The final countdown to August 8th - your FDA comments NEEDED

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dragonpuff

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I think the Act says that the FDA can not ban or eliminate a tobacco "category" like ecigs. I think an agreement was made for tobacco to buy placeholder ecig companies because the FDA figured it would be better to work with one or two of them than with us. That way the FDA wasn't banning the entire category. Reading the GlaxoSmithKline response, they are extremely nervous about ecigs and really want the FDA to do something NOW.

When Judge Leon ruled that 3 of the 12 members of TPSAC (Tobacco Product Scientific Advisory Committee) had to be replaced asap, this was largely due to severe conflicts of interest they had with GlaxoSmithKline. Unfortunately for us, the regulations were written before the judge's ruling, which means that GlaxoSmithKline had a more-or-less direct hand in writing the deeming regulations.

Those regulations may have been written partly to favor BT, but the way that they intend to incorporate e-cigarettes was almost entirely done to favor BP. There is no doubt in my mind about that.
 

VBdev

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From: Me
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38

As an American citizen and consumer of electronic cigarette products I do not support the FDA's proposed regulations as written. I am not strongly opposed to standards and rules for these products; I am strongly opposed to any regulation which slows the process or increases the cost of bringing electronic cigarette related products to the market place. Requiring FDA review of each product is too costly and obtrusive to this blooming industry. These products have significantly improved my health; any impediment to their use can harm me personally as well as Americans in general.

Within the FDA’s mission statement, it says the FDA is responsible for "protecting the public health...", and further in the statement it says the FDA is also responsible for "helping to speed innovations...". Vaping, the act of using an electronic cigarette or "mod", is an alternative to smoking which capitalizes on innovative products that show great promise in improving the overall health of American's. The early indicators and early research of these products indicate a significant reduction of harm as compared to use of traditional cigarettes. Additionally, research on second hand vapor shows it to be significantly less harmful than second hand smoke and present contaminant levels below current occupational safety guidelines. We may, and based on my research I believe we do, have an opportunity to greatly improve the health of countless individuals. The FDA should be utilizing their resources to provide additional research, spread the factual information which exists related to electronic cigarettes to the public, and, if adequate cause exists, endorse electronic cigarettes as a healthier alternative to smoking traditional cigarettes.

The FDA has proposed that makers of these products "Only market new tobacco products after FDA review". The FDA should not impose a costly roadblock which will in effect slow down innovation and make it more difficult, if not impossible, for small business to participate in the electronic cigarette marketplace. The FDA could set forth a series of rules for these products and impose fines in such a way as to sufficiently motivate the electronic cigarette companies to follow those rules. Rules imposed could include banning the sale of the products to minors, labeling of the nicotine content (mg per ml) of the juice, safety warnings, and childproof caps. Ingredients known to be more harmful than cigarette smoke, and proven to be so through the scientific process, could be banned for use. Ingredients such as Diacetyl are no longer used by the majority of e juice producers because it's known to be harmful; note that compound is in traditional cigarettes. I would support the ban of such an ingredient, however, the market has self-regulated in this case. Companies whose products are in violation of the rules should receive significant fines(perhaps scaled by company revenue) sufficient to deter them from violating the rules and motivating them to perform adequate testing of their products. The FDA may then passively test products on the market to ensure products are in compliance in a statistically significant way and impose fines for violations. If the FDA were to offer a reward to consumers and vendors who reported products labeled incorrectly or not using childproof caps the practice would be quickly eliminated. The only fees or taxes should support the minimal cost of registration and product acquisition for testing; the fines may prove sufficient to cover these costs. Fees and / or taxes on electronic cigarette products should not pay the debts made by the traditional cigarette manufacturers who put an irresponsible product on the market, nor a "sin tax". It's important to note these companies are already responsible / liable for the products they bring to the market. The team to propose the rules should be comprised of health experts who support electronic cigarettes as an alternative to smoking, health experts who are skeptical of electronic cigarette products, as well as product subject matter experts; it should not be influenced by outside agendas (i.e. pharmaceutical companies, government tax interests, insurance).

Prior to beginning to use electronic cigarette products, I smoked a pack of Marlboro Medium (now known as red labels) traditional cigarettes each day for over 23 years. My complete transition to electronic cigarettes took a matter of two days from the purchase of my first electronic cigarette. I am completely free of traditional cigarettes and have no intention of ever using a traditional cigarette again. Unlike other nicotine replacement therapy products such as the patch or nicotine gum, I enjoy vaping, even more so than smoking. The broad diversity of the products and flavors of the juices greatly contribute to my overall positive experience. Any regulation considered should not limit or impede this wonderful diversity which is actively improving my health since without these products I would still be smoking. The improvements to my health are irrefutable. My blood pressure has decreased to a level at which I no longer require medication and my lung capacity is significantly improved.

