Legacy urges FDA to ban all e-cigs by “immediately” imposing the “deeming” regulation, makes more false fear mongering claims

[Bill Godshall]

Legacy urges FDA to “immediately” impose the “deeming” regulation on e-cigs, which would ban ALL e-cig products currently on the market (via Section 905(j) and Section 910), misrepresents scientific and empirical evidence on e-cigs, repeats more false and misleading fear mongering claims.
http://www.legacyforhealth.org/cont...e/LEG-Policy_Statement-ECigarette-JAN2014.pdf
Electronic Cigarettes Hold Both Promise And Risk, Require FDA Regulation - American Legacy Foundation

 

[Jenn Perry]

The actual article isn't terrible but has misinformation in it. I agree kids shouldn't use it. But a ban and legislation always goes overboard and then we get screwed.

 

[Jman8]

Isn't implementation of the FDA deeming regulation a given? As in it is going to happen no matter what?

I read the first link in its entirety and don't see it as cause for alarm. Yes, it has portions that are troubling and claims we are familiar with. Such as:

the existing evidence is insufficient to support any informed inference on net public health benefits versus harms at this time.

Followed by a paragraph that tries to provide an informed inference on the net public health benefits vs harms at this time.

Also it says,

Two randomized studies showed e-cigarette use resulted in low cessation rates (4- 13%) and differences were not significant compared with NRTs (5.8%) or no-nicotine e-cigarettes. Other studies’ results are mixed and have design limitations.

And doesn't cite sources for these studies, which leads me to think they are working with older data. While pro vapers, like myself, will use abundance of anecdotal evidence to counter this rhetoric, the larger point I get from the Legacy piece is that jury is still out when it comes to science of ecig benefits and harms. Which I think we vapers welcome, the more peer reviewed studies the better (hopefully by less biased researchers). Legacy attempts to make inferences after doing all it can to say ignore the inferences of those who have stake in promoting ecig use.

But I honestly don't get from this piece that they just assume see all eCigs banned. Nor do I get that from my reading of FDA literature, but as my top line of this post says, the deeming regulations are a given, and not a - it might not happen if we pro vapers try a little harder in our efforts. Deeming regulations, as I understand things currently, is a done deal. They are forthcoming. And when they are rolled out, we will see if it results in mass banning of all ecig products, not only in words, but in action.

 

[Sundodger]

Isn't implementation of the FDA deeming regulation a given? As in it is going to happen no matter what?

I read the first link in its entirety and don't see it as cause for alarm. Yes, it has portions that are troubling and claims we are familiar with. Such as:



Followed by a paragraph that tries to provide an informed inference on the net public health benefits vs harms at this time.

Also it says,



And doesn't cite sources for these studies, which leads me to think they are working with older data. While pro vapers, like myself, will use abundance of anecdotal evidence to counter this rhetoric, the larger point I get from the Legacy piece is that jury is still out when it comes to science of eCig benefits and harms. Which I think we vapers welcome, the more peer reviewed studies the better (hopefully by less biased researchers). Legacy attempts to make inferences after doing all it can to say ignore the inferences of those who have stake in promoting eCig use.

But I honestly don't get from this piece that they just assume see all eCigs banned. Nor do I get that from my reading of FDA literature, but as my top line of this post says, the deeming regulations are a given, and not a - it might not happen if we pro vapers try a little harder in our efforts. Deeming regulations, as I understand things currently, is a done deal. They are forthcoming. And when they are rolled out, we will see if it results in mass banning of all eCig products, not only in words, but in action.

Well by looking at the citations at the bottom of the pdf it explains where they got their "information" from, only more of the same from the same bunch that has skin in the game. If you doubt it look at those citations. And then to save some time here is a copy job from the bottom of the article from Legacy itself:

" Located in Washington, D.C., the foundation was created as a result of the November 1998 Master Settlement Agreement (MSA) reached between attorneys general from 46 states, five U.S. territories and the tobacco industry."

Once again, follow the money.

