FDA FDA deeming regulation proposals

[Jman8]

Your response implies that anything isn't specifically "authorized" is somehow less than legitimate; that we need to get "permission" before we do anything. Somehow, I never considered the products that my business makes and sells to be "unauthorized".

I don't mean before you do anything. But before you bring a product to market with a legitimate business, you need some sort of (stamp of) approval. If bringing a product to market that FDA went after in 2009(ish) that includes same drug that BT has been using for 100+ years, then yeah, you are going to need get some approval. Believe me, I wish it was otherwise.

If product does not contain that drug, then might not need the same type of approval at all.

How long would your customers keep buying from you? Are they as willing to thumb their nose at "authority" as you are? A few probably would. If I were your customer, I'd certainly be one of them. Yet if certain much larger competitors have "FDA Approved" juice on the market and the media is full of stories about the dangers of juice that "made in somebody's bathtub" my guess is you're not going to have enough customers left to stay in business.

If "approved juice" is as extensive in offerings as say 1/10th of what is available today, then I'm thinking I'm not going to be in business very long. If it is 1/1,000,000th of what is around today, then I'll be in business for a very long time. I could make it in my toilet and I'd be in business for a long long time. Alright maybe not that, but I think you get what I'm saying.

 

[Danoman]

Do they?

The thing that always worries me most is the "inside the beltway" bubble disconnecting with reality. I know there are those who worry about "tyranny" (possible with any government, we're not immune) but I think even that fear is optimistic in the sense that some dark oligarchy of bad people is pulling the strings. They may be Bad People but they're sane and rational.

What if it's pandemic stupid instead?

I find that to be much more terrifying. I've seen the FDA saying "industry". What if they can no longer conceptualize the very idea of "mom & pop" shops or garage based businesses? Their world is billionaires and corporate execs and board rooms. Are they even able to understand people like the guy who started the little shop here who's a vaper who wanted to make a living doing something he enjoyed? And whose big splash is a branch in two other little towns nearby?

How do we get accross to folks used to dealing with mega-corporations, global trade, billionaires to "see" a grass roots movement?

I completely agree... there is a serious divide in those that have power, and the idiots that vote them in. Personally, I think ALL of government needs to be all regular blue collar workers that know what a dollar is and cares for our dollars as much as he does our own. ALL PORK and Lobbyists and lawyers are running this country as there is no common sense in the ones in power, I believe. It's not a Dem OR Rep problem, it's all of them as they are all one in the same. (minus just a very, very few)

 

[Danoman]

Heck yeah and then take a vape off his sonic screwdriver

*Wants a sonic screwdriver...* Although, my son says my OVALE EVIC looks like one... Hahahaha

 

[EddardinWinter]

I don't mean before you do anything. But before you bring a product to market with a legitimate business, you need some sort of (stamp of) approval. If bringing a product to market that FDA went after in 2009(ish) that includes same drug that BT has been using for 100+ years, then yeah, you are going to need get some approval. Believe me, I wish it was otherwise.

If product does not contain that drug, then might not need the same type of approval at all.



If "approved juice" is as extensive in offerings as say 1/10th of what is available today, then I'm thinking I'm not going to be in business very long. If it is 1/1,000,000th of what is around today, then I'll be in business for a very long time. I could make it in my toilet and I'd be in business for a long long time. Alright maybe not that, but I think you get what I'm saying.

Excuse me, but how is losses down to 1/10th of the current available market not destruction of the market? The term "decimation" comes from the Romans when they would "decimate" a unit who fled in battle by killing 1/10th of the survivors.

Losing 10% of the industry is very bad. Losing 50% is a severe setback to vaping that could hurt the industry for decades. Losing 90% of the industry is completely unacceptable, and worthy of an epic fight to prevent.





Roaring thunderously via Tapatalk...

 

[Devonmoonshire]

Well all I am gonna head to bed. I think I have a Mole watching everything I say on here now. Yes I know how to spot a mole when I see one.

A Mole is someone who has never made a post yet "Likes" and monitors specific subject matter and most likely reports it back to whoever they may be working for. It started today with my "Changing the Approach" Thread, there is a user with zero posts that has been a member since 2011 and has not posted once.