Please take note that I enjoy candy and fruit flavored e liquid. I am 36 years old. I enjoy a very broad range of flavors for my e juices; this is a big part of the advantage over traditional cigarettes for me. The FDA should do nothing to limit the flavor diversity of these products. Only ingredients known to produce significant direct risk to the user’s health should be in consideration for regulation. I am a father and it’s not the responsibility of the e juice manufacturer’s, or the FDA’s regulations on them, to motivate my children to choose to abstain from electronic cigarette use.

Regulations which significantly impact the marketplace and small businesses’ ability to bring new products to the market place would cause me to face a significant moral dilemma. On one hand I believe the products, based on the scientific research I have read, to be greatly improving my health, quality of life, and length of life in addition to the fact I enjoy these products. Thus I am strongly motivated toward the continued use of electronic cigarettes despite regulations. On the other hand I set an example for my loved ones and respect the law of the land thus civil disobedience is not a path I am likely to choose. It would be a grave injustice if I end up back on traditional cigarettes however. I would actively support legislation to overturn any regulation the FDA imposes which limits my right to choose to vape and select from diverse product choices; I’d likely be forced back to traditional cigarettes. There is no need for the FDA to limit my ability to vape or diversity of the products I use in order to take steps to prevent use by minors, use responsible ingredients and labeling, or limit the marketing language used by the companies and vendors.

Although I would not strongly oppose some responsible regulation implemented in a way as to promote rapid product innovation, maintain a rapid product development to marketplace environment, and maintain diverse product choices, it is important to note the state of the current electronic cigarette market. All of the e-juice bottles I have purchased state the nicotine content on the bottle; a pack of regulated cigarettes do not. All of them list ingredients; a regulated pack of cigarettes do not. All of them have warnings on the label concerning children and pets; they do so without mandate. 60% of the e juice bottles I own came with child proof caps; children have no problem opening a pack of cigarettes. The ingredient Diacetyl, when found to present a greater risk than other common flavoring ingredients, was publicly discussed as harmful and the responsible companies responded by removing this ingredient which is present in cigarettes. The cigarette industry has not removed its harmful chemical additives despite being in a regulated market.

Given the harmful impact cigarettes continue to have on the American public while being under FDA regulation causes me to have little confidence that the FDA’s proposed regulation on electronic cigarettes will be a positive impact to the American people. Responsible consumers are buying responsible products from responsible vendors in a rapid development environment in which innovation is quickly rewarded and small business is actively flourishing. FDA regulation is not needed nor is it warranted for electronic cigarettes. The proposed regulations would harm the American people. The FDA should “advance the public health” by conducting and funding further research on the health impacts of electronic cigarettes as an alternative to traditional cigarettes, publicly endorse and promote the conclusions of properly and ethically conducted research on the topic, and if or when sufficient research shows electronic cigarettes to pose significantly less health risk than traditional cigarettes, publicly advocate that smokers transition to electronic cigarettes.

Thank you for your time and consideration in this matter,
~Me
 

zoiDman

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Dream on. He'll never shut up. Get used to it. :p

I'm Sorry.

But I think Anyone who makes 259 FDA Submissions, either For or Against e-Cigarettes, is a Board Certified Fruit Loop.

And should take a Serious Look at their Caffeine intake. And Probably Needs a Girlfriend to boot.

Fruit-Loop-Smiley-Face-Tags-Cereal-Loops-Bowl-Image-Resolution-X-1796470.jpg
 

Katya

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I'm Sorry.

But I think Anyone who makes 259 FDA Submissions, either For or Against e-Cigarettes, is a Board Certified Fruit Loop.

And should take a Serious Look at their Caffeine intake. And Probably Needs a Girlfriend to boot.

Just for the record--the 259 number was a joke. I think he only submitted 20+ comments.

Other than that, I agree. :)
 

zoiDman

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Just for the record--the 259 number was a joke. I think he only submitted 20+ comments.

Other than that, I agree. :)

That's OK.

Any Time I can work in Board Certified Fruit Loop with Mr. Slantz, I'll take it.

I hope when he Reads this he Realizes what a Pathetic Excuse for a Scientist / Researcher he is. And that People like him give Every Hard Working, Non-Agenda Driven, Individual in the Field of Education a Bad Name.

:facepalm:
 

Katya

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He's not that crazy. It really is all about his bottom line... He stands to lose A LOT if e-cigs succeed.

UCSF is home to Stanton Glantz who is perhaps the biggest ANTZ in America today.
I don't know who this Dutra person is, but they are probably an understudy.

Anyway, here are some answers to your questions...

$500,000 from Big Pharma to project director Stanton Glantz...
Creating a tobacco document archive - Robert Wood Johnson Foundation

$399,000 from Big Pharma to project director Stanton Glantz...
Educational campaign for restaurant owners on smoke-free restaurants - Robert Wood Johnson Foundation

$678,819 from Big Pharma to project director Stanton Glantz...
Educational campaign for restaurant owners on smoke-free restaurants - Robert Wood Johnson Foundation

$300,000 from Big Pharma to project director Stanton Glantz...
Study of tobacco product placement in entertainment media and tobacco industry involvement in political activity - Robert Wood Johnson Foundation


Stanton Glantz is Director of the UCSF Center for Tobacco Control Research and Education...

