Public Policy Analysis of how the EU elections will effect vaping in the EU

The following is a brief analysis of how the EU elections and the resulting shocks to the majority parties will effect Vapor Politics in the EU.  The document was drafted by Peter Becket, a PR and lobbying professional who does a lot of work for EU vaping organizations and companies.  I had the pleasure of getting to know Peter at the SFATA conference and find him to be intelligent, knowledgable and experienced in the vaping industry.  Our EU cousins should pay particular attention to Peter's comments as they may give you guidance on what paths politically will be most fruitful.

Dear all,

Following the recent elections for the European Parliament, I thought that I would give my take on what this could mean for the vapour business. I hope that this summary is helpful and please don't hesitate to get in touch if you have questions, comments or ideas.

Composition of the new Parliament

As you may have heard, the new Parliament is made up of a far larger number of anti-EU and far left/right parties. As a result, the main groups on the left (Socialists, Communists and Greens) or right (Christian democrats, Liberals, Conservatives) cannot form a majority on their own (see here for possible voting combinations). As such, getting the majority required to pass primary or secondary legislation will require the two sides to work together, making the passage of new laws extremely difficult. Gridlock is very likely to ensue.

This matters because under the tobacco Directive, the Commission must propose secondary legislation on e-cigarettes, including the specification of data that will be required in the product notification (essentially a product standard) and the specifics of a mechanism for 'leak free refilling. Once the Commission has made these proposals Parliament will have to approve them, and interested MEPs will be courted by the Commission as they are drafted.

This is an opportunity for industry to have its plans considered more seriously as compromise proposals, but in order to do so alignment and constructive ideas on international product standards will be needed.

Incoming/outgoing MEPs

Many of the most vocal supporters of e-cigarettes in Parliament have lost their seats or resigned. The British Liberal Democrats have been all but wiped out (going from 12 seats to just one) and with them Chris Davies, Rebecca Taylor, Bill Newton Dunn and Phil Bennion -some of the critical influencers who helped get the medicinal route dismissed. Martin Callanan, who worked on the Directive for the UK Conservatives and was also supportive, has also lost his seat, as has his colleague Marina Yiannakoudakis. Some close supporters like Renata Sommer still remain.

This means that, over the coming months, we will need to build new alliances and find new supporters within each of the political groups and Committees. This will require a sustained effort in terms of making our arguments in a logical and coherent way once the new Parliament takes office in July.

Next steps

Given that many of our most vocal supporters in the Parliament have lost their seats, the industry will need to work hard to win over new allies in its drive for bespoke and workable product standards that are technology neutral and encourage innovation. We will need to identify allies, send briefing materials and arrange meetings explaining the situation with the tobacco Directive as soon as the new MEPs take their seats in July.

In November, a new Commission will be appointed and this will have an impact on how the executive and its agencies handle the implementation of the tobacco Directive. I will update the group on rumours and speculation as this date comes near.

The Vaping Independent Retail initiative

In an effort to reach the EFVI‘s 1,000,000 signature requirement EU wide, a new FB page has been set up exclusively for EFVI- supportive vendors and a few of the EFVI-UK admin team . It is a central location where independent specialist retailers can share information regarding support of EFVI (European Free Vaping Initiative) activities. Have a Dodo Box? A sign in your window? You can tell other retailers what’s working for your company to gain new signatures.

The main purpose of VIRI is to share information and to help make the EFVI campaign more effective. This can never be a bad thing, considering how important EFVI is.

There are presently 61 in this closed group from all parts of the EU , if this number could exceed 250+, it could then possibly evolve into far more than just a supportive vendor discussion group.
 Would a European Vaping Retailers Association be something achievable, viable or desirable ?

If all our European Vendors could just take a look to see how they can get involved, I know many of you are just on-line retailers, but even just sending out a card with each order, or a banner on your website would be a great help.

Not all vapers use forums and the likes, and many may still not be aware of the upcoming legislation that will affect their right to smoke healthier.