I feel like I am being watched LMAO
Have a great night all, I am sure with perseverance and a LOT of work this will all work out in our favor to the highest extent possible in the end.

Sincerely;
Nate

 

[Danoman]

Well all I am gonna head to bed. I think I have a Mole watching everything I say on here now. Yes I know how to spot a mole when I see one.

A Mole is someone who has never made a post yet "Likes" and monitors specific subject matter and most likely reports it back to whoever they may be working for. It started today with my "Changing the Approach" Thread, there is a user with zero posts that has been a member since 2011 and has not posted once.

I feel like I am being watched LMAO
Have a great night all, I am sure with perseverance and a LOT of work this will all work out in our favor to the highest extent possible in the end.

Sincerely;
Nate

Hears the DR. Who music playing in the background now... Hahahaha

 

[Myk]

I'm a small business? Cool!

If I'm in business, then I'm writing to FDA in response to their proposal, based on their wording that they seek to streamline submissions and I'm letting them know I have a passion for making eJuice, and I'm very successful at it. I have a great customer base. I am very willing to work with the FDA in gaining approval for my eJuices to be sold as legally available tobacco products. And I am insisting that they lower costs for approvals. I realize that in the past this has not been the case, but this MUST CHANGE.

I'm probably not saying much more than this to the FDA, but I'd be thinking if it does not change, I'll find ways to circumvent the FDA's authority and keep pleasing my great customer base for as long as humanly possible.

Hypothetically speaking, I could be shut down so fast, I'd not have time to say, "but, you see, I, hey get those cuffs off of me!"
Or hypothetically speaking, I'd become a huge player in the black market, making billions and no longer all that small. I'd be the Al Capone of the eJuice business under eLiquid prohibition. And I'd be very good at it.



Didn't we know this before 4/24/14?

Yes, you are a real small business not what the government thinks is a small business with millions in start up costs and overhead. You are the type of small business the government hates.

So basically you agree with the fear mongering then.
It's not the $3500 or so for the fee it's the stack of paper work the FDA estimates will take you somewhere between 2100-125,000 lawyer hours to fill out. There is no hope of talking them out of that, they've been requiring stacks of paper work and destroying small businesses for a long time.

And it's not the liquids that are the issue. I'd expect that and there are liquid makers who've been enjoying their 1000% markup long enough they should be able to afford it, plus all liquid should be possible for substantial equivalence since the basic recipe has never changed (if the FDA was sane, but that's still open for a lawsuit if they continually refuse).
The problem is the small business sells wick, wire, batteries, mods, tanks, tips and liquid separately. That adds up to 7 items compared to BT's single item disposables.

Having a Walter White traveling nicotine lab is an answer but it is not a legal answer.

It sounds like your idea is there's nothing to fear because you can tear apart a toaster, soak some cigarettes and have an ecig. I can turn on my lathe and have an ecig, I don't even need nicotine liquid, I've been thinking of switching to a patch for a more consistent dose anyway. Those personal solutions ignore the real problem.

I hope you all caught the show that just ended. Bill, Greg, Steirs, Richard, etc were great. The main message they want to get out, is for everyone to calm down. Edit and re edit your comment to the FDA, await the call to action from CASAA, plan ahead for a possible peaceful protest, etc, but, mainly, just calm down and don't sign petitions and whatnot. Just sit tight and practice your one and only comment.
You missed a great show... Bill even let a few chosen words slip. . I Love that guy!

Problem is the longer I wait the madder I get.

I am getting some good points in my manifesto though.

What show are you talking about?

 

[Danoman]

Here's the bottom line... (no matter our differences in opinion)

We are all in this together... as a massive group, we get things done the way WE want them done. As individual, we are as helpless as the homeless person begging at your local Walmart corner, it's THAT simple. (bless that homeless person, by the way... prayers for them)

The CASAA is taking the legal responsibility to look out for all of us. I'm a member and very much listening to them, they have a plan of action and ARE the ones that have the ability to do something, in our behalf to represent us all. Let's give them the time to evaluate it all on the legalities and see what THEY recommend we all do as a group. We have a HUGE voice...!!! But, timing is what matters here. They will be coming out with more tomorrow and let's see where it goes from there. Please, put any personal issues between members aside, as none of us have time for any of it and let's just get down to the facts. Bottom line.

