The final countdown to August 8th - your FDA comments NEEDED

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Surf Monkey

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We also had to counter the allegation that e-cigarettes don't help people quit smoking. Each one of the personal stories that I read stated that the author quit smoking because of e-cigarettes--even when all other methods failed. They can't ignore that fact or write that off. I believe it's facts like that that helps to counter the pediatricians' statements, who don't have science or facts on the efficacy of e-cigarettes on their side.

Yeah, I hit that too. I quit smoking the very day I bought my first PV and since then my PCP has told me that he considers me a non-smoker now, fully supports my PV use and considers it a positive boon to my overall health.
 

zoiDman

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... which was also an element of my commentary. That there is a vibrant DOMESTIC market of manufacturers building and distributing popular mods that savvy vapers use when they "graduate" from the low quality, un-satisfying corporate BT products and that killing that burgeoning industry will effectively drive many thousands of vapers back to cigarettes, effectively delivering them a death sentence while also delivering an economic death sentence to a sector that is growing in a damaged economy that needs growth.

If the Only way to Achieve the Goals of Product Standards/Purity or Restriction of Under Age e-Cigarette use was turn e-Cigarettes/e-Liquids over to BT, then So Be it. Because e-Cigarettes Need to Exist.

But this Far From the Case.

Small and Mid-Sized Companies can Comply with FDA Regulations. Yes, some will be Forced out of the Market. But if a e-liquid Company can Not Comply with Regulations aligned with the Food Industry, then they should Go Anyway.

What the Abuse that I see as a Distinct Possibility is that the Regulations are be Drafted to put the Financial Bar to High for all but BT and BB.

If Benzaldehyde is shown to be GRAS at a Certain Concentration in an e-liquid, then Anyone should be Able to use this Chemical as a Flavoring in an e-Liquid. The Concept of Every Vendor must get Approval for Every Flavor is Flawed. And I see it as a Monetary Lever to drive all but BT and BB out of the Market.

And it fits in Well with the Fear Campaign of Many Chest Pumping Senators about "Saving the Children" thru Flavor Illumination.

Let's Let Science Decide what is GRAS to use in an e-Liquid. And stop Using e-Cigarettes as a Pawn to BT, Taxes and Fear Based Agendas.
 

zoiDman

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There is also an International trade issue here and I wish I was privy to the crowd noise going on there.
I wonder what manufacturers such as Innokin, Joyetech,Sigelei, KSD and the like are doing to insure that their massive business is not affected or impeded.
they are making BIG money from this industry.
Not only that, I would imagine that if BT wants to get into the ecig biz they are going to have to import their batts.
Not a good idea to upset people who will quite possibly be your source for hardware.

This has been Perhaps the Most Baffle Aspect to the e-Cigarette "Fight".

The Complete No Comment from the Hardware OEM's.
 

aubergine

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If the Only way to Achieve the Goals of Product Standards/Purity or Restriction of Under Age e-Cigarette use was turn e-Cigarettes/e-Liquids over to BT, then So Be it. Because e-Cigarettes Need to Exist.

But this Far From the Case.

Small and Mid-Sized Companies can Comply with FDA Regulations. Yes, some will be Forced out of the Market. But if a e-Liquid Company can Not Comply with Regulations aligned with the Food Industry, then they should Go Anyway.

What the Abuse that I see as a Distinct Possibility is that the Regulations are be Drafted to put the Financial Bar to High for all but BT and BB.

If Benzaldehyde is shown to be GRAS at a Certain Concentration in an e-Liquid, then Anyone should be Able to use this Chemical as a Flavoring in an e-Liquid. The Concept of Every Vendor must get Approval for Every Flavor is Flawed. And I see it as a Monetary Lever to drive all but BT and BB out of the Market.

And it fits in Well with the Fear Campaign of Many Chest Pumping Senators about "Saving the Children" thru Flavor Illumination.

