did the FDA just find a way around the december ruling?

[sqirl1]

FDA to require substantial equivalence reviews for new tobacco products does this mean that they can block the sale of E-cigs with the new "substantial equivalence" rule, since most of today's E-cigs were made long after 2007, and are totally different from early models? discuss.

 

[Traver]

I don't have any answers but I was wondering if anyone knows anything about public comments on this?

 

[Placebo Effect]

At the time they made this announcement, I believe the FDA told news outlets that this excluded e-cigarettes.

Now, whether this will create problems in the future remains to be seen.

 

[trying]

At the time they made this announcement, I believe the FDA told news outlets that this excluded e-cigarettes.

Now, whether this will create problems in the future remains to be seen.

This only applies to products FDA considers tobacco products.
If and or when FDA does consider E-cigarettes tobacco products, then it applies and the problems begin.

 

[basilray]

Out-freaking-standing FDA! Make another provisional hoop for Big tobacco to jump through on their death march, but try and keep the products that will save lives off the shelves.

I become increasingly disappointed with the constant infringement goverment places on my right to live my life.

 

[smurfette]

i just wanna say i am lovin the devo hat WHIP IT

 

[renstyle]

since this is a discussion, I wanted to ask a question which is Big Tobacco and FDA related, somewhat OT.

Do you think that Big Tobacco is going to try and take over the PV/ecig market like they are trying to do with SNUS? Or would it be too contradictory to their original stance that "we don't think tobacco smoking kills people" logic they used in Congress?

Quite honestly I'm suprised they haven't tried to corner the market, would seem to make *some* business sense? The FDA and regulations play right into that, BT already pays taxes, both at the outset and at the final sale. Money is talking here, which is what I suspect is "hindering" their attempts at domination.

 

[sqirl1]

it just seems VERY odd to me that this came into effect not even a month after the big ruling in december. To be honest I think trying to make E-cigs be regulated as tobacco products is a BIG mistake. why? because

1. the FDA could then slap the "Warning: this product is not a safe alternative to cigarettes" label on it, as well on it, making the mainstream think that we're the ones who don't know what were talking about, and deterring smokers from trying it. they would probably put all the graphic warning labels they're going to put on cigs on E-cigs as well.

and

2. the FDA could then ban flavors. they might even be able to ban tobacco flavors since they're actually not real tobacco and force E-cigs to only be tasteless vapor.

the best thing to do is try to help companies to be able to a afford a full blown testing and approval process, perhaps start a paypal donation program if there isn't one already.

 

[Vocalek]

sqirl1: You're new around here. We have argued and discussed this issue up one side and down another for two years. Here are the facts. E-cigs will be regulated by the FDA one way or another. If regulated under the Food, Drug, and Cosmetics Act as an "unapproved drug / drug delivery device comtination" they will be removed from the market until some company performs years of clinical trials and spends nearly a billion dollars to get them approved as a treatment for nicotine addiction. In the Federal court case where Smoking Everywhere and NJOY sued the FDA, the judge ruled that in the absences of any medical claims, the FDA can only regulate them as tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act. See: http://www.e-cigarette-forum.com/fo...ut-why-do-we-need-watch-how-get-up-speed.html

Yes, I wish there was an Option 3, where they are simply regulated as a consumer product, but it doesn't look as if Big Brother will allow that to happen. Perhaps you could get your Senator or Representative to sponsor legislation that specifies that E-cigarettes will be regulated only by the Consumer Product Safety Commission. The only problem with that approach is that it opens a door, allowing our enemies such as Sen. Lautenberg to introduce amendments that could end up making the situation worse.

Funny you should mention a paypal donation program, since PayPal refuses to process sales of electronic cigarettes. That dog won't hunt.

 

[CountVapula]

if we see the big tobacco companies try to take over the ecig market, i would hope all our wonderfull current vendors would stay in buisness and we could still buy THEY'RE products. i refuse to put any more of my money in the big tobacco companies pockets. what we have going in the ecig community is a really good thing right now, and this is how it should be, but they wont allow it to go on like this, theres no profit for them. we need to stand up and fight, push back.

