FDA Deeming updates VTA issues FDA regulations calendar

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crxess

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And the Exidous is already starting
WE ARE DOWNSIZING! We will no longer be a brick and mortar shop as of Jun 1 2016. A new website will be launched and we will be a Delivery and Pickup Only. Due to new FDA regulations and no clear indication which way they will fall I don't think a location move and new lease would be wise. This doesn't mean that Fog Bank Vapes is going out of business! We will just be using a different business model. Starting today (5-13-16) our juice will be 50mils for $15 and 30mils for $10 through the remainder of the month (5-31-16). This includes any specialty made juices. Starting tomorrow (5-14-16) all other products will be heavily discounted.

Change in Business plan with the ability to shut down, if required, with minimal loss. :(
 

skoony

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I am wondering, wouldn't it be easier for a supplier to get one level of nic plain approved say something low like 6 nic or 10 nic. If approved it only has one nic level and Pg and VG added. Then sell flavor shots of favorite recipes. The flavor shots would not have to be approved would they? Since the flavor shots are pure flavoring blends, wouldn't they be exempt??
No. Any thing that can be reasonably assumed to be used in a finished tobacco
product is a tobacco product and must be in compliance with the regulations and,
of course is up the the sole discretion of the FDA.
(insert emoticon of a balloon being shot out of the air)
Mike
 
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Kent C

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I am wondering, wouldn't it be easier for a supplier to get one level of nic plain approved say something low like 6 nic or 10 nic. If approved it only has one nic level and Pg and VG added. Then sell flavor shots of favorite recipes. The flavor shots would not have to be approved would they? Since the flavor shots are pure flavoring blends, wouldn't they be exempt??

See this:

Deeming Regulations have been released!!!!

"Specifically, “Component or Part” means “any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.

(including e-cigarettes): E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software.

The key is 'intended or reasonably expected' use. So within the same shop or website any flavors would be 'reasonably expected' to be used for human consumption of a tobacco product. IF there were a separate website that had no sign that the flavors would be used for eliquid - say, blurbs about how they are used for food flavoring instead, then perhaps a company could pull that off - but it may have to be a totally separate company than the one that sold ecigs stuff.
 

crxess

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I want to know just what this means:

However, stores have to comply with the rule in about three months (90 days from its publication May 10), and Zeller says contractors tasked with enforcement will be ready to “hit the ground running” on Day 91.

New FDA regulations for vaping

Do I need to start Digging the Moat? o_O
Can anyone Spare some Razor wire?:eek:

And the most OVER USED LINE in the FDA's Bag of CRAP


From a health perspective, to reduce the social acceptance of them is good because frankly, it’s the wild, wild West out there,” she says. “Vape stores are everywhere.”
Not one of these Fools was around to have a Clue what the West was like.:grr:

“What I don’t understand,” he says, “is why they gonna go and make up laws that you can’t enforce? Look at all the bus stops in the morning and all you see are kids smoking cigarettes! The way I see it, nobody’s gonna enforce vaping either.”
:cool:
 
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skoony

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I want to know just what this means:



New FDA regulations for vaping

Do I need to start Digging the Moat? o_O
Can anyone Spare some Razor wire?:eek:
I believe but am not certain this in relationship to B&M's hand mixing
e-juice on the fly behind the counter. Although I believe that it can
be done with a little practice and achieve a result that most of would
not be able to notice any appreciable difference the FDA believes this
constitutes a new tobacco product each and every time if not done
at the sub atomic level or whatever standard they don't have or will not
inform the pertinent parties the details of.
Mike
 

Eskie

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See this:

Deeming Regulations have been released!!!!

"Specifically, “Component or Part” means “any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.

(including e-cigarettes): E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software.

The key is 'intended or reasonably expected' use. So within the same shop or website any flavors would be 'reasonably expected' to be used for human consumption of a tobacco product. IF there were a separate website that had no sign that the flavors would be used for eliquid - say, blurbs about how they are used for food flavoring instead, then perhaps a company could pull that off - but it may have to be a totally separate company than the one that sold ecigs stuff.

