FDA Proposed regulation is available

[AgentAnia]

My spin matches (I think) MorpheusPA's. These regulations are far more reasonable than was anticipated (by vaping community).

I absolutely agree! It could have been much much worse.

I do think Dr. Siegel's blog covers the good, bad and ugly quite well. And IMO, the ugly is not a disaster unless you truly think the worse about any / all regulations. SE items are going to be tricky going forward, but I just don't see it as disastrous.

I'm not sure alot of small manufacturers would agree with you...

If all we are prattling on about from this point forward is the challenges and troubles from meeting SE requirements, then I would think this is a very good day for the vaping community. So many here stocked up on items prior to April 2013, anticipating the worst....

What about all the current smokers out there who haven't switched yet? What about current vapers who aren't even aware or up-to-date on what's happening? I have two perspectives on this issue: Mine personally (I'm stocked up. I'm good for years.); and all the people I've just mentioned, to whom I also feel responsibility (They have not stocked up. They're potentially fracked.)

 

[Jman8]

So youre patting yourself on the back for lacking caution and common sense? ALWAYS better to be safe than sorry.

No, tooting my horn for not buying into the false leading rhetoric by vaping zealots that I called out in early 2013.

 

[AgentAnia]

The most amazing line in the whole paper...

Although the public health impact of e-cigarettes is unknown, FDA believes e-cigarettes
that contain nicotine derived from tobacco should be deemed to be tobacco products.....

What an absolutely beautiful non sequitur!

 

[Fulgurant]

Let me tell you a story about the FDA;

In 2009 I bought a kr808-d from a small local shop here in Richmond Virginia for three times what it worth because I didnt want to have to wait to quit smoking. Shortly after that I found ecf and discovered that better options were out there.

Both my wife and myself saw the enormous potential for e-cigs and started our own company Zap Electronic cigarettes. We pooled our collective savings and made our first order then set about getting a website up and running and applying for vendor status.

We decided to sell 901's kits with no cuts offs for 19.99 as well as re-branded ejuice.We had a favorable video review from a reviewer and word started to get out. Business was booming enough that we sold out within a months time and rolled all of our profits into a new order.

We werent getting rich by any means, just growing our business.My wife and I still worked full time and did this because we believed in the product and its ability to help people. The second order from China came through and sold out even faster than the first so we took all of the money again and placed an order for 15k from China. We started with an initial investment of 5k and months of my free time.

That last order from China never made it as the FDA seized it in New York, then destroyed it and sent us a bill to the tune of 800 dollars.

The seizure was later ruled illegal by Judge Leon BUT it was handled on a case-by-case basis instead of class action. Huge companies like N-Joy were able to afford the attorneys fees but many of the smaller companies were not and ended up going under. One vendor I know lost 250k in merchandise.Imagine trying to recover from a loss that huge.For most of us it would be impossible. 15k was enough to crush our hopes and dreams along with all of our hard work.It affected our marriage for awhile as well.

To those thinking the FDA is your friend.THEY ARENT AND NEVER HAVE BEEN. Showing up late for the party is completely understandable but refusing to do your homework and getting your facts straight isnt and neither is condemning those of us who have been around long enough to know better.

If it looks good on paper now expect the FDA to twist it into something unrecognizable to support their irrational war against e-cigs and ensure that only the largest and most well funded companies (ie big tobacco, Njoy, Blu etc) survive.

This should be quoted, in its entirety, on every page of the thread, if not on every page of the forum.

 

[MorpheusPA]

No, tooting my horn for not buying into the false leading rhetoric by vaping zealots that I called out in early 2013.

Plus, when you're proven mostly or completely right, it's hard to argue a lack of "common sense" and "caution."

Normal caution is always called for--it's the reason I look both ways before crossing the street even if I don't hear anything coming. Laser sighting the road and installing seismic detection equipment would lack "common sense" and show a rather overinflated and potentially pathological sense of "caution."

It was wise to stock up on nic concentrate at the time. If they were going to go after anything, it would be that as the stuff is toxic and must be handled correctly if you use the highest concentrations.

