Why does the FDA apeal case matter?

[Willriker]

Hello All,

I was reading up on the NJoye vs. FDA case thread. And, i am trying to understand why it even matters. Considering the worst case scenario... Please let me know if i am missing something here:

1) The unit its self isnt illegal. Much like a ..... For 3 peice units, there is a battery, an empty container with some foam in it, and an atomizer (vaporizer). A .... or a Pipe is basically the same thing, although most use combustion instead of a heating element. Nothing there is illegal. So, the units themselves can still be sold. Even if by peicemeal.

2) If using a liquid that has no nicotine in it... the liquid can still be sold. Nicotine can be purchased elsewhere, and if the user decides to mix the two without the knowledge of the person you are buying flavored liquid from (the DYI guys) then there is no issue for any of the vendors.

So, why the fus? The only thing i can see, in the very worst case scenario, is that you would need to put some nicotine into the fluid yourself... and shake the bottle a few times. Again, i am new to this... so perhaps i am missing something here.

Or am I?

Please help me understand why i need to care about the outcome of this appeal. Becaause i am, honestly, not seeing why i should.

 

[Rosa]

Well, even in your scenario we wouldn't be able to buy pre-mixed juices. What about all our great juice vendors? What if they decide that ecig parts are like illegal devices?

 

[Rosa]

..and probably there would be fewer new vapers (most people don't want to start something like this with DIY as a first purchase), a drop in business, and eventually it would be harder to get supplies and more expensive.

 

[Willriker]

i can see that, but in terms of taking this away from people who are already familiar/somewhat familiar with the product... i just dont think thats possible. I saw many people freaking out over the FDA "Taking this Away". When they really cant.

All i can see this doing is making this a bit more difficult for newer people looking to get out of the tobacco scene, and into the vapor scene. Even then, I really did a heck of a lot of research before ordering anything. Hehehe, i actually believed the rumor of the antifreeze thing for a while before researching this more in depth. If others do the same, im sure they would be able to find out that you can add nicotine to a flavored PG/VG base.

 

[t9c]

You'll be buying all your parts and nic juice from China and praying customs doesn't seize your order. No biggie?

 

[Mclassy]

The answer in short:

FDA wants to regulate the E-cig market (understandably). Since e-cigs have not gone through extensive trials and testing (which could take up to 10 years) these e-cigs are not an FDA approved product. The FDA has 2 routes that it can take to regulate e-cigs. One route is under the FDCA (Food Drug and cosmetic Act). This act states that if a substance is labeled a drug then to market and sell this drug in the USA it must be FDA approved through said testing and trials. If e-cigs are labeled a Drug delivery device then they would become illegal to sell and market in the USA. (Not illegal to own). AKA - Banned until FDA approved.
The Tobacco Act which was recently given to the FDA to regulate Tobacco with strict guidelines, is much more lax and would not result in banning as it is not a drug and does not need FDA approval to Market and Sell. The tobacco Act prevents the sale to minors, limits flavors, and chemicals that can be added to Tobacco.
This court case holds what law the e-cig falls into. Is it a drug delivery device or a Tobacco product. How much control will the FDA have over the e-cig.
If the e-cig is labeled a drug delivery device then the manufactures with have to pay (ALOT of MONEY) to undergo extensive FDA testing and approval and time. Possibly resulting in the manufactures going bankrupt in the process. As a result, bigger companies who like the idea and have the time/money can afford the FDA approval process can monopolize on the product, such as Pharmaceutical companies and Tobacco companies. This result would most likely increase costs, availability, and a very worst require a prescription.
If they are judged as a Tobacco product then not too much will change as it is now except possibly limiting the flavors to not be appealing to kids. This is an easy fix so this is not too much of a concern as one could order the nicotine mixture separately and the flavor separately and combine the products themselves.
If they are judged a drug delivery device then, yes, we could order a battery from one site, and atomizer at another, cartridges somewhere else, battery chargers at another place, oh and the liquid we could home brew. This makes it much more difficult and the demand would get higher as the products would become scarce. Since the companies wouldn't get the profit margin they would like to expect they would quit manufacturing the products and that would lead to a black market of e-cigs.
At this point, which is easier, buying a pack of (such and such brand) cigarettes or going through all the hassle of maintaining the e-cig hobby / habbit, or even worse quitting both.

