FDA Personally unworried about the regulations

[zoiDman]

One thing I will not do is contain my own opinions or thoughts simply because others may wind up influenced to remain silent and sitting on their duffs doing nothing.

Unfortunately, this is what a Few Members on the ECF have started to Advocate.

That we Can't Win Anything, or that Writing Letters to Reps or Media Outlets doesn't Do anything. So we Shouldn't Do It.

 

[8dragon9]

Unfortunately, this is what a Few Members on the ECF have started to Advocate.

That we Can't Win Anything, or that Writing Letters to Reps or Media Outlets doesn't Do anything. So we Shouldn't Do It.

I do not advocate this at all, everyone can, and should do their part. One thing that I have had explained to me (true or not) is that whether the verbage itself is read or fully looked into, the in general consensus of how many people bother to write makes a huge difference when it comes to this type of legislature, if states and even larger forms of government see that there will be enough angry people if they pass a certain bill, do something to or for us, than it does factor in the decision making process. Look at what just happened here in my home state with bill S1035. None of us really expected that to go through, yet it did (which was a good thing)

 

[Maurice Pudlo]

If regulations become so much that vaping is not an option, I'm doing two things; a) lobby for even higher taxes on combustible nicotine and b) become a tobacco storage facility arsonist advocate.

MP

 

[zoiDman]

I do not advocate this at all, everyone can, and should do their part. One thing that I have had explained to me (true or not) is that whether the verbage itself is read or fully looked into, the in general consensus of how many people bother to write makes a huge difference when it comes to this type of legislature, if states and even larger forms of government see that there will be enough angry people if they pass a certain bill, do something to or for us, than it does factor in the decision making process. Look at what just happened here in my home state with bill S1035. None of us really expected that to go through, yet it did (which was a good thing)

I agree.

California AB-1500 was an Excellent Example of this.

http://www.e-cigarette-forum.com/fo...ipping-bill-ab1500-assigned-committee-24.html

 

[aubergine]

I like the serenity prayer.

The courage to change what can be changed.
I think that we might be able to at the very least significantly modify the blow here. We have some strong players on our side and some of the indifferent persons holding power may be swayable. Others may not have come out of the woodwork yet. Much public opinion is probably on our side, media blitzes notwithstanding, and as vaping and its benefits become more familiar I think that there might be significant push from that direction. The truth is on our side, and both individual rights and public health are at stake. Studies supporting e-cigs for harm reduction are circulating more than ever. So I think there's a chance that we can change things - and thus reason to be clear on the enormous threat, take it seriously, and take action.
If it's really a done deal and doom is certain (doom as inferior ecigs produced by tobacco companes the only game in town, and those under continuing threat), which I don't buy yet, or I wouldn't bother), then

Serenity to accept what can't be changed.
I'm not ready for that one yet. We haven't met the wall yet, and how this unfolds will reveal itself over the next few years, not weeks.
And I think that the community is struggling with

The wisdom to know the difference.

If it's gonna happen big time no matter what we do, then it makes sense to accommodate reality and keep plugging away. (Or rant bitterly, if that's your thing.) I guess I'm still optimistic, in that sense. Otherwise I'm not going to give my afternoon to working up FDA comments & etc.; it'd be pointless. Hope keeps the wheels turning.
I've lost plenty of causes dear to my heart; I've also seen some that were dear to my heart and apparently doomed suddenly reverse. It's not really always a predictable world.

I think we need to be careful not confuse sturdy optimism (needed) with sanguine indifference or a realistic appraisal of the seriousness of the threat (also needed) with pessimistic defeatism.

 

[dragonpuff]

I reiterate, I have hope because I've done something, because many of us have done something. We all need to make sure that politicians know we care about e-cigarettes and our access to them in order for the regulations to be revised in a way that is less harmful to us. Unfortunately, when people believe there is no danger, they are unlikely to prepare for it. I am guilty of that as well. So in order to not worry, we all need to stay on top of this situation and do what we can.

Thanks for the response. In fairness to you, I have heard this basic rational from a number of B&Ms I have visited. We have over 50 in Vegas and while I have not yet visited all of them, I have spoken to about a dozen owners/prinicipals/investors in person. When I visit, I bring my sites business cards, some material from CASAA and the actual FDA regs. I also disclose that I am a former angel investor in two B&Ms, I am not an attorney and or CPA and as I state, I encourage folks to seek a diversity of opinions. I currently have zero connections to the industry and clearly state this. Hers is my takeaway from those instances where I received similar responses to yours and I'm not pointing at you, only posting my takeaways from direct face to face conversations with owners/principals and NOT employees.

