Response to Whitehouse.gov Petition

[aikanae1]

The website wouldn't let me sign in. So I went to reset my password and lo and behold, I had a response to the petition sitting in my email from Whitehouse.gov and here it is:

On Friday, April 25, 2014 9:21 AM, The White House <info@mail.whitehouse.gov> wrote:

Regulation of Electronic Cigarettes by the FDA By Mitch Zeller, the Director of the Food and Drug Administration's Center for tobacco Products. Thank you for your petition on electronic cigarettes. First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them. Some background, which you may already know: The Family Smoking Prevention and tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco -- under the Federal Food, Drug, & Cosmetic Act. And while it didn't apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation. We've issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of "tobacco product" and so they'd be subject to the FD&C Act when the proposed rule is finalized. Now the petition states that sections 905 and 910 of the FD&C Act would "ban all e-cigarettes," and that's not true. If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 -- but this doesn't mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products. There will be two primary ways for tobacco products to obtain that authorization: either an application for "substantial equivalence," or an application for premarket approval. "Substantial equivalence" would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent -- though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be "appropriate for the protection of public health" to allow the product to be marketed. We know that those applications may require time and resources to develop. That's why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application -- so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review. So why are we seeking to regulate these products in the first place? As we discuss in the proposed rule, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. There's still a lot we don't know about these products, and this rule will expand the amount of information available to the FDA and the public -- that's good for everyone. Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don't know enough to make that call. This rule would help us to continue to analyze the potential benefits and risks of e-cigarettes, including their impact on nonusers and on the population as a whole. It's important to remember that this rule isn't final yet, though. We're seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes. The opportunity to comment on FDA's proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments. Related links: See the proposed rule Submit a comment on the proposed rule Tell us what you think about this response and We the People. Stay Connected Stay connected to the White House by signing up for periodic email updates from President Obama and other senior administration officials.

Whaddya think?
They must be getting a lot of response.
Good. Keep it up.

(there were active links in this but I wasn't able to capture them)

One of the things that ticked me off right away was that it sounded as if he was explaning something to a third grader - as if I didn't understand.

 

[natchez]

I got the same email, as I am confident many did. The fact is they really have no idea what to do, ergo the many funky aspects of the proposed regulation.

 

[mauzey]

It appears that they intend, although they deny it weakly, to make sure only the largest corporations are able to survive the FDA "Process".

 

[Lessifer]

I think it's too soon. I haven't even read that far through the regulations yet. From what I've read and gleamed from others' interpretations is that, aside from the possibility of future regulations, the main concern is how the e-liquid product approval process is going to shake out. I haven't actually read the sections that pertain to this, so I don't even know if the answers are there, but is it going to be every juice mixer needs to apply to have each of their recipes approved, or is it going to be wizard labs getting their 100mg nic base approved and as long as a vendor uses that to mix the liquid they're ok? If it's the former, it could be crippling to the industry, if it's the latter not so much. The problem is, the consumers can't be the ones to start this debate, it needs to be the ones who would actually be harmed by it, the e-liquid manufacturers. We can, however, support them when/if they do start that fight.

 

[aikanae1]

I think they've had a huge response which they are trying to nip in the bud. Ha-ha. We'd be fools to do that. I understand business needs to take an alternative course, but the louder and more passionate consumers are, the better.

I did write a response. I kinda doubt the return email address is valid, but we'll see ... (no I didn't spend a lot of time on it. So be kind)

Dear Mitch Zeller,

Imagine my surprise when I wasn't able to sign in to the petition and went to reset my password only to find your response waiting for me instead. I have never seen such a speedy response before. In fact, I believe the last petition was ignored and never responded to.

I am well aware of what the act says and the application process involved for "registering" electronic cigarette devices. You state the act would not ban electronic cigarettes prior to 2007 per section 905 and 910. I have read through those and you must be misinformed since there were no e-cigarettes on the market in 2007 similar to what is in use today. Both application sections would eliminate the several thousand small business' that have developed and innovated the current electronic devices in use because it would take millions of dollars to apply, that is if their applications were even accepted by the FDA.

Need I remind you that the FDA is under staffed for such a process? I believe there are already 3,000 applications waiting to begin getting approval and there isn't an accurate accounting of the applications that have been denied. To my knowledge, the only approvals within the last four years has been for a handful of rolling papers. Hardly ground-breaking or innovative progress.

