Maybe you can help me please...I'm confused

[Janetda]

OH! I see the problem. You think it's already been to court and ruled on. NO, NO, NO! Judge Leon only ruled on a temporary stay on the FDA defacto ban. He has NOT ruled that the e-cig was a tobacco product. He only thought that SE & njoy would probably be successful when they eventually go to trial. So, no there has been no ruling and the OFFICIAL government stand (the FDA) is that e-cigs are a drug delivery device.

 

[Slickstick]

Not to beat a dead horse, but the FDA will get control one way or another because of the court case. If they win the court case, they get to continue treating the products as drug-delivery combinations. Judge Leon has pointed out that they HAVE jurisdiction already to regulate them as tobacco products, but FDA is insisting, no, no, they are not tobacco products. Well, if they lose the court case and lose the appeals all the way up to the Supreme Court, I think we will suddently see FDA doing a 180 and jumping in to regulate them as tobacco products. They can always say "The court made me do it."

But I did want to comment regarding "wrong facts being released." The issue being addressed in the second petition is that the FDA did a major spin job last July in their press release. The media picked up on the idea that the FDA found carcinogens and anti-freeze in cartridges and this erroneous press release is STILL being quoted in news stories and blogs to this very day!

What the FDA "forgot" to mention was that the quantities they found were so miniscule that they present no danger to human health. They also "forgot" to compare these chemicals and quantities to tobacco cigarettes. Here are facts: The "carcinogens" referenced were Tobacco-Specific Nitrosamines (TSNAs). We know from testing performed by Health New Zealand that the 16 mg. cartridge of Ruyan e-cigs contain 8 ng/g of TSNAs. The same test report mentions that a nicotine patch contains 8 ng/g TSNAs. Now don't you think this is information that FDA should have included in their report? FDA also should have put the whole thing into perspective by revealing that a day's supply of tobacco smoke delivers 5,500 to 11,000 ng/g of TSNAs!

The FDA is supposed to be staffed by ethical scientists. They should not be misleading the public. A couple of countries actually banned electronic cigarettes outright, stating that the United States FDA declared they are dangerous.

Wasn't that ANCIENT report based on PG waaaaaaaaaay back? Before we started mixing with or going totally VG. Wasn't the stupid antifreeze crap with the PG and not the nicotine?

 

[CES]

Wasn't that ANCIENT report based on PG waaaaaaaaaay back? Before we started mixing with or going totally VG. Wasn't the stupid antifreeze crap with the PG and not the nicotine?

no, they found trace amounts of DEG, found in toxic antifreeze. PG is used in non-toxic antifreeze as well as asthma inhalers, and other FDA approved things. However, the FDA is STILL being disingenuous (at best) and using the antifreeze thing. To us, it's old news. To the people who are still using that report as the only valid data, then it's new and alarming.

 

[Slickstick]

I know it was DEG and not actually antifreeze, but an ingredient IN antifreeze, such as WATER is an ingredient in antifreeze, but we will not stop drinking water just because it is in antifreeze. My question was pointed at PG vs. Nicotine. Was the DEG found in Nicotine, or PG? If it was found in PG, what the freak is the big deal? as you can vape without ever using a drop of PG. That being said, How can they ban an e-cig kit, if you can vape pure glycerin and flavoring without any nicotine at all? Or even flavored sugar free syrup for diabetics, and splenda for sweetener. I mean, you do not even need pg, nicotine, OR vg to vape. Many people vape with zero nicotine just for the oral fixation. It seems to me if they can ban anything at all, it can ONLY be the nicotine, and not the batteries, atty's or carts. I can go to the local head shop and buy a device to use for illegal drugs. THAT isn't illegal. It doesn't seem possible to me to be able to ban e-cigs, without also banning cigarettes, or to ban e-cigarette devices without banning bongs and pipes.

 

[Vocalek]

I know it was DEG and not actually antifreeze, but an ingredient IN antifreeze, such as WATER is an ingredient in antifreeze, but we will not stop drinking water just because it is in antifreeze. My question was pointed at PG vs. Nicotine. Was the DEG found in Nicotine, or PG? If it was found in PG, what the freak is the big deal? as you can vape without ever using a drop of PG. That being said, How can they ban an e-cig kit, if you can vape pure glycerin and flavoring without any nicotine at all? Or even flavored sugar free syrup for diabetics, and splenda for sweetener. I mean, you do not even need pg, nicotine, OR vg to vape. Many people vape with zero nicotine just for the oral fixation. It seems to me if they can ban anything at all, it can ONLY be the nicotine, and not the batteries, atty's or carts. I can go to the local head shop and buy a device to use for illegal drugs. THAT isn't illegal. It doesn't seem possible to me to be able to ban e-cigs, without also banning cigarettes, or to ban e-cigarette devices without banning bongs and pipes.