I respect everyone's opinion on here, whether I agree or not, we ALL have a LOT at stake here. We will be going against a mountain of power and we all need to be on the same page. As a group, we need to decide what is acceptable and what isn't. (I believe we've already, pretty much driven that down to things we can agree on)

Make no mistake, from what I've been reading all day today, there WILL be regulations imposed on us, as vapor. Whether you own a business in it or not, it affects us all HOW we represent ourselves as a whole. You know the term, one spoiled apple will ruin the whole bunch. WE have to work together, because in the end, it's all that matters... (for most of us, in many more ways)

WORK on those compositions and edit, edit and edit again to make SURE they are as pure, simple to understand and keep it to facts and facts only. Show testimonies with proof of signatures of the ones making those testimonies, the more the better. THIS group is just as important as any other, in fact I believe that THIS group is stronger than any other out there... it matters, for all of us. Write and talk to those running for office in these mid-terms, if they disagree with the facts, SHOW them the facts. If we don't... we'll have only ourselves to blame. We CAN control this by sheer numbers... if we don't, it's over and they can do and impose what they will, driven by their Lobbyists. I can't accept that... and neither can you. Let's all get on the same page and decide what's acceptable in regulation and what isn't, as a whole. Debate it out in private messages so it's not seen openly on THIS Forum so in the end we all come together as one. Again, if we don't... we have no one to blame but ourselves.
*Game on...*

 

[Gato del Jugo]

Interesting & closer look at what we're up against, courtesy of Dimitris Agrafiotis (VapinGreek) via Vape Team Media..

Well worth the 27 minutes, IMO...


An interview with Jeff Stier (FDA Open Seminar and why vapers should stand up)

Published on Apr 20, 2014

In this episode of It's Political we discuss with Jeff Stier, Senior Fellow at the National Center for Public Policy Research (https://twitter.com/JeffaStier) what went down at the FDA Seminar held in San Diego April 5th as well as some interesting things stated at a press conference held at the same place! We also dive in why vapers should wake up and stand up for their right to vape!


https://www.youtube.com/watch?v=10AbJunwOEY

 

[Danoman]

Interesting & closer look at what we're up against, courtesy of Dimitris Agrafiotis (VapinGreek) via Vape Team Media..

Well worth the 27 minutes, IMO...


An interview with Jeff Stier (FDA Open Seminar and why vapers should stand up)

Published on Apr 20, 2014

In this episode of It's Political we discuss with Jeff Stier, Senior Fellow at the National Center for Public Policy Research (https://twitter.com/JeffaStier) what went down at the FDA Seminar held in San Diego April 5th as well as some interesting things stated at a press conference held at the same place! We also dive in why vapers should wake up and stand up for their right to vape!


https://www.youtube.com/watch?v=10AbJunwOEY

Great find... Thank you. I'm posting this on my Facebook... it's important.

 

[Danoman]

I've been looking at some political things going on. Ones that are against Obama, Holder and MANY others in our Senate and Congress... with the 'mid-term' elections coming up, we MAY have more time than we thought in the beginning. There is a lot of puerile happening right now. I'm sure that vaping isn't one of them, where our leaders in this nation are concerned. Maybe this is a positive thing, for us I mean.

These mid-term elections are everything to us... let's use it to our advantage. Washington doesn't know the reality of what we are doing, I don't think. They are ALL focused on being elected again and supporting those in like mind. Let's use this time we have to get set in what we believe in and be ready to roll when the CASAA is ready. These elections are first on their minds at the moment and nothing else and it's all about the money so, let's use this to our advantage, I think. There is NO better time for US to do this than now.

I'm a small business owner and I think we need to look at who the electives are going to be. ASK them pointed questions, ask them what they think and feel about small business, ask them how they'd support small business, ask them about taxes and who they feel about implementing those taxes on ANY business that's struggling to make ends to meet. You'll soon learn who's (supposedly) on your side and who's not... so long as any of them adhere and believe in what they tell you. At least, it's a start.