I believe it would take complete reorganization of the FDA to cope with such an onslaught of development adequately. I would like to highlight the fact that the FDA still refers to phony plastic toys as examples of electronic cigarettes and is either ignorant or unaware of the devices most smokers use for quitting. For that reason, I don't believe the FDA has any intention of approving currently used devices that are manufactured and sold through small to medium sized business'.

In the past, the FDA's approach has been to work with a few mega multi-national corporations like pharmaceuticals and if the same practice is applied to electronic cigarettes, that would be the death of the vaping industry. That is why I am objecting. The FDA is ill-equipped for over sight of the vaping industry.

When the act was signed, the vaping industry did not exist yet, so I do question the legal authority over a non-existant product. Nicotine can be derived from eggplants too.

I, like most of the world, do not trust tobacco companies and do not want to use their products. I want to quit smoking and I have tried every "FDA approved" cessation product as soon as it appeared on the market with laughable, but expensive lack of results. Electronic cigarettes were developed for smokers by ex-smokers much like AA was developed for alcoholics by ex-alcoholics. So why not give them a chance?

I don't want something like a cigarette because I don't want to smoke cigarettes. I don't want the taste of cigarettes because I don't want to smoke cigarettes anymore. A lot can be said for flavors and they might even help with weight loss. I want to adjust the level and delivery of my nicotine as I need it so I don't get more or less than I need, when I need it. Standardized nicotine delivery does not work since addiction to cigarettes is probably more complicated than just nicotine, and that maybe why current cessation products have been an embarrassing failure.

I never thought I could quit after so many attempts to quit. Attempting to quit had become self-defeating and demeaning. Then I tried a real electronic cigarette (not a phony cigarette) and that I could do! I have read the studies and reviews from multiple sources, and I can even quote you saying that electronic cigarettes are less harmful and addiction is probably on a continuum. So why continue repressing the truth and falsifying information about tobacco harm reduction? Why the onerous registration / application process now?

I have found documentation from the '80's - '90's that the FDA approved from tobacco companies for many of the flavorings used today in eliquids. Why was it ok from them back then, but not now? I suspect many of those flavors and probably more are still being used in combustionable cigarettes. I have also seen reports from CIR that FDA approved for PG inhalation that is used as a primary ingredient in eliquids and in cartridges made by tobacco companies. Yet the FDA continues to issue press releases that "PG is also used in anti-freeze" to scare news media, the public and (hopefully?) some mindless medical personal.

From all the information I have uncovered, the FDA and various self-claimed public health agencies, are knowing and willing participants to fraudulently deceive and mislead the public about the benefits of tobacco harm reduction which has resulted in millions of people suffering needless illness and deaths. The FDA and specfic public health agencies are just as guilty as tobacco companies. Maybe more so since the FDA is in a position of trust.

The last Surgeon General's report stated that fewer people are smoking today, yet more people are dying from cigarettes than they did in 1964. Cigarettes have become more lethal under the FDA's oversight. That is exactly what I do NOT want to happen with electronic cigarettes and why I do NOT want FDA's oversight.

If you have a conscious, please do not doom what could be the most important public health improvent of this century into the hands of a few secretive, profit-motivated multi-national tobacco or pharmaceutical corporations. I am most concerned about the health and well being of smokers who have not yet discovered that they do not have to die from smoking and would like to see them have the opportunity that I have had.

Sincerely,

name

P.S. If you would like proof, I have pulmonary tests, xrays and CT scans from before vaping and after. The improvements within the first year were more substantial than medication could do alone. I also have COPD. My doctor supports vapng.

 

[williebb123]

there's a reason why the average joe cannot understand the proposed legislation , so they can turn around later and tell you what it means , come on people we have lawyers who cannot agree on what written law thats been on the books for ever , its awefull hard to twist an honest working mans words for he speaks from the heart not his ....

 

[MrsAngelD]

I think they've had a huge response which they are trying to nip in the bud. Ha-ha. We'd be fools to do that. I understand business needs to take an alternative course, but the louder and more passionate consumers are, the better.

I did write a response. I kinda doubt the return email address is valid, but we'll see ... (no I didn't spend a lot of time on it. So be kind)

Dear Mitch Zeller,

Imagine my surprise when I wasn't able to sign in to the petition and went to reset my password only to find your response waiting for me instead. I have never seen such a speedy response before. In fact, I believe the last petition was <snip>

This is awesome. I found the contact info for that department of the FDA you might want to email it to one of these addresses


Mailing Address and Phone Number:
Center for Tobacco Products
Document Control Center, Room 020J
9200 Corporate Boulevard
Rockville, Maryland 20850
1-877-CTP-1373

• General Consumer Inquiries: AskCTP@fda.hhs.gov
• Tobacco Industry Questions: TobaccoIndustryQuestions@fda.hhs.gov
• Small Business Industry Questions: smallbiz.tobacco@fda.hhs.gov
• Formal Correspondence and Speech and Meeting Requests: ctpexecsec@fda.hhs.gov. Also submit a proposed agenda and attendee list.
• To contact the Ombudsman about complaints and disputes, please email ctpombudsman@fda.hhs.gov or call 301-796-9239.

