Reply From The FDA

[Bill Godshall]

Thanks for clarifications.

To my knowledge, this is the first new information from FDA about e-cigarettes since its April 25, 2011 "letter to stakeholders" that agreed to comply with Judge Leon's ruling (even though the FDA continues posting the same false claims about e-cigarettes that Judge Leon rejected) and stating the agency's intent to propose a regulation to apply Chapter IX to e-cigs and other unregulated tobacco products.

Still not sure how the White House managed to send a personal e-mail to all petition signers.

But its interesting that the Deyton's reply makes even more absurd claims about e-cigarettes including:

E-cigarettes may contain ingredients that are known to be toxic to humans or otherwise harm public health -- for example, if they are attractive to young people and lead kids to try other tobacco products, including conventional cigarettes,

After the FDA falsely claimed that e-cigarette companies were target marketing to youth 29 months ago (without any evidence of youth usage before or since then), I'm surprised that Deyton would now go a step further by claiming that e-cigarettes could "lead kids to try other tobacco products, including conventional cigarettes."

And after FDA agreed to comply with Judge Leon's ruling (i.e. that the FDA cannot regulate e-cigarettes as drug devices, which require clinical studies to be submitted to FDA), I'm surprised that Deyton would now claim "Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products."

 

[matthewbishop]

LAWRENCE R. DEYTON, MD, MSPH
Director
Center for Tobacco Products
U.S. Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: 877/287-1373
E-mail: askctp@fda.hhs.gov

email campaign anyone?

 

[Our House]

Thanks for clarifications.

To my knowledge, this is the first new information from FDA about e-cigarettes since its April 25, 2011 "letter to stakeholders" that agreed to comply with Judge Leon's ruling (even though the FDA continues posting the same false claims about e-cigarettes that Judge Leon rejected) and stating the agency's intent to propose a regulation to apply Chapter IX to e-cigs and other unregulated tobacco products.

Still not sure how the White House managed to send a personal e-mail to all petition signers.

But its interesting that the Deyton's reply makes even more absurd claims about e-cigarettes including:



After the FDA falsely claimed that e-cigarette companies were target marketing to youth 29 months ago (without any evidence of youth usage before or since then), I'm surprised that Deyton would now go a step further by claiming that e-cigarettes could "lead kids to try other tobacco products, including conventional cigarettes."

And after FDA agreed to comply with Judge Leon's ruling (i.e. that the FDA cannot regulate e-cigarettes as drug devices, which require clinical studies to be submitted to FDA), I'm surprised that Deyton would now claim "Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products."

I received the same letter (email). It did indeed come from "The White House info@messages.whitehouse.gov via service.govdelivery.com" as the sender.

Whatever you said, Bill. Without going into too much of a rant, I echo your thoughts. Why in the world is the government spamming us just because we signed a petition? And how did it get forwarded to the FDA??

Those questions aren't even the worst of it. People like us can suck it up. We have thick skin. What concerns me the most is the countless ecig rookies or curious smokers who are receiving this response. The FDA has NO RIGHT to continue posting scarefully (not a typo) thought out lies that have thoroughtly been debunked in court in a clear effort to drive away potential and current users. Why is the FDA legally allowed to do this?? Why was this petition even handed over like it was?? It's like spitting in Judge Leon's face, and the faces of all the appeals court judges as well. It's sickening.

 

[Paul_S]

Hello everyone, I posted this in the new user forum because it was my 5th post. I wanted to share my thoughts here also. I received the email, but from the White House Petition. I re-read the petitions, pretty much all in the last few months, that I signed. I do not see any wording in these petitions where "We The People" signing these petitions were asking for advice on how to quit tobacco products. Mainly cigarettes. It seems to me that by signing these petitions, we are telling government agencies that we found what works for our part of "We The People". We are not asking for their approval, we are telling them. We need to remember this, and keep telling them!!! I hope re-writing this will help keep our growing family motivated.