Please click here for details - http://vapemestoopid.co.uk/the-vaping-independent-retailers-initiative-viri/

Topic: European Free Vaping Initiative - MUST SIGN

SIGN IT AND GET EVERYONE YOU KNOW TO SIGN IT



A call to action: Save vaping!

Hold onto our civil rights!

While the result of the trilogue between the European Commission, the European Parliament and the Council of Ministers, concluded on the 16th of December saved electronic cigarettes from some of the direct threats, it still does contain too many loopholes and poorly elaborated conclusions that may (and most probably will) endanger the future of vaping on national levels as well as on a European level.

If something, then the cumbersome conciliations over the past year clearly display that the matter of electronic cigarettes is of as much importance as tobacco products themselves, therefore solving the issue of e-cigarettes on the margin of TPD is far from being sufficient. We will keep fighting until electronic cigarettes are finally to be discussed at the level they deserve, and until a regulation is born that says no to fears rooted in ignorance, and does not bypass scientific evidence nor the real needs of the people using electronic cigarettes.

Our goal is to express the will of the many, who are already vaping, plan to vape, have a loved one who is vaping or someone who simply respects the values of private sphere and personal rights.

Vapers made an adult, responsible and private decision when they chose this young but very effective alternative that made possible for them to leave or ease up a deadly habit that claims hundreds of thousands of lives of EU citizens each and every year. The fact that vaping poses no harm to the vicinity of the vaper makes this hobby a private matter of no public interest, therefore any kind of attempt towards the regulation of electronic cigarettes and related products is interpreted as serious offense against our personal rights and private sphere.

If the European Parliament intends to get involved in the matters of vaping, the rational choice would be support and promotion and not restriction.

The message is simple and clear: hands off of free vaping in the European Union. Read more about it in our manifesto.

Our weapon of choice is the European Citizens' Initiative, a mechanism provided by the EU that allows its concerned citizens to express their common opinion on how the European Parliament should approach certain subjects, in this case: vaping.

About EFVI

What is EFVI?

An opportunity for vapers to directly address the decision makers of Europe so they can choose to ignore our opinion no more. We need to collect one million signatures before the 25th of November 2014, and reach the minimum quota in seven member states.

What EFVI is not

EFVI is not an another petition to sign. It allows us to participate directly in the development of EU policies regarding electronic cigarettes.

Why is EFVI important?
Once successfully concluded, we will have the opportunity to meet Commission representatives in person and to present our initiative at a public hearing in the European Parliament.   

Welsh Minister Confirms It's Never Been About Health

He may, to borrow a phrase, have the appearance of a low-grade bank clerk and the analytical thinking skills of a mackerel, but I suppose I should be thanking this creature today.

You see, he has helped to categorically prove my long-held assertion that smoking bans have never, ever, had anything whatsoever to do with health.

From the BBC:

Wales could be the first part of the UK to ban the use of electronic cigarettes in enclosed public places. 

Ministers say they are responding to concern that the devices - which can contain nicotine - normalise smoking and undermine the smoking ban.

Health Minister Mark Drakeford (that's him up there - DP) said the aim was to address some of the nation's major public health challenges. 

"I have concerns about the impact of e-cigarettes on the enforcement of Wales' smoking ban. That's why we are proposing restricting their use in enclosed public places."

Concerns? Have you any proof, Mark, that e-cigs have any impact at all on enforcement? Wouldn't that be a prerequisite for installing illiberal legislation? Because I'm damned if I've ever read an article, anywhere, describing even one instance.

"I am also concerned that their use in enclosed public places could normalise smoking behaviour."

Err, wasn't the smoking ban solely and exclusively to prevent the huge piles of barmaids' bodies piled up in every town centre of a weekend due to second-hand smoke? That is, after all, the only possible justification for stealing private property rights outside of a fascist dictatorship, isn't it? In fact, the onlyargument which every politician pointed to as he/she ripped the guts out of the British pub trade a few years ago.