Personally, I want the e-cig liquid to be regulated. I want to know someone isn't sneaking weight gain chemicals in it or sexual depressants in my vapor. Right now we work on trust in a very deceptive world. Am I willing to give up my e-cig for this regulation? No. I will be happy with paying the Tobacco Tax for some regulation.

Hopefully, that broke down the FDA and the e-cig outcome.

 

[Willriker]

I was thinking the device itself cant be regulated. The only thing that would be regulated by the FDA would be the fluids.

I also share in the concern that the contents of the fluids match what is on the label. I am in favor of regulating that as well. But, in my perfect little world, the regulation would stop at insuring the contents match the label. Its probably wishful thinking, but oh well. Even if i had to buy the flavored fluids with no nicotine at all, i could just put a little in.

As for the actual PV's, no i am not seeinghow that would be effected at all. Especially if you could still by flavored fluids with 0 nicotine. Then get the nicotine elsewhere.

I dont know, perhaps i am failing at communicating my perspective on this subject.

 

[Mclassy]

The device would be labeled as a "drug delivery Device". To put that in perspective hypodermic needles are a drug delivery device. How many manufacturers are there of hypodermic needles? How easy is it to get some? What would be needed to get said needles. Is it possible to get needles with a hole in the middle? Sure. Is it possible to get a plastic tube to put the needle into? Sure. Is it possible to get a plunger for the plastic? Sure. All these things are possible. You now have a unapproved hypodermic needle.

 

[t9c]

The FDA calls them "drug delivery devices". Sorta like the old cartridge style nic sticks you used to have to get a script for. If they win their case, best case scenario, you'd be buying them at your local pharmacy upon presenting you doctor's prescription. They can and will continue to confiscate all shipments from China at customs, including batteries, atomizers and carts. No one knows if the FDA will do the same to nic juice. I would bet they will regulate it too.

 

[StormFinch]

Look at it this way; You mention doing all the mixing yourself, but the problem is, pure nicotine is usually, and should be, only sold to people with the proper equipment to process it safely. DIYers at the most use a 10% (100 mg) solution which can still be a little tricky. I got a major nic hangover just from a small amount of 6% (60 mg) that had leaked out of a bottle during transit. The FDA may be dumb but they're not stupid. It's pretty obvious that a solution of nicotine in PG is not going to be intended for anything else other than e-cig juice, which immediately makes it illegal if the FDA has their way. Local suppliers would either close up shop or take the chance of being raided and jailed, and every foreign package that the FDA could get their hot little hands on would be confiscated.

As far as the syringe argument goes, syringes are used for many drugs not considered illegal. They have to be available for people that need home injections. E-cig hardware has absolutely no other intended use. You can't find them at Walgreens or at your local vet supply store, and the FDA is stopping packages right now with just hardware in it. So no, they aren't going to differentiate between juice and hardware if they win. There's a possibility that with a little redesign they could be marketed as herbal vaporizers, but the cat is pretty much out of the bag at this point and hanging by it's claws from the curtains.

 

[DC2]

Nicotine can be purchased elsewhere, and if the user decides to mix the two without the knowledge of the person you are buying flavored liquid from (the DYI guys) then there is no issue for any of the vendors.

Where can you purchase nicotine?

Working with pure nicotine, if you can buy it, is dangerous beyond words.
A drop of pure nicotine on your finger will kill you.

I was thinking the device itself cant be regulated.

The device itself, can and will be regulated if it is deemed a drug delivery device.
The FDA has, and still is confiscating shipments, including batteries and atomizers.

As far as the .... analogy, I hear that all the time, but this is the kind of thing that I worry about...
REGION: Raided smoke shops back in business

Nobody with power or money gives a damn about people selling illegal paraphernalia, that is why it isn't a good analogy.
But we already know the powers that want to stamp out electronic cigarettes.