 

[Cool_Breeze]

Originally Posted by Cool-breeze

From what I read/ understood I see this as worse case scenario. My logic being if the FDA proposed today to ban all ecigs for example everyone who benefits would be outraged and act. This proposal seems reasonable; prohibiting sales to minors, labeling ingredients and appropriate warnings. Personally I almost think these sound like good ideas as will most people so little to no action will be taken. Then I remember the expression "giving someone an inch and they take a mile" or better said:

"It is seldom that liberty of any kind is lost all at once.

Slavery has so frightful an aspect to men accustomed to freedom that it must steal in upon them by degrees and must disguise itself in a thousand shapes in order to be received."

David Hume [1711-1776]

Can you tell I'm skeptical of government involvement on anything?

I don't think they are stupid enough to outright ban them or severly limit.
We the people need our pacifiers; with all the crap they are trying to pull (govt)

It seems the initial quote above may be errantly attributed to Cool-breeze...

 

[aubergine]

YOU GUYS? You are missing something awfully important I think? Smokey Joe is an old, smart vet and doesn't speak lightly. Not sure, but as I read it this is correct. READ BELOW. A month after the bill passes, um... ?
(Note that the tobacco companies, which produce a limited and highly standardized line of devices and also have the means to get approved quickly, win here also, if it's so. So much for unaffected devices? Have a Blu. Vomit.)

!!Wait.!! According to Dr Siegal (http://tobaccoanalysis.blogspot.com/2014/04/fdas-proposed-electronic-cigarette.html) :

"3. The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products.

This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market."

The provisions become effective 30 days after the bill is passed. Does this mean that all e-cig products manufactured after 2007 have to be approved, item by item, before they are sold?

That would effectively shut everything down.

???

Yes, that's exactly what it means.

You'll note there's some discussion asking for comment on how a streamlined pre-authorization process might be achieved, but there's also some important background here: the FDA has over 4000 applications for substantially equivalent products awaiting their decision. They've managed to process 20.

 

[Bob Chill]

Maybe I don't have *enough* faith, but let's skip to the bottom line: Having to comply w/ proposed FDA regulations will most probably drive many small manufacturers out of business. The same result would obtain if FDA were to include "components" in certain circumstances as tobacco products and small businesses might choose to go out of business rather than incur costs of fighting FDA in court.

Also don't forget that the costs of complying will inevitably be passed on to the consumer by those manufacturers staying in production.

I really don't know where its all going to go. There were some important takeaways from the proposed rule. There appears to be (for now) a separation of hardware and juice with only juice containing nicotine being a covered product.

There was an unusual amount of friendly language saying that ejuice may in fact be treated with a much lighter hand than combustible tobacco products. The FDA actually went out of it's way to show fairness and potential streamlined process for small business owners in the ecig business. This could totally be window dressing because it was a lot of maybes without hard and fast decisions. The door is definitely open for now. Could easily slam shut.

There was specific language that the risk of flavors enticing minors will be addressed solely through age restrictions and warning labels.

I see massive market loopholes as long as unflavored nic can be sold in bottles (seems likely). Mom and pops will sell their flavors. Without nicotine they can sell them all day long and ship them everywhere. It's not hard to mix 2 liquids together and shake.

Another thing is the 2 year window. This industry is going to be massive in 2 years. Just look what happened in the last 2 years. In some ways the FDA lost their chance to "have it all" back in 09. It's too big already and only getting bigger. This is one of the main reasons I think only nic will feel the real hand of regs. Where that goes is yet to be determined but we have 2+ years to watch it unfold.

I do thank the FDA in a weird way. It was my concern of this day that taught me to DIY. Now I have 5-8 years supply beautifully stored in my freezer and I have over 15 mixes I can vape all day. If I wasn't afraid of losing my rights I wouldn't have taken the initiative to get into DIY. Now that I do I don't even have much need for premix anymore. But that doesn't in any way imply that I don't want premix available to everyone and mom and pops to continue making their delicious brews.