Thanks!

 

[Poeia]

Dear White House:
Thank you for your reply however, the purpose of the "We the People" petition process is to ensure that the Executive Branch of our government take a new look at issues important to the public (or at least important enough to result in a specified number of e-signatures.) Your response was neither a new look nor responsive.

It was not "new" as you simply pulled up the existing FDA letter filed under "electronic cigarettes" and e-mailed it. The people who signed the petition have all seen the FDA's argument before.

It was not "responsive" because the petition addressed issues that many of us feel the FDA is ignoring and/or deliberately misleading people on. Specifically, the petition addressed small businesses, entrepreneurship and new technology. To answer that a child might see me vaping, run to the computer, buy an electronic cigarette of his or her own, wait for it to arrive, charge it overnight, vape and, as a result, go to the corner store and buy a traditional cigarette is not only ridiculous, it has nothing to do with the subject.

It is, of course, always interesting to see our representational democracy at work. In this instance, for example, I believe we have seen the FDA ably representing both the pharmaceutical industry (and their multi-billion dollar smoking cessation treatments) and the tobacco industry.

 

[VaperEd]

It's not in their best interests to do so. Politicians need money to get elected so they cater to those that can contribute the most to their campaigns and fund-raisers. The American Cancer Society and the Heart and Lung Association survive on grants from the government which is run by politicians that have to cater to big money in order to get elected. Our government no longer represents "We the people", it represents deep-pocket lobbyists and Political Action Committees. The organizations originally set up to protect the public are now as corrupt as the government since they rely on a corrupted government for grant money.

It's a vicious cycle, and I feel completely helpless to do anything about it.

This is and shall penetrate every part of our existence. Big government is just getting bigger while most work their butts off to eat and have shelter and sit in front of a tv screen that is brain washing them into thinking everythings cool. WTFU ( wake the F%#@ up). Sorry, but this really ticks me off.

 

[cavibird2005]

Is this a response from the same guy who runs out to get Barrack his pack of reds every day?

 

[DragonflyVaper]

Bill.... When we signed the Petition, you had to have an account with White House.gov that required your email address. The petition signature did not require an email address or full name but I'm positive with the Patriot Act and all the other security stuff, it's just a press of a button to single out what email communication is being sent and by whom. Heck, we probably all have that satellite dish pointed at our homes and they're watching as I type this email.

I hope you can make'em eat crow sending this information. Someone in the Obama Administration didn't do their homework before sending this mass email response.

Thanks for clarifications.

To my knowledge, this is the first new information from FDA about e-cigarettes since its April 25, 2011 "letter to stakeholders" that agreed to comply with Judge Leon's ruling (even though the FDA continues posting the same false claims about e-cigarettes that Judge Leon rejected) and stating the agency's intent to propose a regulation to apply Chapter IX to e-cigs and other unregulated tobacco products.

Still not sure how the White House managed to send a personal e-mail to all petition signers.

But its interesting that the Deyton's reply makes even more absurd claims about e-cigarettes including:



After the FDA falsely claimed that e-cigarette companies were target marketing to youth 29 months ago (without any evidence of youth usage before or since then), I'm surprised that Deyton would now go a step further by claiming that e-cigarettes could "lead kids to try other tobacco products, including conventional cigarettes."

And after FDA agreed to comply with Judge Leon's ruling (i.e. that the FDA cannot regulate e-cigarettes as drug devices, which require clinical studies to be submitted to FDA), I'm surprised that Deyton would now claim "Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products."

 

[mostlyclassics]

Still not sure how the White House managed to send a personal e-mail to all petition signers.

Bill, in order to sign the petition, prospective signers had to give a valid email address via which you validated your signature. I'm kicking myself that I didn't give them a here-today-gone-tomorrow anonymous-type gmail or google email address. That could come back to haunt me.

 

[Vocalek]

Thanks dude for letting me know about the Great American Smokeout because in 38 years of smoking I never heard of it before.