It isn't safe to assume anything.

 

[Rosa]

The worst part of this whole scenario IMO is that the "enemy" here is the FDA: at this moment in time a well-respected government agency. If the FDA says it's bad, people will listen and bury e-cigs forever.

 

[progg]

The worst part of this whole scenario IMO is that the "enemy" here is the FDA: at this moment in time a well-respected government agency. If the FDA says it's bad, people will listen and bury e-cigs forever.

Well respected by whom? I get your point, and it's a shame people will listen.

Mclassy



FDA wants to regulate the E-cig market (understandably).

Personally, I want the e-cig liquid to be regulated. I want to know someone isn't sneaking weight gain chemicals in it or sexual depressants in my vapor. Right now we work on trust in a very deceptive world. Am I willing to give up my e-cig for this regulation? No. I will be happy with paying the Tobacco Tax for some regulation.

Mclassy you did a lot of work to present your post.

But how is it understandable that the FDA should regulate the E-Cig market or liquids? I know it's like putting toothpaste back in the tube but must we be dependent on a political body for everything?

Right now because of the fear of government intervention reputable vendors can't get lab certified.

Would you not buy liquid from a non-government approved vendor who used a certifiably independent laboratory inspector?
Mclassy, I'm not dumping on you here, I'm just trying to point out a less defensive position. Thanks for all the thought you put in to your post.

 

[Mclassy]

First ~ that post was made by me. I was reading that some eliquid supplier was putting ...... and ...... in the liquid. I wouldn't want that. I would like to see a universal market in ingredients and strength.
Strength :
One website states 24 mg another states 2.4%
One website says 24 mg and claims a high dosage another says super high

Ingredients:
Tested and certified from an outside source I am fine with that. I would like verification that what I ordered is what I got. (not hidden additives)
Recipes should be trade secrets ~ no need to share that with the world.

Price:
I understand this is a competitive market but raping people should not be allowed.
I was looking around and found someone selling a 10ML bottle for $40. (That liquid should have gold flakes)

Regulation should be more standardized. This would make a ultra low 8mg, low 11mg, med 16mg, high 24mg, super high 36mg etc. When i first read 2.4% i was a bit confused. Once i figured out 2.4% equaled 24 mg i understood.
Required testing that eliquid is certified to contain ingredients (again outside source fine as long as it is reputable).
Laws should be in place limiting sales to minors.

These were the regulations that are general concerns for e smokers and FDA (presumably) alike. It is kind of scary not really knowing that people aren't putting questionable chemicals in the eliquid. Call me paranoid but i limit my purchases to Totally wicked, Johnson's Creek and recently Pure Smoker. They get their liquids tested. I will pay more for the piece of mind.

 

[jrmithdobbs]

The device would be labeled as a "drug delivery Device". To put that in perspective hypodermic needles are a drug delivery device. How many manufacturers are there of hypodermic needles? How easy is it to get some? What would be needed to get said needles. Is it possible to get needles with a hole in the middle? Sure. Is it possible to get a plastic tube to put the needle into? Sure. Is it possible to get a plunger for the plastic? Sure. All these things are possible. You now have a unapproved hypodermic needle.

I bought 5 syringes with needles and 5 additional bigger needles yesterday no problem. Horrible analogy.

 

[chuckie]

I've got a friend in Canada where E-cigs are banned,and he has more of them than he could ever use.His short answer to the problem is "can you say China".
P.S. Between myself and friends,we've gotten dozens of orders from China and never had a customs problem.

 

[StormFinch]

Stormfinch you did a lot of work to present your post.

But how is it understandable that the FDA should regulate the E-Cig market or liquids? I know it's like putting toothpaste back in the tube but must we be dependent on a political body for everything?

Right now because of the fear of government intervention reputable vendors can't get lab certified.

Would you not buy liquid from a non-government approved vendor who used a certifiably independent laboratory inspector?

Stormfinch, I'm not dumping on you here, I'm just trying to point out a less defensive position. Thanks for all the thought you put in to your post.