Just an idea... an important one, I believe.
No matter, it affects us all... as we have families we all need to provide for and children to feed and care for.

 

[Jman8]

Excuse me, but how is losses down to 1/10th of the current available market not destruction of the market?

Because in context from what I was saying about being a black market dealer for eJuice, if 10% of the flavors that are currently available, are approved, then that would mean around 2 million flavors I have to compete with. In which case, I believe what Rossum was getting across would be accurate - which is I might not be in business very long. 2 million flavors is a lot to to compete with. But if I were competing against a market of say 200 flavors, then I think I'll do alright in that scenario and stay in business for much longer.

More realistically, I think if was curtailed to less than 1000 flavors, it would likely be less than 10 that were approved, possibly even just 2 or 3. Black market dealers will be making a killing in that environment.

 

[Jman8]

Yes, you are a real small business not what the government thinks is a small business with millions in start up costs and overhead. You are the type of small business the government hates.

So basically you agree with the fear mongering then.
It's not the $3500 or so for the fee it's the stack of paper work the FDA estimates will take you somewhere between 2100-125,000 lawyer hours to fill out. There is no hope of talking them out of that, they've been requiring stacks of paper work and destroying small businesses for a long time.

I believe there is hope of talking them out of that, hence not agree with those who express fear via messages of "there is no hope."

And it's not the liquids that are the issue. I'd expect that and there are liquid makers who've been enjoying their 1000% markup long enough they should be able to afford it, plus all liquid should be possible for substantial equivalence since the basic recipe has never changed (if the FDA was sane, but that's still open for a lawsuit if they continually refuse).

Heck, if you believe this, then we are nearly on the same page.

The problem is the small business sells wick, wire, batteries, mods, tanks, tips and liquid separately. That adds up to 7 items compared to BT's single item disposables.

I'm of the opinion that we don't know if these items are included. To the degree they might be, I think a bunch of things but given reality of language in current proposal, I think it would be rather easy challenge if these non-nicotine items are included as tobacco products.

You are citing these as the problem and I'm saying I don't see them as the problem with current regulations. I will acknowledge they could be, but hard to say they will be and furthermore that if they are, it will be (certain) end to smaller businesses getting into the market.

It sounds like your idea is there's nothing to fear because you can tear apart a toaster, soak some cigarettes and have an ecig. I can turn on my lathe and have an ecig, I don't even need nicotine liquid, I've been thinking of switching to a patch for a more consistent dose anyway. Those personal solutions ignore the real problem.

I'm not (mainly) referring to personal problems in this thread. Not sure where you are getting that. If flavors are, according to you, not a problem, then I honestly see very little problem going forward. If you are saying those will get approved rather easily, without much fee, holy crap, will things get better financially in this industry. I actually don't even agree with this, but I like the sound of it.

I see you, and others, saying that the 'real problem' is given track record of FDA in approving ANY ecig product as 'new tobacco product' will be very costly. And because it will be costly, it'll price smaller vendors/manufacturers out. If we left it right there, and had discussion on that point and how we might go about addressing that, collectively, in our talking points to FDA (among other topics), then I'd not be in disagreement with anyone on this thread. Yet, if we are saying things like "no hope in changing FDA's mind" or "because all smaller business will be excluded, by design, the industry will die" or "regulations are only to protect BT's investment and anyone that concludes otherwise is plain wrong" then I may show up as challenging that, labeling it as counterproductive, so on and so forth.

Thing is, we are all saying a bunch of different things. You say flavors no problem. Next person that disagrees with what I'm saying here will say flavors have 6 components and each of those needs separate application and so business with 10 flavors must spend 20 million dollars to get all flavors approved, which is the problem Jman. How can you not see this?

To me the ambiguity vs. the anticipated heavy handed approach that many of us thought FDA would take on proposed regulations, is a good thing, in the short term. In 2013, I would've thought for sure heavy handed approach given countless discussions here and elsewhere. In early 2014, I would've thought heavy handedness for sure, given local bans galore popping up.

