FDA’s Youtube Channel released feature on ecigs (August 19)

[Stephaniems]

The FDA allows diet pills to be sold OTC even after lot of people die from that phen phen (sp?)

So yes I am frustrated at the FDA for the bullcrap they are pulling with their bogus reports and news spins.

I know that PVs' are better for me. Because I can breathe better, I no longer stink, I no longer have to clean ashes up or dump ashtrays. My house and vehicle smell fresh.

Even when I visit my mom her little dog doesnt sneeze and scratch around me anymore (her dog is allergic to tobacco cig smoke) I am inhaling way less detrimental things, even adding in the flavorings.

So I don't appreciate being told to get mad at the manufactures, I love those guys. I'm mad that I cannot be an adult and decide what is best for myself. Seriously I have to have a organization that has been proven to be corrupt and incompetent tell me that the peanut butter that killed people is safe but the contraption and concoction of liquid I am using now EVEN that all the individual component are GRAS by their own studies is an unknown and not SAFE? Screw that I don't trust the FDA at all.

My best friend was on the verge of killing her self with tobacco cigs, her heart rate and blood pressure was out of control, and her lung function was not very good. She switched exclusively to using PV's and nicotine liquid. Now her hr and bp are controllable and her lung function has improved by 10 percent.

See I just don't care if PVs are safe, they are better for me then tobacco cigs and I should not be forced to go back to tobacco cigs (100 percent unsafe) for my addiction?? WTF they have methodone clinic for junkies! Non alcoholic beer for drunks(which by the way has a slight bit of alcohol in it). Why is there a problem? Ok fine more studies need to be done, but don't take them off the market and don't give me bull****e about me saying im being forced back on to cigs. Obviously I got addicted to nicotine a long long time ago, and none of the approved ****e works. I don't have any desire to quit nicotine, I enjoy the benefits from it. We all pay plenty of taxes for the government to fund a study like that, that would help soo many nicotine addicts!!!!

 

[Apatel]

Why dosen't the FDA just ban regular cigarettes? They know for a FACT that cigarettes cause cancer, and a number of other diseases, and ultimately death. They know that cigarettes are unsafe, and cause fires as well.

The truth is that the government would dissolve the FDA before ever letting them ban cigarettes and the millions (billions?) of dollars that they generate in taxes and jobs.

 

[Sun Vaporer]

Why dosen't the FDA just ban regular cigarettes? They know for a FACT that cigarettes cause cancer, and a number of other diseases, and ultimately death. They know that cigarettes are unsafe, and cause fires as well.

The truth is that the government would dissolve the FDA before ever letting them ban cigarettes and the millions (billions?) of dollars that they generate in taxes and jobs.

Due to the deep cultural and econimic history of tobacco farming in the US, A 1930's statue prohibited any and all restrictions on tobacco products other then by and act of congess. In 2000, the Supreme Court upheld the 1930's statute and stated that the FDA has no jurisdiction over cigarettes or other traditional tobacco products. Then, just this year, Congess enacted legislation that allows the FDA to regulate traditional tobacco products, but not ban them outright.

Sun

 

[HighTech]

The FDA allows diet pills to be sold OTC even after lot of people die from that phen phen (sp?)

So yes I am frustrated at the FDA for the bullcrap they are pulling with their bogus reports and news spins.

I know that PVs' are better for me. Because I can breathe better, I no longer stink, I no longer have to clean ashes up or dump ashtrays. My house and vehicle smell fresh.

Even when I visit my mom her little dog doesnt sneeze and scratch around me anymore (her dog is allergic to tobacco cig smoke) I am inhaling way less detrimental things, even adding in the flavorings.

So I don't appreciate being told to get mad at the manufactures, I love those guys. I'm mad that I cannot be an adult and decide what is best for myself. Seriously I have to have a organization that has been proven to be corrupt and incompetent tell me that the peanut butter that killed people is safe but the contraption and concoction of liquid I am using now EVEN that all the individual component are GRAS by their own studies is an unknown and not SAFE? Screw that I don't trust the FDA at all.

My best friend was on the verge of killing her self with tobacco cigs, her heart rate and blood pressure was out of control, and her lung function was not very good. She switched exclusively to using PV's and nicotine liquid. Now her hr and bp are controllable and her lung function has improved by 10 percent.

See I just don't care if PVs are safe, they are better for me then tobacco cigs and I should not be forced to go back to tobacco cigs (100 percent unsafe) for my addiction?? WTF they have methodone clinic for junkies! Non alcoholic beer for drunks(which by the way has a slight bit of alcohol in it). Why is there a problem? Ok fine more studies need to be done, but don't take them off the market and don't give me bull****e about me saying im being forced back on to cigs. Obviously I got addicted to nicotine a long long time ago, and none of the approved ****e works. I don't have any desire to quit nicotine, I enjoy the benefits from it. We all pay plenty of taxes for the government to fund a study like that, that would help soo many nicotine addicts!!!!