 

[Jman8]

These are the details that contain the devil, IMO. The paperwork involved in submitting these applications is formidable, to say nothing of the person-hours involved at the manufacturer's level to prepare *each* application. And remember, *every* different flavor, at *every* different nic level, will be considered a *new product* requiring a separate application. (Unless, of course, FDA comes up with a different, more workable application process...)

ETA: And the question arises as to whether the FDA CTP, which already is buried under a mountainous backlog of Substantial Equivalence applications for existing tobacco products, is planning to add staff resources to process the further avalanche of SE and PMA applications that will result from this new rule.

IMO, this is what we, the vaping community, or perhaps CASAA ought to be addressing as commentary. FDA is virtually begging for comments that help streamline that process. If I were to write on that, willy nilly in my approach, I'd be thinking going in and after submitting my comments that they'd likely get lost in the shuffle and/or not be received with any sense of credibility to take action on.

But in today's high tech world, streamlining the process does seem very doable in my mind, and is something we could assist FDA with, which would greatly benefit us. Or we could ignore the FDA, hope for the best, and trust that they'll get to application review and approval as fast as their bureaucratic methods will allow them to. I'm saying though, we could organize around this item, submit comments that are a collective idea, with several options and then post those publicly so world wide web would see that there are ways to streamline the process.

 

[zapped]

No, tooting my horn for not buying into the false leading rhetoric by vaping zealots that I called out in early 2013.

Little early for that isnt it?

It will be two years before we start to see most of the effects of these regulations and NONE of us know how those are going to play out. We can try to interpret it according to the wording used but the missing component here is intent.

I for one am not naive enough to believe that they have our best interest at heart since the best predictor of future action is past behavior.

 

[MorpheusPA]

YOU GUYS? You are missing something awfully important I think? Smokey Joe is an old, smart vet and doesn't speak lightly. Not sure, but as I read it this is correct. READ BELOW. A month after the bill passes, um... ?
(Note that the tobacco companies, which produce a limited and highly standardized line of devices and also have the means to get approved quickly, win here also, if it's so. So much for unaffected devices? Have a Blu. Vomit.)

Doubtful. This is likely to impact cig-alikes far more than our PVs, actually. With separate units, our batteries are NOT nicotine delivery devices as they can be easily used to vape 0 nic liquids.

Only medical devices fall under the FDA's umbrella, to my knowledge. The FDA just deemed these as tobacco products--and they do not currently require approval of every type of tobacco pipe on the market, nor hookahs.

As mentioned earlier, it's for this reason head shops can legally sell items as long as illegal substances are never mentioned. That interesting device? Jelly bean holder.

 

[ClippinWings]

Just did a follow up with the AP.

The reporter totally understands the SE process, and how it is almost unworkable for ecigs...

He said that he just got off the media call and Non-Nic items are NOT under FDA jurisdiction

That they said they "only have authority to regulate nicotine as a tobacco product"

which he seemed to think, means pre-filled, cig-a-like and liquid are the only things the FDA can regulate here....

Mods, Attys, Tanks, Etc, Etc, Etc don't contain nicotine

 

[Ed Faught]

If I am reading this right, The next 2 years will show the tell tale signs of what will happen with the Industry, the DIY'ers, and all interested parties. Sounds to me like they drug their feet to just drag their feet some more.This also seems like more of a fact finding mission then regulations. I get the legal side of getting laws published, at least I think I do lol. Ok now who is going to tell me I am wrong???? GO!!!! LMAO

 

[2coils]

I don't think there should be ANY celebrating until we have some questions answered. The SE and any type of approval process could be disastrous. Lets not forget the pile of apps already sitting on the FDA's desk. We need to hear more from attorneys. I have yet to see Bill G's thoughts on this as well!!

 

[aubergine]

Doubtful. This is likely to impact cig-alikes far more than our PVs, actually. With separate units, our batteries are NOT nicotine delivery devices as they can be easily used to vape 0 nic liquids.

