Fda allows 600,000 to be sold, then bans e-cigs?

[palermo45]

I have several issues against what the FDA is doing. It isn't like e-cigs are brand new. The FDA has known about them for well over a year and as seen in the complaint from SE, they have sold over 600,000 units. Besides SE, if you include njoy and several other players, I would put the total number of e-cigs allowed into the US at around 2 million units. This is not an FDA "emergency" stop to a product. If they planned on doing something, they should have nipped it in the bud. They allowed so many units to be sold, allowed smokers to get used to the units, then decide to halt imports. If I were the Judge, I would ask why they permitted so many sales over such a long time while FULLY knowing they were selling and selling in droves. Besides that, what about the millions of people who paid a lot of money for their product? They will simply have to take the loss and toss their product in the trash, simply because it took the FDA 18 months to initiate simple proceedings?? It is unfair to the consumer is so many ways!!!

SE has the funds to initiate the lawsuit and kudos to them. I hope njoy also initiates a similar if not stronger suit against the FDA.

If they do decide to ban them, then watch out for contraband to proceed!!

Talk about a busted system!!!

 

[Wildsky]

See taxes were just raised on ciggies, 100's more folk are looking at e-cigs and now its becoming a problem because so many people are able to quit smoking (no more tax money)
Its probably more the big tobacco companies that are getting their knickers in a knot!

 

[breakfastchef]

This is not an FDA emergency" stop to a product. If they planned on doing something, they should have nipped it in the bud. They allowed so many units to be sold, allowed smokers to get used to the units, then decide to halt imports.

Actually, FDA really does not have jurisdiction over e-cigs since the devices and liquids fall into an undefined gray area. Any action they may take to stem imporatation could be considered far-reaching, possbily ineffective. I think there is some political pressure right now and the FDA is posturing, perhaps acting as though they will be given rule over nicotine and tobacco in the near future.

The FDA can go after those companies that marketed e-cigs as nicotine replacement therapy devices or claimed that they are healthier than analogs. In those cases, the FDA has control over the importation and sale of medical devices, as I understand. The SE lawsuit will be interesting to follow.

I also understand there are several Congressmen that use PVs. This is actually good news for vapers.

 

[ladyraj]

Actually, FDA really does not have jurisdiction over e-cigs since the devices and liquids fall into an undefined gray area. Any action they may take to stem imporatation could be considered far-reaching, possbily ineffective. I think there is some political pressure right now and the FDA is posturing, perhaps acting as though they will be given rule over nicotine and tobacco in the near future.

The FDA can go after those companies that marketed e-cigs as nicotine replacement therapy devices or claimed that they are healthier than analogs. In those cases, the FDA has control over the importation and sale of medical devices, as I understand. The SE lawsuit will be interesting to follow.

I also understand there are several Congressmen that use PVs. This is actually good news for vapers.

The problem is that RJR had a similar problem with it's Eclipse brand which warmed tobacco but didn't burn it. This process started about 1996 got worse and worse until 2000 and RJR responded with a limited release. I have never heard of the product until today but I think you can buy it online. Excerpts from the debate against the product:

In the most recent development in the ongoing debate over the Eclipse cigarette, ACS experts published a letter in the Dec. 20 issue of The Journal of the American Medical Association (JAMA). Michael Thun, MD, vice president of epidemiology and surveillance research, and Thomas Glynn, MD, director of science and trends, say the product should be regulated by the U.S. Food and Drug Administration (FDA).
"The only appropriate body to evaluate and regulate nicotine delivery devices, including Eclipse, is the [FDA] the only entity with the expertise, objectiveness, and appropriate authority to determine whether, and on what terms, such devices should be available in the marketplace," they write.
"Pharmaceutical companies must meet rigorous scientific review and approval by the FDA before they market nicotine replacement devices such as gum, patch, and nasal spray," Thun and Glynn continue. "The public is unaware that Eclipse, like other tobacco products, remains unregulated merely because a tobacco company manufactures it and wraps it in white paper to look like a cigarette."

 

[LaceyUnderall]

Actually, FDA really does not have jurisdiction over e-cigs since the devices and liquids fall into an undefined gray area. Any action they may take to stem imporatation could be considered far-reaching, possbily ineffective. I think there is some political pressure right now and the FDA is posturing, perhaps acting as though they will be given rule over nicotine and tobacco in the near future.

The FDA can go after those companies that marketed e-cigs as nicotine replacement therapy devices or claimed that they are healthier than analogs. In those cases, the FDA has control over the importation and sale of medical devices, as I understand. The SE lawsuit will be interesting to follow.

I also understand there are several Congressmen that use PVs. This is actually good news for vapers.

Yes! My sentiments exactly.

Sorry... not much more to say because you are dead on!

 

[jmoney]

i just cannot believe they would be able to ban products that don't say they are a smoking cessation device...ones that are properly marked on their intended use just really don't break any laws

 

[LaceyUnderall]

i just cannot believe they would be able to ban products that don't say they are a smoking cessation device...ones that are properly marked on their intended use just really don't break any laws

hence our need to make absolutely sure that the Waxman Bill as is, fails in the Senate and that the Kennedy Bill which I hear might just be introduced, has a provision for products like the ecig.

According to Tobacco Free Kids, anything that IS NOT a tobacco cigarette is a smoking cessation device and should therefor go through testing just like the patch, gum and puffers did. This means that for at least 2-5 years you are looking at clinical trials (during which time they will be banned) and then after that, at least 2 years of having to get an RX from your doctor to smoke your ecig.

