FDA 23 self proclaimed health/medical groups sign CTFK letter urging FDA to make Deeming Regulation even worse

[Bill Godshall]

Twenty three self proclaimed health and medical groups commit public health malpractice by signing letter to FDA (written by Big Pharma funded e-cig prohibitionist CTFK) urging agency to make Deeming Regulation even more protective of cigarette markets and threaten the lives of even more vapers and smokers, fail to ethically disclose the hundreds of millions of dollars they’ve received from Big Pharma. Letter grossly misrepresents scientific and empirical evidence, repeats false and misleading fear mongering claims about e-cigs, cigars and OTP, urges FDA to ban flavored e-cigs and OTP (but not deadly menthol cigarettes).
http://www.aafp.org/dam/AAFP/documents/advocacy/prevention/tobacco/LT-JT-FDA-ECigs-080814.pdf


Had CTFK not written this letter (and circulated to other Big Pharma funded ANTZ groups for cosignatures), I doubt most of the 23 cosigner groups would have submitted their own comments to FDA on the Deeming Regulation (because they don't know much about e-cigs except how to repeat CTFK propaganda).

 

[Kent C]

People like to throw the 'extreme' label around here. This is extreme regulation.


Under: FDA SHOULD IMMEDIATELY DEVELOP RULES PROHIBITING CHARACTERIZING FLAVORS IN THE DEEMED PRODUCTS


"Some e-cigarette manufacturers claim that non-tobacco flavors, by making e-cigarettes more appealing to adult smokers, increase the number of smokers who switch from cigarettes to e-cigarettes. It is important to note that these assertions have not been subjected to scientific review. The proper regulatory response to such an assertion is for FDA to require, as to each non-tobacco flavor, that the manufacturer submit valid scientific evidence prior to addition of the flavor pursuant to Sections 910 or 911 of the TCA, that the flavor (1) enhances the efficacy of the product in increasing the number of smokers who quit smoking, (2) does not contribute to initiation of tobacco product use, including e-cigarette use, particularly among youth, or relapse into tobacco product use, and (3) does not result in continued use of tobacco products by those who otherwise would have quit. Thus, the burden would be on the manufacturer to establish that marketing of the particular flavored product would meet the statutory public health standard, which necessarily involves an assessment of the risks and benefits to the population as a whole, including users and nonusers of tobacco products, the likelihood that existing users of cigarettes will stop using those products, and the likelihood that non-users will start using those products."

It's laughable as far as logic goes. They say "Some e-cigarette manufacturers claim that non-tobacco flavors, by making e-cigarettes more appealing to adult smokers, increase the number of smokers who switch from cigarettes to e-cigarettes." and so the burden of proof is on the manufacturers, when the manufacturers and supporters were only replying to claims that flavors only attract kids.

It is THAT initial claim, where the burden of proof lies. And even IF they don't believe what the manufactures say "in reply", all they would have to do is visit one of our eliquid forums to find the truth. There's all the surveys/science you need - what people say about how flavors affect switching. You don't need taste receptor and olfaction studies to determine that! Yet, that appears to be the type of science they want - something unachievable, which of course is their intent. Sigh.....

 

[dragonpuff]

Unfortunately none of this surprises me. All of the signatories and the authors get giant amounts of funding from big pharma, and they're going to make whatever ridiculous claims they have to make to protect their financial interests.

I do find it interesting, however, that they keep making the same claims even though they've been proven false. Children are not flocking to e-cigarettes in large numbers, no matter how many fruity and sugary sweet flavors there are. There's tons of data to prove them wrong, and yet they turn around and claim there is no proof at all it's baloney.

The flavors thing is getting old, and they're really beating a dead horse at this point. They need to just let it go.

 

[Kent C]

The flavors thing is getting old, and they're really beating a dead horse at this point. They need to just let it go.

They know it's BS.... we get flavor without the bad stuff....