 

[ClippinWings]

I got this as well....

And I just realized this was a response to our old 36,000 signature petition... the one that never got answered.

I FIND THIS HIGHLY OFFENSIVE!

Why would Mitch Zeller respond to a petition to the President?
One that specifically asks the White House to prevent the FDA, led by Mitch Zeller, from doing exactly what he goes on to crow about doing in his response?

It's ego-maniacal. It's offensive. It's wrong.

MAN I wish we could get some media coverage of this!

This is akin to calling 911 to report a burglary at your house, but instead of 911 sending the police... they send the burglars back to steal the phone you used to call 911... and beat you with it while they're there.

 

[Katya]

I got this as well....

And I just realized this was a response to our old 36,000 signature petition... the one that never got answered.

It was??????????????

I had no idea. I just got the same email...

 

[Bill Godshall]

Nothing like the Obama administration waiting 14 months, and then having FDA's Mitch Zeller respond to our petition urging Obama to not let FDA ban e-cigs on the same day FDA proposes to ban virtually all e-cigs.

Here's our 14 month old petition.
https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd

Its interesting that Mitch claims the proposed deeming reg won’t ban e-cigs, but fails to acknowledge that deeming reg WILL BAN ALL E-Cig products that aren’t explicitly approved by FDA, that it is unlikely any SE applications will be submitted/accepted for any e-cig products, and that FDA still hasn’t approved (or even accepted) any new tobacco product applications for tobacco products. So while the deeming reg may not ban all e-cigs, it almost certainly will ban >99% of e-cig products now on the market two years after the Final Rule is issued.


Back in 2011, more than 5,000 people signed a Petition to the White House to “Recognize electronic cigarettes as an effective alternative to smoking and support job creation in this new industry”
https://wwws.whitehouse.gov/petitio...gov&utm_medium=shorturl&utm_campaign=shorturl
http://www.e-cigarette-forum.com/forum/law-e-cigarette/250506-my-response-white-gov-post.html

In response to that 2011 White House Petition, FDA’s then Director of the Center for Tobacco Products Lawrence Deyton unscientifically, dishonestly and misleadingly responded by writing:

“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 chemical are found in these products, or how much nicotine people inhale when they use these products. . . . 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."

 

[Marc411]

I just received this via e-mail from MOV

On the heels of the recent FDA Proposal many people are asking what can I do? There is now a 75 day public comment period on the proposed deeming regulations in which industry professionals, scientists and consumers can submit their comments on these proposals.


Regulations.gov



The above URL will take you to the place where you can submit YOUR comments! Some information you may be able to share as a consumer includes:


1. A personal and concise story about how the E-Cigarette products that have been introduced into the market in the past 4 years have helped keep you away from using traditional tobacco products.


2. Express that while flavors may be appealing to youths, they are also much preferred to the nasty taste of tobacco cigarettes. These flavors and the variety of options available are paramount to the success of E-Cigarettes as an alternative choice for adult smokers.


3. Explain any and all health benefits you have seen since this change in your life style!


There are many other options as well to convey your story and we encourage you only to share that information which you feel truly represent the impact these products have had on your life.


Encourage friends & family members to submit their comments as well!

Below are a list of some studies that you may find helpful, but there are many more that can be found!

http://www.mdpi.com/1660-4601/10/12/7272 (Downloadable PDF of the Impact of Flavour Variability)

http://informahealthcare.com/doi/abs/10.3109/08958378.2013.793439 (Downloadable PDF - Toxicology study on vapor proves electronic cigarettes are much better than tobacco)

http://www.mdpi.com/1660-4601/11/4/4356 (Downloadable PDF - Switching from cigarettes to e-cigarettes has significant health benefits, according to a survey of more than 19,000 users)

http://www.nature.com/srep/2014/140226/srep04133/full/srep04133.html (Downloadable PDF - Nicotine Abosprtion from Electronic Cigarette use between "First generation" (pre 2007) and Third Generation Devices)

