FDA FDA deeming regulation proposals

[Kent C]

In the same way that you seek to squelch any message that you deem as 'fear mongering'? Is that the sort of control you speak of?

I now call you out...I mean...I call your posts that use of that term out for what they are in my eyes: thinly-veiled attacks on a fellow vaper's honest reactions to bad regulations placed on us all by unelected bureaucrats.

I think their reactions, even if some are positions l disagree with, are heartfelt and genuine expressions of vapers. They are not attempts to control anything, in my opinion.



Roaring thunderously via Tapatalk...

Who else is using 'fear mongering' and 'wild west' in their commentary?

 

[Myk]

And I'm calling this "fact" fear mongering.

Thing about 'fear mongering' and politics, is the mongering could end up being correct. In this case, I don't believe it will. I feel very confident it will not be. But I don't know, and I find this assertion of (alleged) fact to be counterproductive to where we are today.

FDA seeks comments on streamlining approval process. That may be a great thing. That may be way to get all products (by any sized vendor) approved and able to be legally sold forever and ever. If I say, "it is a fact that every small business will meet these regulations and have products approved and available for legal purchase," that would be the opposite of what you are purporting. I would call that "wishful thinking" and plausibly, very misguided.

I think reasonable people feel it'll be somewhere between these two realities. But us otherwise reasonable people are able to prop FDA up as boogeyman that regardless of how wonderfully intellectual, persevering and honest / respectful we are in our approach to reasonable regulations, FDA could, theoretically, play hardball and regulate the industry out of existence. Very challenging to argue with one that holds that bias. Argue enough with someone that has that bias and there can be no other 'reasonable' conclusion than you are a BT shill and are part of the grand conspiracy to kill vaping.

IMO, we have grand opportunity to shape policy going forward. Will we get everything we want? I say no. If you are expecting that and will be .... hurt if you don't get all that you want, get out now. Run! If able to accept certain things, while also willing to fight indefinitely on other things, which may or may not be part of a black market, then you're good to go.

You're a small business. You're clearing $20K-$50K. You have a family to feed and think about.
HOW are you planning on coming up with this $100K-$1M to sink into getting ONE single item applied for with no guarantee of approval and no refund? With FDA's history of tobacco approvals you're most likely throwing that money away.

Getting everything I want or being .... hurt has nothing to do with the fact that as written there will be no small businesses able to meet the proposed rules and no small upstarts if they pass.
If anyone does start up a new ecig business it will be like what I figured up to go pro for winemaking, it would cost me more than $3,000,000 to get started. Hardly a small upstart. The fees were so great that I had to keep bumping it up to the next level to make it pay for the investment.
The problem with the FDA proposal there is never any point where they stop increasing so the business can increase their profit margin to pay for the regulation.

 

[EddardinWinter]

Who else is using 'fear mongering' and 'wild west' in their commentary?

I have seen no others in this thread.

Have you?

I do not mean to imply Jman is an ANTZ. I can assure you, he is not. He is not a bad person at all, in fact, I have fought many an issue by his side on this forum. I respect him a great deal. This one disagreement won't change that.

I simply see his use of this term as inappropriate in this case. I am truly baffled by it.



Roaring thunderously via Tapatalk...

 

[Myk]

Illinois has a statewide ban against the sale of nicotine under "safe packaging to protect children" until ... forever? Who knows when their health dept will get around to writing those regs up.

No we don't. It's on my other computer but last I checked (recently) it seems the bill has died in the senate. It hasn't moved at all since it was assigned to committee. Granted it's only been a month and it's between sessions but generally if a bill is going to go they don't stop moving around. Perhaps our letters did something.
Perhaps they'll try to sneak it through now with the focus on the FDA when they come back for the next session. Perhaps the FDA moving will get them figuring it's a waste of time.
But as for now it has not passed and even when it does it probably won't get signed until August I think.

And the claim is it won't ban liquids until Health Dept comes up with the rules.

 

[Jman8]

You're a small business. You're clearing $20K-$50K. You have a family to feed and think about.
HOW are you planning on coming up with this $100K-$1M to sink into getting ONE single item applied for with no guarantee of approval and no refund? With FDA's history of tobacco approvals you're most likely throwing that money away.

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.

The problem with the FDA proposal there is never any point where they stop increasing so the business can increase their profit margin to pay for the regulation.

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

 

[Danoman]

Jman...

"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."