Let's Let Science Decide what is GRAS to use in an e-Liquid. And stop Using e-Cigarettes as a Pawn to BT, Taxes and Fear Based Agendas.

Diacetyl and all sorts of things are "approved" and appear in cigarettes at much higher levels than found in e-cigs; they'd have to go after those if they wanted to start banning them in e-cigs, right?
I've always thought that that's why we don't really hear so much about that in the campaigns - it's all about children, and gateway to smoking, and 'second-hand smoke' - haven't heard anything about specific toxins since 2010. I don't think they can coherently go very far with that one.
 

moze229

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I think I commented on this thread over a year ago somewhere or another, but I have something to add. It's been mentioned that oversight of e-liquid production might not necessarily be viewed as a bad thing, considering that mistakes can happen in production, simple neglect or cutting corners for higher profit margins, or safety quality standards could drop. I get all of that. The problem is, I'm a bit pessimistic in anything that a government entity becomes entangled with. Along with the ulterior reasoning and motives for any such regulation, there's also the factor of a government screwing up anything that it touches.

I implore those who view ANY regulation of this market "maybe not a bad thing" to consider two key points -

1.) Up to this point, there has been not one case that I know of (there may be a couple or many - I will admit that I do not know) where someone has received a e-liquid product that was too strong or toxic in some way. It could have occurred that someone was allergic to an ingredient or base (VG or PG), but no regulations would have stopped that anyway. ANY regulations would be most harmful to the small liquid manufacturers that are in a nickel and dime business to begin with. Prices will skyrocket, and attention will be placed more on the health benefits of not smoking rather than saving money. (This is all good, but I like things the way that they are.) There's also a potential for 'black-market' items to find their way into the industry, muddying the quality of what's out there now.
2.) Regulations with anything have always started with good intentions, but once the regulators begin to see the dollar signs, every bureaucratic organization is diving to have their first hand in the pot. Once this happens, safety is the last thing on the list. To this day, regulations to any government entity just means one thing - taxation. Taxation = income. And don't think the big tobacco companies aren't in on it. Regulations on alcohol, smoking, vaping - it's never about safety or better health. It's all about bringing in more money. It's another avenue of taxation without representation. That's all it is. If a government cared about its people, cigarettes would have been outlawed a century ago. They were in on the racket right along with the big tobacco companies. They saw the dollar signs. Between all of the chemicals added to cigarettes to allow inhalation without irritation to the lawsuits brought forth by those who claimed to be misled, who's come out smelling peachy the whole time? The entity that's made money on both sides of the fence.

I prefer to be left alone. There is no law against using or possessing nicotine. Let the people handle it their way. We don't need regulations for every aspect of our lives. Micro managing is something that really irritates the hell out of me. Their already telling our power plants and other manufacturing facilities that the more pollution they produce, the more taxes they have to pay. (As if that does anything beneficial for the environment.) If you want to stop pollution, attack the problem and try and find ways to help change the situation. Don't just try to collect on it, while allowing the damage to continue anyway.

And I'm sorry this turned into a rant, but all of this stuff really rubs me the wrong way. The most aggravating part about all of it is that a lot of people don't even think about it or realize it. Or they do and don't say anything.
 
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tA71ana

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This has been Perhaps the Most Baffle Aspect to the e-Cigarette "Fight".

The Complete No Comment from the Hardware OEM's.
I wouldn't expect them to show up in the Comments because whatever negotiations that are taking place would be happening totally behind the scenes.
 

Rickajho

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Folks, We are dealing with the Feds here.
Their Technology is a bit behind the times - trust me.
They might be compiling all of these comments with a program that still runs COBOL (no joke)

Aha! That makes sense. The real count might be 42,975,735 now and it can't display more that 5 digits left of decimal.

That, or someone forgot to wind up the computer again before they left for the weekend.