Back then, we were told over and over again that it wasn't an attempt to force smokers to quit; not an attempt to interfere in freedom of choice. Oh no, nothing could be further from the truth! This was purely a health matter, and certainly not social engineering or pandering to the selfish, intolerant and anti-social in society.

Has there been a load of debate today about how harmful second-hand e-cig vapour is to pub workers (who have no choice whatsoever but to work in a pub, of course)? Nope, not even a polite nod towards it. Was there even full and frank discussion about how people are dying from using e-cigs themselves? Well what do you think?

This would be because there is no smoking ban in the world which was designed to protect bar workers. Every single one was sold that way, yes, but was purely to bully and cajole smokers into quitting because 'public health' rent-seekers and politicians are nasty little control freaks who think they know what is best for us. Simples.

So thank you, Mark Drakeford, you lovely man, for giving us incontrovertible proof that it's not about health. When a policy is so ludicrous that even ban-friendly Guardian readers variously describe the proposer as muppet, twerp, paranoid, bonkers, idiot, dullard, plank and loon, it's clear that your fallacious reasoning is embarrassingly transparent and that the carefully-constructed lies have been rumbled.

Still, he's doing exactly as the unelected WHO has decreed for e-cigs so there'll probably be a generously-paid cushy job for him in the future. And that - not the public, not liberties and not wise governance - is the only thing which really interests modern politicians, isn't it?

UPDATE: This Drakeford guy is even more stupid than I first thought. Responding to the suggestion that banning vapers from using e-cigs indoors and instead banishing to the smoking area means they will encounter that horrid passive smoke, he came out with this!

"Of all the arguments that could be made against the idea of preventing the use of e-cigarettes in enclosed public spaces, I think that would be amongst the weakest I have ever heard. There is no obligation on anybody using an e-cigarette to go and use one next to someone using a conventional cigarette. They can use it anywhere else that they choose to use it. In their own homes, wherever else they might want to use it."

Euphoric Vaping - Watermelon Review

Electronic Cigarettes: Evidence for Harm Reversal

Abstract: Electronic cigarettes (e-cigs) are marketed as safer alternatives to tobacco cigarettes and have shown to reduce their consumption. Here we report for the first time the effects of e-cigs on subjective and objective asthma parameters as well as tolerability in asthmatic smokers who quit or reduced their tobacco consumption by switching to these products. We retrospectively reviewed changes in spirometry data, airway hyper-responsiveness (AHR), asthma exacerbations and subjective asthma control in smoking asthmatics who switched to regular e-cig use. Measurements were taken prior to switching (baseline) and at two consecutive visits (Follow-up/1 at 6 (±1) and Follow-up/2 at 12 (±2) months). Eighteen smoking asthmatics (10 single users, eight dual users) were identified. Overall there were significant improvements in spirometry data, asthma control and AHR. These positive outcomes were noted in single and dual users. Reduction in exacerbation rates was reported, but was not significant. No severe adverse events were noted. This small retrospective study indicates that regular use of e-cigs to substitute smoking is associated with objective and subjective improvements in asthma outcomes. Considering that e-cig use is reportedly less harmful than conventional smoking and can lead to reduced cigarette consumption with subsequent improvements in asthma outcomes, this study shows that e-cigs can be a valid option for asthmatic patients who cannot quit smoking by other methods.

Product Review: Cornish Vendor Leads the County Forward.........

The moment I discovered that a local e-cig vendor in Newquay, Cornwall, was stocking the Kamry K100 – I was overjoyed.

Jess, the proprietor of Johnny’s; a prominent tobacconist, has been trading in the popular holiday resort of Newquay, Cornwall since 1970. If you want top of the range items, such as pipes, lighters, and an abundance of loose tobaccos – this has always been the place you need to be.

As with everything, times change, and attitudes towards smoking are by no means exempt. We have seen many diverse tactics by the government, as well as ad-lib organisations such as ASH, desperately trying to steer people away from the pastime, which for many is a way of life.