What?

 

[VaperEd]

Reply to DragonflyVapers post.

Don't get me started on the tca toirtap. lol

 

[Poeia]

mooreted:

Was that reply from the FDA in the form of a personal e-mail from Deyton? And if so, what was the date.

And was the subject line of the e-mail "Protecting Public Health Through Safe and Effective Treatments"?

Also, was it sent to you because you signed that petition?

I've sent Deyton many dozens of e-mails, but have yet to receive a reply.

Please explain the details, as this could be very important.

Here's a copy of the whole e-mail (except for my e-mail address.) I don't have a paint program so I did it as 4 screengrabs. The stuff I just typed in between the pictures to let you know what I deleted is in lavender.

To: my e-mail address

4 lines about unsubscribing that contain my e-mail address

I hope that helps.

 

[Luisa]

LAWRENCE R. DEYTON, MD, MSPH
Director
Center for Tobacco Products
U.S. Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: 877/287-1373
E-mail: askctp@fda.hhs.gov

email campaign anyone?

Well,at the end of the email sent to us,it says not to email a reply but contact the White House. That would be interesting to see what type of form letter we would receive in return. Oh well,the staffers need to be kept busy.

 

[hairball]

I wonder just how much money that Deyton guy is making per year? I bet it could feed a bunch of homeless for years to come. How much is the FDA giving him to lie to fellow mankind? I bet enough to shelter a bunch of homeless for years to come. Must be nice to be a puppet on a string.

 

[bluffer]

I received this bull.... response too.
It should not come as a surprise. We knew in high school (back in the early '70's) that they were full of ...., from the garbage they tried to feed us about pot. It has taken 40 years for those laws to BEGIN to show some common sense. Hopefully enough of us have learned something since then and it will not take another 40 years for our government to apply a little common sense to e-cigarette regulation.

 

[matthewbishop]

Well,at the end of the email sent to us,it says not to email a reply but contact the White House. That would be interesting to see what type of form letter we would receive in return. Oh well,the staffers need to be kept busy.

What about a direct email campaign to Lawrence Deyton himself?
Just found his direct email and his direct phone number...

Lawrence Deyton
lawrence.deyton@fda.hhs.gov
DIRECTOR CTP
301-796-9217
Rockville MD 20850

 

[Cyatis]

I received the same response, and here was mine.

What I'm reading is that Tobacco smoking, that absolutely contains ingredients in it, that will kill me is perfectly ok, because you say its alright and legal, even though you know it will kill me. Conversely, that because you cannot prove whether an E-cigarette, ever has or had harmful ingredients in it, are really scared it might kill me, and that we really need to regulate their use.

The facts are that the use of an E-cigarette cannot possibly pose any greater risk of use to me than smoking tobacco. Smoking tobacco will result in my death. So I have made a decision to quit smoking, by using the E-cigarette. I started over a year ago and have had no obvious negative effects from doing so. I have had several positive effects, the most obvious one is that I can actually breathe normally again.

Saying that you need to pass legislation on a product that will make it harder to use and cost more is not productive at the present time.

I have no issue in restricting products from minors, that clearly have risks that only adults should deal with. However, you have failed to prove there is anything wrong at all with the use of the E-cigarette whatsoever. You clearly state that you do not know or have any reliable scientific data regarding the subject. However, we all do know what happens when a minor gets hooked on smoking cigarettes. They end up with a habit that will likely kill them. If you cannot keep minors from smoking cigarettes, when it is clearly illegal, it is clear that to regulate the E-cigarette out of the hands of minors will not be any more effective than what is already in place if your real concern is to keep them from smoking cigarettes. It is a fact that most people who start smoking started by smoking, not by picking up an E-cigarette.

Therefore blaming the E-cigarette for the vast majority of minors who started smoking tobacco is wrong, misplaced, and unjustified.