Now, I'm thinking FDA was tame, amendable and providing for reasonable framework, and that I think serves us going forward.

 

[EddardinWinter]

Fear mongerer!

Just kidding.

Financial requirements need to change then. Not my opinion. They need to. I'm not looking to engage in wishful thinking here, nor do I want to be told by someone why they are 'certain' it can't be. If it is that much, it can be. You can't ask for "ways to streamline" and then think the tech people amongst us can't come up with innovative ways to do just that. IMO, we can handle this.

Now, let's pretend FDA doesn't want it to be handled, and by design, wants it to price out little guys. I don't agree with this line of thinking, but let's entertain it. IMO, then it will go route of black market. Not maybe, it will. And admittedly, with the words 'black market' it could be very scary, very dicey, or insane to think that could work. It'll work. Black market won't be invented by eLiquid vendors. They won't be doing anything new. They'll fit right in, especially if demand is high. Channels now for obtaining whatever you want are pretty good. I can understand why anyone would be nervous to go this route, but once thousands are, you'll take the risk or you'll go with industry approved products (all 7 flavor choices) or you'll stop vaping.

The fact that DIY is relatively easy (and I say that without ever trying it), means the black market will be wide open for business and unless you truly only care to engage in online vending, you'll likely not get caught and likely have dozens of people in your neighborhood who are dealers and who are very good at what they do, very popular, great on quality, generous on provisions.

For FDA to not realize this is what they are, in part, creating would be sad for them. Kiss all that revenue goodbye. Consumers win.

Yet again.

You see, this is where I disagree.

I don't see the creation of a black market as the only viable juice option as a "consumer win". I view that as a dreadful setback to consumers (current and future).

If you think the FDA will change the financial (and other) requirements for application then you must posses some information or insight I lack. Just because we need it to change doesn't mean it will. The FDA has been openly hostile to vaping all along; there is no reason to believe they would adopt a new streamlined policy that I can see.

Unless the grandfather date is changed for application of approval, the industry stands to lose a great deal of the manufacturers that make it what it is today. The FDA has already stated that they believe this date is dictated by the tobacco settlement, so getting them to change it won't be easy.

If I could change one, and only one, thing in this deemed regulation I would change that arbitrary and capricious date.



Roaring thunderously via Tapatalk...

 

[Anjaffm]

You see, this is where I disagree.

I don't see the creation of a black market as the only viable juice option as a "consumer win". I view that as a dreadful setback to consumers (current and future).

I agree.
I do not see a Black Market as a "win" for consumers. Not at all.
I see a Black Market as a kind of refuge. As a way to continue our way of harm reduction - and enjoyment.

Oh yes, I will purchase from the Black Market as well. But being driven into illegality in order to live a healthier life - no, that is not a "win".

 

[Thundernoggin]

Yet if certain much larger competitors have "FDA Approved" juice on the market and the media is full of stories about the dangers of juice that "made in somebody's bathtub" my guess is you're not going to have enough customers left to stay in business......

Just my thoughts as I feel there will be no black market.. just a gray market that skirts around just about anything the FDA comes up with.Just my 2 Cents!

I agree.
I do not see a Black Market as a "win" for consumers. Not at all.
I see a Black Market as a kind of refuge. As a way to continue our way of harm reduction - and enjoyment.....

To me we are already in a "black" or "gray" market. If there is one thing that concerns me the most about all of this it's the current state of the E-juice market. For every one upstanding juice vendor who is putting out good product and trying to help their customers we have many more who are just cashing in. In the short time I've been vaping I have been astounded by how many vendors do not openly disclose their PG/VG ratios, address diacetyl or other harmful additives, or in general talk about what is in their juice openly on their websites or product packaging. We are in a market where more and more Facebook juice vendors are selling on name and hype without disclosing anything about what's in it.

And "made in somebody's bathtub" is something that could be argued here in my area. I've got two local places selling E-cig stuff. One of them is a grow your own gardening shop who sells second hand Ebay clearomizers along with their own juice line which was the most chemical laden vape I've had to this point. And another tobacco store who is much more helpful but also has 100s and 100s of e-juice bottles for sale, labeled only for flavor, and that have clearly been oxidizing in the sun for a very long time.