757px-IBM_Electronic_Data_Processing_Machine_-_GPN-2000-001881.jpg


No - the number still hasn't changed since the Thursday figure. I just checked it again.
 

zoiDman

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Diacetyl and all sorts of things are "approved" and appear in cigarettes at much higher levels than found in e-cigs; they'd have to go after those if they wanted to start banning them in e-cigs, right?
I've always thought that that's why we don't really hear so much about that in the campaigns - it's all about children, and gateway to smoking, and 'second-hand smoke' - haven't heard anything about specific toxins since 2010. I don't think they can coherently go very far with that one.

I think the Very First thing that the Vapers (and the FDA for that matter) should do is Forget that Cigarettes even Exist.

There is a Tangled and Subverted History of What is allowed in Cigarettes. Cigarettes should have No Bearing in what goes into an e-Liquid.

The Mistakes and Deceptive Practices off the Past are Not Present in e-Liquids. We are Starting with a Clean Slate. And Once Again, Let the Science Dictate what goes in an e-Liquid.

I Don't Care if Diacetyl is in Cigarettes, Nicotine Gum, Energy Drinks or Pet Foods.

If the Science shows that it is Not Suitable for Habitual Inhalation (Which I Believe it has) the it Should Not Be Allowed to be in an FDA Approved e-Liquid.
 

zoiDman

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I wouldn't expect them to show up in the Comments because whatever negotiations that are taking place would be happening totally behind the scenes.

I didn't mean in the FDA Comment Period. I kinda Meant in the Years leading up to Today.

I Can't recall reading Much from ANY Hardware OEM in the Last 5 Years with Regards to Regulations. And Very Little from the Major Retailers.

With the Possible Exception of Njoy. Who some Feel might Not have been as Good of a Friend to the Vaping Community as they Could have.
 

zoiDman

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Aha! That makes sense. The real count might be 42,975,735 now and it can't display more that 5 digits left of decimal.

That, or someone forgot to wind up the computer again before they left for the weekend.

757px-IBM_Electronic_Data_Processing_Machine_-_GPN-2000-001881.jpg


No - the number still hasn't changed since the Thursday figure. I just checked it again.

That looks like a Honeywell 66 processing RPG Punch Cards.

LOL

(BTW - Check out the Asbestos Fiber Floor Tiles.)
 

aikanae1

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I have to apologize in advance for my ignorance--I'm an old lady college student, and that's been eating me alive for the past several months. I haven't read the entire FDA document(s), so please forgive me that.

I've read the line here several times that 99% of existing vape products will be banned by the FDA (perhaps pending endless piles of paperwork and experiments on monkeys before being accepted for public consumption). Can someone kindly break this down for me? For example, I've read that IBTanked tanks and Ikenvape cartos will be banned specifically, presumedly among nearly every other product.

I'm just going to jump in without reading the rest of the responses on this.

The devil is in the details. Conceptually, the regulations don't sound terrible, maybe even survivable - until a person begins reading the fine print and the more you read, the more a person's head swims. An example is there's nothing written guiding application submissions. It's a crap shoot. A very expensive one at that. A few of the fees have been guessimated, but they are rough enough so that they can't be narrowed dowm between $100k - $1mill per SKU, for every product requiring a SKU number (which now have to be registered - also $$$).

Basically there is no way to give anything but an opinion when answering your question. In order to believe it, you'll have to read it - if not the original docs, opinions from those who have read them and make up your own mind.

IMO it was very hard to grasp just how insane theses regulations are or the fact that they will do nothing towards promoting health or safety, not even when it comes to dubious eliquid manufacturing because there's a good chance we'll know LESS about what's in them. The documents are 100% about who is entitled to profit from nicotine sales and it's not small business'.

Even the questions the FDA asked appeared to be a smokescreen and distraction since nothing in the deeming was or would ever deal with those issues. Dual use? They've already approved dual use for nicotine, so why are they suddenly pretending like it's an issue??? Com'on. Everything in eliquid is FDA approved for dual and long term use even as an inhalant. That's not all there is to the issue, but they weren't asking nor did they want to know about the things that might be of real concern.

