Deeming Regulations have been released!!!!

[Katya]

So what's the timeline here before these regulations would come into place assuming they don't change much? Like as someone who is still smoking but wants to start vaping?

If you're over 18, you have two years + 3 months with no changes whatsoever. Go for it. After that it's anyone's guess.

 

[cd729596]

Seems like rule start in August, then companies have 2 years to comply, I just brought my little company public right before this and will sell juice till the very last day

They regulations as they stand put me out of business though

 

[skoony]

Any first year legal student could defeat that argument, if the FDA even chose to make it. As I said, 18650's etc were around before vaping, were designed for other devices, and are currently used in other devices.

IMHO the argument is undefeatable on that basis and if you read
the reg.s there is nothing excepting these batteries I am aware of.
Cotton wicks and kanthal wire has other uses and is covered. PG/VG
has other uses and is covered. These are necessary components of
a finished tobacco product,the e-cigarette. The specific manufacturers
of these products are not covered. Buyers and sellers are covered if
these products wind up in devices covered under deeming.

Mike

 

[Relaxed99]

Maybe I'm stupid, but I just don't understand how the FDA can regulate any battery. There is no tobacco or nicotine in a battery.

While I understand safe batteries are important, there is no Food or no Drug in a battery, so therefore, there is no Association.

 

[nomore stinkies]

The FDA has addressed that too. Am I the only one who thinks this sounds dismissive?

"Additionally, FDA has determined that some e-cigarettes and other ENDS were manufactured in 2006 and commercially marketed in the United States in early 2007. In particular, we have identified an ENDS product that may have been on the market on February 15, 2007. This product may possibly be able to serve as a valid predicate for purposes of the SE pathway.

"The burden of demonstrating that a valid predicate exists rests with the manufacturer submitting a SE report. To facilitate the determination that a product is eligible to serve as a valid predicate, any individual who has evidence that an e-cigarette or other ENDS was commercially marketed in the United States on February 15, 2007, may submit a stand-alone grandfather submission to FDA (See final guidance, "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007" (79 FR 58358, September 29, 2014)). (Based on FDA's experiences to date, and since stand-alone grandfather submissions are purely voluntary, FDA does not anticipate that many manufacturers will make such submissions, but this option is available.)"

"Lol!" says the FDA. "You can give it a try, but the process is very expensive, time consuming and there's only a minute chance you will succeed. How much money do you have?"

I'm sure the ENDS product they have identified is NJOY. They may have the money to make it through the quagmire, but it's still a cigalike.

http://dealbook.nytimes.com/2014/02...eceives-funding-valuing-it-at-1-billion/?_r=0

I have several of those circa 2007 Njoys and the eliquid and the filter for the liquid. Its like going back to the rotary phone. I just tried one of them (using my current e liquid). OMG no wonder I didn't quit back then.

 

[LoriP1702]

I have several of those circa 2007 Njoys and the eliquid and the filter for the liquid. Its like going back to the rotary phone. I just tried one of them (using my current e liquid). OMG no wonder I didn't quit back then.

I know, I started with a blu kit. I actually quit using that. Thankfully I found the forum here shortly thereafter.

 

[Steamix]

That's the catch : PMTA

The A stands for Application , not for Approval.

Means you front serious money and the FDA still can turn your application down for not dotting all the i's and crossing all the t's. And they can drag their heels about giving you an answer till doomsday too.

Then you're out of money and out of a product to sell.
Unless you're one of the B's with a few dozen millions to burn.

IMO that's way way too much power in the hands of one single government agency. Especially when that very same agency isn't really concerned about the well-being of you and me. Government is supposed to govern.
Means putting checks and balances into place to prevent exactly that : one branch getting too much power.

'Deeming' - nailing nicotine-free juice as 'tabcco products' : 2+2=5

Freedom is the freedom to say that two plus two makes four.
If that is granted, all else follows
(George Orwell '1984')

 

[7sixtwo]

IMHO the argument is undefeatable on that basis and if you read
the reg.s there is nothing excepting these batteries I am aware of.
Cotton wicks and kanthal wire has other uses and is covered. PG/VG
has other uses and is covered. These are necessary components of
a finished tobacco product,the e-cigarette. The specific manufacturers
of these products are not covered. Buyers and sellers are covered if
these products wind up in devices covered under deeming.

Mike

So what are you suggesting? That flashlight manufacturers etc will have to submit their products for FDA approval? That the FDA will come to your home and check to see what specific device/s you put your 18650 batts in? That's ludicrous.

The FDA will not be able to prevent anyone from buying simple wire, (not sure about all the "hybrid, alien, fused, etc claptons", especially if pre-made and not on a spool), cotton pads, beauty coil rayon, or batteries separate from an "ENDS", as none of these are even remotely exclusive to use in vaping.