 

[sqirl1]

know who could really help us right now is something like wikileaks. I can only hope somebody leaks out the many conversations between BT and the FDA or BP and the FDA (or whatever other relevant government agency) telling them to slam these as much as they could, the truth is out there somewhere, let's just hope theres some leakers who are also vapers. I think that would be the one thing that could save us. (DISCLAIMER TO KEEP THE MODS HERE, SECRET SERVICE, FBI, OR WHOEVER ELSE OFF MY BACK: I'M NOT SAYING ANYBODY HERE SHOULD DO ANYTHING LIKE THAT I'M JUST HOPING SOMEBODY WHO ALREADY HAS THE BALLS TO LEAK INSIDE INFORMATION SHOULD HAPPEN TO LEAK OUT INFORMATION ON THIS PARTICULAR TOPIC.)

 

[Papa Lazarou]

know who could really help us right now is something like wikileaks. I can only hope somebody leaks out the many conversations between BT and the FDA or BP and the FDA (or whatever other relevant government agency) telling them to slam these as much as they could, the truth is out there somewhere, let's just hope theres some leakers who are also vapers. I think that would be the one thing that could save us. (DISCLAIMER TO KEEP THE MODS HERE, SECRET SERVICE, FBI, OR WHOEVER ELSE OFF MY BACK: I'M NOT SAYING ANYBODY HERE SHOULD DO ANYTHING LIKE THAT I'M JUST HOPING SOMEBODY WHO ALREADY HAS THE BALLS TO LEAK INSIDE INFORMATION SHOULD HAPPEN TO LEAK OUT INFORMATION ON THIS PARTICULAR TOPIC.)

Yeah, and end up being held in solitary confinement for months, shackled and interrogated at one of the FDA's processing centre's. No-one crosses the FDA! 8-o

 

[Vocalek]

Yeah, and end up being held in solitary confinement for months, shackled and interrogated at one of the FDA's processing centre's. No-one crosses the FDA! 8-o

Papa, you are downright wicked!

 

[Zal42]

The article says that the equivalency rule will only apply to those products that entered the market after Feb. 15, 2007. E-cigs were on the market before then, I believe...

 

[Papa Lazarou]

Papa, you are downright wicked!

Just a surreal and dark sense of humour at times

 

[Traver]

The article says that the equivalency rule will only apply to those products that entered the market after Feb. 15, 2007. E-cigs were on the market before then, I believe...

We had a thread on this before. I think the conclusion was that there either were e cigs at that time or they were being test marketed. Proving to the FDA it may be another matter. There is also the question on wether that would include all of the different liquids on the market.

 

[N2rock]

“Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

I think that one right there protects e-cigs. Most operate the same way (and have the same basic ingredients) as the original e-cigs that were out before. And those that are operating differently, do not raise any different questions of public health- all ecigs will raise the same questions as the originals

 

[Our House]

Papa, you are downright wicked!

...and spot on.

 

[sqirl1]

Yeah, and end up being held in solitary confinement for months, shackled and interrogated at one of the FDA's processing centre's. No-one crosses the FDA! 8-o

I don't know.... wiki leaks has crossed more powerful agencies than the FDA..... I think if something got leaked out the FDA would be FORCED to give in since the truth would be exposed. so Julian Assange if you're reading this please help us out!

 

[DataPhreak]

The article says that the equivalency rule will only apply to those products that entered the market after Feb. 15, 2007. E-cigs were on the market before then, I believe...

That's not to say that ecigs in general will not be applicable, only ecig products that were released before that date. Thus, any new ecig can, and probalby will, fall subject to this. Further, I don't trust the FDA. Sure they say ecigs will be excluded, untill it passes, at which point they will proceed as such. Then, when they get in the court: "Your honor, the FDA said ecigs would be exempt." "Son, (I hate it when judges call people son,) the law clearly states:" and then read whatever ecerpt they choose from the legeslation applies. Unless the bill clearly states that they are exempt, they are not.

At the time they made this announcement, I believe the FDA told news outlets that this excluded e-cigarettes.

Now, whether this will create problems in the future remains to be seen.

That's because they expect to persecute ecigs as drugs.