 

[Pickleskunk]

"delay smoking cessation by encouraging smokers to “dual use” e-cigarettes while they continue to smoke" They are grasping at whatever they can to announce that it NEEDS TO BE REGULATED. They claim that because it is unregulated, that it is attractive to younger people. Bible are unregulated, I don't see kids flocking to buy Bibles. The whole article is hogwash. I guess they think children are the only ones that like different flavors also. They need to apply these same theories to alcohol and coffee and energy drinks and food. {MODERATED}

 

[pamdis]

"delay smoking cessation by encouraging smokers to “dual use” e-cigarettes while they continue to smoke" They are grasping at whatever they can to announce that it NEEDS TO BE REGULATED. They claim that because it is unregulated, that it is attractive to younger people. Bible are unregulated, I don't see kids flocking to buy Bibles. The whole article is hogwash. I guess they think children are the only ones that like different flavors also. They need to apply these same theories to alcohol and coffee and energy drinks and food. {MODERATED}

That's what always burns me, the constant refrain of "because it's unregulated, we don't know what's in it, therefore we need to regulate it". Regulation has NOTHING to do with knowing or not knowing (willful ignorance) what's in it!!!

 

[AegisPrime]

I have no idea what the heck the dual use argument is anyway - if you're vaping, you can't smoke - if you're smoking, you can't vape - if someone is dual-using they're still smoking less cigarettes

 

[DC2]

But I honestly don't get from this piece that they just assume see all eCigs banned. Nor do I get that from my reading of FDA literature, but as my top line of this post says, the deeming regulations are a given, and not a - it might not happen if we pro vapers try a little harder in our efforts. Deeming regulations, as I understand things currently, is a done deal. They are forthcoming. And when they are rolled out, we will see if it results in mass banning of all eCig products, not only in words, but in action.

Just to clarify, the proposal of the deeming regulations is forthcoming.
After that there will be a public comment period, which could lead to changes in the proposed regulations.

As for the American Legacy Foundation, they have repeatedly shown themselves to be dedicated opponents of electronic cigarettes.

 

[Jman8]

I have no idea what the heck the dual use argument is anyway - if you're vaping, you can't smoke - if you're smoking, you can't vape - if someone is dual-using they're still smoking less cigarettes

I dual use, and am fairly proud of being a moderate smoker.

But give any smoker (and I do mean any smoker) the right gear and right level of nic juice, and I challenge them over 90 days to maintain same level of smoking, if they take 100 puffs of day off a eCig device. I've seen a good 20 or stories on vaping forums where long time smokers (25+ years or more) who smoked 3-4 PAD (way more than I've ever smoked on any day in my life) were able to greatly reduce or eliminate their smoking habit/addiction. Some saying they quit in the first week. While also noting they tried all other methods including: cold turkey, patches, chantix, gum, etc. etc. etc.

To paint 'dual use' as if it is as bad as heavy abuse is either disingenuous propaganda or mere claim from ignorance. I'm currently a PAM user (spending $7 on smokes in a month). How this would equate me to people that smoked all their lives at 1 PAD and then resulted in shorter life expectancy is, I believe very strongly, BS. I no longer crave smokes, and yet find a way to enjoy them when I choose to light up.

I further don't get how any vaper thinks they have something to worry about if they went back to smoking. If vaping worked for you once, and in many cases without even trying to quit, then I think you can assume or trust that it would work again should you happen to have a smoke and actually enjoy it that one time, or one pack. Again, I challenge any smoker to vape nicotine for 90 days and not notice vaping eliminating or greatly curtailing their smoking use/habit/addiction.

 

[pamdis]

I have no idea what the heck the dual use argument is anyway - if you're vaping, you can't smoke - if you're smoking, you can't vape - if someone is dual-using they're still smoking less cigarettes

Their argument:
Make it hard to smoke anywhere.
You get frustrated and just quit

Since they believe this actually works and because:
E-cigs make it harder to frustrate you
E-cigs make it easier to get from one non-smoking area to another without frustration

Ergo, e-cigs must be bad because they allow you side-step their attempts at frustrating you into quitting.

Ergo, since their frustration attempts would have worked without e-cigs, dual use causes you to smoke more (than you would have if you had just quit)

Oh, and because:

'It's not how many a day you smoke, but how many years you smoke', if you use e-cigs to cut your cigarette consumption down to one cigarette a day, it's still just as bad as a pack a day in the long run.

Ergo, e-cigs are bad, because without them you would just quit!

 

[Sundodger]

I dual use, and am fairly proud of being a moderate smoker.