He gets it! Flavor without the calories

(just so people know, this is not a slam - I like that he likes his ices and burgers, etc. and it was a recent pic from his vacation).

 

[sonicdsl]

We really need to come up with a huge letter signed by all the vapers to all of them stating they need to be honest about their conflicts of interest and send it to all the media and everyone everywhere.

It's time to come up with a good PR move so this stuff blows up in their collective faces.

I wish I was more creative...



so...frustrated.

 

[DrMA]

Unsurprisingly, and as Bill pointed out, the CTFK letter is yet another malicious opening of the ANTZ slurry gusher.

This proves yet again that the only difference between Colombian drug cartels and the industrial complex formed by Big Pharmafia + their pet so-called "public health" groups is an FDA rubber stamp.

 

[DC2]

People like to throw the 'extreme' label around here. This is extreme regulation.


Under: FDA SHOULD IMMEDIATELY DEVELOP RULES PROHIBITING CHARACTERIZING FLAVORS IN THE DEEMED PRODUCTS


"Some e-cigarette manufacturers claim that non-tobacco flavors, by making e-cigarettes more appealing to adult smokers, increase the number of smokers who switch from cigarettes to e-cigarettes. It is important to note that these assertions have not been subjected to scientific review. The proper regulatory response to such an assertion is for FDA to require, as to each non-tobacco flavor, that the manufacturer submit valid scientific evidence prior to addition of the flavor pursuant to Sections 910 or 911 of the TCA, that the flavor (1) enhances the efficacy of the product in increasing the number of smokers who quit smoking, (2) does not contribute to initiation of tobacco product use, including e-cigarette use, particularly among youth, or relapse into tobacco product use, and (3) does not result in continued use of tobacco products by those who otherwise would have quit. Thus, the burden would be on the manufacturer to establish that marketing of the particular flavored product would meet the statutory public health standard, which necessarily involves an assessment of the risks and benefits to the population as a whole, including users and nonusers of tobacco products, the likelihood that existing users of cigarettes will stop using those products, and the likelihood that non-users will start using those products."

The unfortunate part is that this is basically what the deeming regulations, as currently written, already require.
No need to make the regulations worse in this respect, because this is how bad they already are.

 

[nomore stinkies]

Beyond Frustration! Someone please tell me the difference between nicotine in the NRT gum and the nicotine in e-liquid? If they are saying that because they classify e-cigs as a tobacco product (due to the nicotine) then why isn't NRT nicotine gum a tobacco product? I keep reading that e-cigs are not a tobacco product. They are driving me out of my mind. I agree we need to do something. It might not do any good but it might make us feel better albeit temporarily.

I wrote Lisa Madigan (atty. general) in Illinois after she and 22 others got together and wrote that ridiculous whopping lie on e-cigs. HHMMM haven't heard from her yet. Oh I'm sure she is a little busy reading Stanton Glantz Lies. oops....articles. I'll give her a little more time. Just a little more time........

We really need to come up with a huge letter signed by all the vapers to all of them stating they need to be honest about their conflicts of interest and send it to all the media and everyone everywhere.

It's time to come up with a good PR move so this stuff blows up in their collective faces.

I wish I was more creative...



so...frustrated.

 

[Bill Godshall]

Someone please tell me the difference between nicotine in the NRT gum and the nicotine in e-liquid?

The difference is that e-liquid companies (and other e-cig companies) haven't given hundreds of millions of dollars to CTFK, ACS, AHA, ALA, AMA, AAP, Legacy and many others who have been demonizing and lobbying to ban e-cigs.

Its all about the selfish greed of the very well paid executives at CTFK, ACS, AHA, ALA, AMA, AAP, Legacy, etc.

 

[Endor]

People like to throw the 'extreme' label around here. This is extreme regulation.
...

It's laughable as far as logic goes. They say "Some e-cigarette manufacturers claim that non-tobacco flavors, by making e-cigarettes more appealing to adult smokers, increase the number of smokers who switch from cigarettes to e-cigarettes." and so the burden of proof is on the manufacturers, when the manufacturers and supporters were only replying to claims that flavors only attract kids.