Just to pull this particular section out:
"(including e-cigarettes): E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software." (emphasis added by me)

The issue of trying to regulate electrical/electronic components might very well be a legal flaw in this regulation. How can you extend regulation to components such as batteries or digital displays that can have multiple uses? And if the definition of a component or part is intended or reasonably expected, then wouldn't that properly extend to a Bic lighter or even the book of matches you get when you buy a pack of cigs? Sure, they have other purposes, but as they are routinely obtained at the time of a tobacco product purchase, there is certainly a reasonable expectation that's what they'll be used for, so wouldn't the same regulations apply? Maybe they'll sneak in under the 2007 grandfather clause, but think, no more innovations in lighters or matches going forward.

It seems like the number of contortions they've gone through to create these regulations with the hopes of avoiding any loopholes to allow vaping products to exist might very well be the best argument to challenge them on. How many more unintended consequences and reach beyond just vaping a nicotine e-liquid will turn up the longer this 500 page regulation is studied and reviewed?
 
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mostlyclassics

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It was my Understanding that before a Major Rule, such as what the FDA is making, could be Finalized that it had to be Reviewed by BOTH Houses of Congress.

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

U.S.C. Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

I have brought this Up in a Few Threads. But No One seems to be Able to confirm this.

ZoiDman, theoretically both houses of Congress do have to review the regulations before they become law. But I read somewhere that, out of the 3,000 or so piles of regulations proposed since that law was passed, only a couple were bounced. The rest were rubber-stamped into law.
 

zoiDman

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... How can you extend regulation to components such as batteries or digital displays that can have multiple uses? And if the definition of a component or part is intended or reasonably expected, then wouldn't that properly extend to a Bic lighter or even the book of matches you get when you buy a pack of cigs? ...

JMO, but I believe that much will have to do with How a Product is Branded, Labeled, Marketed and or Advertised.

I understand everything you Mentioned in your Post. But consider this that I posted in another Thread...


I have said Many Times that much will have to do with how a product is Marketed/Advertised.

Take 3 Spools of the Exact Same Wire...

26Nichrome100_1024x1024.png

Easy for the FDA to Regulate with the word "Vapes" on the product.

---

51FLWR1nlkL._AC_UL320_SR274,320_.jpg


Perhaps not as Easy. But Intended use thru the use of Clouds on product?

---

nichrome1lb_03.jpg


Almost Impossible for the FDA to Regulate if sold from a Site that has No Association to Tobacco or Vaping.

This is All the Same Wire. But the Top Two Spools come from a Company that Exclusively sells Vaping Products. Where as the Bottom Spool comes from a Company that sells Hundreds if not Thousands of Line Items for the Manufacturing Sector.
 

zoiDman

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ZoiDman, theoretically both houses of Congress do have to review the regulations before they become law. But I read somewhere that, out of the 3,000 or so piles of regulations proposed since that law was passed, only a couple were bounced. The rest were rubber-stamped into law.

That's Fine. If it is Going to be Rubber Stamped, then it is going to be Rubber Stamped.

I would just like to see a Physical Floor Vote done in Both Houses then. So the Voting Public, especially those 5 ~ 12% of the Entire US Population, can see how their Rep(s) voted on this.
 

Kent C

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How can you extend regulation to components such as batteries or digital displays that can have multiple uses?

By selling it side by side with other vaping products. No questions would be asked of a Radio Shack. Only a "Vape Shack".
 

Eskie

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JMO, but I believe that much will have to do with How a Product is Branded, Labeled, Marketed and or Advertised.

I understand everything you Mentioned in your Post. But consider this that I posted in another Thread...

This is All the Same Wire. But the Top Two Spools come from a Company that Exclusively sells Vaping Products. Where as the Bottom Spool comes from a Company that sells Hundreds if not Thousands of Line Items for the Manufacturing Sector.

I do understand your point, which is what a reasonable person would conclude. But in the regulation, they state “any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product." There is no mention regarding the branding, labeling, or advertising in their definition of a "Component or Part". There is quite a bit specifically in the regulation regarding advertising, claims, and labeling, but not in this definition. Relying on the current description of a Component or Part, it is conceivable it can be applied on parts not necessarily labelled as for vaping use only, as they added the reasonably expected to the definition. That's a lot of wiggle room for an enforcing agency to play around in, which seems to me way overreaching any authority they were granted in regulating tobacco products.

