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FDA Deeming Regulations

What BREXIT Means For Vaping in The UK

By Drake Equation | October 15 2016

BREXIT has happened — the UK has opted to leave the EU. But what does BREXIT have in store for vapers?

UPDATE: The UK has decided to leave the EU. This is a HUGE situation that will, in all likelihood, take several or more years to play out. The markets are all over the place, but appear to be doing better than expected, but it is the political chaos that is the most unnerving thing — the major parties appear to be in free fall.

The post below was written WAY before the BREXIT vote. I penned it mainly to speculate about what would happen in the event of the UK leaving the EU. The other point I wanted to stress in the post was the EU’s glaring ignorance towards vaping and its on-going love of corporatism — the EU wants vaping destroyed. And the reason is its pals in Big Pharma want it that way.



But now the vote has been cast, what does the immediate future look like? What will change? Is the TPD void?

“The short answer is nothing,” says a report from Vaping 360. “The vapor products provisions of the TPD will stay in effect until the UK negotiates the terms of its exit from the EU. Presumably the government will continue on the path it has already begun, enforcing the regulations lightly and creating as little disruption to vapers as the regulations allow. But a new government could make different choices.”

NNA Wants TPD KILLED

Clive Bates and Sarah Jakes of the New Nicotine Alliance (NNA) have penned a joint letter to the Right Honourable Jeremy Hunt MP asking for the TPD to be repealed. If successful, this will be a HUGE boon for the UK vaping market and also set a precedent for the rest of the world to follow.

Here’s what the NNA said in a statement posted on Clive Bates’ Blog:

“We recognise that the primary purpose of the Great Repeal Bill to be announced in the 2017 Queen’s speech is to bring most of the body of European Union law into UK law substantively unchanged,” write the NNA harm reduction advocates. “However, we hope that ministers will consider actually repealing some of the worst examples of European Union Law, especially where a domestic approach would have multiple benefits to health, wellbeing, commerce, personal freedom and competitiveness.”

“Public health supporters around the world will be looking to the UK to defend safer alternatives to cigarettes,” writes Professor Gerry Stimson, emeritus chair at Imperial College London, in The Spectator. “So far, France is the only EU country to share the UK approach. These two, the only countries in the EU where cigarettes must now be in plain packaging, are rightly recognised as Europe’s leaders on tobacco control. They must hold their ground. A billion lives could depend on it.”

Read on below the break for the full original post.


 

Whatever your stance on the issue, either in or out, is entirely up to you, but there is one thing we can ALL agree on and that is the EU’s continuing war of ignorance against vaping.

Personally, I’m all for an exit — but not because of the vaping thing. I am, and always have been, wary of large, top-down-managed superstates. And the EU certainly meets all the criteria for this with its love of bureaucracy, corruption and general air of totalitarianism.

But that’s a story for another day and another website; no, here I want to talk about vaping and what BREXIT will mean for the future of vaping in the UK should we decide to leave the EU and go it alone on the global stage.

Let’s take a look at all the factors currently facing the UK vaping scene, including the about to hit TPD, BREXIT and finally what it would mean if we left or remained part of the EU.

BREXIT & The TDP As It Stands

As of May 2016, the TPD — a European piece of legislation that aims to pretty much kill the vaping scene here in the UK — is now in effect. The knock-on result of this piece of legislation is limited choice of products, restrictions on what you can and can’t vape, increased prices and mountains of red tape for those looking to design and develop new products.

Basically, the TPD will do for vaping in the UK what the FDA’s Deeming Regulations will do for vaping in the US inside the next two years. And in case you’re not reading between the lines what I’m talking about here is now good — this is effectively the end of the line for vaping as we know it.

Who voted for this law? Who asked for it? Do we need it? The answers to all those questions are simple: no one, nobody and no. The EU simply dreamed it up, likely at the behest of Big Pharma and Big Tobacco, and it now about to become a reality.

This isn’t fair, of course. And no one likes this kind of legislation, regardless of whether you’re a vaper or not. It’s bullshit of the highest order.

“At the heart of the TPD is the simply untrue assertion that e-cigarettes are tobacco products,” says The Electronic Tobacconist. “They aren’t, they don’t contain tobacco, and this kind of perverse Orwellian doublethink doesn’t reflect well on the EU at all. E-cigarettes are only superficially similar to cigarettes; nicotine is the only shared ingredient, and the nicotine-free e-cigarettes, of which there are many, will be regulated just the same. In fact, they are much more similar to nicotine inhalers, a product which gets a preferential 5% tax treatment.”

The House of Lords may block this bill and stop it from happening. This is not guaranteed, though. There are petitions you can sign and things you can do, however, which you can read more about HERE. And say the Lords do block it: what’s stopping the EU trying again and again and again?