1- NONE had obtained legal advice in writing from a qualified attorney. This is always my first recommendation
2- Some owners/principals/investors had not read the deeming
3- Some where simply "spinning" the issue so their employees did not freak out
4- Some in private had a general same page view as myself BUT intended to make as much money as possible up to the very end and then vanish.
5- Some continued to "spin" me which to a certain degree is understandable. Believe it or not, one of these habitual spinners finally got religion and made a contribution to one of the activist organizations. THAT made me very happy

In conclusion OP, have the owners/principals in your company obtained a written opinion from a qualified attorney which you have read and which supports your current views?

^ This

My fellow dragon PLEASE talk to your employer about seeking consult from an attorney who is experienced in these matters, if he hasn't already.

 

[8dragon9]

My fellow dragon PLEASE talk to your employer about seeking consult from an attorney who is experienced in these matters, if he hasn't already.[/QUOTE]

 

[8dragon9]

darn it... In regards to that quote. Its a step worth taking, ill be getting on it.

 

[Jman8]

Unfortunately, this is what a Few Members on the ECF have started to Advocate.

That we Can't Win Anything, or that Writing Letters to Reps or Media Outlets doesn't Do anything. So we Shouldn't Do It.

Really, you've seen someone do this on the FDA issue, or with legislative bodies? Pray tell, who are you referring to?

 

[pamdis]

I don't see flavor selection getting smaller, 36mg is what it looks like for a cap on nic strength, Liquid should remain a liquid, and I am entirely unsure where someone pulled 330k out of their .... for FDA registration on liquids...Thats just simply not how it works for larger companies. Once blanket policies go into affect its not going to cost 330k damn dollars for John Q liquid maker to register liquids. Things will settle down, this is pretty common politics (or like haggling at a garage sale) Hit everything with the biggest baddest worst case scenario that way once negotiations and amendments etc etc etc settle down you wind up where both parties are fairly happy with the final outcome.

The $330k is not to register the product. There are no registration fees. This number is the estimate that FDA put on the cost for a vendor to create a product application.

The fact that you don't know where this number came from or what is for tells me your non-worry may be slightly misplaced.

 

[Robino1]

For those of you that aren't worried about the availability of vaping as we know it, think about when the government started to get involved with smoking. First they said you can only smoke in certain sections and they put a small tax on cigarettes. Hmmmm that made them some money. The smoking sections got smaller and bars were required to put in costly smoke eaters in to take care of the smoke. Taxes were raised on cigarettes and then the states decided to get into the action.

So now we are at the point when they decide to make the smokers go outside. We complied. Then they said that we had to move to so many feet away from the door. Ok....we complied. Then they said that OMG! we couldn't smoke OUTSIDE in National Parks. Then employers got involved and so did the insurance companies. Hey, there is money to be made here!! If you smoke, we raise your rates. Easy peasy money. Now employers are thinking hmmm, ok. If it works for the insurance companies how about if we make a policy that if you want to work for us, you have to be smoke free. (This IS happening in the health care field all over).

Did any of us fight those small regulations? I know I didn't. I honestly didn't think it would go that far.

Yeah, I don't trust the government to be fair in any 'regulation' they have in mind. It will start off slowly and build from there. I will not roll over this time.

 

[SeniorBoy]

The $330k is not to register the product. There are no registration fees. This number is the estimate that FDA put on the cost for a vendor to create a product application.

The fact that you don't know where this number came from or what is for tells me your non-worry may be slightly misplaced.

Thank you! And since it's an APPLICATION the FDA can unilaterally EITHER deny (byby moola), suspend, approve, or take years to reach a final conclusion. It's as written non refundable! And their in lies the "rub" weather it's ultimately 100K or 300K (rounded).

BTW OP, I complied with your wishes and sent you my Yes or No question via PM but you chose not to respond to me but at least you responded in this thread so your answer was NO!

Good luck!

 

[Steamix]

"You can have your T-model on any color. As long as it's black" - Henry Ford

Problem with regulations - any regulations - is that they tend to develop a life of their own. Providing jobs for bean counters to implement them, change them, update them and of course sanction those not abiding by them. Cushy jobs all around. Even more cushy jobs when the regulations are crafted into some legalese jive that needs a batallion of lawyers to make sense out of it. Examples of regulations with adminstrations bloated to the point of non-functionality are abundant. Declaration of Independence, the Constitution...all pretty straight-forward texts. Goes rapidly downhill after that.... The Ten Commandments fit on a scrap of paper. The regulatory paperwork to observe to build a humdle dewlling for you and your family fills a bookshelf....

