FDA and the E-Cig Industry

[Bunnykiller]

Ive been watching this mess over the last couple of years and Im wondering why the FDA is trying to regulate the hardware involved with vaping...
FDA stands for Food and Drug Administration correct? How does hardware fall under the jurisdiction of food and drugs? Wouldnt an agency such as CE or UL have that venue? And since we are using a product derived from tobacco, why isnt the ATF covering this? If anything, FDA should only have the option to be concerned with the juice... nothing else. FDA is stepping beyond its boundaries as far as trying to control vaping...

 

[Froth]

How does hardware fall under the jurisdiction of food and drugs?

Simple, it's a delivery device for a product they intend to regulate(e-liquid).

Just because it's called the FDA doesn't mean all they can do is regulate any foods and drugs, they have a VERY broad reach for regulation. For instance, the FDA has complete control over the nicotine inhaler delivery systems(Nicotrol) because it is a system for delivering a nicotine/tobacco product, so because they're the FDA they must ensure it's safe for the population to use, just as they can potentially regulate the delivery device for e-liquid to ensure it's safe for population to use.

What does FDA regulate?

 

[tj99959]

Ive been watching this mess over the last couple of years and Im wondering why the FDA is trying to regulate the hardware involved with vaping...
FDA stands for Food and Drug Administration correct? How does hardware fall under the jurisdiction of food and drugs? Wouldnt an agency such as CE or UL have that venue? And since we are using a product derived from tobacco, why isnt the ATF covering this? If anything, FDA should only have the option to be concerned with the juice... nothing else. FDA is stepping beyond its boundaries as far as trying to control vaping...

Yes they are IMO, but they have the power to do so.
The FDA is funded by BP, and without smoking related illnesses they would be out of business.

 

[Butch]

Our elected officals ( congress & senate ) gave the power to FDA they are bing careful to try to make it loophole free..........They need the money dont ya know.

 

[Bunnykiller]

Simple, it's a delivery device for a product they intend to regulate(e-liquid).

Just because it's called the FDA doesn't mean all they can do is regulate any foods and drugs, they have a VERY broad reach for regulation. For instance, the FDA has complete control over the nicotine inhaler delivery systems(Nicotrol) because it is a system for delivering a nicotine/tobacco product, so because they're the FDA they must ensure it's safe for the population to use, just as they can potentially regulate the delivery device for e-liquid to ensure it's safe for population to use.

What does FDA regulate?

do they regulate the food delivery devices that are used to help me eat?? my fork and plates and bowls?

 

[Froth]

do they regulate the food delivery devices that are used to help me eat?? my fork and plates and bowls?

Yes, they already do.

FDA Food Code 2009: Chapter 4 - Equipment, Utensils & Linens

 

[Bunnykiller]

Yes, they already do.

FDA Food Code 2009: Chapter 4 - Equipment, Utensils & Linens

sheeshhh.... I noticed that the paper wrapper for hamburgers isnt included

 

[Butch]

sheeshhh.... I noticed that the paper wrapper for hamburgers isnt included

That is chapter 5...........

 

[Salt&PePPer]

It's just going to be a Tax on the Juice. And just as long as I can get my 24mg or bottles of nicotine I will be fine.

But if the FDA becomes tyrant's on this issue I will start buying my juice from over seas. A place that doesn't declare they are sending ejuice.

A Few Tobacco Companies have jumped into the eCig foray. I believe Blue eCig is now owned by a Tobacco company. While the other Tobacco companies see eCigs as a threat to their business. They should be scared of course. The past three years the industry has grown a lot. When was the last time any one ordered or seen Cartomizer's?

I just don't want my bottles of eJuice to double in price due to tax. Also Big Tobacco having their lobbyist on Capital Hill doesn't help and they have a lot of resources. Further I don't want the FDA dictating to us that we can only buy certain levels of nicotine in our products.

 

[oplholik]

• It's just going to be a Tax on the Juice. And just as long as I can get my 24mg or bottles of nicotine I will be fine.
  
  But if the FDA becomes tyrant's on this issue I will start buying my juice from over seas. A place that doesn't declare they are sending ejuice.
  
