FDA comment asking for its competition to be banned

[JustJulie]

By design, closed-system cartridges cannot be altered or tampered with by consumers. In contrast, there are a growing number of open-system manufacturers—namely, aerosol tank manufacturers (which are typically located in China) and retail "vape shops" in the United States that sell, mix, and compound flavored liquid nicotine solutions that can be used across or within other aerosol tank products. By their very nature, open-system vapor products present a unique
risk for adulteration, tampering, and quality control not exhibited by any other class of tobacco products. Moreover, due to their variability and use with any number of components, it is unclear if or how these products could gain clearance from the Agency, regardless of the pathway prescribed. For this reason, FDA should, in its final rule, ban the sale of open-system e-cigarettes, including all component parts.

Regulations.gov (pp. 2-3 of the comment)

 

[cmknight]

"... ban the sale of open-system e-cigarettes, including all component parts."

Personally, I can't see this happening. Anyone with any modicum of machining skill can make the 'component parts'. What happens when we buy cotton? Will we have to sign waivers at Walmart? Resistance wire ... I guess we'll have to take our toasters in to show that the heating elements are fried. If I buy a Tap & Die set, do I have to prove I'm not using it to make threads for a PV? Will I have to go to court to get permission to buy an 18350 or 19650 battery for my bicycle light? What about PG, VG, and Flavourings? Will a baking license be required? Must I own a restaurant?

 

[readeuler]

Feasible or not, it's really pretty egregious. Camels were my smoke of choice for several years, and I'm glad I jumped ship when I did.

They've mailed me coupons for quite a while, and doubled down on them this last month since I've stopped buying. Try though they might, they won't get another one of my dimes!

I'd rather go without, than buy a Vuze if all of my "open-system" components stop working at an inopportune time.

 

[LaraC]

On pages 18-19
RJR rightly (imho) argues against setting any arbitrarily chosen grandfather date between Feb 2007 and April 2014. But I had to laugh at one of their self serving, whiny reasons below (bold emphasis mine):

4. FDA Should Reject Grandfather Dates Between February 15, 2007 and April
25, 2014.
As explained above, February 15, 2007 would be the most reasonable grandfather date
(provided that FDA establishes adequate pathways formarketing authorization), and April 25,
2014 also would be a reasonable grandfather date. For several reasons, however, FDA should
reject any proposed date between February 15,2007 and April 25, 2014.

Third, and perhaps most importantly, conferring such a competitive advantage on early
entrants would actually be contrary to public health. As discussed above, older e-cigarette
products—even of the closed-system variety — generally present more quality issues than
modern entries. See supra at § I.A.3. Take, for example, the VUSE products created by R.J.
Reynolds Vapor Company. As described below, VUSE products employ a closed system that
prevents accidental access to the nicotine liquid. In addition, VUSE products prevent the use of
copycat e-cigarette cartridges, only allowing VUSE cartridges to work with the VUSE power
unit, thereby preventing tampering or counterfeiting. VUSE products also protect consumers
from using a dry cartridge, which occurs when a product continues to operate even where no
liquid nicotine remains in the reservoir; this is a problem earlier models from other
manufacturers have exhibited. From a public health perspective, therefore, it would make no
sense to accord more favorable treatment to older, lower-quality products simply because they
were marketed earlier than VUSE.[12] Instead, it would perversely reward companies that rushed
inferior products into the market, and would disfavor companies that took the necessary time to
develop high-quality, tamper-resistant products.

All those "inferior products" which were "rushed" to market! haha The very products (particularly tank systems) that successfully grew the electronic cigarette industry to the point that RJR took notice, rushed in belatedly, and came up with a cig-alike that can be used only if you keep buying its proprietary RJR components.

And now they want the FDA to smash all tanks to smithereens.

 

[twgbonehead]

By design, closed-system cartridges cannot be altered or tampered with by consumers.

So we need to be protected from ourselves????

 

[UrKungFuNoGood]

of course we do you dolt! sheesh...

 

[Kent C]

Despite attempts by certain philosophies to alter the nature of man - the uberman, the socially conscience, altruistic man, etc. etc., man (and companies run by men/women) will continue, by their nature, to pursue their own self-interest. Our founders knew this. Madison:

"Ambition must be made to counteract ambition. The interest of the man must be connected with the constitutional rights of the place. It may be a reflection on human nature, that such devices should be necessary to control the abuses of government. But what is government itself, but the greatest of all reflections on human nature? If men were angels, no government would be necessary. If angels were to govern men, neither external nor internal controls on government would be necessary."

'Ambition can counteract ambition' in government, by separation of powers, and checks and balances; and in the economy, by allowing competition in the free market. When government favors one company or product over another (unless a product actually violates a right), it no longer is an "objective referee" upholding the 'rule of law', and it corrupts the concept of "equality before the law", as well as the concepts of fairness, justice, good government and the laws of nature.

