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

[tA71ana]

Bill G. said the Chinese factories will not pay to get their products approved by the FDA. They’ll just retool and start making something different.

J.R.

Dang (10 Char)

 

[zoiDman]

Bill G. said the Chinese factories will not pay to get their products approved by the FDA. They’ll just retool and start making something different.

J.R.

Someone is going to have to make the Hardware that BT is planning on getting FDA Approval on.

And I Don't see it being Made in America.

 

[tA71ana]

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.

LOL...I was thinking about that but didn't want to say anything

 

[tA71ana]

Someone is going to have to make the Hardware that BT is planning on getting FDA Approval on.

And I Don't see it being Made in America.

True that.

 

[zoiDman]

Dang (10 Char)

I hate that 10 Char Thing!

 

[WorksForMe]

Someone is going to have to make the Hardware that BT is planning on getting FDA Approval on.

And I Don't see it being Made in America.

In that case, BT will pay for the FDA approval.

J.R.

 

[tA71ana]

In that case, BT will pay for the FDA approval.

J.R.

True also.
If BT attempts to manipulate the situation so folks have no other options but them, it may just backfire, especially since everyone knows that they adulterated their tobacco products with all manner of garbage and folks will expect that they will do it with any ecig product they put out.
Sales won't be as good as they think and many Vapers won't go back to smoking but will in fact learn to build and fix their own mods or quit altogether.
There may still be a lot of smoking going on but it is going the way of the dinosaur.
vaping (in one form or another) is here to stay and BT may eventually find out that they have in fact shot themselves squarely in both feet.

 

[bigdancehawk]

It's possible that many of the duplicate cigar comments have been removed, thus accounting for the total comment count dropping to about 43,000. Here's what they say:

"Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign."

Oddly, however, if you click on the link to "open docket folder," the count is 75,735. Then, if you elect to just view all the comments, the count drops to 59,578.

If you search all the comments for the word "cigarette" (which also yields comments containing "electronic cigarette," "e-cigarette" and the plural forms of those words, you only get 7,058 comments.

It seems it's no longer possible to comment on any comments.

 

[aikanae1]

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.

In response to that there have been a couple of "oops" that I know of; a major one over 4 years ago that had the POTENTIAL (and it didn't) to kill. That manufacturer isn't mentioned on the forms and is out of business now. Word spread like wildfire - maybe even faster. It's because people here are so well-informed and knowledgable that disaster was avoided.

I think one thing the DIY community has done is get into the why's what's how's of what many of us take for granted. There was an interesting (imo) thread on purity of nicotine and I didn't realize that "we" as vapers demand rates of purity higher than what's used for pharmaceticals. Patches, gums, mists, all use lower levels - "dirty" nicotine but it's approved. We expect more from flavorings, which are all FDA approved without exception - "we" (as a community) demand more = diacetyl issue.

I think it is very important to recognize the difference between what is said / promised vs. what will it actually DO. There is NOTHING in the deeming regulations that is designed to, mentions or addresses anything about eliquids might require a higher standard of purity than what the FDA already reguards as "safe for pharmecituical use". In fact, there have been occasions that people have been prevented from filing cases against drug or device manufacturers for causing harm because they are faced with lawyers from the USA govenment saying they were "approved" - - yes, if the FDA says it's "approved" to have to wage war with them if you believe it's caused harm. Not the manufacturer. (That's not always true). The FDA still defends Chantix. That dangerous CRAP will never get pulled no matter how many people die.

IMO there was nothing in the deeming regulations designed to make anything actually "safer" for vapers. From what I could tell, once products were registered that would be it. "WE" wouldn't always be entitled to know more. Nothing about the source of nicotine, where or how flavors came from; picture a nutrition label - "artifical and natural flavors added" and that's it. The end.

It's really wonderful to want someone to require safer stuff, but do they really do that? In this case, NO.

 

[Wow1420]

What's the expected timeframe for the FDA's next move?

 

[zoiDman]

What's the expected timeframe for the FDA's next move?

That is the $64,000 Question.

 

[tA71ana]

I'm hoping that it dawns on the FDA that they have created a real cluster and they table the issue for a few years.
One can hope.