It is THAT initial claim, where the burden of proof lies. And even IF they don't believe what the manufactures say "in reply", all they would have to do is visit one of our eliquid forums to find the truth. There's all the surveys/science you need - what people say about how flavors affect switching. You don't need taste receptor and olfaction studies to determine that! Yet, that appears to be the type of science they want - something unachievable, which of course is their intent. Sigh.....

I, too, found it interesting that they are asking that the burden of proof be put on the manufacturer to somehow PROVE that flavors do not attract youth. Doesn't this fly in the face of the American belief that a person making a claim of guilt has the burden to prove that guilt?

Further, where is the evidence to support the postulate to begin with, other than the oft-misused CDC study?

FDA, ignore that man behind the curtain... we are the great and powerful Protectors of Health.

 

[dragonpuff]

I, too, found it interesting that they are asking that the burden of proof be put on the manufacturer to somehow PROVE that flavors do not attract youth. Doesn't this fly in the face of the American belief that a person making a claim of guilt has the burden to prove that guilt?

My mother and I were just discussing today how for just about everything in our country, it has to be proven dangerous to be banned, yet for e-cigs they want to ban it preemptively on the assumption that it's dangerous with no proof. That is rather unique.

What's the expression? Ah yes, they're putting the cart before the horse

 

[DrMA]

A more appropriate expression would be: when all you have is a hammer, all problems look like nails.

 

[dragonpuff]

A more appropriate expression would be: when all you have is a hammer, all problems look like nails.

Yes indeed they seem to have lots of hammers don't they?

 

[Kent C]

The unfortunate part is that this is basically what the deeming regulations, as currently written, already require.
No need to make the regulations worse in this respect, because this is how bad they already are.

True, but this seems to be they want action on this before the final rule....

 

[Kent C]

I, too, found it interesting that they are asking that the burden of proof be put on the manufacturer to somehow PROVE that flavors do not attract youth. Doesn't this fly in the face of the American belief that a person making a claim of guilt has the burden to prove that guilt?

Further, where is the evidence to support the postulate to begin with, other than the oft-misused CDC study?

FDA, ignore that man behind the curtain... we are the great and powerful Protectors of Health.

re: bold - yes it does and not just American ideals - tenets in philosophy and logic as well. It's the old classic of 'God exists' and then making those who don't believe it, prove it. You can't prove a negative. (not trying to start a conversation on that - only giving the 'classic argument' in Philosophy 101) It is the person making the assertion that has the burden of proof. This assertion is 'flavors only attract kids' - that is what needs to be proven by them and simply can't be. There's way too much counterfactual evidence. Even the Senate 'candy desk' disproves it.

 

[Jman8]

All organizations that I just lost a little more respect for. Some of them already had zero respect for their anti-smoking spin, but others still had a modicum of respect. Not anymore.

 

[trying]

Is the requested finalized regulation date of April 25, 2015 a date FDA can comply with ?
I have heard it would be 18 to 24 months but I am not sure if that was from the publication of the deeming regulations on April 25, 2014 or from the end of public comments on August 8th.

 

[DC2]

Is the requested finalized regulation date of April 25, 2015 a date FDA can comply with ?
I have heard it would be 18 to 24 months but I am not sure if that was from the publication of the deeming regulations on April 25, 2014 or from the end of public comments on August 8th.

The only honest answer to your question is that nobody here knows.

 

[DrMA]

Is the requested finalized regulation date of April 25, 2015 a date FDA can comply with ?
I have heard it would be 18 to 24 months but I am not sure if that was from the publication of the deeming regulations on April 25, 2014 or from the end of public comments on August 8th.

The only honest answer to your question is that nobody here knows.

Yep. All we can hope is that the upcoming elections will result in an indefinite delay to the finalizing of these regs.