Same thing I said. Just not as many words... Nice post Steph!

 

[mintee]

If you want to vent your frustration, do it at them and not the agency charged with protecting public health. The FDA does not what to ban the e-cig ---what I hear them saying is --"If they are in fact safe, show it, prove it" As was pointed out in the FDA's brief, the do not want to ban the e-cig, rather they what it to go though the appoval process.

Sun

Sun, I agree with you, however, given the cost from the manufacturers and the quantity they are selling, I'm not sure if they can provide the FDA with the millions of dollars of tests that they are asking for. I assure you that they should provide some information, but it's also the FDA's job to double check the analysis reports.

There should be a 50-50 waypoint between the manufactureres and the FDA IMHO.

 

[Sun Vaporer]

Sun, I agree with you, however, given the cost from the manufacturers and the quantity they are selling, I'm not sure if they can provide the FDA with the millions of dollars of tests that they are asking for. I assure you that they should provide some information, but it's also the FDA's job to double check the analysis reports.

There should be a 50-50 waypoint between the manufactureres and the FDA IMHO.

Mintee--I know that NJOY et al though out these huge costs and time frames, but that is a lot of vape. Take for example this small company that is about to get FDA approval. No big pharm here:

See Smoke-Break®

PS--might have a lttle value in making e-liquid.

Sun

 

[Skeezix]

-what I hear them saying is --"If they are in fact safe, show it, prove it" As was pointed out in the FDA's brief, the do not want to ban the e-cig, rather they what it to go though the appoval process.



Sun[/quote]

On DaKang's website, and in their posts here, they emphasize that they have applied for certification from the FDA.

In fact, it was at the urging of the FDA that DaKang ceased distribution of 36mg e-liquid.

Why do they ignore the Ruyan/Laugensen report?

I believe the Chinese companies are trying to cooperate but are being stonewalled.

 

[MVP]

And, no, you will never see a comparison to tobacco cigarettes. E-cigs must stand on their own, compared to nothing. Are they safe? How safe compared solely to not using them? That's the way regulation works.

So using Chantix is safe compared soley to not using it?!?!?

 

[Sun Vaporer]

-what I hear them saying is --"If they are in fact safe, show it, prove it" As was pointed out in the FDA's brief, the do not want to ban the e-cig, rather they what it to go though the appoval process.



Sun

On DaKang's website, and in their posts here, they emphasize that they have applied for certification from the FDA.

In fact, it was at the urging of the FDA that DaKang ceased distribution of 36mg e-liquid.

Why do they ignore the Ruyan/Laugensen report?

I believe the Chinese companies are trying to cooperate but are being stonewalled.[/quote]


I can understand how you could think that Ske--but the playing field has to be level when it comes to the requisite studies that the FDA requires. The standards they set are for all applicants and the Ruyan/Laugensen reports, although have a lot of validity, where not done under the same standards as all other applicants to the FDA. When you really look at it, the FDA is simply asking the Manufactures to do is what all the other companies have done that have gained approval.

Sun

 

[Webby]

When you really look at it, the FDA is simply asking the Manufactures to do is what all the other companies have done that have gained approval.
Sun

Sun,

What would be (IYO) a reasonable time frame to expect these to undergo enough of an approval process to be allowed for sale - in whatever form?

I'm not one who wakes up early to scan the horizon for black helicopters, but if the FDA gets their way, I have a strong feeling the deck will be stacked harder against getting approval that it would for many other products that "played ball" with them from the beginning.

E-cigs have already become Public Enemy Number One on the FDA's hit parade. Most (voting) non-smokers could care less about our "right to vape" and honestly believe the propaganda that e-cigs cause gout, scurvey, toe cancer, eat kittens and will shoplift lipstick if allowed to continue to infest our <insert patriotic music> God Bless America(n) shores...

<humming Battle Hymn of the Republic>

<fade to images of children, kittens and people paying for lipstick ending with flag waving in breeze>

 

[HighTech]

I can understand how you could think that Ske--but the playing field has to be level when it comes to the requisite studies that the FDA requires. The standards they set are for all applicants and the Ruyan/Laugensen reports, although have a lot of validity, where not done under the same standards as all other applicants to the FDA. When you really look at it, the FDA is simply asking the Manufactures to do is what all the other companies have done that have gained approval.