But give any smoker (and I do mean any smoker) the right gear and right level of nic juice, and I challenge them over 90 days to maintain same level of smoking, if they take 100 puffs of day off a eCig device. I've seen a good 20 or stories on vaping forums where long time smokers (25+ years or more) who smoked 3-4 PAD (way more than I've ever smoked on any day in my life) were able to greatly reduce or eliminate their smoking habit/addiction. Some saying they quit in the first week. While also noting they tried all other methods including: cold turkey, patches, chantix, gum, etc. etc. etc.

To paint 'dual use' as if it is as bad as heavy abuse is either disingenuous propaganda or mere claim from ignorance. I'm currently a PAM user (spending $7 on smokes in a month). How this would equate me to people that smoked all their lives at 1 PAD and then resulted in shorter life expectancy is, I believe very strongly, BS. I no longer crave smokes, and yet find a way to enjoy them when I choose to light up.

I further don't get how any vaper thinks they have something to worry about if they went back to smoking. If vaping worked for you once, and in many cases without even trying to quit, then I think you can assume or trust that it would work again should you happen to have a smoke and actually enjoy it that one time, or one pack. Again, I challenge any smoker to vape nicotine for 90 days and not notice vaping eliminating or greatly curtailing their smoking use/habit/addiction.

Absolutely, I'm one also. I smoked 2-3 PAD for over 30 years, non filter Pall Malls (thank you U.S. Army), tried everything to quit, best was 2 years cold turkey, then stupidity set in again. Now most days I do 1-2 cigs, some days none, other days up to 4. But nothing like I was just several months ago.

Oh and the Legacy Foundation had the citations on the pdf file. Also we have to remember that Stanton Glantz is their professor of tobacco control. More money for the foundation and their professor as long as the MSA funds are coming in. They don't get any money from vaping, hope they never do. IMO they don't care if we stop smoking or not, just so we aren't doing it were they don't like it. Otherwise they would be going for an all out ban on cigs.

 

[AgentAnia]

A perfect expression of ANTZ logic:

...."because it's unregulated, we don't know what's in it, therefore we need to regulate it"....

And this....

I have no idea what the heck the dual use argument is anyway - if you're vaping, you can't smoke - if you're smoking, you can't vape - if someone is dual-using they're still smoking less cigarettes

brings to mind the image I see when someone mentions "dual use": Someone with an ecig on one side of his mouth and a cigarette on the other side, inhaling both at the same time...

(Actually, I think dual use should be encouraged, if it means smokers might be smoking less and vaping more. From then on, each person will taper off, or not, as suits him/her, so what's the big deal?!?)

As for this latest from Legacy, my informed analysis: More crap. Wouldn't line the bird's cage with it.

 

[03FXDWG]

There is a Nicorette commercial on tv right now about how it is now ok to dual use when quitting. One of the actors in it even comments about his 15 days but not all in a row.

The article was well written & seemed to be informative until I got to the second to last paragraph. Then they had to go throw in the banning flavors & saving the children crap. That's when their true colors started to show. The last paragraph, in a different font, is a self-sell job to keep grants & donations rolling in.

 

[Bill Godshall]

Once again, e-cig prohibitionist tombaker is posting lies about the deeming regulation to deceive vapers.

If/when the deeming regulation is imposed by FDA, all provisions of Chapter IX that apply to "tobacco products" will (by federal law) apply to e-cigs, including the 2007 and 2011 deadline dates in Section 905(j) and Section 910).

Further, Section 911 would make it a federal felony for any e-cig manufacturer or importer to truthfully claim that e-cigs are less hazardous than cigarettes.

Even if FDA exempts e-cigs from Section 905(j) and Section 910 (which the agency has yet to indicate it might do), the rest of the deeming regulation will give the entire e-cig industry to Big Tobacco (and perhaps NJOY), and would ban >99% of e-cig products as soon as the premarket approval of e-cig products is required.

 

[Orb Skewer]

Once again, e-cig prohibitionist tombaker is posting lies about the deeming regulation to deceive vapers.

If/when the deeming regulation is imposed by FDA, all provisions of Chapter IX that apply to "tobacco products" will (by federal law) apply to e-cigs, including the 2007 and 2011 deadline dates in Section 905(j) and Section 910).

Further, Section 911 would make it a federal felony for any e-cig manufacturer or importer to truthfully claim that e-cigs are less hazardous than cigarettes.