I agree that cigarette smoking is dangerous for your health, at least we agree on something.

If I attend the great american smoke out with my E-cigarette, would I be welcome? I quit smoking, I haven't smoked a cigarette since November 3rd, 2010. Or would I be chastised for not really quitting and still considered a smoker?

I can tell that the government is watching me and my habits, but rest assured I'm watching how my government works, and how they think, and will use that information accordingly to the best of my ability on election day. Considering, I no longer smoke, my chances of being around to attend that event are actually pretty good.

 

[John Phoenix]

ARE YOU FREAKING KIDDING ME ???? !!! (just saw my e-mail)

They did NOT even read the proposal that was written. They did Not even address the stated issues one time in that reply. All they did is re-issue the same pat response they gave in the past. It reads like they never read what the proposal actually said !!

This is an OUTRAGE !

They did not address the issue of jobs creation. They side stepped the issues proposed. i am sure they are aware of recent studies from the scientific community that show e-cigs are safer than smoking tobacco and are effective by as much as 50% in one study as a quit smoking method. There are people in government who's jobs it is to know these facts to present it to the legislators. They do examine all these pros and cons, you can bet they are not ignorant of those studies.

Yet, do they say, ' We have seen some promising data and promise to study the issue more closely then make a decision based on facts gathered." ? No.

You KNOW they outright LIED about having data that proves otherwise. These studies are all over the news and the internet and like I said it's peoples jobs to report these things.

However, in light of the lack of validated scientific data, including a lack of reliable indicators of nicotine and harmful chemical content, FDA cannot at this time conclude that electronic cigarettes are an effective alternative to smoking.

This statement

E-cigarettes may contain ingredients that are known to be toxic to humans or otherwise harm public health -- for example, if they are attractive to young people and lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death. Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products.

Is insane if you compare the same to cigarettes smoking.

Would they ever dare say,

Tobacco cigarette smoke may contain ingredients that are known to be toxic to humans or otherwise harm public health -- Because clinical studies of these products have not been submitted to the Food and Drug Administration (FDA), consumers currently have no way of knowing what types or concentrations of potentially harmful chemicals are found in these products, or how much nicotine people inhale when they use these products.[and therefore we cannot allow the use of them]

Hell No they would not say that yet still allow the sale of tobacco cigarettes. That's Government working for and being controlled by a corporation. That is by definition Fascism.

No political rhetoric here just stating an opinion based on facts.

 

[CharlieGirl]

Ya know, that reply would be laughable in it's inaccuracy and outright lies if it didn't pi$$ me off so bad! How dare they!!! I especially love the usual heart-rending reference to "our children", sob sob. Most adults can barely get the hang of e-cigs, and pray tell how would kids afford it anyway? As if that were even an issue! Yet it is still okay to sell cigarettes!!! (That any kid can get their hands on...how many of us "borrowed" our first cig from our parents?) Just divert our attention and distort the truth and we'll be fooled because we are just stupid sheep anyway. Right. Just puke up the same OLD lies and throw it back at us, and oh boy, I feel so much more informed now, and secure in my bed because I know my government cares and is watching out for me. Don't get me wrong, I love my country and what it stands for, I just despise the money grubbing ...... who think we are fooled into believing this is still a democracy and we have any input. Yeah, vote? For WHAT? Travesty? Something has got to give! Of course I am ticked about this current issue at the moment, but it is just a drop in the bucket. I'm not just angry though, I'm scared. Really scared. But WHAT can we do? There is a cancer in the heart of our country and "We the people" need to excise it before it kills us too. Literally.

 

[CaminoDiablo]

Sorry but this cracks me up...".Make no mistake, the Obama Administration shares your concern" HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHA he's also gonna pay for my house and give me free health care that I have to pay for anyway sorry but I hope people got what they wanted from him, didn't like him and his ideas to start with. BTW this is my opinion and if I offended anyone I just spoke how I feel, sorry if you where offended.