Sun

Agreed. But, it makes ZERO sense to ban these products while they go through the approval process. These products have been in the marketplace for at least 4-5 years and I haven't heard of anyone dying or getting sick. What I have heard is thousands of voices saying how much the products have helped. How much their health has improved. How they have their life back.

It's the little girl saying "Thank you for not letting my daddy die". Or the 55 year old window that just layed her husband to rest who died of lung cancer and will spend her golden years alone. THAT, my brother, is what this is ALL about. This is about LIVES. And the rhetoric of the US Federal Government, with its cash-lined pockets of OUR tax money, and special interest money, put above the lives of the American citizen is a travisty at best.

YouTube - FDA Advisory & Big Pharma Conflicts of Interest, Psychology

 

[Sun Vaporer]

Sun,

What would be (IYO) a reasonable time frame to expect these to undergo enough of an approval process to be allowed for sale - in whatever form?

I'm not one who wakes up early to scan the horizon for black helicopters, but if the FDA gets their way, I have a strong feeling the deck will be stacked harder against getting approval that it would for many other products that "played ball" with them from the beginning.

E-cigs have already become Public Enemy Number One on the FDA's hit parade. Most (voting) non-smokers could care less about our "right to vape" and honestly believe the propaganda that e-cigs cause gout, scurvey, toe cancer, eat kittens and will shoplift lipstick if allowed to continue to infest our <insert patriotic music> God Bless America(n) shores...

<humming Battle Hymn of the Republic>

<fade to images of children, kittens and people paying for lipstick ending with flag waving in breeze>

Webby--with the limited ingrediants in e-liquid, and the fact that all of ingredients are not cases of first impression and are household names (meaning we are not looking at out of the box, never have been scene before products like a Vioxx or other Cox 2 inhibitor) the timing would be be 18-24 months at most. You see the issue here is that anyone that does make the application and does the studies, and then is denied, has the "Case of the Day" against the FDA, as then, if the studies show it is "clean", it can be readily shown that the FDA is exceeding its authority.

Sun

 

[Sun Vaporer]

Agreed. But, it makes ZERO sense to ban these products while they go through the approval process. These products have been in the marketplace for at least 4-5 years and I haven't heard of anyone dying or getting sick. What I have heard is thousands of voices saying how much the products have helped. How much their health has improved. How they have their life back.

It's the little girl saying "Thank you for not letting my daddy die". Or the 55 year old window that just layed her husband to rest who died of lung cancer and will spend her golden years alone. THAT, my brother, is what this is ALL about. This is about LIVES. And the rhetoric of the US Federal Government, with its cash-lined pockets of OUR tax money, and special interest money, put above the lives of the American citizen is a travisty at best.

Hightech--Agreed, that is why I keep harping on the fact that I hope that SE and NJOY are trying to settle, not just in their best interest, but in our interest as well. Remember that NJOY has many other markerts it can sell in while waiting approval---we can not wait. That is why I really had hoped that the ECA at least wrote a brief for the Court with regards to pointing out all interests from all concerned.

Sun

 

[Skeezix]

I agree Sun, the Chinese really jumped the gun with this one from a marketing standpoint. They did it the way they always do it over there underestimating the more strict standards in other parts of the world.

Had they, two years ago, submitted nice pure samples of e-liquid, prototypical devices, and patent information the e-cigarette would have enjoyed quite a different reception than the one it has now.

And you are saying it's not too late for them to follow the proper protocols and set things aright.

 

[Sun Vaporer]

I agree Sun, the Chinese really jumped the gun with this one from a marketing standpoint. They did it the way they always do it over there underestimating the more strict standards in other parts of the world.

Had they, two years ago, submitted nice pure samples of e-liquid, prototypical devices, and patent information the e-cigarette would have enjoyed quite a different reception than the one it has now.

And you are saying it's not too late for them to follow the proper protocols and set things aright.

Skee--not to late at all, and if they do everything the FDA requires, and prove it to be safe, the Court will at that point have to intevene and override the FDA.

Sun

 

[ProtoType]

I gotta say that I don't find this video that bad. She's just pointing out the unknown effects. And well.... it is a NEW product and MANY things are unknown. But what is KNOWN so far has far EXCEEDED what is KNOWN about real cigarettes.

Don't get mad at someone doing their job (regardless of how much they make).

The only problem I had with the video is that they claimed ecigs are targeted towards those that are underage.

 

[Sun Vaporer]

I gotta say that I don't find this video that bad. She's just pointing out the unknown effects. And well.... it is a NEW product and MANY things are unknown. But what is KNOWN so far has far EXCEEDED what is KNOWN about real cigarettes.

Don't get mad at someone doing their job (regardless of how much they make).

The only problem I had with the video is that they claimed ecigs are targeted towards those that are underage.