There is an awful lot of e-juice being manufactured in spare bedrooms and kitchens across America by completely untrained people hiding behind slick websites and social media marketing. To me this is the biggest danger to this industry. If the FDA was driving around my area collecting bottles to sample this would already be over and I'd be trying to figure what I'm going to do now that vaping is illegal.

 

[Danoman]

To me we are already in a "black" or "gray" market. If there is one thing that concerns me the most about all of this it's the current state of the E-juice market. For every one upstanding juice vendor who is putting out good product and trying to help their customers we have many more who are just cashing in. In the short time I've been vaping I have been astounded by how many vendors do not openly disclose their PG/VG ratios, address diacetyl or other harmful additives, or in general talk about what is in their juice openly on their websites or product packaging. We are in a market where more and more Facebook juice vendors are selling on name and hype without disclosing anything about what's in it.

And "made in somebody's bathtub" is something that could be argued here in my area. I've got two local places selling E-cig stuff. One of them is a grow your own gardening shop who sells second hand Ebay clearomizers along with their own juice line which was the most chemical laden vape I've had to this point. And another tobacco store who is much more helpful but also has 100s and 100s of e-juice bottles for sale, labeled only for flavor, and that have clearly been oxidizing in the sun for a very long time.

There is an awful lot of e-juice being manufactured in spare bedrooms and kitchens across America by completely untrained people hiding behind slick websites and social media marketing. To me this is the biggest danger to this industry. If the FDA was driving around my area collecting bottles to sample this would already be over and I'd be trying to figure what I'm going to do now that vaping is illegal.

I've seen that very thing too... even in the local vape shop, most of it has a perfume or soap aftertaste to it with just a hint of a flavor it's supposed to be. Not good at all. To him, it's more about sales than anything... which, in my opinion does us ALL damage as this is all across this nation. The quick buck scenario...

 

[Myk]

I believe there is hope of talking them out of that, hence not agree with those who express fear via messages of "there is no hope."



Heck, if you believe this, then we are nearly on the same page.



I'm of the opinion that we don't know if these items are included. To the degree they might be, I think a bunch of things but given reality of language in current proposal, I think it would be rather easy challenge if these non-nicotine items are included as tobacco products.

You are citing these as the problem and I'm saying I don't see them as the problem with current regulations. I will acknowledge they could be, but hard to say they will be and furthermore that if they are, it will be (certain) end to smaller businesses getting into the market.



I'm not (mainly) referring to personal problems in this thread. Not sure where you are getting that. If flavors are, according to you, not a problem, then I honestly see very little problem going forward. If you are saying those will get approved rather easily, without much fee, holy crap, will things get better financially in this industry. I actually don't even agree with this, but I like the sound of it.

I see you, and others, saying that the 'real problem' is given track record of FDA in approving ANY ecig product as 'new tobacco product' will be very costly. And because it will be costly, it'll price smaller vendors/manufacturers out. If we left it right there, and had discussion on that point and how we might go about addressing that, collectively, in our talking points to FDA (among other topics), then I'd not be in disagreement with anyone on this thread. Yet, if we are saying things like "no hope in changing FDA's mind" or "because all smaller business will be excluded, by design, the industry will die" or "regulations are only to protect BT's investment and anyone that concludes otherwise is plain wrong" then I may show up as challenging that, labeling it as counterproductive, so on and so forth.

Thing is, we are all saying a bunch of different things. You say flavors no problem. Next person that disagrees with what I'm saying here will say flavors have 6 components and each of those needs separate application and so business with 10 flavors must spend 20 million dollars to get all flavors approved, which is the problem Jman. How can you not see this?

To me the ambiguity vs. the anticipated heavy handed approach that many of us thought FDA would take on proposed regulations, is a good thing, in the short term. In 2013, I would've thought for sure heavy handed approach given countless discussions here and elsewhere. In early 2014, I would've thought heavy handedness for sure, given local bans galore popping up.

Now, I'm thinking FDA was tame, amendable and providing for reasonable framework, and that I think serves us going forward.