The only way to stop this happening is to leave the EU. This way the UK can make its own laws and decide its own legislation on vaping — if any. I mean, we have the Royal College of Physicians’ approval and many, many scientists and researchers have been shouting about the benefits of vaping.

No one in the EU is listening, though. Whether this is kick-backs from lobby money, outright bribes or ignorance, I have NO idea, but what I do know is that there has been ZERO debate and ZERO serious discussion on the subject.

THEY decided and WE have to obey.

And like all good conspiracies, there is an “official story” mouthed by a few anointed “experts” that is designed to quell the public from enquiring further. Get the mainstream media on board, publish a few scaremongering stories here and there, and voila, you’ve got 90% of people onboard with your bullshit arguments and regulations.

That is what happened with vaping, the TPD and the FDA Deeming Regulations in the US. They saw a viable, disruptive alternative to tobacco and Big Pharma’s products and, either through coercion or lobbying, or both, they set about in a totally corporatist manner to destroy a vibrant, life saving industry.

“Pharmaceutical companies make a killing from completely ineffective smoking cessation products (gums, patches and inhalers),” the report added. “This lucrative industry has taken a hit thanks to the arrival of e-cigarettes, which not only work better but are also more enjoyable. To steady the ship, big pharma lobbied the EU hard.”

This isn’t democracy. This isn’t about your well being. It is corporatism. It is about money. And it is going to keep on happening over and over again until the public wakes up and realises it is being governed by a pack of liars, thieves and war criminals who couldn’t give a rat’s ass about your well being, your children or the planet you live on.


 

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Filed Under: Advocacy, News Tagged With: BREXIT, FDA Deeming Regulations, TDP, vaping

Vaping is NOT a Gateway To Smoking — FACT

By Drake Equation | July 28 2016

There is a WAR ON VAPING raging at present, but thankfully UK institutions like the Royal College of Physicians are waking up

The war of vaping is real and is now in a very dangerous place for vapers and the vaping industry at large. Draconian legislation from both the EU and FDA in the US look to destroy the one thing that has helped millions of taxpayers quit smoking for good.

I say, taxpayers, because this decrease in smoking has cost the US and EU positively nothing. In fact, the resurgence of small businesses that have popped up all over the UK and US has actually HELPED the economy by creating new jobs and opportunities.

But none of this is good enough, apparently. The powers that be have a bee in their bonnet about vaping, likely on account of their buddies in Big Tobacco and Big Pharma losing money hand over foot, and have set about to derail the vaping industry in the only way it knows how: RED TAPE, TAXATION and BUREAUCRACY.

The main argument put forward by these so called do-gooders is that vaping is “gateway” drug for children. Apparently if you start vaping eventually you’re going to become a cigarette smoker, which is an odd position to take when you consider vaping has done more to kill smoking than any public body in history — odd, indeed.

But the reason this sounds a bit off is because it is not true. Don’t forget these same “people” are happy for your kids to eat GMO food and actively support parasitic corporations like Monsanto. They do not care about your well being. They care about profits and bottomline and margins. And if they’re “friends” are getting stiffed you can bet you ass these corporatists will do EVERYTHING they can to re-introduce the balance of power in their favour.

I mean, just look at the facts. In the UK the Royal College of Physicians has just completely backed vaping, saying that smokers should be “reassured and encouraged” to use them.

The RCP released a 200-page report on the subject of vaping in which it concluded: “This report lays to rest almost all of the concerns over these products, and concludes that, with sensible regulation, electronic cigarettes have the potential to make a major contribution towards preventing the premature death, disease and social inequalities in health that smoking currently causes in the UK. Smokers should be reassured that these products can help them quit all tobacco use forever.”

As well as concluding that vaping is NOT a gateway to smoking, the RCP also found that there is ZERO evidence that e-cigarettes result in the normalisation of smoking in the hearts and minds of children.

And it’s not just the RCP, either. There is ALSO this from the the Onassic Cardiac Surgery Centre in Athens, Greece.

“These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study,” said Dr. Konstantinos Farsalinos, a cardiologist at the Onassic Cardiac Surgery Centre in Athens, Greece, and the principal investigator of the study. “The European Union data show that the use of electronic cigarettes seems to have a positive impact on public health for two main reasons: 1. High smoking cessation and reduction rates are observed, and 2. Electronic cigarette use is largely confined to smokers (current and former), with minimal use by non-smokers.” Farsalinos was quoted in a press release from the University of Patras in Greece.

Public Health England (PHE) has now chimed in on the debate as well. And guess what: it TOO takes a positive stance on vaping.

Rosanna O’Connor, director of drugs, alcohol and tobacco at PHE, said: “Vaping is not the same as smoking, second-hand smoke is harmful to health but there is no evidence that e-cigarette vapour carries the same harms.

