FDA FDA deeming regulation proposals

[mynewtoy]

I like this video of Gutfeld:

Gutfeld: Senate Democrats ignore science, block progress | The Five | Fox News

i just found out i love The Five on Fox news. Finally some common sense in the media and not just spitting out the fear mongering the fda is feeding them

 

[Sirius]

Stossel was the first one to support ecigs and vaping--three years ago:

Thnx Katya -- Yes he's about as amused as I am about how people just go along with these stupid bans. (the texting while driving is not a ban but a law here in Georgia. One I am glad passed btw.)
A new tyranny of kindness...I like that.

 

[Katya]

Arnold saved us then.

Who's going to save us now?

 

[Sirius]

Alexis De Tocqueville - "Democracy In America", 1840

A network of small, complicated rules. It does not break wills, but softens them. It does not tyrannize, it hinders, represses, stupefies, and finally it reduces each nation to being nothing more than a flock of timid animals, of which the government is the shepherd.

Nice find Katya!

 

[salemgold]

Oh no. The pro-FDA FAQ ECBlend had up expressing their "happiness" for the new regs immediately after they were released is now gone. 8-o

View attachment 330978

I guess somebody actually read them.

Buwhahahahaha!!! Now that is funny!

 

[Myk]

I passed that SBA thing off to ECIGattorney on Twitter to see what he has to say.

 

[NorthOfAtlanta]

Oh no. The pro-FDA FAQ ECBlend had up expressing their "happiness" for the new regs immediately after they were released is now gone. 8-o

View attachment 330978

I guess somebody actually read them.

Nah, they read this and found out that it was going to cost ~$334,000 per item, it wasn't posted until Monday.

http://www.fda.gov/downloads/AboutFD.../UCM394933.pdf

From Kent C's post on the Economic Impact Analysis thread:

pg 36

"The estimated cost of premarket tobacco applications for electronic cigarettes is summarized in Table 21. We assume in this analysis that there will not be any premarket applications for other types of products subject to the proposed rule.

Table 21 Costs for Premarket Tobacco Applications (Electronic Cigarettes or Other Novel Tobacco Products)

.................................First 24 months Lower Bound.....First 24 months Medium....First 24 months Upper Bound
Number of applications.............20....................... .................50............................... ...80
Time for submission (hours)......5,016................................ ...5,016..............................5,016
Total cost ($)..........................6,671,079............ .................16,677,698....................... 26,684,317

As usual, follow the money.

 

[Danoman]

So is freedom .. closer than the illusion of freedom big government is or would like imho.

I think you and I are going to get along... especially where this government and it's position are concerned. Lol

 

[Gato del Jugo]

Given Johnson Creek's response, they can't possibly believe the regs mean every, single flavor has a separate registration. I doubt even they could stay in business then.

Or they're wrong?

Or they figure they can make The One Approved Juice for tobacco owned vape like Blu (who they have an exclusive contract of some kind)?

Exclusive blu-supplier Johnson Creek isn't worried in the least bit.. That should tell people something right there...

And when the time arrives, I'm sure JC shareholders will have no issue with getting acquired by blu/Lorillard & cashing out at a nice premium...


As we already know, forced, extreme & sudden consolidation of this industry is not a good thing for vapers..

Just imagine BT monopolizing the nic base industry.. That alone should make everybody want to fight this thing...

 

[Gato del Jugo]

No, but they should. There are plenty of vapers out there who have no idea what is going on. And vendors who seem to be strangely apathetic...

Nothing wrong with customers putting a little pressure on their favorite vendors...

 

[Katya]

Nothing wrong with customers putting a little pressure on their favorite vendors...

No...

First casualty.

It's beginning already. Tropical Vapors closeout sale

FINAL Newsletter
After over two years of being in business, we have decided to pack it in and close the store. The regulatory environment is just becoming more than we want to deal with.
Jurisdictions across the country are proposing and passing laws targeted at vaping, that frankly we don't have the resources to keep up with. Now the state of Ohio has proposed a new excise tax (45%) on anything that is vaping related. Since the tax is based on wholesale price and not retail price it would be a nightmare to implement and monitor compliance. And Ohio is just one state. The complexity of applying this type of tax correctly, keeping the appropriate records for the tax man (or woman) and filing and paying the taxes across multiple jurisdictions is mind boggling.

Also, depending on how the law is ultimately written, it would make it very difficult for us to compete in the market with those online vendors, both US-based and overseas, that choose to ignore the regulations.

We believe in this industry and hope that the powers that be don't do anything to make it too difficult or expensive for you all to keep vaping.
We will still be open for a while as we close out our existing inventory. All warranties will be honored for products purchased prior to this announcement. The length and scope of the warranty in effect is based on the specific product as described in our terms and conditions.
But our loss is your gain. We have already sold some of our stock to local vape shops and are offering our remaining inventory at crazy, China-level prices on our web site.

This is just a small sample of some of our prices:
Tropical Vapors e-liquid - 5ml at $1.75, 30ml at $7.99
ECHO and EGO batteries starting at $7.99
High-quality 808 batteries (280 mAh) for only $7.99
Clearomizers for EGO and ECHO from $2.29
All of our thread adapters just $1.99
EGO Epower 18650 only $13.99
Vivi Nova Clones from $3.99
Kanger Protank 2 just $13.99
Five packs of all replacement coils (except Nautilus) only $6.99
Aspire Nautilus Tank - $25.99, 5 replacement coils $12.99
E-cigarette cases are just $3.49 and EGO lanyards for only $1.29
So stop by today at Tropical Vapors and stock up and save a lot of cash. Supplies are limited and some of it will go pretty fast.
We truly thank you for your business and all of your support over the past two years. I have really enjoyed interacting with all of you.