 

[rolygate]

True also.
If BT attempts to manipulate the situation so folks have no other options but them, it may just backfire, especially since everyone knows that they adulterated their tobacco products with all manner of garbage and folks will expect that they will do it with any ecig product they put out.
Sales won't be as good as they think and many Vapers won't go back to smoking but will in fact learn to build and fix their own mods or quit altogether.
There may still be a lot of smoking going on but it is going the way of the dinosaur.
Vaping (in one form or another) is here to stay and BT may eventually find out that they have in fact shot themselves squarely in both feet.

When the cigarette corporations started buying into ecigs 18 months or so ago, there was a lot of argument about the pros and cons. Some felt it was a terrible idea, some that is was good. The benefit to us probably looks like an inverted bell curve graph: a good idea at first because in essence it means ecigs can't be banned (no one can beat BT - whatever they want, they get, so if they are in ecigs, then ecigs can't be banned); high on the benefits graph for us, then, at that time.

As they gradually begin to strangle the market with regulations (whatever they want, they get), it starts to become very bad for us. That phase started about 6 months back with Reynolds beginning to introduce State laws to get rid of the independent vape product vendors and the community who back them. It will get a lot worse, as the cigarette corporations work with the FDA to eliminate all their opposition. That's right down at the bottom of the inverted bell curve of the graph representing their cost/benefit to us.

In five or six years, they'll want to improve their products and move from minis into mid-size tank system ecigs of the type most of us use now. This is after all the independents have been put out of business, of course. So, they'll have the FDA allow those models. That will be the start of a returning benefit to us, and the graph will start to move up again. It won't go too high though, as they are a massive hindrance to us now: they will never allow any competition to exist, and in the regulated market they are expert players in, all competition can be eliminated by convenient regulation. In the tobacco and pharmaceuticals markets, all small players are eliminated by regulations brought in to help the big guys.

 

[choochoogranny]

Thank you, Bigdancehawk. Thought my computer was going crazy.....it's old like me.

Anyway, looks like the FDA is doing the "numbers" shuffle again. Maybe that's why CASAA asked for your comment posting number....to fill in where the IRS.....um--m-m-m, the FDA conveniently "lost" a few thousand posts.

 

[tA71ana]

Say, aren't there supposed to be comments delivered to the FDA that aren't electronic (i.e., letters, ect.)?

 

[tA71ana]

When the cigarette corporations started buying into ecigs 18 months or so ago, there was a lot of argument about the pros and cons. Some felt it was a terrible idea, some that is was good. The benefit to us probably looks like an inverted bell curve graph: a good idea at first because in essence it means ecigs can't be banned (no one can beat BT - whatever they want, they get, so if they are in ecigs, then ecigs can't be banned); high on the benefits graph for us, then, at that time.

As they gradually begin to strangle the market with regulations (whatever they want, they get), it starts to become very bad for us. That phase started about 6 months back with Reynolds beginning to introduce State laws to get rid of the independent vape product vendors and the community who back them. It will get a lot worse, as the cigarette corporations work with the FDA to eliminate all their opposition. That's right down at the bottom of the inverted bell curve of the graph representing their cost/benefit to us.

In five or six years, they'll want to improve their products and move from minis into mid-size tank system ecigs of the type most of us use now. This is after all the independents have been put out of business, of course. So, they'll have the FDA allow those models. That will be the start of a returning benefit to us, and the graph will start to move up again. It won't go too high though, as they are a massive hindrance to us now: they will never allow any competition to exist, and in the regulated market they are expert players in, all competition can be eliminated by convenient regulation. In the tobacco and pharmaceuticals markets, all small players are eliminated by regulations brought in to help the big guys.

Yes...I just get the feeling that BT is opening a can of worms here with all manner of unintended consequences wiggling out.

 

[Katya]

Say, aren't there supposed to be comments delivered to the FDA that aren't electronic (i.e., letters, ect.)?