You're talking about what goes into effect. I'm talking about as written.
If we don't complain about how hopeless the proposal is for the ecig future we won't be talking them out of it.
As written the proposal kills ecigs.

There is no hope of talking government out of their stacks of paperwork. Paperwork reduction act is mentioned and then they go into talking 2100, 5000 and 125,000 hours of paperwork. This IS their reduced paperwork idea.
We may be able to convince them to not include everything separately. A Vamo is a Vamo, Kanthal is Kanthal, etc.
I hope to convince them the hardware can be covered with GMP. Once each ingredient is approved mixing liquids can be covered with GMP. But the FDA doesn't want to cover tobacco with GMP because they can't ban as easy doing that so it will be a tough job convincing them.
I'm not saying there's no hope, I'm just not holding out much hope because the FDA are ANTZ and ANTZ rarely change their minds.

We do know as written every item that goes into making up an ecig will need to be approved. Since those items are sold separately by the small businesses they will need to be approved separately. Since they are sold as a unit by the big corporations they will only need one approval.
If you want wick and wire you can still buy them for other purposes but when they are sold for ecigs they are treated as a tobacco product. It clearly says this.

I don't think anything will get approved easily outside of what the big companies want.

 

[DC2]

To me the ambiguity vs. the anticipated heavy handed approach that many of us thought FDA would take on proposed regulations, is a good thing, in the short term. In 2013, I would've thought for sure heavy handed approach given countless discussions here and elsewhere. In early 2014, I would've thought heavy handedness for sure, given local bans galore popping up.

Now, I'm thinking FDA was tame, amendable and providing for reasonable framework, and that I think serves us going forward.

I believe that the ambiguity is a smokescreen.
I believe the hint of possible concessions is a smokescreen.

And I think they are all very bad things.

The heavy-handed approach would have riled up the entire vaping world.
it was crucial for them to to avoid that.

And they left wide open the back door to let themselves in any time they want.
To do what they really intend to do.

If I was the FDA and I wanted to hand vaping over to Big Tobacco, I would have done EXACTLY what they did.
In fact, I can't even think of a single thing I would have done differently.

Some people think the FDA don't understand what they are doing here.
I think they know exactly what they are doing.

 

[Danoman]

You're talking about what goes into effect. I'm talking about as written.
If we don't complain about how hopeless the proposal is for the ecig future we won't be talking them out of it.
As written the proposal kills ecigs.

There is no hope of talking government out of their stacks of paperwork. Paperwork reduction act is mentioned and then they go into talking 2100, 5000 and 125,000 hours of paperwork. This IS their reduced paperwork idea.
We may be able to convince them to not include everything separately. A Vamo is a Vamo, Kanthal is Kanthal, etc.
I hope to convince them the hardware can be covered with GMP. Once each ingredient is approved mixing liquids can be covered with GMP. But the FDA doesn't want to cover tobacco with GMP because they can't ban as easy doing that so it will be a tough job convincing them.
I'm not saying there's no hope, I'm just not holding out much hope because the FDA are ANTZ and ANTZ rarely change their minds.

We do know as written every item that goes into making up an ecig will need to be approved. Since those items are sold separately by the small businesses they will need to be approved separately. Since they are sold as a unit by the big corporations they will only need one approval.
If you want wick and wire you can still buy them for other purposes but when they are sold for ecigs they are treated as a tobacco product. It clearly says this.

I don't think anything will get approved easily outside of what the big companies want.

I agree... unfortunately. The obvious intent is to make it as difficult as possible. I rebuild my wicks anyway and I can always go get kanthal wire by the spool, but most out there (commonly speaking) don't know how to make their coils. Where my curiosity sits is the companies that make our unflavored nicotine. Will the FDA require us, as individuals to have some sort of limit on even being able to purchase the unflavored nicotine we use for making our own juice...? If they do then, we ALL have a serious problem. If that's the case, I promise there will be a black market, at least in that area for certain. I know how to extract it from tobacco but, it'll taste like tobacco and would still have those tobacco chemicals in it, therefore nullifies ANY pureness of liquid that's made from an extraction. So, it'd be no better than just smoking an analog cigarette, in my opinion.