FDA Deeming regulations are published

Just a thought if we stick to one thing a safer alternative to smoking the fact that many of us smoke for many years .and now it works for us I hate to say it but my own town.I gave some one a little I stike and a kanger pro tank to try and help him get off the cigs stopped in a new local vape shop to try some juice had one tobacco flavor but my friend liked it the max nic they had was 6 I said you got to be kidding me nope most of are juice is o nic now I will most likely never go back .and I am so glade the first few B&M I went to were nothing like that

This Sucks so bad!!! Lots of questions to be answered. So a vape shop making juice has to stop immediately or do they have the 2 year window plus 1 year after they have submitted the paperwork? So confusing, It says that the warning and age information is going to take place in 90 days but when will small mom and pop vendors have to stop making juice?

Signed it thanks !
Since reading this I have blown up every site I could. I am enrolled with CASAA as well.

Even my gear would be considered new for 2007 not that I’m hating on my mini p3 and mini kanger’s and mini nautilus :heart:

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Effective date for the FDA rules is August 8, 2016. There will be no Vape Shops, Juice companies in operation. None have the money to get juice approved AND equipment to use it in approved. Only the Tobacco companies and Pharma Companies have that kinda money. They just assume our kinda equipment go away anyway. They want us to use the crappy cig-a-likes…

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So if I understand this correctly, it will also mean that any hardware (coils, tanks mods etc) made after 2007 will not be available for sale or export to the US by anyone without the millions to pay off the FDA? .

That’s what it sounds like. Guess we are all sitting on pins and needles waiting for clarification…

In 2 years plus 30 days from August 8th (or 10th, I’ve heard that date too), the vaping products we see on the market now will very likely be 1) not available at all, or 2) extremely limited choices available for APV hardware and e-liquid manufactured by companies who have the wherewithal and resources to file PMTA for EVERY product they wish to keep on the market, or 3) BIG Tobacco’s cigalikes, such as the Vuse, Blu, and similar (*lame, IMHO) devices being the only alternatives available, other than patches or gums, or 4) (which is what the FDA is REALLY after) MANY peoiple turning back to analog cigarettes and traditional tobacco products.

Don’t kid yourselves, folks. This has nothing to do with “public health” under the guise of it being all about keeping youth from smoking or vaping. This is all about tax revenue and money. Yesterday, the FDA single-handedly murdered an industry (in this country anyway) which really showed promise, and was having a more positive impact on public health than ANYTHING the FDA could accomplish. Fecking Dumb Asses, indeed.

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On the other hand, the deeming regulations don’t apply to food grade flavorings, propylene glycol, or vegetable glycerin, and I’m assuming we’ll still be able to get nicotine (or?), so I would assume those of us who DIY are in a better place than those who rely on commercial juice. Correct me if I’m wrong. I do think I should probably stock up on batteries, tanks, and coil heads, though.

Without getting too deep into bi-partisan politics; it should be stated that the Commissioner of the FDA is appointed by the seated President. This begs the question… WHO is voting Democrat in November? Just saying…

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Mark, read the fine print more closely. The way the deeming regulations are written, any product that can be considered a part or component of APV hardware AND e-liquid is considered a “tobacco product” by the Fecking Dumb Asses. The regulation will surely have an effect on the availability of nicotine solution. Flavors, PG and VG, maybe not so much, as they have widely varying uses such as cosmetics, foods, aromatherapy, etc.

True, though, that the DIY’ers will be in better shape. than the general community at large.

Not I. Too bad there’s not a viable libertarian choice.

I have a brand new freezer and some disposable income. If the nic providers can keep going for a while, I’ll be in good shape for years.

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Nic providers should be able to operate for a while still, I think. I’ll be interested in what CASAA’s legal team’s analysis has to say about that.

My new hobby this summer may be learning how to DIY NET nicotine.

@ringling:

You say nicotine solution is an FDA-approved product. I’ve never heard that. Can you cite something for us which shows us this is true, or a link to the vendor who offers such a product? I would be very grateful for the enlightenment.

@ZeroedIn - It seems to me that the regulations wouldn’t be problematic for nicotine solution specifically, since how many different formulations of it do we really need? The problem comes when a new application is required for each new formulation of commercial e-juice (add another flavor, and it’s a whole new application process). They could move to make nicotine illegal, but that wouldn’t make much sense in light of the fact that the FDA already approves of over-the-counter sale of nicotine patches, gum, etc. I understand, of course, that the FDA does a pretty poor job of displaying logic.

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Most of the anit-vaping idiots in Washington belong to the party of Big Government. I’ll never support that IDEAL.

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I can’t point to any specific info however nicotine is in every cigarette on the market and cigarettes are a FDA approved product. Don’t forget the nicotine patch, gums, chewing tobacco, etc. Need I say more…

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@ringling - exactly. It’s not about whether nicotine is FDA approved, because it is. The issue is with individual products having to go through the approval process. Cigarettes are perfectly legal, but change the formulation of a cigarette and that requires a whole new application process. This is the issue that’s going to affect vaping. Small companies can’t afford to spend a million dollars for FDA approval every time they come up with a new product . . . AND it’s retroactive. If an e-juice manufacturer has 20 different juices in their line-up, that’s 20 million dollars for FDA approval. If any vaper doesn’t currently DIY, I suggest they learn. Let’s see the FDA try to outlaw PG and VG - no more mouthwash or toothpaste for you!

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@MarkM - The regulations, as I understand what I’ve read, but I’m no legal expert, mind you, state that a nicotine solution would be in-scope. The regulations even state that 0-nic juice (i.e. straight PG and VG), if intended to be used in an ENDS, would fall in the scope of the deeming regulations. This, of course, is an abusive over-reach of authoritarian tyranny; as is most of it really, IMHO.

Consider this: A manufacturer of nicotine solutions offers both PG-based, and VG-based solutions, at concentrations of 12, 24, 48, and 100 mg/ml (which most current vendors offer). That is a total of 8 different solutions. The talk on the street is that a PMTA application to the FDA for these products could cost $300K - $1M PER APPLICATION. Since the solutions have differing amounts of ingredients (i.e. nicotine), each strength solution requires a separate application. Doing the math, the manufacturer would have to fork over to the Fecking Dumb Asses somewhere between $2.4 - $8M for processing the PMTA applications - and the manufacturer has NO GUARANTEE that the Fecking Dumb Asses will approve the product for market in the US.

How many manufacturers do you think there are that have the resources to throw $8M at the Fecking Dumb Asses, and still may not be able to market their product? So, how available do you think nic solution will be in a couple of years? Do you see where this is going?

@ringling: Yes, because cigarettes contain nicotine because tobacco naturally contains nicotine, as does eggplant, and tomatoes, and other flora.

Also, just because there are other FDA approved nicotine products, such as patches and gums, it does not necessarily mean that the FDA will be approving or has approved a liquid nicotine solution.

Last I checked, one cannot vape a cigarette, a patch, or a piece of Nicorette. If you can point me to some information which states that a liquid nicotine solution is an FDA-approved product, I would like to see that. Otherwise, I’m going to go about my business preparing for what’s coming. I see a light at the end of the tunnel, and I think its a train, if you get my drift.

Go ahead and prepare, you would be a fool not to. The way it’s sounding now is any part of the juice, any part for a piece of equipment, anything used for the purpose of vaping is covered. Won’t matter even if it is FDA approved…

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