Proto--you are right--the video is not bad. Woodstock is asking the manufactures to prove the product is safe and wants to see age restictions in place. That is what the FDA is charged with doing. I am not all on board with a conspiricy here as the FDA did in 2000 try to gain control of regulating cigarettes and the Supreme Court shot them down---does not sound like the FDA was in "anybodys pocket' then.

Sun

 

[Webby]

I agree Sun, the Chinese really jumped the gun with this one from a marketing standpoint. They did it the way they always do it over there underestimating the more strict standards in other parts of the world.

I mentioned this in another thread, but they've done this several times over the years. Mexico has VERY tight restrictions when it comes to Asian products due to an issue in the 60's when the US rejected massive amounts of poorly made electrical products only to have them dumped on the Central American (primarily Mexican) markets. Several deaths were attributed to faulty wiring and it was eerily reminiscent of the lead paint toy fiasco recently.

I have to say I wish I shared your enthusiasm for Njoy and SE's motives. As a veteran of several corporate wars, I've been "grin-f**ked" by the best of 'em. CEOs and CFOs will lie to their mothers when it comes to CYA and protecting the bottom line. You're sadly mistaken if you think the term 'exit strategy" hasn't come up in more than one board meeting.

There is a global market (we sell in 7 countries), but the US makes up almost 90% of our sales. I may be wrong, but I'd wager most global suppliers are seeing the same numbers in their footprints. Losing the American market (even for 12-24 months) would hurt us and probably shut down many US suppliers altogether.

That said - Sun, I have a follow up question:

Who would have the authority to start the process of requesting approval? I assume it would have to be a manufacturer (as opposed to a supplier, PAC or lobbying group of users) and how would that process work?

I apologize if this has been answered ad nauseum, but I don't see anyone (publicly) making that step. Is it a cost issue? If so, couldn't the ball be started rolling, papers submitted, yada yada yada and we all start a fund or look for a >cough cough< good attorney to do this pro bono for the publicity and go all Erin Whatshernamavitch for the cameras?

 

[Sun Vaporer]

I mentioned this in another thread, but they've done this several times over the years. Mexico has VERY tight restrictions when it comes to Asian products due to an issue in the 60's when the US rejected massive amounts of poorly made electrical products only to have them dumped on the Central American (primarily Mexican) markets. Several deaths were attributed to faulty wiring and it was eerily reminiscent of the lead paint toy fiasco recently.

I have to say I wish I shared your enthusiasm for Njoy and SE's motives. As a veteran of several corporate wars, I've been "grin-f**ked" by the best of 'em. CEOs and CFOs will lie to their mothers when it comes to CYA and protecting the bottom line. You're sadly mistaken if you think the term 'exit strategy" hasn't come up in more than one board meeting.

There is a global market (we sell in 7 countries), but the US makes up almost 90% of our sales. I may be wrong, but I'd wager most global suppliers are seeing the same numbers in their footprints. Losing the American market (even for 12-24 months) would hurt us and probably shut down many US suppliers altogether.

That said - Sun, I have a follow up question:

Who would have the authority to start the process of requesting approval? I assume it would have to be a manufacturer (as opposed to a supplier, PAC or lobbying group of users) and how would that process work?

I apologize if this has been answered ad nauseum, but I don't see anyone (publicly) making that step. Is it a cost issue? If so, couldn't the ball be started rolling, papers submitted, yada yada yada and we all start a fund or look for a >cough cough< good attorney to do this pro bono for the publicity and go all Erin Whatshernamavitch for the cameras?

Webby--the application process can be done in tantum between a Manufacture in China, a Supplier here in the US, and Counsel for both the Manufacture and the Supplier, all in a concert to get the requiste paperwork filed and hire third party parties to conduct the studies and clinical trials. It is complicated from the outside, but those that do it for a living (Counsel, Doctors, Labs) walk though this process all the time.


Sun

 

[OutWest]

why should it even have to be done, though? I know, because the FDA says so. But look at all of the non-FDA approved drugs and such that are legally sold every day in the U.S. You can get everything from hangover cures, to penis elargement and erectile dysfunction drugs, weight loss cocktails, etc. I saw a weight loss drug infomerical the other day that claimed you would lose x amount in x number of days; and at the end they ran the "these statements have not evaluated by the FDA, not intended to treat, diagnose, or prevent any disease" disclaimer. There are hundreds of similar products sold every day in the U.S. Even some prescription drugs are not FDA approved.

The FDA lawyers are claiming that we're advertising ecigs as stop smoking devices. Sure, some vendors are. Most are not. In my opinion, they should only take issue with those that make health claims and stop smoking claims and leave the rest of us alone.