PLOS Medicine: A Peer-Reviewed Open-Access Journal
 

aikanae1

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I don't have a clue what you just said?????

I'm not sure what you don't understand. The FDA had to submit deeming to OMB (office of management and budget) they issued an Economic Impact Report which IMO was very revealing document. They admit 90% of the products on the market will "exit". They also state that 'although consumer choice will be limited that doesn't necessarly mean that volume of sales will be' - i.e. addicts will by anything.

We already know that foriegn manufacturers are not going to apply for approval and that eliminates Kanger, Segelei, Aspire, Innokin, SMOK, Vision, Joyetech, OEM's, EHPro, Rainbow Heaven, Tobbecco, the greeks, on and on...

So what is a retailer going to sell?

If they are in a strip mall with a convience store they probably have a non-compete clause in their lease which will prevent them from selling the same products like BLU, MarkTen, Crowne, Vuse, and most cigalikes.

Sure ... business as usual? I think not.
They could probably do ok as a head shop.
 
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zoiDman

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He's not that crazy. It really is all about his bottom line... He stands to lose A LOT if e-cigs succeed.

Slantz is a Blight on the California University System.

And he should Stick to Teaching Mechanics. Verses Pushing/Promoting his Agenda thru Junk Science and Biased Half-Truths.
 
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Megan Kogijiki Ratchford

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Slantz is a Blight on the California University System.

And he should Stick to Teaching Mechanics. Verses Pushing/Promoting his Agenda thru Junk Science and Biased Half-Truths.

Yes, thank you!!! Again bad science makes me yelly but not as yelly as bad, corrupt "scientists". :mad:
 

Rickajho

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Just checked the site and the number has been updated: Regulations.gov

82,181
Comments Received


However the number of comments you can view and have access to in order to rebut is still stuck at 59,578. I checked in order by date and the top most comment that was there Friday evening is still at the top of the heap today.

It also appears the capacity to put up rebuttal comments is now closed.

Will poke it with a stick again some time Sunday to see if anything has changed.
 

zoiDman

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i have been trying to view comments by others on the FDA site. when i search using the term e-cigarette i get about 2,700 results. i tried to peruse 2 to 3 pages and the tag on the left states comments not accepted. what does that mean?
regards
mike

Not Sure?

Because I am Sure there was More than 2,700 Comments from ANTZ alone.
 

VBdev

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In case you are curious...


CASAA last night submitted a 53-page comment to the FDA on behalf of consumers regarding the Deeming Regulations.

Here's a link to their blog about it, which includes highlights, as well as a link to the PDF of the full 53-page comment:
CASAA: CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

Just finished this. Very strong and very thorough. Thank you CASAA.

Wonder how much attention (reading, discussing, potential change) it will get inside the wall's of government. I don't think I understand at what level FDA has to care about what we submit. Seems like they are going to put together some stats on it, make a "pro e-cig count" and such. The comments become public record, available for future discussions, and politicians and such... but other than that paper pile drill, does this have any chance of impacting their planned course of action barring outside political intervention? Are they mandated to take these comments into consideration? Are they even mandated to do the paper drill?
 

Rickajho

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i have been trying to view comments by others on the FDA site. when i search using the term e-cigarette i get about 2,700 results. i tried to peruse 2 to 3 pages and the tag on the left states comments not accepted. what does that mean?
regards
mike

You mean the tag - on the right - on each comment? It means you can no long submit a rebuttal comment, or a "comment on a comment" now.
 

dragonpuff

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i have been trying to view comments by others on the FDA site. when i search using the term e-cigarette i get about 2,700 results. i tried to peruse 2 to 3 pages and the tag on the left states comments not accepted. what does that mean?
regards
mike

Also in reply to Zoidman above, excuse my lazy quoting:

When you search for e-cigarette, electronic cigarette, e-cig, and vaporizer, you get wildly different results for each. There is some overlap for sure, there are a lot of people who use both e-cigarette and e-cig in their comment and will show up in both of those searches. There are also people who exclusively use one term (i.e. vaporizer) and only show in that search. So you can't just take all of those results and add them.

Due to the fact that the comments are not being categorized (i.e. putting all cigar comments into one category and e-cig comments into another), we may never know what the exact count is, or even be able to come up with a close estimate.

Also, not all of the comments have been posted yet. One of my comments appears on the first page (when I search for e-cigarette, change the settings to 50 results per page and sort by newest posts), but it's one I made about a week ago. Who knows when they'll go through all the comments and post them. When you first go to the page it says how many comments have been received, then when you go to search for comments it gives you a number that's about 25,000 less - I think that is the difference between how many comments they received vs. how many they've read through and posted.

To answer your second question, "comments not accepted" just means the comment window is closed.
 
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