Only medical devices fall under the FDA's umbrella, to my knowledge. The FDA just deemed these as tobacco products--and they do not currently require approval of every type of tobacco pipe on the market, nor hookahs.

Oh yeah, well, phew on that piece then, if you're right. If you are, though, why is there any legislation at all regarding products manufactured after 2007, which it says will need approval? They surely aren't talking about juice...

 

[ClippinWings]

We need you Bill G!

LOL... seriously... eagerly awaiting Mr Godshall's take on this.

 

[KODIAK (TM)]

That they said they "only have authority to regulate nicotine as a tobacco product"

which he seemed to think, means pre-filled, cig-a-like and liquid are the only things the FDA can regulate here....

Mods, Attys, Tanks, Etc, Etc, Etc don't contain nicotine

Well, isn't that like controlling gun sales by regulating the cartridges they fire?

I really don't know what good my PV will be without nicotine. Yes, I know it's an extreme but when they start fooling with that, it just won't be the same.

Added: And where are we at with extracting nicotine from other sources besides the tobacco plant? The regs are full of that evil "T" word.

 

[Jman8]

I don't know why people have such a problem with home or basement mixers. It doesn't take a brain surgeon to add 2 drops of this, 1 ml of that, some pg and vg plus nic. Seems people think there is a whole lot more involved. If the same sentiment was applied to restaurants there wouldn't be any.

I personally don't have issue with how my juice is made. Perhaps some general concerns, but I'm like Mikey, I'll vape anything.

From FDA / government perspective, the problem as I understand it comes from mass distribution. So, perfectly okay to make your own homemade concoctions of juice and use it personally however you may desire. Maybe share it with close friends and family. But, and this is a huge but, if you want to suddenly become a distributor and establish a (brand) name for your mixed juices, and sell it, hopefully making a profit, then you are no longer peanuts in the scheme of things. Perhaps peanuts compared to huge companies that make juice, but it is plausible you could outsell them, or at very least be a strong competitor in the market. All this is great from us free market people's perspective. Keep that train going indefinitely. Problem comes when something goes wrong with what you put out. Someone gets ill or worse. Then, investigators are going to want to know precisely how your ingredients were mixed, all the materials you use in your production process and can you replicate that promptly. If not, then just easier to shut you down than play the game of eradicating problem, improving the situation. Lab facilities can replicate the situation promptly, and want to play that game, to please investigators first and the public at large foremost.

I don't see home mixing going away anytime soon (likely never). But those who want to play the game of mixing juice for a profit, and just starting out, ought to know that here in 2014, this is now a big business game, and if you really really want to play, you'll have your legal ducks and safety ducks all in a row. If not, then let the chips fall where they may should your operation be subject to local, state and federal investigation.

 

[MorpheusPA]

Oh yeah, well, phew on that piece then, if you're right. If you are, though, why is there any legislation at all regarding products manufactured after 2007, which it says will need approval? They surely aren't talking about juice...

I can't be completely certain, and at this point I don't think anybody can supply a definitive answer--the section is quite poorly written.

I can state that the FDA cannot regulate an item under the regulations that is not used for nicotine inhalation--just as Those Shops sell Those Items to inhale cloves and whatnot. I can't see how they can possibly make any regulations stick on our PVs without facing a legal (and very fast) smackdown.

 

[MorpheusPA]

From FDA / government perspective, the problem as I understand it comes from mass distribution. So, perfectly okay to make your own homemade concoctions of juice and use it personally however you may desire. Maybe share it with close friends and family. But, and this is a huge but, if you want to suddenly become a distributor and establish a (brand) name for your mixed juices, and sell it, hopefully making a profit, then you are no longer peanuts in the scheme of things.

Beautifully said. I DIY for myself and my mom, and like making dinner in my kitchen, the FDA has no involvement as it doesn't fall under their rules.

As soon as my potential to do damage extends past the people who personally know me and ask for my liquid (one), the FDA does have an interest in the public harm aspect. There's no way everybody could know me personally and know my mixing "lab." Laws protecting the consumer are useful in this instance to establish basic sanitation and ingredient usage.