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Christopher

FDA Deeming Regulation - What we know so far

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Hey Vapor Talkers, 

So as most of you have probably heard by now the FDA has release their deeming regulations for electronic cigarettes. It's extremly broad and a potential devastating blow to the industry. Especially for small to medium sized vape shops that produce their own hardware or e-liquids. I'll leave my own opinion out of the top post and reserve this for the most current information. There seems to be a lack of simplified summaries so I'll do my best, with what we know so far, to explain the situation.

Please see updated thread here: 

 

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So many outlandish changes all at once is just too much to take in. Thanks, Chris, for the summary of the long document full of legalese.

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I have heard various numbers for the application cost, it seems to have everyone perplexed at the moment.

If you are a supplier, please join SFATA. http://sfata.org/

All consumers should either join or keep an eye on Casaa. http://www.casaa.org/

Both these groups will keep you informed and tell you when, where and how to act to save the vaping industry.

Right now the two most important things we can do is write or call our reps to support the Cole-Bishop Amendment and HR 2058. Both of these provisions are set up to change the February 2007 grandfathered date the FDA has set.

The cigar industry is also included in the FDA deeming regulations. They are pretty pissed. Check out Youtube for their reactions.

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3 hours ago, BirdDog said:

I have heard various numbers for the application cost, it seems to have everyone perplexed at the moment.

If you are a supplier, please join SFATA. http://sfata.org/

All consumers should either join or keep an eye on Casaa. http://www.casaa.org/

Both these groups will keep you informed and tell you when, where and how to act to save the vaping industry.

Right now the two most important things we can do is write or call our reps to support the Cole-Bishop Amendment and HR 2058. Both of these provisions are set up to change the February 2007 grandfathered date the FDA has set.

The cigar industry is also included in the FDA deeming regulations. They are pretty pissed. Check out Youtube for their reactions.

Well said, complacency among vapers will ensure these regulations are set in stone. I was in orange county yesterday and happened to walk by a cigar store, they had a huge gather of cigar enthusiasts looking for ways to fight the newly enacted regulations.  (and this was just a random store, on a Monday no less) 

EDIT: Looks like Nicopure has filed the first suit against the FDA. https://www.nicopure.com/news/nicopure-labs-challenges-fdas-deeming-rule/

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42 minutes ago, Christopher said:

Well said, complacency among vapers will ensure these regulations are set in stone. I was in orange county yesterday and happened to walk by a cigar store, they had a huge gather of cigar enthusiasts looking for ways to fight the newly enacted regulations.  (and this was just a random store, on a Monday no less) 

EDIT: Looks like Nicopure has filed the first suit against the FDA. https://www.nicopure.com/news/nicopure-labs-challenges-fdas-deeming-rule/

Interesting that Nicopure has gone ahead and filed a lawsuit. I do know that SFATA suggested vendors not file any lawsuits. They felt it was not the appropriate time and will be costly for suppliers to take on. More power to Nicopure if they feel they can take on this endeavor.

I was wondering if Johnson Creek Vapor might do something like this. They have been around as long or longer than Nicopure. But then I remembered that they have/had some deal with one of the big companies. I don't remember which, but I remember it being linked to big tobacco.

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2 minutes ago, BirdDog said:

Interesting that Nicopure has gone ahead and filed a lawsuit. I do know that SFATA suggested vendors not file any lawsuits. They felt it was not the appropriate time and will be costly for suppliers to take on. More power to Nicopure if they feel they can take on this endeavor.

I was wondering if Johnson Creek Vapor might do something like this. They have been around as long or longer than Nicopure. But then I remembered that they have/had some deal with one of the big companies. I don't remember which, but I remember it being linked to big tobacco.

At one point they were part of the Blu/Lorillard buy out but I'd heard they'd spun off from that since. I can't confirm but happened to be speaking with someone who works closely in the industry about a year ago.  I had assumed the FDA would follow suit with the TPD regulations in Europe (Which are stricts but very reasonable) instead they've gone full dumbass mode. 

 

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13 hours ago, Christopher said:

Mods will be limited to sealed units with no removable batteries and no rebuildables

So if I read this right all that will be available is cigalikes. Because if a tank has a replaceable coil it could be considered rebuildable.

Time to stock up on mods, tanks, and RBA coils.

Edited by FXRich

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23 minutes ago, FXRich said:

So if I read this right all that will be available is cigalikes. Because if a tank has a replaceable coil it could be considered rebuildable.

Time to stock up on mods, tanks, and RBA coils.

Potentially yes. I've heard mixed things on this but from what I understand, that would be the case. 

Another thing to think about is that companies in the US that can afford these large applications are going to want a way to recover the costs. If Big Tobacco were involved, naturally they're going to prefer the sealed no coil change method because obviously they can pull in far greater sales. This is just speculation. 

In the other hand though, like the Chinese companies or not, they're fighting alongside of us.  Kanger Tech (who are HUGE now in China) has already formed a legal team to assist them with the new FDA regulations.  They've always been pretty creative and I assume that'll be no different when it comes to these regulations.  (See this unit for example which is in preparation for Europe's TPD regulations: 

Thing is, most of the new vapers on the board are dealing with this for the first time. Back when Vapor Talk was first founded we had similar restrictions in place. But they weren't direct, rather the FDA simply blanket banned everything coming into the country. It didn't stop vapers then.... As Americans we have a long history of not following the rules are tip toeing around them. There are more vapers now than ever and lots of intelligent users. It's very early now but I'm sure we'll prevail. At least the dedicated users. 

