AP: FDA Sending Warning Letters

[HeatherC]

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

Am I interpreting the above statement wrong?..... does it not eqaul:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people to quit smoking traditional cigarettes WHICH WILL be through expensive clinical trials.....not to mention the YEARS it will take and as someone else mentioned, the "additives" big Pharma piece of the pie wil include side effects such as suicide, homicidal thoughts and ...........The side effects will discourage people from using them, thus rendering them ineffective....WHICH will then make tobacco industry happy...AND the Feds won't loose thier precious tax dollars nor will they have to pay Social Security to the 500,000 people who will CONTINUE to die each year from smoking related illnesses....

FDA Approval = Companies with enough money in their coffers to play the game
FDA + tobacco + Big Pharma = Electronic Cigarette NRT "APPROVED!"
No?

Just checking in case my interpretor is broken, lol!

I think this is what the FDA WANTS us to think. I think that as Judge Leon has already said in his decision against the FDA that they have no jurisdiction over ecigs as drug delivery devices. I think the FDA thinks we're all idiots with no brains and I have a HUGE problem with that.

 

[Drakos]

I truely do believe that there should be standards of QC and safety in this industry. Without this, the FDA does have valid claims. Despite e-cigs being much safer than cigs, they do pose imminent safety risks. Bio-contamination, possibility of ingestion by childeren are my biggest concerns. I have brought up these issues once before but they kinda got shrugged off. The industry MUST set standards of QC and safety to be a proven product. No different than any other product we consume. When the FDA sees strides of this progression, they will be more accomidating to further evaluation. I haven't been here as long as many of you, nor vaping as long as many of you, but I do not see great attempts in making these products more viable in regulation. Standards of quality and safety are accross the map. I believe in this product very strongly but considering how long e-cigs have been around, there are so many inconsistancies where the viability of this product becomes in question. Example...the other day my son climbs on top of my office chair to get to my cabinet where I put my e-liquid. Luckily I walked in when he was trying to open up the cap. What affect would this have had if he were to drink the e-liquid? I know we are fed up with the FDA's stance, but viability must be proven.

 

[PoliticallyIncorrect]

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

Am I interpreting the above statement wrong?..... does it not eqaul:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people to quit smoking traditional cigarettes WHICH WILL be through expensive clinical trials.....not to mention the YEARS it will take and as someone else mentioned, the "additives" big Pharma piece of the pie wil include side effects such as suicide, homicidal thoughts and ...........The side effects will discourage people from using them, thus rendering them ineffective....WHICH will then make Tobacco industry happy...AND the Feds won't loose thier precious tax dollars nor will they have to pay Social Security to the 500,000 people who will CONTINUE to die each year from smoking related illnesses....

FDA Approval = Companies with enough money in their coffers to play the game
FDA + Tobacco + Big Pharma = Electronic Cigarette NRT "APPROVED!"
No?

Just checking in case my interpretor is broken, lol!

It's a poorly worded sentence any way you slice it--not grammatically, it's just unclear on a point that would swing monumentally, depending on which way it went.

I'm as guilty of this as anyone, but in calmer moments I try to keep knee-jerk conspiratorial reflexes under control. Remember that the passage begins with the FDA urging the industry to "work with them." That's new verbage out of them--haven't seen that before. They're not going to ask the industry to cooperate by folding up their tents voluntarily.

It goes on to seek the "...the safety and effectiveness of the devices, " i.e., PVs, "to help people quit smoking traditional cigarettes through usually expensive clinical trials." That could mean they're asking for the industry's financial backing of (usually expensive) clinical trials to ascertain the effectiveness of PVs as smoking cessation devices.

Yes, I tend toward foolish optimism at times. But the argument could be reasonably made.

 

[Drozd]

States definitely don't want all smokers switching over to e-cigs, they would lose millions in tax dollars and the federal government is in much the same position. Both the states and the federal government rely on smokers continuing to smoke cigarettes for the millions in tax dollars that they pay in.

not just tax dollars either but in tobacco master settlement monies...
several states have securitized those payments (sold them for a one time payment which are then sold as tobacco bonds to investors) and then guaranteed those bonds...
so if cigs don't sell the tobacco companies don't pay as much to pay off those bonds....and well the states guaranteed them...so then the state is on the hook for that money if and when the bonds are cashed in..