Jess, along with many other retailers in his field, has started stocking, and even using the revolutionary invention; the e-cig.

He now stocks a wide range of e-cigs, from the Ego-C’s and Intellicig, (of which, he was the UK’s first stockist), through to the more advanced mods like the k100 and even Kamry’s renowned e-pipe.

I could not wait to get my hands on the famous K100, and even grabbed myself a couple of bottles of juice from the extensive range that Jess also stocks.

So, my view on the K100 – it is sold as a complete kit, which consists of a charger, two Samsung batteries, a generic "Protank", and of course the sleek looking telescopic device itself, coming in a choice of either blue or black. You will also get a carry case.

I intended to “vape” the device for two days, so as to give a fair account of how I thought it performed, but instead it has become my “go to” mod.

Its vapour production is, simply put, awesome, as is the flavour, and the high drain batteries ensure you get at least around 8 hours vaping time, (at a minimum).

Although many advanced users tend to use the K100, it is completely straightforward enough for the novice to use confidently and successfully.

It is light enough to slip into the pocket and the locking feature ensures you are not going to suffer from any misfires while driving or sitting.

In terms of prolonged performance and comfort, I am going to rate it at a staggering 9 / 10, putting it right up alongside the formidable Provarie. 

As far as compatibility with other tanks, it rates a 10 / 10 – its diversity offering you the standard 510 fitting, together with an Ego-threading.

This kit is charged at just £49.99.

So, if you fancy giving this device or any of the others that Johnny’s stock, pop along to the store, which is based in Newquay’s main shopping centre and have a chat. Alternatively, you can always give them a call on 01637 859375.

I NEVER SAW THIS COMING...........

WINTERVILLE, N.C. -

For "Smoke Smart" store manager Rachel Fleming, the news out of the North Carolina state house isn't a surprise.

"We had a feeling it was going to happen sooner or later," Fleming said. "Not that we wanted it to happen."

The state House of Representatives is giving preliminary approval to a new tax for electronic cigarettes or "e-cigs."

"I don't agree with it but the government's pretty much going do what they want to do," Fleming said. "So if they want to tax it, they're going to tax it."

The plan is to tax the nicotine containing liquid used in "e-cigs" by five cents per milliliter.

"E-cigs" are becoming the popular alternative to cigarettes because they eliminate the smell and replace the smoke with less harmful vapor, and because of that, some traditional smokers like David Crandol say "e-cig" smokers should be taxed like him.

"For smokers like me that can't smoke in every day places, we pay taxes on our cigarettes and people that can smoke an electronic cigarette, you can smoke them anywhere so it's only fair," Crandol said.

Others like Mike Croford point to the potential benefits of e-cigarettes as an alternative to traditional cigarettes.

"I think a lot of people use e-cigarettes to wean them off regular cigarettes," Croford said. "Taxing the e-cigarettes, they're just going to go back to smoking regular cigarettes."

Which is why Fleming doesn't expect her business to suffer even if the tax is passed.

"If customers really come, they really want to try to quit smokers, and they're serious about it, they'll keep coming in," Fleming said. "I don't think it will affect business too much."

A final vote is expected for Wednesday. If it passes, it will go to the Senate.

A SECOND CALL TO ACTION

There is an interim deadline for comments on the deeming regulation.  Specifically, any comments on the Paperwork Reduction Act aspects of the proposed regulation are due on Tuesday, May 27, 2014.  To a large extent, these are comments that merchants and manufacturers should be making rather than consumers, and we understand that the vendors are being mobilized to do it.  However, we have determined that it would be useful for consumers to make one particular comment in response to that, as appears below.

For those who do not know, the Paperwork Reduction Act is intended to force regulators to consider the costs of merely doing the paperwork and such needed to comply with a regulation (i.e., not the actual substantive requirements of the regulation).  We believe that FDA has used completely inappropriate estimates for the paperwork costs of this regulation.  In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products.