http://publichealth.drexel.edu/~/media/Files/publichealth/ms08.ashx (Downloadable PDF - Chemicals generally found in E-Cigarettes pose no health concerns)

http://......................./wp-c...tion-When-Less-is-More-E-Cigarette-Summit.pdf (Downloadable PDF - Dangers of over-regulating E-Cigarettes)

http://www.biomedcentral.com/1471-2458/14/18/abstract (Downloadable PDF - No Concern for Bystanders of Second Hand Vapor)

http://www.biomedcentral.com/content/pdf/1471-2458-11-786.pdf (Downloadable PDF - Effect of E-Cigarettes on smoking reduction and cessation)

http://goo.gl/LhEDoK (Downloadable PDF - Study that found of more than 2000 former smokers in this survey, 96% reported that the e-cigarette helped them to stop smoking.)

Many more studies exist, and more research can be found on various sites including this great collection: http://onvaping.com/the-ultimate-list-of-studies-on-e-cigarettes-and-their-safety/

You can add attachments to your comments.

 

[aikanae1]

Yup. Flavors attract kids.

 

[Berylanna]

I just received this via e-mail from MOV.

What is MOV ?

 

[drksideken]

I have a question. There is synthetic Nic isn't there? Would that fall outside of their definition then of a tobacco product? Since I can only imagine synthetic means not derived from the actual plant. I know it sounds like a dumb question, but I'm just curious.

 

[Marc411]

Mountain Oak Vapors, I am registered on their site and purchase from them quite a bit.

 

[~Sue~Feb2012]

I have a question. There is synthetic Nic isn't there? Would that fall outside of their definition then of a tobacco product? Since I can only imagine synthetic means not derived from the actual plant. I know it sounds like a dumb question, but I'm just curious.

Yes but probably too costly to synthesize.

And here's one sentence from the proposed deeming:

"FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products." ....

 

[aikanae1]

I have a feeling I'm going to end up taking the full 30 days to submit an official response. This is coming on the heels of a mounting massive attack to preserve net neutrality also. Less than 24 hours apart from each other. Not fair.

 

[rothenbj]

This is awesome. I found the contact info for that department of the FDA you might want to email it to one of these addresses


Mailing Address and Phone Number:
Center for Tobacco Products
Document Control Center, Room 020J
9200 Corporate Boulevard
Rockville, Maryland 20850
1-877-CTP-1373

• General Consumer Inquiries: AskCTP@fda.hhs.gov
• Tobacco Industry Questions: TobaccoIndustryQuestions@fda.hhs.gov
• Small Business Industry Questions: smallbiz.tobacco@fda.hhs.gov
• Formal Correspondence and Speech and Meeting Requests: ctpexecsec@fda.hhs.gov. Also submit a proposed agenda and attendee list.
• To contact the Ombudsman about complaints and disputes, please email ctpombudsman@fda.hhs.gov or call 301-796-9239.

Heck, email it to all the addresses. I think I'll do the same when I put together my story and my feelings about the promulgated regulation AND comments I've read made by Zeller. In addition I'd make the email an open letter to all the newspapers in my general location. I think we may have a better chance of getting exposure in print than any other media. The only question is, does anyone still buy papers?

 

[aikanae1]

In a number of places, newspapers and local tv news are owned by the same company. They'll cover a story if they are getting a lot of response to it.

 

[Berylanna]

Folks, for the FDA thing we have 75 days, and only ONE response apiece. And the document is 271 pages with 79 embedded questions for comment. CASAA is asking people to NOT use their ONE comment until CASAA issues a Call-To-Action with pointers to the most-important parts to address.

Bill Godshall was thrilled when someone said they'd like to cc the media with their comments, and said please also CC your representatives in DC, though we might skip some uber-liberal Democrats. I plan to cc all my DC reps except Boxer.

But here is the important point: "Comments" on the FDA ruling are fundamentally different than normal comments. The comments need to be written in such a way as to require the FDA to SHOW that they considered the comment in a scientific light. That means we need to make the most of opportunities to point to specific studies regarding specific questions in the doc, and say things with an eye to future judges that might be reading the comment and deciding if the FDA addressed that issue properly.

So CASAA's scientists, lawyers, gov't activists, and others with experience in the matter are analyzing the FDA document now and request that we give them a few days to complete their analysis and recommend the right type of comments.

This is NOT the same as trying to get through to legislators how we feel. This is about requiring the FDA to follow the law that requires them to do this right.

I've seen this CASAA request all over FB and in vape web shows, both video and audio.

Thank you.