Even if FDA exempts e-cigs from Section 905(j) and Section 910 (which the agency has yet to indicate it might do), the rest of the deeming regulation will give the entire e-cig industry to Big Tobacco (and perhaps NJOY), and would ban >99% of e-cig products as soon as the premarket approval of e-cig products is required.

The most important 2 letter word ever uttered by controllers.

 

[kristin]

We are trying very hard to make it an "if," Orb. "If" we can stop them from just deeming them a new category of tobacco product. Right now, based on the FDA's Letter to Stakeholders, it's looking more like a "when."

 

[Jman8]

If/when the deeming regulation is imposed by FDA, all provisions of Chapter IX that apply to "tobacco products" will (by federal law) apply to e-cigs, including the 2007 and 2011 deadline dates in Section 905(j) and Section 910).

Further, Section 911 would make it a federal felony for any e-cig manufacturer or importer to truthfully claim that e-cigs are less hazardous than cigarettes.

Even if FDA exempts e-cigs from Section 905(j) and Section 910 (which the agency has yet to indicate it might do), the rest of the deeming regulation will give the entire e-cig industry to Big Tobacco (and perhaps NJOY), and would ban >99% of e-cig products as soon as the premarket approval of e-cig products is required.

Then again, there is absolutely nothing that pro vapers can do in response to this deeming regulations and CTA's, with regards to FDA matters, are a waste of time?

Not really a question as FDA work is done as I understand things and Bill is saying they will be banned, end of story. Or at very least, eCigs will be controlled by BT.

If there is another message from someone that carries as much weight in this political fight as Bill and would care to speak to this issue, I'm open to that.

 

[kristin]

{MODERATED}

The above is incorrect.

The Letter to Stakeholders makes it very clear:

"Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”

"The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm

Red Part: The FSPTCA currently covers specific tobacco products, but it allows the FDA to create a regulation to add new tobacco product categories.

Blue Part: The FDA intends to create said regulations to create new categories of tobacco products, including e-cigarettes and/or e-liquid (which would be the purpose of sending this letter to e-cigarette companies.)

Green Part: The new categories (which now include e-cigarettes and/or e-liquid) would be subject to all of the same "general controls," including all of the things listed. Registration and the adulteration and misbranding provisions are what would require all e-cigarette companies to apply for an order from the Secretary that their products are either eligible to be grandfathered or are substantially equivalent. If they do not receive such an order, they cannot sell their products.

It doesn't matter how long they've already been on the market, unless the company is applying to have a product grandfathered into the Act. The idea that the "law cannot go back in time" is silly. Laws are passed all of the time that ban or restrict existing products.

The burning question is, will the FDA allow those existing products to remain on the market while they go through the process or not?

 

[kristin]

{MODERATED}

Yes, as soon as the FDA deems them subject to FSPTCA, there are no regulations SPECIFIC to e-cigarettes, HOWEVER, e-cigarettes WOULD be immediately subject to the same "general controls" as every other tobacco product. As the letter states, that includes: registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Therefore, as soon as e-cigarettes/e-liquids are deemed tobacco products, they are immediately subject to FSPTCA regulations including registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

 

[Jman8]

Yes, as soon as the FDA deems them subject to FSPTCA, there are no regulations SPECIFIC to e-cigarettes, HOWEVER, e-cigarettes WOULD be immediately subject to the same "general controls" as every other tobacco product. As the letter states, that includes: registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Therefore, as soon as e-cigarettes/e-liquids are deemed tobacco products, they are immediately subject to FSPTCA regulations including registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Just to (hopefully) be clear:
- First there is the proposal to deem them, yes? And this is the next step, right?
- the proposal to deem changes nothing from today, correct?
- During proposal, it will, among many things, make clear a date that will lead to possible implementation of the original proposal plus possibly any updates during feedback period, correct?
- And it will be that implementation/imposition (enactment, whatever) that will change things that we keep hashing over and over, right?

I ask, cause I think what I'm saying is true, but if not, and FDA already has 'deeming regulations' in OMB, and if Bill Goodshall's take is correct, then our work for advocacy and fighting to change things would appear done. Thus, I hope the process is still that proposals happen first, and feedback period comes next. If not, and deeming happens next, and Bill is correct on his take on things, then I'd like to be clear what Bill, or any other 'leader' in this fight suggests can be done.

To me, urging congress to change things that FDA is clearly determined to do based on letter of the law (TCA) seems implausible.