We all know that these numbers are far below the number of actual e-cigarette products on the market, and we need comments that make that known.  Basically FDA is either wrong about their estimates or are explicitly saying that all of the other products will be driven off the market.  While consumers cannot effectively comment on the question of whether that is accurate, you can definitely make the point about what you would be losing and that perhaps their estimates are naïve.

Some Common Sense At least.....

The survey of nearly 6,000 smokers found a fifth had quit with the aid of e-cigarettes.

That was 60% higher than those who did not use the devices, the study said.

The University College London team said they were "cautiously positive" about the role e-cigarettes could play.

E-cigarette use has shot up in recent years.

Action on Smoking and Health estimate there are more than 2m people using them - triple the number from two years ago.

Half of smokers have tried them compared to 8% in 2010.

Users experience the sensation of smoking by inhaling a vapour which contains a concentration of nicotine.

But they remain controversial. The Welsh government wants to restrict their use in public places, because of fears they normalise smoking.

'Widespread appeal'

However, lead researcher Prof Robert West, one of the UK's leading experts in this field, said: "E-cigarettes could substantially improve public health because of their widespread appeal and the huge health gains associated with stopping smoking."

But he also pointed out that despite the findings - published in the journal Addiction - by far the most effective way of quitting was to use NHS stop smoking services which tripled the odds of a smoker quitting when compared to buying nicotine replacement treatments without specialist help.

And he added: "Some public health experts have expressed concern that widespread use of e-cigarettes could 're-normalise' smoking. However, we are tracking this very closely and see no evidence of it.

"Smoking rates in England are declining, quitting rates are increasing and regular e-cigarette use among never smokers is negligible."

E-cigarettes are currently not available on the NHS, but the drugs regulator the Medicine and Healthcare Products Regulatory Agency is looking to licence them as medicines from 2016.

Prof West said it was too early to say whether and which e-cigarette products could be made available, as there needed to be more research into the safety of long-term use.

However, he said from what is currently known the contents of the e-cigarette vapours will be much less risky than smoking.

A Department of Health spokeswoman said: "E-cigarettes are not risk free, but they carry a lower risk to health than smoking tobacco and may help people who want to stop smoking.

"Any e-cigarette products that are licensed as medicines can be made available on the NHS. We will continue to closely monitor all emerging research."

Euphoric Vaping - A Review

Euphoric Vaping, based in Inverness, Scotland are a brand new up & coming vedour, which i used for the first time.

I ordered from Euphoric Vaping at around 1pm yesterday afternoon, (Firday 16), and my merchandise arrived just 24hrs later. So, first impressions regarding delivery is fantastic.

Rye 4

I don't normally vape this flavour, (or indeed any tobacco tasting e-juice), due to some bad experiences early in my vaping journey. However, something screamed inside my head, "try it!!!" - so I did, and it really is delsh'.
Great caramel taste going on in the background, and the tobacco flavor is strong, but by no means overpowering. I will be buying this again, so coming from a non-tobacco flavor user, it really does show you how nice it is to vape. 10/10

American Hazelnut

This is the sort of flavoring which I have always steered away from, but from a "I'm not too keen on nuts, so why would I vape them?" point of view, rather than past tasting experiences.
So, how did I like this one? To start with I wasn't too impressed, but as I vaped on it kinda grew on me. I think it's one of those flavors, (for me at least), that you have to savor and see if it grows on you. I'm not saying I'd buy this one again, but that's from a personal choice point of view, rather than its quality.  7/10

Watermelon

I started getting into fruity type juices just before Christmas last year, and so i thought I'd give this one a pop -  and I'mso glad I did - love it! Tangy, fresh, sweet, refreshing - just like the real thing really. Fantastic aftertaste, brilliant on the inhale - a perfect all-rounder, and certainly an ADV. 10/10

Overall

Great service - great juice - and will most certainly be throwing some more of my hard earned cash in Luke's direction.

www.euphoricvaping.com

SFATA Template

SFATA has now released its first template FDA Comment letter and link to the correct Docket for filing of that letter.  At this time SFATA is urging all ECIG business owners to simply request an extension of the comment time that the FDA has allowed for.  The SFATA template letter is focused on that single request.  We all need more time to effectively provide comments to the FDA that will be impactful. 