 

[Drozd]

I think this is what the FDA WANTS us to think. I think that as Judge Leon has already said in his decision against the FDA that they have no jurisdiction over ecigs as drug delivery devices. I think the FDA thinks we're all idiots with no brains and I have a HUGE problem with that.

in a way we are...we read his ruling as e-cigs.......it's not.... it's njoy's products...it was SE and njoy...but se bowed out.... no other manufacturer or distributor chose to join in on the lawsuit... at best it'll set presedence that could be used by other e-cig manufacturers and distributors...

 

[t9c]

I truely do believe that there should be standards of QC and safety in this industry. Without this, the FDA does have valid claims. Despite e-cigs being much safer than cigs, they do pose imminent safety risks. Bio-contamination, possibility of ingestion by childeren are my biggest concerns. I have brought up these issues once before but they kinda got shrugged off. The industry MUST set standards of QC and safety to be a proven product. No different than any other product we consume. When the FDA sees strides of this progression, they will be more accomidating to further evaluation. I haven't been here as long as many of you, nor vaping as long as many of you, but I do not see great attempts in making these products more viable in regulation. Standards of quality and safety are accross the map. I believe in this product very strongly but considering how long e-cigs have been around, there are so many inconsistancies where the viability of this product becomes in question. Example...the other day my son climbs on top of my office chair to get to my cabinet where I put my e-liquid. Luckily I walked in when he was trying to open up the cap. What affect would this have had if he were to drink the e-liquid? I know we are fed up with the FDA's stance, but viability must be proven.

I can't find anything in this argument that FDA regulation would prevent. Just watch and remember this when the drug companies gain total control over e-juice and ask yourself, what's different now than then. The number one and possibly only difference will be there aren't as many choices. The FDA will have given BP the right to destroy a thriving free market and they won't give a damn.

 

[PapaJoe8]

Take a look at what happened to the U.S. internet poker players. They got hit it w/ a sucker punch big time. It didn't get killed it but it is only just barley breathing. Beware tha sucker punch from the Gov guys!!! They CAN do it and they will !!!
Joe

 

[AJMoore]

Well here are few ideas.... Have the moderators here apply a CASAA logo under you screen name when you donate say 10 bucks

That is a great idea, I'm in. They have "Supporting Member" under your name for those that support the forum as well, too bad more people don't contribute.

 

[PoliticallyIncorrect]

That is a great idea, I'm in. They have "Supporting Member" under your name for those that support the forum as well, too bad more people don't contribute.

Roger that. If ECF were to add credit/debit as a payment option, they might have a little more success with it. And perhaps even more if they were to add the following: 10% of your contribution to ECF will be donated to CASAA for their effots on behalf of us all. Or words to that effect.

 

[lmrasch]

It's a poorly worded sentence any way you slice it--not grammatically, it's just unclear on a point that would swing monumentally, depending on which way it went.

I'm as guilty of this as anyone, but in calmer moments I try to keep knee-jerk conspiratorial reflexes under control. Remember that the passage begins with the FDA urging the industry to "work with them." That's new verbage out of them--haven't seen that before. They're not going to ask the industry to cooperate by folding up their tents voluntarily.

It goes on to seek the "...the safety and effectiveness of the devices, " i.e., PVs, "to help people quit smoking traditional cigarettes through usually expensive clinical trials." That could mean they're asking for the industry's financial backing of (usually expensive) clinical trials to ascertain the effectiveness of PVs as smoking cessation devices.

Yes, I tend toward foolish optimism at times. But the argument could be reasonably made.

Lol! Well....my knee jerk conspiratorial reflexes lends me to believe that "the new verbage" is strictly to make them appear to be reasonable and truly concerned.....I don't buy it...

 

[AJMoore]

Roger that. If ECF were to add credit/debit as a payment option, they might have a little more success with it. And perhaps even more if they were to add the following: 10% of your contribution to ECF will be donated to CASAA for their effots on behalf of us all. Or words to that effect.