What makes you think that regulations aimed at all things vaping are going to be different ?

Been away to shangri-la-la land long ?

 

[zoiDman]

Really, you've seen someone do this on the FDA issue, or with legislative bodies? Pray tell, who are you referring to?

The Internet is a Funny Place. I have heard people say All Kinds of Bizarre Things.

Like we should Impersonate ANTZ and then Join Anti e-Cigarette Crusades. Or that there should be No Age Limit for Kids Buying e-Liquids.

 

[potholerepairman]

The Internet is a Funny Place. I have heard people say All Kinds of Bizarre Things.

Like we should Impersonate ANTZ and then Join Anti e-Cigarette Crusades. Or that there should be No Age Limit for Kids Buying e-Liquids.

Their are some crazy folk for sure, luckily we have the sane but in the present form of litigation,I hope its enough.Ty.

 

[zoiDman]

The $330k is not to register the product. There are no registration fees. This number is the estimate that FDA put on the cost for a vendor to create a product application.

The fact that you don't know where this number came from or what is for tells me your non-worry may be slightly misplaced.

Another Thing about that is, as I Understand it, is that Each Product will have to have it's own Application.

So if I want to sell a Cherry e-Liquid, I need to spend they 100 ~ 330K. Another 100 ~ 330K for Cola. Now I have 2 FDA Approved Products.

But If I Now want to sell Cherry-Cola, using the Same Ingredients, I need to do it All Over Again. Spending another 100 ~ 330K.

And BTW. There is No Guarantee that my Application will be Approved. Because some Pin Head at the FDA may say that Kids Like Cherry-Cola.

What would seem more Equitable is to Consider Flavorings like in Foods. Once a Flavoring has be deemed GRAS, then Anyone can Use that Flavoring.

And if No Harmful Interactions are found between Cherry and Cola flavorings, and both have been deemed GRAS, then Anyone should be able to use that Combination Also.

Or Cherry-Chocolate. or Cherry-Banana. Or Cherry-______

But that gets back to that Pin Head at the FDA saying what Can and Can't be Sold do to what might Appeal to Kids.

Don't get me Wrong. I am a Stanch Believer that e-Cigarettes should Not Be Sold to Anyone Under 18 Years Old. Just Like with Regular Cigarettes and Other Tobacco Products.

I just think the FDA is going to use the Boxer, Diane F, Harkin mantra of "Only Kids like Flavors" against us.

 

[dragonpuff]

I'm not sure where the exact figure of $330,000 came from, but it is true that the cost of filing a premarket approval application for a drug or medical device has always been prohibitively high. The FDA states in the deeming regulations that every new tobacco product will also have to file a PMA, or they will have to file for substantial equivalence if the product is incredibly similar to one that has already been approved or was on the market before 2007 - in other words, ALL e-cigarette devices that aren't cigalikes will have to go through filing a PMA. PMA procedures and fees haven't been defined specifically for tobacco products yet, but I expect they will be similar to that of medical devices and pharmaceuticals. Here is a link to the FDA's summary of fees for medical devices as an example of what we might expect:

PMA Review Fees

Notice that in some instances a waiver is given, but that doesn't apply to all fees, and each of them number in the thousands.

When the deeming regulations were first written, it's clear that the FDA didn't really have an understanding of what they are - the whole thing is written as if all e-cigs are disposable cigalikes, composed of one solid piece. Many people here have argued that the e-liquid will be regulated as tobacco while the rest of the components will be deemed accessories and unregulated, but they can still turn around and say that tanks and batteries serve as drug delivery devices so we really don't know. If they do that, given the way that the e-cigarette market is with interchangeable parts being sold separately all the time they may require applications for separate parts. All we know is that we really don't know, and neither do they.

As far as liquid is concerned, once it is approved within a certain range of doses, certain additives can be approved for use in it, and then any flavoring that falls within this range of additives can be used as flavoring. So it's highly unlikely that, if they allow flavors, they'll require a separate PMA for each one.

 

[zoiDman]

I'm not sure where the exact figure of $330,000 came from, ...

I believe it came from this...

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

ETA: Here is a Thread where the Potential Costs were Discussed.

http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html

 

[zoiDman]

BTW - e-Cigarettes are not being defined as a "Medical Device".

So I Don't believe those PMA's are Applicable.

 

[dragonpuff]

BTW - e-Cigarettes are not being defined as a "Medical Device".

So I Don't believe those PMA's are Applicable.

I know that, they haven't defined the premarket applications for e-cigarettes yet. Scratch that, I was wrong. I was using medical devices as an example of what we should expect to see. I'll go back and edit that post to make that more clear...