If I misunderstood you, I apologize, but the the meaning of your last post wasn't very clear.

 

[Relaxed99]

If the FDA is given the power to regulate batteries of any kind, what's next? Cigarette lighters? Ashtrays? That opens up a slippery slope. Next the EPA will be regulating my toilet paper (waste removal). Being a bit cynical here, but the FDA regulating a battery is like the IRS regulating clean drinking water.

 

[pamdis]

The batteries that fall under these regulations are the "vape pens" and APV's with built-in batteries. 18650's, 26650's etc were not created specifically for vaping, and are used in other electronic devices. They will not be affected.

They absolutely do intend to regulate the batteries. Even if they have other uses. My best guess would be that any shop or online seller will simply remove things like the batteries, wires, silica, etc. from their offerings. Or maybe they could set up a separate company to sell only those things, but I imagine that if FDA saw that an online company selling only generic things like the batteries, wire, etc is in anyway associated (like owners of record) to a company that also sells e-liquid or mods or tanks, then it will say the intended use of the products in the generic item company is for the tobacco products in the first company, and will seize their goods for selling unapproved products.

On page 163-164:

This final deeming rule deems all tobacco products as they are defined in section 201(rr) of the FD&C Act, except accessories of newly deemed products, but including components and parts as defined in this rule. The wires, screws, and silica meet the definition of component or part, as they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and are not accessories of a tobacco product. FDA also remains concerned about reports of exploding batteries. Batteries that are co-packaged with other components or parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with or for the consumption of ENDS are components or parts and subject to FDA's tobacco product authorities. However, as noted elsewhere in this document, for ENDS hardware or delivery system components or parts, such as batteries, FDA expects that it may be difficult for manufacturers to obtain premarket authorization for such products, given the great extent of possible variations in combinations of hardware components, if all considered and sold separately. Thus, with respect to such apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components. Elsewhere in this issue of the Federal Register, FDA also has made available draft guidance, which when final will represent some appropriate means of addressing the premarket authorization requirements for newly deemed ENDS products and will include FDA's current thinking regarding compliance with existing voluntary standards for ENDS batteries.
​

And on page 168:

(Comment 75) Some comments stated that items also used for purposes other than for tobacco use (i.e., a lighter or matches that can be used to light candles) should be classified as accessories and, therefore, not subject to FDA's chapter IX authorities. For example, batteries used in advanced personal vaporizers can be found in laptop battery packs or cordless drill packs. These comments also stated that items such as lighters and batteries may (or may not) be used in consumption of a tobacco product or are regulated by the Consumer Product Safety Act (as are child-resistant lighters) and, therefore, should not be subject to FDA's tobacco product authorities.

(Response) FDA agrees that it is not necessary to regulate batteries that are not intended or reasonably expected to be used with a tobacco product under its tobacco product authorities. However, it is important that batteries that are co-packaged with other parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with ENDS are components subject to FDA's tobacco product authorities. FDA remains concerned about reports of exploding e-cigarette batteries and finds that regulating them can help address these problems.​

 

[7sixtwo]

They absolutely do intend to regulate the batteries. Even if they have other uses. My best guess would be that any shop or online seller will simply remove things like the batteries, wires, silica, etc. from their offerings. Or maybe they could set up a separate company to sell only those things, but I imagine that if FDA saw that an online company selling only generic things like the batteries, wire, etc is in anyway associated (like owners of record) to a company that also sells e-liquid or mods or tanks, then it will say the intended use of the products in the generic item company is for the tobacco products in the first company, and will seize their goods for selling unapproved products.

On page 163-164:

This final deeming rule deems all tobacco products as they are defined in section 201(rr) of the FD&C Act, except accessories of newly deemed products, but including components and parts as defined in this rule. The wires, screws, and silica meet the definition of component or part, as they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and are not accessories of a tobacco product. FDA also remains concerned about reports of exploding batteries. Batteries that are co-packaged with other components or parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with or for the consumption of ENDS are components or parts and subject to FDA's tobacco product authorities. However, as noted elsewhere in this document, for ENDS hardware or delivery system components or parts, such as batteries, FDA expects that it may be difficult for manufacturers to obtain premarket authorization for such products, given the great extent of possible variations in combinations of hardware components, if all considered and sold separately. Thus, with respect to such apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components. Elsewhere in this issue of the Federal Register, FDA also has made available draft guidance, which when final will represent some appropriate means of addressing the premarket authorization requirements for newly deemed ENDS products and will include FDA's current thinking regarding compliance with existing voluntary standards for ENDS batteries.
​

And on page 168:

(Comment 75) Some comments stated that items also used for purposes other than for tobacco use (i.e., a lighter or matches that can be used to light candles) should be classified as accessories and, therefore, not subject to FDA's chapter IX authorities. For example, batteries used in advanced personal vaporizers can be found in laptop battery packs or cordless drill packs. These comments also stated that items such as lighters and batteries may (or may not) be used in consumption of a tobacco product or are regulated by the Consumer Product Safety Act (as are child-resistant lighters) and, therefore, should not be subject to FDA's tobacco product authorities.