Another really great idea.

 

[lmrasch]

That is a great idea, I'm in. They have "Supporting Member" under your name for those that support the forum as well, too bad more people don't contribute.

Roger that. If ECF were to add credit/debit as a payment option, they might have a little more success with it. And perhaps even more if they were to add the following: 10% of your contribution to ECF will be donated to CASAA for their effots on behalf of us all. Or words to that effect.

I'm liking this....maybe using Paypal as well. Suppliers could also contribute by giving discounts to those that support CASAA.

 

[PoliticallyIncorrect]

Lol! Well....my knee jerk conspiratorial reflexes lends me to believe that "the new verbage" is strictly to make them appear to be reasonable and truly concerned.....I don't buy it...

That's entirely possible, absolutely. I can't disprove the scenario of smoke-filled rooms and small armies of tobacco and pharmacuetical lobbyists tending to a handful of FDA brass with wads of cash and sex-for-hire. But I can't prove it either. Hey, if a scandal like that in the ever appears in the New York Times, no one will be happier than me.

 

[lmrasch]

That's entirely possible, absolutely. I can't disprove the scenario of smoke-filled rooms and small armies of tobacco and pharmacuetical lobbyists tending to a handful of FDA brass with wads of cash and sex-for-hire. But I can't prove it either. Hey, if a scandal like that in the ever appears in the New York Times, no one will be happier than me.

Here's an excerpt from Tobacco News Analysis and Commentary:

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3
Big Pharma: 4
Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

To read the rest of the story, follow the link:
The Rest of the Story: Tobacco News Analysis and Commentary: Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Influence of Industry on FDA Grows

 

[PoliticallyIncorrect]

Here's an excerpt from Tobacco News Analysis and Commentary:

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3
Big Pharma: 4
Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

To read the rest of the story, follow the link:
The Rest of the Story: Tobacco News Analysis and Commentary: Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Influence of Industry on FDA Grows

Did you intend for there to be any clickable links? I wouldn't mind giving this thing a look.

 

[PoliticallyIncorrect]

I'm liking this....maybe using Paypal as well. Suppliers could also contribute by giving discounts to those that support CASAA.

I believe I'm going to lay this idea before my vendor of choice, Strictly E-Juice: Like most eveyone else, they give a 10% discount by use of their code. They could, by slight modification to their online ordering, offer the buyer the option of donating the 10% to CASAA in their name.

Won't cost me anything to fire off an email.

 

[mpetva]

Here's an excerpt from Tobacco News Analysis and Commentary:

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3
Big Pharma: 4
Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

To read the rest of the story, follow the link:
The Rest of the Story: Tobacco News Analysis and Commentary: Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Influence of Industry on FDA Grows

Link
The Rest of the Story: Tobacco News Analysis and Commentary

This is a great site and I read it every day!

 

[Poeia]

Is the liquid a "components for the plastic and metal devices that heat a liquid nicotine solution?" If not, when did Johnson Creek start selling hardware as well as liquid?

 

[lmrasch]

Did you intend for there to be any clickable links? I wouldn't mind giving this thing a look.

Actually yes I did, lol! Not sure why the bottom part was originally a link, obviously didn't show up that way, try this:
The Rest of the Story: Tobacco News Analysis and Commentary: Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones

 

[Vocalek]

I believe I'm going to lay this idea before my vendor of choice, Strictly E-Juice: Like most eveyone else, they give a 10% discount by use of their code. They could, by slight modification to their online ordering, offer the buyer the option of donating the 10% to CASAA in their name.

Won't cost me anything to fire off an email.

I think this is a great idea. Kristin already donates money to CASAA from the sale of her case that has the CASAA logo. So if other vendors jump on board with this, that would be great. CASAA could come up with some type of special logo for vendors to post on their site if they make it a practice to donate a portion of sales.

And BTW, the other suggestions I have seen are excellent as well. We will have to see whether the ECF management is amenable to the suggestions that involve either work (CASAA logo under Screen Name of donors) or money (donating a percentage of ECF donations to CASAA.)

Thanks for all the great suggestions, folks.