But you are totally right... ones properly marked are not doing any thing wrong and shouldn't be stopped. Unfortunately, there are some old school, heavy hitters who believe otherwise.

 

[jmoney]

If the judge has any logic whatsoever, there is no way I see these things actually being banned...they can huff and puff all they want but at the end of the day I believe each company interested in continuing their business will be required to register with the FDA and submit their product from preliminary testing, it all comes down to how many business want to go through the effort thats the only problem I see here. At the end of the day most of you retailers out there will be shut down, the big boys are going to stay around. Then of course the taxes will come to "fund" the research and the continuing future of the device.

this is all just my speculation, but an all ban just does not seem to be a likely solution...the problem is quality and product control which there is none...you know this because almost every device out there has cheerleaders saying there are no problems and others have nothing but problems...there can only truly be a solution that finds a balance that will continue the research of these devices.

 

[LaceyUnderall]

If the judge has any logic whatsoever, there is no way I see these things actually being banned...they can huff and puff all they want but at the end of the day I believe each company interested in continuing their business will be required to register with the FDA and submit their product from preliminary testing, it all comes down to how many business want to go through the effort thats the only problem I see here.

You make it sound so easy (and inexpensive)! If that's the case, we are totally in! No... we are totally in either way and willing to do what it takes. But when the FDA comes to us and says that will be $insert outrageous amount here.00, yep... you're right, we're done. And so are the big boys... well... the ecig big boys anyways.

 

[Kendra]

hence our need to make absolutely sure that the Waxman Bill as is, fails in the Senate and that the Kennedy Bill which I hear might just be introduced, has a provision for products like the ecig.

Are any people on board to vote against this?

Also, I think that this is a minor issue to most people who don't use them. Most people don't even know about them. The day I went to visit my Dad was the first he heard of them yet, that very day, NPR did a very negative story on them and mentioned how they were NOT proven safe, they were and UNregulated they were and UNapproved by the FDA. For people "not in the know" they automatically believe that these things NEED to be APPROVED, REGULATED, and SAFE. . . I mean, most people really are sheep it seems and don't stop and think, 'oh, well why the hell do they NEED to be regulated and approved?" (yep, even my dad said to me, "you know, kendra, these aren't approved by the FDA", lol)

 

[jmoney]

there are laws that prevent discrimination against enterprising individuals, if the company has a credible product that may be of some health/medical benefit there can funding for these trials provided by the FDA. If only rich people could get their product approved...then it wouldn't be considered an equal opportunity system...which it has to be.

 

[jmoney]

money just comes in to play on how fast you want your trials to go through...thats the problem...

 

[Webby]

there are laws that prevent discrimination against enterprising individuals, if the company has a credible product that may be of some health/medical benefit there can funding for these trials provided by the FDA. If only rich people could get their product approved...then it wouldn't be considered an equal opportunity system...which it has to be.

...which is why they most likely will follow the 5-7 year new product approval process in the US if there isn't a grassroots effort to prove e-cigs are NOT tobacco and therefore don't fall under the Family Smoking Prevention and Tobacco Control Act passed last month.

Like gum, patches and anything else that caught the public eye (and became too big of an elephant to ignore) politicians will ramrod the government agencies, the mainstream news will rehash SE mall interviews, all the non-smoking public will hear is that their local Senator stopped another of those nasty smoking things.

Oh yes...and e-cigs will fall into governmental study. Kind of like that really cool couple you knew who had kids and fell off the face of the earth. You won't see them for years, and when they come back they won't be quite like you remembered them...

 

[LaceyUnderall]

Are any people on board to vote against this?

Also, I think that this is a minor issue to most people who don't use them. Most people don't even know about them. The day I went to visit my Dad was the first he heard of them yet, that very day, NPR did a very negative story on them and mentioned how they were NOT proven safe, they were and UNregulated they were and UNapproved by the FDA. For people "not in the know" they automatically believe that these things NEED to be APPROVED, REGULATED, and SAFE. . . I mean, most people really are sheep it seems and don't stop and think, 'oh, well why the hell do they NEED to be regulated and approved?" (yep, even my dad said to me, "you know, kendra, these aren't approved by the FDA", lol)

I was in a bar the other nite when someone at the table sitting next to me, smoking with his five friends said "You see that blue lite ciggie thing she is smoking on, that's not FDA approved and will kill you". Then he put his cigarette into the ashtray and left it burning while he nibbled on some girls neck. LOL.

Yes, right now not many everyday people have not heard of the ecig, even though there have been a guestimated 1,000,000 kits sold in the US which being conservative, there are between 100,000 and 500,000 ecig smokers out there, just simply not united.

AND... It is very interesting to me that the Waxman bill was a sure thing... then some murmuring on the hill occurred (our letters perhaps and other factors?) and a few Senators became hesitant. Now, the Kennedy bill is going to make it's appearance, which for a week or so there, wasn't going to.

This is all good good news. Things on the hill are slowing down a bit... this rush to judgment seems to be in less of a rush... we definitely have an excellent chance of being heard and those propaganda, unfounded claims of health will be easily dispelled. Everyday, more and more big names come out in praise of the ecig and it will just be a matter of fight and time.

I totally agree with you on this crazy idea of FDA regulation. Why compare the e-cig to pharmaceuticals when it comes to scale of harm? Compare them to tobacco cigarettes. This is a recreational product and should be compared as such. It would be like comparing alcohol to orange juice. You just wouldn't do it. It's not a rational argument and well... those days will be over soon...