They have been delivered. Here's what Free To Vape team wrote in their email to me (Thursday, August 7):

Hi Everyone,
Wanted to take a minute to update everyone on where were are at now, and what is next.
We sent the Printer the first 39,000 submissions last night at 3:00am EST. They are letting us send them any additional we receive, up to 7:00AM EST tomorrow August 8th. They just called, and the first 10,000 are already printed and ready to go.
The FDA documents look GREAT! They did a really good job formatting them in the end! We will put up a copy of one soon, so you all can see what they look like. They are formatted correctly to make sure they are legal, accepted, and recorded.
We are picking them up at the Printer in the morning at approximately 10:00.
We will be dropping them off at the FDA at 2:30pm EST. We just got off of the phone with the FDA to confirm the time, and that we would like a receipt for them. They groaned... about having to stamp all of them in LOL

The address is:
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD. 20852
Some Vaper's are wanting to/ planning on coming and helping. We plan to all meet at the front of the building around 2:00pm EST... so we can get organized. Anyone else that would like to help, "please come" and meet us there at 2:00. Bring your cameras (grin). We will be video taping this, so we can post it on the website, YouTube, etc.
Please remember to ask your Family and Friends to also submit, in your behalf. Their Comments are also very important! Their Comments will also be sent to their Congressman. They will make a difference!
Look for more information soon. FTV gathered "real world" data from Vapers', that is going to be valuable and informative in this fight. There are real stats on how many of you support (or don't) - 18 and over, child safety caps, etc. We will be correlating that data - and creating an abstract report for the FDA, your Congressmen, and advocacy efforts towards the future.
-Free To Vape Team

 

[aikanae1]

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.

Bonus Points.

At least on the west coast, NJOY has shown up when not a single retailer has. Even if they had no testimony to add, they've been there and from what I've read, been willing and helpful as to process, expectations and behind the scene events. In almost every case they take guff as being big tobacco, but BT has been absent from the bulk of these mini-city and state wars. Again it makes me think they are putting all their eggs into another basket. A number of state level legislation has omitted BT products from packaging and tax requirements ???

Hardware and vendors? I gotta say I'm amazed. The response has been better. There are some very, very good and intelligent submissions from store owners that I've seen submitted. But equial to 5,000 b&m shops? Nope. In all fairness, obviously not everything is online either. This time, I got daily emails from several vendors pushing for comments and some did special advertising and promotions around it. One store in town opened their computers to help people submit comments. The enviroment is improving.

I tried to submit something into the vapors forum on Fast Tech and it was blocked. I know other chinese vendors display big CASAA and Vaping Malitia banners. I'm going to be changing vendors, just as I have with stateside ones. But I can't understand silence either. At times I've had the feeling that customers cared more about some of the business' than the owners did.

 

[tA71ana]

They have been delivered. Here's what Free To Vape team wrote in their email to me (Thursday, August 7):

YaY Team!

 

[tA71ana]

Bonus Points.

At least on the west coast, NJOY has shown up when not a single retailer has. Even if they had no testimony to add, they've been there and from what I've read, been willing and helpful as to process, expectations and behind the scene events. In almost every case they take guff as being big tobacco, but BT has been absent from the bulk of these mini-city and state wars. Again it makes me think they are putting all their eggs into another basket. A number of state level legislation has omitted BT products from packaging and tax requirements ???

Hardware and vendors? I gotta say I'm amazed. The response has been better. There are some very, very good and intelligent submissions from store owners that I've seen submitted. But equial to 5,000 b&m shops? Nope. In all fairness, obviously not everything is online either. This time, I got daily emails from several vendors pushing for comments and some did special advertising and promotions around it. One store in town opened their computers to help people submit comments. The enviroment is improving.

I tried to submit something into the vapors forum on Fast Tech and it was blocked. I know other chinese vendors display big CASAA and Vaping Malitia banners. I'm going to be changing vendors, just as I have with stateside ones. But I can't understand silence either. At times I've had the feeling that customers cared more about some of the business' than the owners did.

Yes I wonder about Customers seeming to care more as well.
Perhaps some of the Sellers in the Vape community are waiting for the regs to come down because it will cause (for all intents and purposes) a run on supplies, hardware and juice.
They will sell out of all of their inventory, close up shop and take the money and run.