(Response) FDA agrees that it is not necessary to regulate batteries that are not intended or reasonably expected to be used with a tobacco product under its tobacco product authorities. However, it is important that batteries that are co-packaged with other parts of an ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably expected to be used with ENDS are components subject to FDA's tobacco product authorities. FDA remains concerned about reports of exploding e-cigarette batteries and finds that regulating them can help address these problems.​

Seems clear to me that batteries with uses other than in "ENDS" will not be affected, unless they were sold with other "suspected components".

If you buy OEM, (LG, Sony, Samsung), batteries by themselves, the FDA has no basis to interfere with that in any way.

 

[Sugar_and_Spice]

Next they will ban our cell phones cause it's the same type of batteries used in a lot of the box mods today. Remember when cell phones were relatively new and those same type of haters yelled loud about them causing brain cancer? No body listened then.
So much can happen between now and 2+years. And if you add the additional year companies have before FDA has to rule on an application, well then, it will be almost another election year.
I think the FDA had to put such a broad scope on these deeming regs knowing they only got this one shot to get it all, so they had to include everything but the kitchen sink.
Remember in 2010 the courts ruled that they couldn't prove the ecig had or would harm anyone, so they can regulated nic products but can't do anything about the use of them.

I waiting to see the law suits start.....

 

[pamdis]

Seems clear to me that batteries with uses other than in "ENDS" will not be affected, unless they were sold with other "suspected components".

If you buy batteries by themselves, the FDA has no basis to interfere with that in any way.

That would be my understanding also. So, you will have to find other sources for all those things other than your local vape shop or online vape seller. Because I don't think they will be allowed to sell them without approval.

 

[Bronze]

After 2 years of fighting the regs through proper channels I think we're pissin' in the wind here folks. We've all seen the social engineering machine work it's magic to get where it is now. Plus, it's an election year.

Shoot me in the head!

 

[7sixtwo]

That would be my understanding also. So, you will have to find other sources for all those things other than your local vape shop or online vape seller. Because I don't think they will be allowed to sell them without approval.

Yep, that's fine. I already buy mine from imrbatteries.com. They sell nothing that is directly connected to vaping.

 

[mikepetro]

While it is without a doubt that the FDA has set their sights on vaping, and while they use some pretty strong and threatening sounding language, it is not the doomsday that many fear.

There is an army of lawyers pouring over the regulations on our behalf, there will be lawsuits brought, and items confiscated. I personally am not going to wait and roll the dice and see what happens. We have been given a 90 day warning, and now it is our fault if we are not prepared! It is time to take control of your own destiny and learn to be as self sufficient as possible!

Many, in fact most, of the items we use come from other industries. While the FDA uses a lot heavy language, and is trying to push an "Intended Use" clause through, the fact remains that realistically they wont be able to stop most of the hardware. It will all come down to "what the item is marketed for". Here are some examples:

Ejuice - YOU CAN MAKE YOUR OWN EJUICE:
Ejuice is comprised of PG, VG, Nicotine, and Flavorings

• PG and VG are readily available to the cosmetics market, food industry, and many others. As long as the product isnt labeled as being "intended" for vaping they wont be able to stop its availability.
• Flavorings. Most of the flavors used in ejuice are actually artificial food flavors anyway, and they will still be sold. Now if your favorite flavor is some "vape" labeled line (like VZ) then you might want to stock up. Brands like Capella and LorAnn have long been established as food flavorings, and many people use it in ejuice. Just make sure to get the water-soluble flavors and not the oil based. Search the DIY forums, there are many other brands. As long as it is used for the food industry the FDA wont be able to stop it.
• Nicotine. This is where the FDA will be able to be the most restrictive. However, please remember that many nicotine suppliers are already FDA approved. Companies like Wizard Labs, eLiq, RTS, and many more already sell USP certified and FDA approved nic. Now, how the FDA might restrict them in the future remains to be seen, but these companies already have an inroad to the licensing process.

Mods:
I am sure the manufacturers will get creative here. For example, a dimmable flashlight is essentially the equivalent of a VV mod. If you are handy, learn to make your own mod. A simple Mod is not difficult to make. Look at youtube and on the DIY forums here, It doesnt have to look like a diamond to work and keep the nico-demon off your back!

Attys:
This is the one item where I dont see any other reasonable intended use other than vaping. Perhaps aromatherapy, I dont know. I am sure the vendors will push the envelope here though. My recommendation is to stock up on a few high quality SS rebuildable atomizers NOW while they can still be had. Learn how to build your own coils and wicks, again it honestly is not hard at all, I could teach my grandmother to do it. A good quality SS atty will last damn near forever with little more than a new wick/coil now and then, and some new o-rings (available everywhere) twice a year.