Please use the below links and instructions to draft your comment period extenstion request.

Click here for a sample letter request.

Submissions should be filed directly on the docket at www.regulations.gov.
The Deeming Regs docket can be accessed here.
Scroll down the page slightly, to the “Comment Now” link.
You can submit the extension request by attaching a file or typing their request in the allotted area.

If you have a problem with the links above, please visit www.SFATA.org to access them there.

At a later date SFATA will be providing guidance manuals and in-depth analysis of the FDA’s proposed Deeming Regulations on E-cigs.  Please reset assured that SFATA’s attorneys and other professionals are working diligently on the industry’s behalf to come up with comments that help save the small to mid-sized Ecig business owner. 

Great Article On The Gateway Argument

There has been a degree of concern that electronic cigarettes could re-normalise smoking. Bubblegum and obviously non-adult flavours have a clear target, and in the absence of regulation adverts indistinguishable from those selling actual tobacco products get an easy ride.

But while many worry that the adverts and products will entice a new generation of non-smokers, who will later go on to smoke actual tobacco, a new YouGov survey for ASH finds no evidence for this.

Only 0.1% fall into the problem group: people using e-cigarettes regularly but not yet smoking. Negligibly more (1.1%) have tried an e-cigarette but have never smoked.

---

he worry about children becoming gateway users also seems unfounded. 99% of aware, never-smoking 16-18 year olds have never tried an e-cigarette.

In reality, e-cigarette use appears to be mainly among current smokers (52% have used one). And for the increasing numbers of ex-smokers who use them (12%, up from 7% in 2013 and 4% in 2012), 71% say the main reason for use is to help them stop smoking tobacco entirely.

---

Smokers, on the other hand, are most likely to say they use them to reduce the amount of tobacco they smoke, but not to stop completely (48% say this).

The e-cigarette industry say the survey shows that public health opponents are wrong to oppose the products. "Study after study is showing that scaremongering that e-cigarettes are luring people into tobacco is baseless nonsense. The reverse is going on – smokers are switching into e-cigarettes as the way to reduce the harm from tobacco," said the legal and corporate affairs director of E-Lites.

CASAA A Call to Action

On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  This is the first of several Calls to Action anticipated in CASAA's Action Plan.   (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate. 

The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments.  We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances--along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)

SUGGESTED LETTER REQUESTING EXTENSION 

YOU SHOULD EDIT AS APPROPRIATE

Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

II.

INSTRUCTIONS ON HOW TO MAKE THE REQUEST

1. Create a document with your comment.  You can use the above sample letter as a template and edit to make it your own.
2. Access the comment form for the deeming regulation (FDA-2014-N-0189-0001):  FDA Comment Form
3. Click in the Comment field and copy and paste your comment from Step 1 into the box.
4. Click in the First Name field and type your first name.
5. Click in the Last Name field and type your last name.
6. If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
7. Click to uncheck the box, "I am submitting on behalf of a third party."
8. Click the arrow next to the "Category" field to display a menu.
9. Select a category from the menu.  We recommend "Individual Consumer" for individuals wishing to request an extension personally and not on behalf of any business or group.
   
   NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns.  There has been some criticism of this position, and FDA has indicated that it will be  publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name.  Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
10. Click the Continue button.  After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it.  (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)
11. On the Your Preview page, click to check the box "I read and understand the statement above."
12. Click the Submit Comment button.
13. After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below.  (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below.  Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment and comment number.)
14. Please send the comment number to casaa.fdacommentarchive@gmail.com. It is important that CASAA have a count of how many such requests have been made.  (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)

This Is IMPORTANT Guys an' Gals

The following is written by my friend and fellow vaper Mark Burton of South California


What I would strongly suggest instead is that folks go read the CASAA style and background information on commenting to the FDA and focus on that for the moment.  Well written comments that touch on the issues that all of the major vaping organizations have agreed should be focused on are what we really need right now.  It is what will be made as part of the public record for the notice and comment phase of this rule making process and what will be used in the almost certain litigation to come.