A couple of worthwhile opinions I submitted
6/11/14- Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act | The U.S. Small Business Administration | SBA.gov

http://mercatus.org/sites/default/files/Marlow_ecig_PIC_062714.pdf
 
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Rickajho

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Not to Darken this Thread. But in the Interest of Fairness. The Same can be said about Anonymous Submissions using a CASAA Forum Comment.

The Long and the Short of it is the FDA Comment Period is Over.

And we should be Formulating a Organized Game Plan as to how to Proceed in this Next Phase of the FDA Rule Making Process.

Ummm... I'm a gonna take a break and not think about this all that much - at least for the entire weekend. Honestly, I'm feeling much relieved that the comment period is closed. (For the moment. Maybe the whole weekend...)
 

rbrylawski

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If the Only way to Achieve the Goals of Product Standards/Purity or Restriction of Under Age e-Cigarette use was turn e-Cigarettes/e-Liquids over to BT, then So Be it. Because e-Cigarettes Need to Exist.

But this Far From the Case.

Small and Mid-Sized Companies can Comply with FDA Regulations. Yes, some will be Forced out of the Market. But if a e-Liquid Company can Not Comply with Regulations aligned with the Food Industry, then they should Go Anyway.

What the Abuse that I see as a Distinct Possibility is that the Regulations are be Drafted to put the Financial Bar to High for all but BT and BB.

If Benzaldehyde is shown to be GRAS at a Certain Concentration in an e-Liquid, then Anyone should be Able to use this Chemical as a Flavoring in an e-Liquid. The Concept of Every Vendor must get Approval for Every Flavor is Flawed. And I see it as a Monetary Lever to drive all but BT and BB out of the Market.

And it fits in Well with the Fear Campaign of Many Chest Pumping Senators about "Saving the Children" thru Flavor Illumination.

Let's Let Science Decide what is GRAS to use in an e-Liquid. And stop Using e-Cigarettes as a Pawn to BT, Taxes and Fear Based Agendas.

I'm glad you posted this. I was at my local vape store yesterday. I asked the owner about the pending regulations and what it would do to his juice lab. He said he's prepared to pay the price of certification imposed and he only uses the purest ingredients. Of course he said he'd have to raise juice prices, but that's inevitable to begin with.


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tA71ana

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Aha! That makes sense. The real count might be 42,975,735 now and it can't display more that 5 digits left of decimal.

That, or someone forgot to wind up the computer again before they left for the weekend.

757px-IBM_Electronic_Data_Processing_Machine_-_GPN-2000-001881.jpg


No - the number still hasn't changed since the Thursday figure. I just checked it again.

The frightening part of this is that I remember using IBM punch cards to run programs.
After the Keypunch Operator was done with the run we'd pile them up in the stacker...the first card was the executable.
Lawd, I'm getting old, lol
 

tA71ana

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I didn't mean in the FDA Comment Period. I kinda Meant in the Years leading up to Today.

I Can't recall reading Much from ANY Hardware OEM in the Last 5 Years with Regards to Regulations. And Very Little from the Major Retailers.

With the Possible Exception of Njoy. Who some Feel might Not have been as Good of a Friend to the Vaping Community as they Could have.

Oh, I see :D
But there is a real threat now that these regs will negatively impact their cash flow.
I believe it may be getting real for them now.
No one, whether individuals, groups, corporations or sovereign nations like to have their pocketbook messed with.

But then....the overseas Manufacturers may have a plan.
APVs disguised as flashlights? :D
 

zoiDman

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Or candelabras.....look for the REALLY initricate ones....... those are for sure APVs :D
Authorities here will wonder why there is a sudden interest in candelabras...

The possibilities are endless.

One thing that is Kinda Funny about the Entire Hardware thing is that if it is Marketed as something to Use for the Things we can Not Talk about, there doesn't seem to be any Problems.

And the FDA has No Authority over it.

Go Figure.

:blink:
 
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