“In fact a ban on using e-cigarettes in public places could be damaging, as it may put off smokers from using e-cigarettes to help them quit. ”

So what in the actual FUCK is going on?

Vaping is safe. Vaping is not a gateway drug. Vaping does not normalise smoking. And yet vaping is about to be destroyed by completely over the top regulation that will effectively kill the industry that has so far helped millions of people quit smoking.

If you can work out the logic in that then you should probably be working for the government. If like most reasonable people you see this as yet another attack on the personal liberties of people and private enterprise by corrupt elites then I’d advise you to drop your local MP or congressman a call or an email and get some answers.

Longterm, Widespread POSITIVE Effect of Vaping

Not only is vaping not a gate-way to proper smoking, but it is also a beneficial technology for society at large. In a new study published inside the Nicotine & Tobacco Research journal, the findings of Dr. David T. Levy were published and the conclusions are very positive — especially for those fighting to keep vaping alive and kicking in the wake draconian FDA regulation.

“Our study indicates that, considering a broad range of reasonable scenarios, e-cigarettes are likely to reduce cigarette smoking and not lead to offsetting increases in harm from the use of e-cigarettes and more deadly cigarettes,” said Levy.

“When we consider the plausible positive and negative aspects of e-cigarette use, we find vaping is likely to have a net positive public health impact. Unlike the previous studies, the current study distinguishes between young vapers who would not otherwise have taken up any nicotine product, and those who use e-cigarettes, who would otherwise have smoked traditional tobacco cigarettes. When both vaping groups are taken into account, the researchers found that benefit outweighs the harm.”

“Our model is consistent with recent evidence that, while e-cigarette use has markedly increased, cigarette smoking among youth and young adults has fallen dramatically,” Levy added. “Under most plausible scenarios, vaporised nicotine products [VNP] use generally has a positive public health impact. However, very high VNP use rates could result in net harms.”

Let’s Save Vaping!

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Filed Under: Advocacy, News Tagged With: FDA Deeming Regulations, war on vaping

Open Source Vapor KILLED By FDA Deeming Regs

By Drake Equation | June 23 2016

Open Source Vapor is just one of the FDA’s victims, as company confirms it will be closing down on June 30

The bureaucrats are winning and we’re starting to see some initial fallout from the FDA’s Deeming Regulations. Open Source Vapor has confirmed that it will be closing its doors as of June 30.

Shit’s getting REAL now, guys. And this should be a MAJOR eye-opener for anyone who thinks all this FDA nonsense will just “blow over”.

This is a HUGE blow for the vaping community, and a very alarming sign of the times. Independent vape labs all over the country are now feeling the pressure, as the FDA — as well as bizarre State laws — begin to take effect, forcing small, independent businesses into impossible positions.

Here’s an email Joshua McCord of Open Source Vapor sent to his customers. It’s a sad read, as it is never nice to see a business closing its doors, but what makes things worse is that this will start happening more and more as we progress through 2016 into 2017.


 

We no longer have any shot at complying with Indiana’s new e-liquid laws. Last chance to order! HB 1432 never made any sense. A ton of really specific rules that seemed to have no bearing on the quality of our juice. These incredibly specific regulations required any e-liquid manufacturer to contract with a security company for five years, right before deeming regulations hit, presumably to make sure nobody broke in to sneak drugs into their e-liquid.

There wasn’t one security firm in the state that could actually meet the requirements. An employee who is a rolling steel fire door technician certified by the International Door Association? And the same person must also be an Architectural Hardware Consultant, certified by the Door and Hardware Institute? And that security firm must have continuously employed somebody who met those requirements for the past year!?

So no local security company had the time to get in compliance. Nobody. But then, at the last minute, one of them comes out and announces that they have the guy to meet those requirements. But they’ve already accepted all the applications they’re taking, and don’t have time to handle anyone else.

I am saddened to say, we will be mixing our last juice on June 30th, 2016. The last orders accepted will be on June 29th, after that ordering will be disabled. As of July 1st, even DIYing my own juice will be illegal under state law. And none of the approved Indiana companies offer a PG-free option. Two out of the six approved companies don’t even have facilities up and running.

My most sincere apologies for the last-minute nature of this, I truly believed we could find a way to continue, in compliance with these “regulations.”

Joshua McCord Open Source Vapor


 

Again, the extent of how bad this actually is should not be lost on anybody. Read what Joshua wrote, take it in, and see the level of bullshit we’re up against here. It is an impossible position to be in and it is one that will only serve to increase the amount of people smoking and shut down small, local businesses.

What can you do? Go and buy and absolute BOATLOAD of E-Liquid from Open Source Vapor before it’s too late! They make great stuff, so if you’re in the area make sure you drop by and pass on your condolences and buy some stuff!