 

[Bill Godshall]

Now we know why Reynolds didn't post their FDA deeming regulation comments on the company's website, and why they didn't issue a press release about them.

That's why I urged ECF members (and others) to search for and post Reynolds' FDA comments several weeks ago (as I suspected they'd urge FDA to impose the deeming reg and ban nearly all vaping products that are more effective for smoking cessation than Reynolds' cigalike Vuse).

I'm pleased somebody found Reynolds comments, and that Julie posted them here.

I suspect that British American Tobacco and Philip Morris International (and perhaps Japan Tobacco and/or Swedish Match) submitted similar comments to FDA (as none of those companies' websites have their FDA comments posted or cited).

If someone can find them, please post.

 

[UGADAWGs]

Wow was just linked to this!! This is my post about RJ Reynolds Vapor Company

http://www.e-cigarette-forum.com/forum/general-vaping-discussion/613597-big-tobacco-e-cigs.html#post14360624

 

[Silence]

This is another problem I see...

By their very nature, open-system vapor products present a unique
risk for adulteration, tampering, and quality control not exhibited by any other class of tobacco products.

Correct me if I am wrong but there isn't any tobacco in my tank.

 

[stevegmu]

Nicotine is a tobacco product. For the e-cigarette business, it is exclusively extracted from tobacco. If you are vaping 0 nic juices, then you are not vaping a tobacco product...

 

[DrMA]

Nicotine is a tobacco product. For the e-cigarette business, it is exclusively extracted from tobacco. If you are vaping 0 nic juices, then you are not vaping a tobacco product...

That's incorrect. The current statutory definition of tobacco product in the FSPTCA does not include nicotine per se. That's why patches or gums (NRT) are not tobacco products. The FDA deeming is proposing to expand the definition to include other items such as e-juice, e-cigs, mods and accessories.

 

[stevegmu]

That's incorrect. The current statutory definition of tobacco product in the FSPTCA does not include nicotine per se. That's why patches or gums (NRT) are not tobacco products. The FDA deeming is proposing to expand the definition to include other items such as e-juice, e-cigs, mods and accessories.

I think that is because they are considered medicinal or medical devices, rather than recreational.

 

[dragonpuff]

I think that is because they are considered medicinal or medical devices, rather than recreational.

E-cigarettes are not currently considered a tobacco product nor a medical product in the US - the FDA is currently trying to deem them a tobacco product.

Right now they are not in any regulatory category. The FDA wants to regulate them, but when they attempted in the past to treat them as medical products they were struck down in court. So now the FDA is trying to deem them tobacco products instead.

 

[stevegmu]

E-cigarettes are not currently considered a tobacco product nor a medical product in the US - the FDA is currently trying to deem them a tobacco product.

Right now they are not in any regulatory category. The FDA wants to regulate them, but when they attempted in the past to treat them as medical products they were struck down in court. So now the FDA is trying to deem them tobacco products instead.

I was referring to the patch, gum, etc. Those are considered a medical product, thus not a tobacco product, even though they contain nicotine.

E-liquid with nicotine will be deemed a tobacco product. An electronic cigarette can't be, as it is simply a delivery device...

 

[Jman8]

Correct me if I am wrong but there isn't any tobacco in my tank.

This to me is like if you were vaping {other stuff} and when caught said the law is not applicable because it is not in it's natural/usual form.

At the end of the day it will be up to a court to decide and how you as an individual choose to behave with regard to existing laws/regulations.

 

[zoiDman]

...

Correct me if I am wrong but there isn't any tobacco in my tank.

I guess it gets down to how one Defines what "Tobacco" is.

And in what Context they are using the Word.

 

[DrMA]

This to me is like if you were vaping {other stuff} and when caught said the law is not applicable because it is not in it's natural/usual form.

At the end of the day it will be up to a court to decide and how you as an individual choose to behave with regard to existing laws/regulations.

This is incorrect. {other stuff} is a Schedule I substance both in its plant form (7360), and as the active compound (7370).

 

[Jman8]

This is incorrect. {other stuff} is a Schedule I substance both in its plant form (7360), and as the active compound (7370).

I feel this makes the point I was going for. As post #11 of this thread states the blunt truth, so does your post. But I imagine some users trying to weasel out, thinking they've found a loophole.

Again, I'm up for the courts deciding and I hope they side with us on this issue, but just calling it like I see it.

 

[Oliver]

Nicotine is a tobacco product. For the e-cigarette business, it is exclusively extracted from tobacco. If you are vaping 0 nic juices, then you are not vaping a tobacco product...

I mean, yes - this is true. But it's also a complete nonsense.

The "meta" to this is that the FDA has been trying to regulate all nicotine as a drug since the early 90s. The tobacco act allows this (in a sense) but only if the nicotine is tobacco derived. If it's not tobacco derived, it's outside of the purview, and non-tobacco nicotine is on its way, very, very soon.

I wonder whether the non-tobacco nicotine will be regulated as a supplement? Probably that's the only regulatory option available under current laws.