  A Few Tobacco Companies have jumped into the eCig foray. I believe Blue eCig is now owned by a Tobacco company. While the other Tobacco companies see eCigs as a threat to their business. They should be scared of course. The past three years the industry has grown a lot. When was the last time any one ordered or seen Cartomizer's?
  
  I just don't want my bottle double in price due to tax. Also Big Tobacco having their lobbyist on Capital Hill doesn't help and they have a lot of resources.

I received some cartos just a couple weeks ago, they are great to have around. You should see all the cartos I have stashed away.

 

[Salt&PePPer]

I received some cartos just a couple weeks ago, they are great to have around. You should see all the cartos I have stashed away.

Well the Carto isn't as prevalent as it once was. They were much more common before the days of box mods and all ecig's were designed as tubes. Nothing wrong with that. As a matter of fact the next job I get I want to get a good cigarette look a like with cartomizer's. Just fill up about ten good carto's for the day and you are on your way. Very inconspicuous in the office cubicle setting. Don't want to be blow huge plumes of smoke in the office. But my office's are usually tucked away in the corner of some Server Room where I prefer. Usually my work is high demand and I only respond to trouble ticket's because once I get seen people stop me because something went wrong with their system or such.

 

[edyle]

Ive been watching this mess over the last couple of years and Im wondering why the FDA is trying to regulate the hardware involved with vaping...
FDA stands for Food and Drug Administration correct? How does hardware fall under the jurisdiction of food and drugs? Wouldnt an agency such as CE or UL have that venue? And since we are using a product derived from tobacco, why isnt the ATF covering this? If anything, FDA should only have the option to be concerned with the juice... nothing else. FDA is stepping beyond its boundaries as far as trying to control vaping...

This is one of the central issues:
FDA stepping beyond its boundaries.

The FDA would have roles to play with respect to vaping but the problem arises when they overstep.

On every pack of cigarettes there is the Surgeon General's warning, but you can still buy the cigarettes.

 

[skoony]

do they regulate the food delivery devices that are used to help me eat?? my fork and plates and bowls?

Fingers, you forgot fingers.

Mike

 

[englishmick]

sheeshhh.... I noticed that the paper wrapper for hamburgers isnt included

Damn, when I was a kid in England you got your fish and chips wrapped in newspaper. Servers in chippies could take a sheet of newspaper and fold it into a cone shape faster than the eye could follow. As far as I know nobody ever died of newspaper poisoning, but someone decided it wasn't sanitary so now fish and chips have to come in proper approved wrapping material.

 

[oplholik]

Damn, when I was a kid in England you got your fish and chips wrapped in newspaper. Servers in chippies could take a sheet of newspaper and fold it into a cone shape faster than the eye could follow. As far as I know nobody ever died of newspaper poisoning, but someone decided it wasn't sanitary so now fish and chips have to come in proper approved wrapping material.

Well, it was good for the wrapping material industry.

 

[Dzaw]

Do not forget the fact that nicotine is a drug. We are using this hardware to deliver a drug to our bloodstream via our mucous membranes.

As drugs go, it's pretty darned innocuous, but a drug nonetheless. While the toxicity of nicotine has been proven to be at least one order of magnitude less than was previously published, and there is mounting evidence that it lacks addictive potential when separated from other compounds in tobacco, it nonetheless falls within their wheelhouse.

FDA also has authority over medical devices. If the tobacco deeming weren't the mechanism of choice, then a medical device deeming would be. That's why you don't see the hardware advertised by manufacturers as a smoking cessation product. However, there would be a legit legal argument to be made based on universal (or nearly so) common perception that any reasonable person would expect this product to help quit smoking.

Don't get me wrong, I don't like living in a nanny state either, I just think this discussion is a wasteful barking up of the wrong tree. The jurisdiction issue is one we cannot hope to win.

 

[Elizabeth Baldwin]

The truth of the matter is it doesn't matter what we think. The FDA can and will take control of the market. It's just a matter of time. That ship has already sailed. Now it's just a matter of time. During that small amount of time I suggest stocking up on what you'll need to vape comfortably for a few decades or however long you feel the need. I have 5 gallons of 100mg nic in my freezer. That should hold me, my husband and my Mom over until we all die. I also have enough mods, wire, RDAs, and RBAs to do me til then too.