Then again, there is little information on just how they will go about enforcement, so I guess we'll have to wait and see how they apply it.
 

zoiDman

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I do understand your point, which is what a reasonable person would conclude. But in the regulation, they state “any software or assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product." There is no mention regarding the branding, labeling, or advertising in their definition of a "Component or Part". There is quite a bit specifically in the regulation regarding advertising, claims, and labeling, but not in this definition. Relying on the current description of a Component or Part, it is conceivable it can be applied on parts not necessarily labelled as for vaping use only, as they added the reasonably expected to the definition. That's a lot of wiggle room for an enforcing agency to play around in, which seems to me way overreaching any authority they were granted in regulating tobacco products.

Then again, there is little information on just how they will go about enforcement, so I guess we'll have to wait and see how they apply it.

And This is Why people are Filing Injunctions against the FDA. Because it is Over-Reach in Many peoples Mind.

And to Me, it is Unacceptable to write a Federal Rule, one which States will have to Abide By, where the Reasonability is Dependent on Non-Enforcement.
 

Eskie

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And This is Why people are Filing Injunctions against the FDA. Because it is Over-Reach in Many peoples Mind.

And to Me, it is Unacceptable to write a Federal Rule, one which States will have to Abide By, where the Reasonability is Dependent on Non-Enforcement.

I absolutely agree. And it will be sections just like this one that can illustrate how unreasonably overreaching the regulations are. And it is sections like this that will keep it tied up in litigation for many years. It's just too bad all that money will go into legal fees instead of new product innovation.
 

crxess

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We do all know - THEY - are likely reading all of this, right? o_O

That said - :censored: FDA

Time to check in on the March on DC thread.......see if they plan on changing the Title to Silver Spring :oops:

Personally, I believe we need to be at the Nations Capitol, the FDA is set in their decision. We need to focus on those which MAY be willing to listen.:glare:
However, it almost takes an act of congress and a years wait to get a Permit in DC.:grr:


ETA: never take the scenic Route:

To get the FDA’s permission, an applicant must demonstrate that its product will not only “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users” but also “benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”

:ohmy:
 
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bnrkwest

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No. Any thing that can be reasonably assumed to be used in a finished tobacco
product is a tobacco product and must be in compliance with the regulations and,
of course is up the the sole discretion of the FDA.
(insert emoticon of a balloon being shot out of the air)
Mike

So even something not related to vaping like cotton, if sold in a tobacco/vape shop is considered a tobacco product. This is so insane do they regulate cotton filters on cigarettes? They are part of the finished product yes, but the cotton filter is not the tobacco part, neither is the paper. It is getting so crazy insane it is really hard to follow. Did the cotton producers have to get permission to sell their cotton for filters to cigarette companies?
 

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There will be some increase in jobs - DEA, ATF, FDA enforcement of the black market. Local Police for drive-bys, snitches, CI's, more prisons, prison guards, etc. etc. :- )

I thought about this topic on my glorious, stunningly beautiful Carolina Blue Sky day with a cool breeze but a warm sun.....you get the picture, it was a 10 for weather. I doubled down and went to the U Joint for a spicy black bean quesadilla and a Bloody Mary, perfect.

Then wandered again to the topic and one thing is very clear, as you said. Law enforement, lawyers, judges, jailers and prison supply house will all have a tick up in business. Millions, maybe billions will be spent on the "crack down" and for what? What have they made illegal successfully in the past? How many times have they said oops, our mistake, we were wrong. They are wrong a lot.

My brain can't get around the fact that alcohol and tobacco cigarettes are still legal. IF they think with all the laws, ID's and policing has successfully keep underage children from having access, well I don't want to be the one to tell the, their efforts are fruitless.
 

Kent C

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How many times have they said oops, our mistake, we were wrong.

One significant time - Prohibition. When there was such a demand for the product, that no amount of lies would stop the black market from thriving. In the process, they enriched neighborhood thugs who only ran the numbers market in their cities, to be able to create Las Vegas, and the organized crime racket we all have come to know and love :nah:

It's great to see you again AJ..... :toast:
 

bnrkwest

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I have visions of Vape speak easy's, password is Smooth Nick. If you order Ice Tea 6 that is code for 6 Nic Tea flavor e juice ;) you order Lemonade 12, you get lemonade flavor 12 Nic juice. LOL Or maybe it will a bakery with a "back room", password Betty Crocker :)
 
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