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Well put @Christopher....  we will prevail...

I've been through the Deeming, and it makes my head spin.  The FDA is basically setting up these regulations like the Patent Office, where you must file your brief, do your studies, prove your relevance, and still can get told "no".

@FXRich you are correct.  Big Tobacco had their hands in setting the date, and in setting restrictions on "sealed" units.  This effectively puts the likes of BLU and Vuze as the the only viable products.  Juice manufacturers will spend millions jumping through hoops to get their liquids approved, but will have zero market if the only products available cannot be refilled....  It is a ban via regulation, yes...

Personally, I thought of another avenue to sting the FDA with...  Isn't there a regulation from the EPA which refers to battery waste, chemical waste, etc.?  All these disposable cigalikes will surely cause some environmental disaster, right? :D  I mean, rechargeable mods/batteries and refillable tanks should surely be praised by the Green movement....

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As it stands right now my business will be done in Aug. There is no way I can afford this as it stands. Of course I'll be playing it by ear, but as it stands, I'm looking at being done as a business. I know I won't be the only one if things don't change. To me  this is taking away jobs and supporting big tobacco at is finest. So much for supporting a heather way of life. Not that I'm a big conspiracy theorist, this just supports depopulation and saving the Tax losses from big tobacco sales. We the people must suffer for quitting burnable tobacco.

Even at the lowest number Chris posted, I would need $15,600,000.00 just to register my 52 flavors. That does not include all the testing.

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I wouldn't throw in the towel just yet, comp.

 

looking at all these regulations and requirements - can someone pleases show me how this is even possible to implement, let alone enforce, in under two years?  It just doesn't seem possible....

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@Compenstine See the quote below of what will happen in 90 days. You still have 2 years before you need to file and pay. Who is to say what will happen in 2 years. I wouldn't throw in the towel just yet.

15 hours ago, Christopher said:

Over the next 90 days (First Deadline 8-8-2016)

  • Vape stores must check ID for anyone who appears to be under 27 years of age
  • Vape stores can only sell to vapers 18 and over. (Most stores do this now to begin with) 
  • Vape stores may no longer offer free samples. This includes hardware and eliquid. 
  • e-Cigarettes cannot be sold via vending machines unless in an adult only facility. 
  • New new products may be released (eliquid or hardware) after the 90 day window has passed

The date the FDA choose was Feb 2007. Which we all know are the dreaded closed battery system. This is the whole point of HR 2058 and Cole-Bishop Amendment. This will give congress the ability to change that date. Hopefully something for the better. They are going to try and shoot for it to be changed to the year 2016.

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This is why I'm playing it all by ear. I have supported HR2058 in every way possible to me and will continue to support it. I will not stop and close until the time I'm no longer able to continue. As you have said a lot can happen in two years. These deeming regs can (pipe dream) can be stopped and the FDA may have to start from square one. I'm keeping a close eye on everything that is being said and done.

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How do these new regulations apply to DIY online sales? The way I understand it the new Regulations only apply to ready to vape juice, or did I miss something.

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I could be off the mark here because I'm not a lawyer, but as I read it anything that is used to or "Sold As" an ingredient that it used in the manufacture of e-liquid is considered part of these regs. As an individual if I were to buy and make what I need via DIY it is fine. As a business if I sell flavoring for the purpose of making E-Liquid then I would be considered under these regs and have to register every flavoring, PG, VG, or Nicotine base I sold for said purpose.

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So if you labeled your juice as a scented skin conditioner, that would be OK? Most flavor makers could reclassify their flavors for cooking, with a recommendation that they not be used for ejuice, but the nic base would be different. 

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It could, but that would also mean renaming the business, new domain,  yada yada... it would be hard sell to the FDA that a company named Fadora Vapor selling flavorings would be using it for cooking or making hard candy. LOL :D

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DIY will not be affected. You can still buy flavorings, PG, VG and other materials . The only item that might be difficult to get will be Nicotine. But that is still 2 years out. Flavorings will be sold as baking or candy making supplies and can't be listed for use in making eliquid.

Supplies for coil building will also still be available. Most of those materials are used for other purposes, they just won't be marketed for vaping.

Some suppliers are planning on selling 0nic flavors only. Then it would be up to the end user to add the nicotine. They will not be able to offer advice on adding nic and you may have to agree when purchasing that you will not alter the product in anyway.

We, as a group, are pretty inventive. The minds are already turning on how to continue on.

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Aromatic therapy, is a option.

There are websites that sell supplies to make your own nicotine laced gum.

Edited by FXRich

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But, even 0 nic flavors are mentioned in the deeming regs and must be registered. They must be labeled as "Tobacco Products" even though there is no tobacco in them or any part of it derived from the tobacco plant. Even bottles used for the storage of |E-Liquid" are covered in these regs.

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3 minutes ago, Compenstine said:

But, even 0 nic flavors are mentioned in the deeming regs and must be registered. They must be labeled as "Tobacco Products" even though there is no tobacco in them or any part of it derived from the tobacco plant. Even bottles used for the storage of |E-Liquid" are covered in these regs.

This part is really confusing and has been interpreted different ways. But yes, 0 nic is mentioned. This whole thing has been a headache. lol

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