Please be sure to support your local Vape Shop and CASAA as they fight to keep vaping accessible.

Good luck and thanks again.

 

[Jman8]

Nah, they read this and found out that it was going to cost ~$334,000 per item, it wasn't posted until Monday.

http://www.fda.gov/downloads/AboutFD.../UCM394933.pdf

From Kent C's post on the Economic Impact Analysis thread:

As usual, follow the money.

I'm glad this other document exists (online). Takes a lot of the ambiguity out of the first (and main) document.

 

[pamdis]

Nah, they read this and found out that it was going to cost ~$334,000 per item, it wasn't posted until Monday.

http://www.fda.gov/downloads/AboutFD.../UCM394933.pdf

From Kent C's post on the Economic Impact Analysis thread:

pg 36

"The estimated cost of premarket tobacco applications for electronic cigarettes is summarized in Table 21. We assume in this analysis that there will not be any premarket applications for other types of products subject to the proposed rule.

Table 21 Costs for Premarket Tobacco Applications (Electronic Cigarettes or Other Novel Tobacco Products)

.................................First 24 months Lower Bound.....First 24 months Medium....First 24 months Upper Bound
Number of applications.............20....................... .................50............................... ...80
Time for submission (hours)......5,016................................ ...5,016..............................5,016
Total cost ($)..........................6,671,079............ .................16,677,698....................... 26,684,317
As usual, follow the money.

Keep in mind, that this chart is the estimated cost to the vendor to prepare one new product application. This has nothing to do with any fees that have to be paid to FDA.

 

[Jman8]

No...

First casualty.

... of the Ohio excise tax regulation/policy.

 

[Myk]

... of the Ohio excise tax regulation/policy.

I was going to say it makes no sense to close now for something that won't happen for at least 2 years and isn't even set in stone yet.

 

[Katya]

... of the Ohio excise tax regulation/policy.

If it makes you feel better.

The regulatory environment is just becoming more than we want to deal with.

War of attrition has begun. On all fronts.

 

[Gato del Jugo]

No...

First casualty.

Sounds like they're bowing out pretty early..

Which leads one to believe that there might be other issues behind the scenes there, totally unrelated to any looming regulations, that any non-vaping business can face...


What I'm saying is, there's nothing wrong with inquiring & trying to persuade somebody's favorite vendors to get a little more active in all this -- both for their current & future customers, as well as for the very survival of the business, itself..

I don't think it's unreasonable for some of the medium & larger-sized juice-makers out there to forfeit a small portion of their arguably high margins & instead direct it towards something that could very well save their long-term butts...


Of course, I'm sure there will be a few vendors out there who for whatever reason(s) totally disregard that line of thinking, which is their right, and decide to keep as much for themselves as possible while the going is still good, knowing they might be out of a job in a few years -- you know, because they decided not to fight ("ironically" enough)..

Obviously customers can choose to take their business elsewhere, in that case, if the vendor continuously refuses to lift a finger... And if customers do decide to move on, just make sure to let them know why you're going elsewhere.. Maybe after a while the biz will get the hint & change their tune...

 

[Katya]

Well, NN is doing just that:

http://www.e-cigarette-forum.com/fo...y-related-questions-here-31.html#post12970966

Repost from NN:

And in lieu of this past week's recent semi-disrupting news from the FDA, we want everyone to know that we a Nude Nicotine have prepared for this moment! The pharmaceutical style production environment and documentation we live by wont need much editing before submitting for applications from the FDA, but we are beginning to bring in outside auditing agencies to evaluate our market potential.

ECF houses a core of extremely valuable vaping activists who ACTUALLY VOICE THEMSELVES, and we couldn't be more appreciative of this fact. We'd like to extend a coupon code to you all in the hopes that you can give a few DIY supplies to a friend/family member looking to start their DIY adventure. Only in numbers can we bring to light how important this DIY community is

Use the coupon code DIYtillIdie15 for 15%-off the ENTIRE Nude Nicotine website, from now until Friday of next week (5/2)!

For now we all must continue to vape strong and support the DIY community by fighting for unflavored DIY nicotine solutions to remain available on the open market. Write to your congressman, comment on this post (Regulations.gov), and PLEASE voice your opinion that eLiquid DIY supplies, just like hand-rolling tobacco and other DIY tobacco items, must remain available to the public.

 

[Thundernoggin]

I was going to say it makes no sense to close now for something that won't happen for at least 2 years and isn't even set in stone yet.

True. But I can understand their less than optimistic outlook. I'm certain this is going to get nasty before it's over and I'm fairly certain sockpuppets are already in play. Too much money on the line. As a local retailer (of unrelated items) I can tell you things are already hard enough without the government bailing on again.

 

[Jman8]

If it makes you feel better.

War of attrition has begun. On all fronts.

But mainly on the state front is what they are specifically citing. IMO, that matters within context of this thread's discussion. The excise tax is significant issue and is arguably more pertinent, right now than what this thread's discussion is mainly about.

Now the state of Ohio has proposed a new excise tax (45%) on anything that is vaping related. Since the tax is based on wholesale price and not retail price it would be a nightmare to implement and monitor compliance. And Ohio is just one state. The complexity of applying this type of tax correctly, keeping the appropriate records for the tax man (or woman) and filing and paying the taxes across multiple jurisdictions is mind boggling.