Wicks:
Koh Gen Do Organic Cotton pads, Rayon, etc will all be available at the local cosmetics store. "Vapin Bacon" might get regulated, but facial pads certainly will not.

Coils:
Kanthal, NI200, TI, etc are all just types of "resistance wire". Applications for resistance wire include heated hoses, heated seats, freeze protection, leak detection, composite curing and many more. You will be able to buy resistance wire all day long, but the FDA might successfully regulate pre-wound Clapton Coils. Again, learn to wrap your own coils!

Batteries:
The FDA specifically cites batteries as being part of an "ENDS" (electronic nicotine delivery system) and therefor subject to regulation. This is the same 18650 used in a ton of flashlights, RC toys, Robotics, and even your Craftsman Drill. The only way they can regulate an 18650 is if it is "marketed" for vape use. There is no way they could regulate Sony VC5s or Samsung 18650s, but they could regulate "VapePower" batteries.

Bottom line is we have been given a 90 day warning. After that 90 days is up who knows what will happpen, but things will definetly change, and not for the better.

Prepare your strategy NOW!

 

[TVC70]

On page 163-164:

FDA remains concerned about reports of exploding e-cigarette batteries and finds that regulating them can help address these problems.​

 

[skoony]

Maybe I'm stupid, but I just don't understand how the FDA can regulate any battery. There is no tobacco or nicotine in a battery.

While I understand safe batteries are important, there is no Food or no Drug in a battery, so therefore, there is no Association.

to have a device that mimics smoking but using vapor instead the battery is an integral part of the finished product that does so ,so therefore is considered a tobacco product just as the parts of a cigarette are regulated..

So what are you suggesting? That flashlight manufacturers etc will have to submit their products for FDA approval? That the FDA will come to your home and check to see what specific device/s you put your 18650 batts in? That's ludicrous.

The FDA will not be able to prevent anyone from buying simple wire, (not sure about all the "hybrid, alien, fused, etc claptons", especially if pre-made and not on a spool), cotton pads, or batteries separate from an "ENDS", as none of these are even remotely exclusive to use in vaping.

If I misunderstood you, I apologize, but the the meaning of your last post wasn't very clear.

I am not suggesting that the manufacturers of the raw materials or components of parts that have
been used in other devices or things will have any regulatory burdens. The deeming reg.'s specifically
state as much.

You are looking at it the wrong way. What the FDA is regulating is what happens to these things
after they are sold. If they wind up in tobacco products by whatever means,either bought directly
for that purpose or indirectly by any means to circumnavigate the regulatory process they are covered
under the FDA's regulatory authority.

Regards
Mike

 

[IMZed]

Know this is a bit off topic, but had to respond...



As an asthma sufferer taking a similar medication with the same warnings, this is a gross misunderstanding. The issue with this class of drugs is that they suppress the inflammation normally associated with asthma. The flip side is that if you do happen to overcome this level of suppression with enough acute exposure to an allergen enough to induce a full blown asthmatic attack, it's a biggun, and by the time you realize it's come on and how bad it is, it may be too late to get to a hospital. I still gladly take this class of medication and knew all about the "increased risk of death" before I ever took my first dose. It's the choice of breathing normally day in, day out with a very, very small risk of an asthmatic attack severe enough to kill me, or breathe "through a straw" 24/7. I'm already at an increased risk for a respiratory related death because I'm asthmatic, increasing that risk a few percent while giving me a normal quality of life is a trade off I'm happy to make.

I admit that I am not an asthma sufferer. And I would presume that you have exhausted all natural therapies and found them not working for you. So, good for you that you can take that drug. My point was not to belittle asthmas sufferers. My point was that the people who are supposed to be protecting us are more interested in lining their own pockets. I sincerely doubt that that particular line was put in that commercial at the behest of the FDA. I believe that it was put in there to provide a means of defense during potential lawsuits.

Keep on believing in the FDA and your local white-coats. They surely have your interests in mind.

 

[Sloth Tonight]

So what are you suggesting? That flashlight manufacturers etc will have to submit their products for FDA approval? That the FDA will come to your home and check to see what specific device/s you put your 18650 batts in? That's ludicrous.

The FDA will not be able to prevent anyone from buying simple wire, (not sure about all the "hybrid, alien, fused, etc claptons", especially if pre-made and not on a spool), cotton pads, beauty coil rayon, or batteries separate from an "ENDS", as none of these are even remotely exclusive to use in vaping.

If I misunderstood you, I apologize, but the the meaning of your last post wasn't very clear.

(I am a male)

Why of course, Officer...this beauty coil rayon is for my perm