I love that people are getting active in the movement.  May I suggest that those of you who are consumer vapers join CASAA (its free)www.CASAA.org and those who are vendors please either go to the SFATA website www.SFATA.org or feel free to contact me.  These along with the Vaping Militia website are the best places to get up to date and accurate information and calls to action. 

VapeSmart: I Came Across This Today (CASSA)

Two weeks ago the FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.

Early on, we asked CASAA members to be patient and to refrain from making formal comments about the proposed regulations until CASAA leadership  had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that  makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.

The last two weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the Tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers.

This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness.

The Action Plan will include, among other things, Calls to Action with specific requests directed towards members of Congress. To support this massive undertaking, we have subscribed to CQ Roll Call, a program which will help connect our members easily and in a targeted fashion with their state and federal legislators on specifically crafted campaigns we design.   This tool will be valuable as we move forward to the next stage of our battle, and it will also help us in our continuing efforts at state-level advocacy.

The CQ Roll Call program represents a significant commitment of financial resources, but we have been careful with the money our membership has donated over the years, practicing sound fiscal management to ensure that the money will be available when the time is right. That time is now. We are working with the company to get the program rolled out as quickly as possible, and we have been told that we should have it functional enough within the next two weeks, in time for our second Call to Action (which will be the first of several directed at Congress).

Which brings us to the first Call to Action, which will be issued in the next day or two.

FDA, which took more than three years to issue these enormous documents, has given us a mere 75 days to comment. While responding in that timeframe is challenging in the base case, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is, at best, inadequate.  

The first Call to Action will be for all consumers to request an extension of the comment period. Such an extension is needed for anyone who is going to attempt to compile the information required to answer FDA’s substantive questions. The Call to Action will provide details on how to do that. We expect that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers. The cigar interests are doing the same.

We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait. There is absolutely no benefit to making substantive comments now, and, in fact, it can undercut the very reasonable and truthful position that we have taken that the comment period must be extended. Early comments will lack the useful information that we will be able to assemble over the coming months. While FDA is required to read all comments, it would not be surprising or unreasonable if they were to gloss over those that are submitted early as being completely uninformative (as, indeed, many are, based on our spot review of what has been submitted and posted  to the web). Moreover, organized interests who support the regulations, or who want to suggest that they become even more prohibitionist, will undoubtedly wait until near the deadline to submit; they will take advantage of what they can learn about our arguments by reviewing the early submissions.  

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline. Submitting comments earlier than that has no benefit and might have substantial costs.

In the meanwhile, there are still many things you can do to prepare:

• Submit your testimonial
• Prepare a one- or two-paragraph summary of your personal story for use with various Calls to Action that will be issued.
• Continue to encourage others to join CASAA.  Membership is free, and more members will increase our influence and reach. CASAA members are more informed on the issues, and having the proper information  will result in more effective advocacy.
• Ask vendors to provide information on CASAA to their customers:
• CASAA has a "We Support CASAA" Graphic for use on commercial sites.
• CASAA offers vendor kits at cost which is designed to let customers know about CASAA.
• Informational flyers and brochures are also available on our website for download to print and hand out at vape meets and stores or even for employers and medical professionals.
• Let people know about CASAA’s social networks and encourage them to join our forum on ECF, follow us on Twitter, subscribe to our blog and/or join us on Facebook, so they do not miss important information.
• Share CASAA’s blog posts and emails about the FDA rules and our plan, so they also know what we are doing and what to expect.
  

Also, while the proposed FDA regulations are by far the biggest issue we are dealing with, we continue to address other matters, including state and local Calls to Action. (And we encourage our members to continuing paying attention to state and local legislation!) We also just released our White Paper on civil disobedience.