Sorry progg, not my post. See mclassy's, post #7.

Personally, I would rather see an independent, or self regulating, governing body of e-cig suppliers, but unfortunately I simply don't see that happening at this point. Like "my" post said the cat is already out of the bag. I believe that we will probably either find ourselves SOL with the e-cig as a drug delivery device, or it will regulated as a tobacco product. If I have to choose between the two, I'll take tobacco product, simply because the e-cigs won't disappear for the next 3 to 5 years while Pharma figures out a way to patent it and charge through the nose.

 

[Mclassy]

Can you buy an unapproved hypodermic needle? Those needles have been FDA approved. They are Drug delivery devices. Can you buy them at the local gas station?
Would you want to buy an unapproved hypodermic needle? ~ no guarantee that they are clean / sanitized. No guarantee that they wont break or explode upon use.
The answer is No. You want some guarantee. Everyone does. Before the birth of the FDA people and doctors were recommending horrible things such as using Lysol to douche with if you weren't so clean. Or Bleach to get rid of Jock itch. Yes these things worked but would you want to do that now. Heck, even cigarettes at one time were used to help respiratory infections such as Tuberculosis. Without some government regulation people will do things and include things without testing and hope for the best. I am not a big fan of big government but at the same time understand that without some set rules life becomes chaos.
Want to test that:
Tell your kids there is no rules for one week. How dirty would your house get? How late would they stay up? How much would they talk back. People need structure / boundaries without government to step in who is to set boundaries for drug companies or doctors suggestions. E liquid and the E cig are no different. Yes we are passionate and we are in love with the product but someone somewhere is not and they don't care what goes in it as long as it makes them money.

 

[progg]

First ~ that post was made by me. I was reading that some eliquid supplier was putting ...... and ...... in the liquid. I wouldn't want that. I would like to see a universal market in ingredients and strength.
Strength :
One website states 24 mg another states 2.4%
One website says 24 mg and claims a high dosage another says super high

Ingredients:
Tested and certified from an outside source I am fine with that. I would like verification that what I ordered is what I got. (not hidden additives)
Recipes should be trade secrets ~ no need to share that with the world.

Price:
I understand this is a competitive market but raping people should not be allowed.
I was looking around and found someone selling a 10ML bottle for $40. (That liquid should have gold flakes)

Regulation should be more standardized. This would make a ultra low 8mg, low 11mg, med 16mg, high 24mg, super high 36mg etc. When i first read 2.4% i was a bit confused. Once i figured out 2.4% equaled 24 mg i understood.
Required testing that eliquid is certified to contain ingredients (again outside source fine as long as it is reputable).
Laws should be in place limiting sales to minors.

These were the regulations that are general concerns for e smokers and FDA (presumably) alike. It is kind of scary not really knowing that people aren't putting questionable chemicals in the eliquid. Call me paranoid but i limit my purchases to Totally wicked, Johnson's Creek and recently Pure Smoker. They get their liquids tested. I will pay more for the piece of mind.

Very sorry about the misidentification.

I'm with you on the caution pertaining to liquids it's always on my mind, just don't think the FDA is required.

People get ripped off all the time unfortunately, government regulation will minimize it at best and once the foot is in the door, well, see tobacco. 10ml for 40$, eeks.

The three vendors you mentioned:

Do you know who tests their liquids and what their qualifications are? What exactly are they testing, content etc.? Do they get their labs tested?

This could be very valuable info.

Thank you

 

[progg]

Sorry progg, not my post. See mclassy's, post #7.

Personally, I would rather see an independent, or self regulating, governing body of e-cig suppliers, but unfortunately I simply don't see that happening at this point. Like "my" post said the cat is already out of the bag. I believe that we will probably either find ourselves SOL with the e-cig as a drug delivery device, or it will regulated as a tobacco product. If I have to choose between the two, I'll take tobacco product, simply because the e-cigs won't disappear for the next 3 to 5 years while Pharma figures out a way to patent it and charge through the nose.

Thanks for pointing out my woops.