Everything will need approved except the cheap cigalikes. Getting anything but cigalikes approved will be too costly for 99% of the industry. The cost, as I read it, will be between $333,000 and $1million+ to get one product even considered. That's the application process... then after paying all that for one flavor in one strength, they more than likely will be denied. The FDA has already made it public that they are doing away with flavors (the children and all). So, the only thing you might see getting approved will be menthol and tobacco flavors... and those will be Big Tobacco's mixes. All the other juice makers will close up shop because I doubt they'll waste a million dollars on a pipe dream that will never happen.

Everybody who loves vaping better learn how to make their own juice and stock up on nic. Don't be the one who stuck their head in the sand hoping it blows over because it won't.

 

[Elizabeth Baldwin]

Ive been watching this mess over the last couple of years and Im wondering why the FDA is trying to regulate the hardware involved with vaping...
FDA stands for Food and Drug Administration correct? How does hardware fall under the jurisdiction of food and drugs? Wouldnt an agency such as CE or UL have that venue? And since we are using a product derived from tobacco, why isnt the ATF covering this? If anything, FDA should only have the option to be concerned with the juice... nothing else. FDA is stepping beyond its boundaries as far as trying to control vaping...

Well I'd rather they leave it all alone. But that's not going to happen. The FDA lost in court when they tried in 2007 to regulate it as Pharmaceutical. They were told to first get regulative authority as a tobacco product then they could have the power to do what was needed. So, it took them several years but here they are doing exactly that.

 

[crxess]

The WHY is simple.

WE allowed it to reach this point.

Save us FDA, save us....................well, guess what

 

[FlamingoTutu]

Damn, when I was a kid in England you got your fish and chips wrapped in newspaper. Servers in chippies could take a sheet of newspaper and fold it into a cone shape faster than the eye could follow. As far as I know nobody ever died of newspaper poisoning, but someone decided it wasn't sanitary so now fish and chips have to come in proper approved wrapping material.

Last I was there they were still serving in newspaper. It was hell trying to read the news after the oil soaked in, but the coastal views made it so worth it. So want to move there.

Do not forget the fact that nicotine is a drug. We are using this hardware to deliver a drug to our bloodstream via our mucous membranes.

As drugs go, it's pretty darned innocuous, but a drug nonetheless. While the toxicity of nicotine has been proven to be at least one order of magnitude less than was previously published, and there is mounting evidence that it lacks addictive potential when separated from other compounds in tobacco, it nonetheless falls within their wheelhouse.

FDA also has authority over medical devices. If the tobacco deeming weren't the mechanism of choice, then a medical device deeming would be. That's why you don't see the hardware advertised by manufacturers as a smoking cessation product. However, there would be a legit legal argument to be made based on universal (or nearly so) common perception that any reasonable person would expect this product to help quit smoking.

Don't get me wrong, I don't like living in a nanny state either, I just think this discussion is a wasteful barking up of the wrong tree. The jurisdiction issue is one we cannot hope to win.

I say this respectively, not as a challenge. Nicotine is a drug, so is caffeine. They don’t regulate coffee or coffeepots. Caffeine-“laced” soda is sold to children in school vending machines. Caffeine and nicotine are very similar. There was a study done, perhaps a year ago, that showed something like 44% of UK doctors thought nicotine was a carcinogen, more than that in Sweden. Thank you ANTZ propaganda.

Found it:

The survey findings show that a substantial proportion of GPs (40%) believe nicotine to be the first or second riskiest component of cigarettes, incorrectly identifying it as more harmful than smoke. Many (44% UK, 56% Sweden) also wrongly believe that nicotine in tobacco products is associated with cancer, while 15% in the UK and 22% in Sweden believe the same for pharmaceutical nicotine.
A survey of GPs reveals that many identify nicotine as a harmful cigarette-smoke component

Barking up the wrong tree isn’t a problem, getting people to bark up every tree is the problem. What has been predicted to come down from the FDA isn’t going to hurt “us” so much as those that are still unaware or those that haven’t tried/found vaping yet. We need to bark our butts off for them.

I don’t think the jurisdiction issue will do us any good either, money (taxes and bribes) speak louder than words. The world is infuriated by terrorists (rightly so, I am at the head of the line on that), but not on the silent killers (I’m at the head of the line there also) like BT, BP and Big Health Insurance companies.

May they all rot in hell (said without apology or guilt ).