It was found in a Smoking Everywhere cartridge which contained nicotine in a PG base. Can't tell where it came from. It could have come from the nicotine extracted from tobacco that had had DEG added to keep it moist. It could have been a contaminant in the PG. It might even have been a contaminant introduced by the FDA lab staff (accidentally, I'm sure).

Regardless of where the DEG came from, the quantity was so small that it clearly did not present a danger to human health.

The "ban" in question would be a "de facto" ban. If the FDA prevails in court and can regulate e-cigs as a drug-delivery combination, then it can pull all the products off the market that have not gone through the drug approval process. Since none of them meet that criteria, all would be pulled off the market.

According to a Veterans Administration web site:

It usually takes about 10 years for a drug to be developed and approved for prescription. Many people would like to take the newest medicine as soon as it is proven to work. However, even after a drug has been successful in a Phase III trial, it still may take six to 12 months before that drug is approved for prescription.

How Long Before a Drug is Approved by the FDA? (U.S. Department of Veterans Affairs)


A Washington Times article published today had this to say:

Foods that promote certain health benefits are now, according to the FDA, "considered to be drugs and must meet the regulatory requirements for drugs." Cereal maker General Mills got a taste of this treatment last May when the FDA told the company the way it markets Cheerios causes it "to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease." Pretty soon, Americans with high cholesterol may have to pick up two prescriptions at the pharmacy - one for Lipitor and one for Cheerios.

It costs about $1.2 billion and takes 10 to 15 years to bring a new drug from the laboratory through the FDA approval process.

PERO: Your Cheerios prescription - Washington Times

 

[Slickstick]

That sounds horrible, unless I am reading it wrong. This sounds like it could be in limbo til the end of the world. Considering no Vapers have billions of dollars to do the tests themselves, and it wouldn't be fair to taxpayers to have the tests done considering such a small amount of people vape. I still do not see how they can effectively ban parts and supplies.

 

[DC2]

I can go to the local head shop and buy a device to use for illegal drugs. THAT isn't illegal. It doesn't seem possible to me to be able to ban e-cigs, without also banning cigarettes, or to ban e-cigarette devices without banning bongs and pipes.

The only reason you rarely see anyone go after bongs is because no one cares enough.

Here where I live, for one reason or another, enough people cared enough.
And they swept through the city of Vista and confiscated all paraphernalia such as bongs.

It not only can happen, it already has happened, right here in my backyard.

 

[natura]

Sources quotes above were not repected as valid no matter what they say..
Here is one from the FDA blog hope this one is good enough for you
FDA Law Blog: Tobacco

from Jan 2010

Oh and the Cheerios CRACKS me UP!! FDA keep it up your public perception -will be one of taxpayers waste money with the things you do ..to supposedly protect us
FDA Law Blog: FDA Says Cheerios Cereal is a Drug

 

[zelda]

I am trying to understand this too natura.

From the posts I've read here here is what I think.
The FDA wants to designate e-cigarettes as a drug-delivery system.
The judge said no and suggested they may be regulated as tobacco products. That ruling is under appeal by the FDA.
According to the new tobacco laws devices cannot be regulated but products containing tobacco can. .

CASAA is hoping to have them classified as tobacco products rather than drug delivery systems.

There is hope they will be taxed as less harmful products. This would have to be proven by testing accepted by the FDA I would imagine.

I have 2 questions maybe people can help me with.

If they are classified as tobacco products would e-cigs and e-liquid be off the market until proven safe?
Would the devices themselves be considered tobacco products or not?

 

[CES]

If they are classified as tobacco products would e-cigs and e-liquid be off the market until proven safe?

It would be exactly the opposite. If classified as tobacco products, they could remain on the market, and be regulated, but to a lesser extent than if they were drug delivery devices (and yes, probably taxed). If the FDA gets to retain them in the drug delivery category, they would be "unapproved" and likely unavailable until and if testing is completed and the FDA approves them.

Potentially they could attempt to regulate both the devices and the liquid- but i don't know the answer for sure.

 

[(So) Jersey Girl]

I am trying to understand this too natura.

From the posts I've read here here is what I think.
The FDA wants to designate e-cigarettes as a drug-delivery system.
The judge said no and suggested they may be regulated as tobacco products. That ruling is under appeal by the FDA.
According to the new tobacco laws devices cannot be regulated but products containing tobacco can. .

CASAA is hoping to have them classified as tobacco products rather than drug delivery systems.