I believe we are going to see a LOT of this happening... (gut feeling) *yeah, seriously...* The COST of flavor submitting is why, and they know that a small business just can't comply with financial requirements like that.

 

[Katya]

Who else is using 'fear mongering' and 'wild west' in their commentary?

Stanton Glantz (I believe he actually coined the term "wild west").

I also heard it used several times on NPR and in mainstream press. Also on this forum (both "fear mongering" and "wild west"). I was personally accused of "fear mongering" yesterday by tombaker.

I could do a search, if you want me to.

 

[Uma]

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!

 

[Rossum]

Wait, "unregulated" equals "unauthorized"?

In effect, yes.

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'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.

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.

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.

IMO that plan can only succeed if eJuice is either outlawed completely or taxed to the point where you can undercut the vendors with legitimate product by a substantial amount while still making big margins yourself.

 

[mkbilbo]

Stanton Glantz (I believe he actually coined the term "wild west").

I also heard it used several times on NPR and in mainstream press. Also on this forum (both "fear mongering" and "wild west"). I was personally accused of "fear mongering" yesterday by tombaker.

Well, your avatar is "cute mongering"!

And what IS "mongering" anyway? A pawn in game of life?

(Sorry, hyperventilating makes me giddy)




(Wait, you know Doctor Who?)

 

[Katya]

 

[Danoman]

Yes, Dr. Who rules...!!! (he'd do this the right way and just leave it alone, if he could...) LOL

 

[mkbilbo]

Jman...

"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."

I believe we are going to see a LOT of this happening... (gut feeling) *yeah, seriously...* The COST of flavor submitting is why, and they know that a small business just can't comply with financial requirements like that.

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?

 

[Devonmoonshire]

Yes, Dr. Who rules...!!! (he'd do this the right way and just leave it alone, if he could...) LOL

Heck yeah and then take a vape off his sonic screwdriver

 

[Jman8]

Jman...

"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."

I believe we are going to see a LOT of this happening... (gut feeling) *yeah, seriously...* The COST of flavor submitting is why, and they know that a small business just can't comply with financial requirements like that.

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.

 

[badwolf91]

dr who's sonic screwdriver is totally a futuristic PV, with additional accessories added

 

[mkbilbo]

I'd say he could give the FDA a good sonicing but it don't work on wood...

(Boom tish!)



(Hey... "mongery" is a word. Must work that into conversation.)

 

[Danoman]

*sorry, the fingers did it... not me* Hahahaha...

Honestly, I think we should all just loosen up a bit... present ideas, become closer as a group and just be prepared. Allow the CASAA (in which i'm a member of too) to do their thing on the legal basis. WHEN we are all called to action, THEN we can all speak in a uniform way. We are all going to have differences. (It's a good thing) It's no different than us all liking different flavored juices. But, if/when it ever came together that we individually can't enjoy those 'different' juices are infringed upon, then we can speak in one VERY loud voice that the government work for the people instead of the government telling us what we can and can't do.

Speaking of, we have mid-terms coming this year. I think it'd be a good idea to ask all of those running on THEIR opinion when it comes to our industry. Congress are the ones who can legally make the laws only... this may matter as they would be in office, given the time frame we'd all be looking at before the hammer came down. I'd suggest, it'd be a good idea to ask, write letters and question THEIR stance on vaping, then hold them to the fire when that time came.

 

[TotlKaos]

This is my take on the "deeming". Seeing that it costs hundreds of thousands of dollars to get something even in front of the FDA's eyes not even knowing if it will be approved - (I have done work for companies that all they do is help you PREPARE the paperwork for the FDA and charge almost a base cost of $50,000 - Just for the paperwork!).
PV's... will come with flashlight attachments on the top. They screw into the 510 Connector. Just unscrew it and put on your Tank or RBA/RDA. Remember these items started as Flashlights and can easily be disguised as one again!

RBA / RDA's will stay the same as they can be labeled as anything really. Also since they do not come setup and ready to work it will need a burden of proof for what it is for.

Tanks - Most likely the easiest way is to sell them without coils or with manually built coils. Since they are non functioning as sold they cannot be construed as a E-Cigg device? (Maybe I'm wrong)

E-Liquid, possibly being sold with 0 Nicotine in all of them. And purchase Nicotine base and adding that yourself. Personally I can't see how they can do anything to the E-Liquids that have no nicotine - as this is what they are trying to say gives them power over the e-cigarettes as a "nicotine delivery device"

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!

 

[Katya]

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

We need to remind them that some of the best American inventions started in people's garages.