There is hope they will be taxed as less harmful products. This would have to be proven by testing accepted by the FDA I would imagine.

I have 2 questions maybe people can help me with.

If they are classified as tobacco products would e-cigs and e-liquid be off the market until proven safe?
Would the devices themselves be considered tobacco products or not?

You're not the only one confused, as I have spent many hours reading and checking sources and links.

The issue is not that the FDA wants to designate PVs as drug delivery devices. The FDA already has designated them as drug delivery devices and wants them removed from the market until they are proven to be "safe and effective" as a medical/pharmaceutical smoking cessation product. That would take them off the market, cost millions of dollars and 8 or more years of testing before the FDA would even consider approving them.

Judge Leon said no to the FDA and scolded them for overstepping their authority. He basically said that e-cigarettes are recreational smoking products that meet the definition of a tobacco product and should be regulated as such. This would leave e-cigs on the market as they were available as a tobacco product before the new tobacco law was passed.

The new federal tobacco law places the regulation of tobacco products in the FDA's lap. The FDA has attempted to claim jurisdiction over cigarettes (under their drug provisions) for years. The Supreme Court ruled against them. The SC said that the FDA could only gain authority over tobacco if Congress gave it to them, hence the new law. However, under this new law, they cannot regulate tobacco the same way they regulate drugs and drug devices.

CASAA (members - correct me if I am wrong) supports their classification as tobacco products so they remain available to us. If they are classified as drug devices, they're gone.

Taxes on e-cigs have nothing to do with the FDA, whether or not they approve it.

This is they way I see it, anywhoo.

 

[DC2]

This is they way I see it, anywhoo.

Perfect summary.

 

[kristin]

CASAA (members - correct me if I am wrong) supports their classification as tobacco products so they remain available to us. If they are classified as drug devices, they're gone.

Taxes on e-cigs have nothing to do with the FDA, whether or not they approve it.

This is they way I see it, anywhoo.

Exactly.

Not only that, but as a tobacco product, they are still open to interpretation and can be lobbied into a new classification as a "reduced harm" tobacco product and subject to tax breaks and different standards from regular tobacco.

If the FDA gets their way and keeps them as "drug delivery devices," we will have no options. They will be pulled from the market, until one or two pharmaceutical companies do the clinical trials, gain a monopoly and sells them for 3 times the price of cigarettes, with the Nicotrol standard of 10mg carts.

 

[zelda]

I'm curious where that information is on "reduced harm" products that get tax breaks.

 

[kristin]

I'm curious where that information is on "reduced harm" products that get tax breaks.

There are no rules on reduced harm tobacco products. We will have to pave the way and lobby for them.

But if these are categorized as drugs, we won't have that opportunity.

 

[(So) Jersey Girl]

I'm curious where that information is on "reduced harm" products that get tax breaks.

The FDA is required by the new federal tobacco law to develop "reduced harm" tobacco products. Taxes are not mentioned in this law. The idea is that reduced harm products will not be subject to the same high "sin" taxes as cigarettes which are harmful. Reduce the harm, reduce the amount of tax. That's the way it should work (in theory).

 

[ChipCurtis]

The FDA is required by the new federal tobacco law to develop "reduced harm" tobacco products.

The FDA doesn't develop anything. They just oversee things.

 

[natura]

I am trying to understand this too natura.

From the posts I've read here here is what I think.
The FDA wants to designate e-cigarettes as a drug-delivery system.
The judge said no and suggested they may be regulated as tobacco products. That ruling is under appeal by the FDA.
According to the new tobacco laws devices cannot be regulated but products containing tobacco can. .

CASAA is hoping to have them classified as tobacco products rather than drug delivery systems.

There is hope they will be taxed as less harmful products. This would have to be proven by testing accepted by the FDA I would imagine.

I have 2 questions maybe people can help me with.

If they are classified as tobacco products would e-cigs and e-liquid be off the market until proven safe?
Would the devices themselves be considered tobacco products or not?

"According to the new tobacco laws devices cannot be regulated but products containing tobacco can. ."

Just guess here (<---like so many) definitely sounds like they have the ability "now" to ban the nic juice?????

Why distributors in China ship without the e-juice in kits now...makes even more sense. (smart move). This kinda scares me more for the petition though. Wish, I was a fly on the wall when FDA approached them...and then the ability to follow them back to their offices to see if they were snickering8-o (Yes-I've read Foutainhead)

 

[zelda]

Thie information on this link helped me understand more.

Why Doesn’t The FDA Want The Electronic Cigarette As a Tobacco Product? | Electronic Cigarettes by Instead E-Cigarette