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Filed Under: News Tagged With: FDA Deeming Regulations, open source vapor

FDA Deeming Regulations Play Right Into Big Tobacco’s Hands — And That SUCKS

By Drake Equation | May 10 2016

FDA Deeming Regulations: Are Independent Vape Labs About To Get Muscled Out of The Market They Helped Create?

America is an odd country. I travel there a lot and, generally speaking, positively love the place, its culture and most of all its people. Shame the same thing cannot be said for its government which seems to thrive on making knee-jerk decisions about everything and everybody it encounters.

Vaping, for instance, is now Enemy Number 1 in a lot of people’s eyes in the US. Ditto Canada and many places in Asia, like China which is apparently considering a complete ban on vaping (including the manufacture of vaping and ecig hardware, too — odd seeing just how many products are made and shipped from there).

They wanted vaping regulations and today the FDA announced its Deeming Regulations. This will effectively mean vaping products — juice, hardware — are treated like cigarettes.

The entire vaping community — users, shops and suppliers — have been waiting with baited breath for the release of the FDA’s Deeming Regulation. And what was announced today is not good. Not good at all. The FDA has effectively setup on its plan to completely destroy the vaping industry — and industry that has helped MILLIONS of people quit smoking.

Gregory Conley, President of the American Vaping Association, issued the following statement:

“Without action by Congress, the FDA’s proposed regulations threaten to ban 99%-plus of vapor products currently available on the market. This would be a disaster not only for thousands of small businesses, but also public health.

“This proposal does not remove the FDA’s ability to regulate vapor products. The FDA will retain the authority to immediately move forward with science-based product standards, disclosure requirements, and many other measures. Anyone who claims that this bill would somehow render the FDA toothless is either not familiar with the law or not being forthright.

“We are thrilled to see movement on this issue. Clear evidence is emerging from around the world that vapor products are helping smokers quit. It is unconscionable to effectively ban the sale of tens of thousands of vapor products while leaving combustible cigarettes freely available.”

You Can Follow ALL The Action & Reaction Here:

  • Gregory Conley live Twitter updates
  • Vaping.com live FDA feed
  • SFATA website
  • Reddit Deeming regs thread

Full FDA Deeming Regulation Document In Full

This is the ENTIRE 500 Page Document — Be warned, though: the bastard’s 500 pages long!

Here’s what Alex Clark of CASAA had to say on the matter via Vaping360:

“Please keep in mind that this is not the end of the process. CASAA will continue to focus our efforts to develop sensible regulation of vapor products that will have maximum benefit to consumers. The most important thing to remember is that consumers will continue to have access to the wide variety of vapor products for a period of time before the regulations take effect. But, for now, vaping as we know it will continue and we are not done by any means. Keep calm.”

But the real issue is the testing they want implemented, as it will cost small companies millions of dollars to have it done — millions of dollars 99% of them DO NOT have. And if they do not comply, well, they will not be able to sell their ejuice.

This would make it next to impossible for smaller, independent vape labs to stay in business. Only the biggest players can afford to do this, and even then it’d be a push.

Here’s some comment from DIRECTVAPOR:

“Today, the U.S. Food and Drug Administration released a rule extending its authority to all tobacco products, including e-cigarettes. We are aware, and have been preparing for the FDA to release regulations since 2013.  As always DirectVapor will be here to serve you and continue to be a leader in the vapor business for many years to come.  In the meantime join us and sign the petition to the white house to overturn the FDA’s ruling on ecigarette classification as a tobacco product, and let the white house hear your voice.”

It is also VERY important we ALL now make our voices heard; this is very much a dogfight now. And we need to show the FDA and congress that we will not be pushed around. PLEASE — if you’re in the US — Sign this Petition 

Because if everything goes to plan for the FDA and its cronies, small, independent vape labs are going to be squeezed out of the market place they created in order to make way for big tobacco-produced eliquids and cig-alike products. And that would SUCK big time.

“I’m not a fan of Big Tobacco,” said A Billion Lives’ director, Adam Biebart, in a recent interview with Vape Beat, “but I don’t think it’s the biggest enemy of vaping. They just want to make money and that’s something we can always trust. They are starting to do that by selling E-cigarettes now. At the Global Forum for Nicotine, I ended up sitting by a Vice President of a major tobacco company. He indicated that they’d like to switch as much of their business to E-cigarettes as possible. He said they make more money on that business.”

But is anyone going to want to give their money to Big Tobacco? I mean, that’s like going out of your way to become a Jedi and then re-joining the Dark Side because they have slightly better pension options. A few people will, but most will not want anything to do with such businesses, not when home-grown brands have been forced out of business by crippling regulation likely sponsored in part by tobacco and big pharma lobby money.

But here’s the rub: vaping is not as bad as they’re making out, especially when compared to smoking. This has been proven time and time again, should you care to look at the research, of which there is plenty of (as you can see below).

  • Scientific Errors in the Tobacco Products Directive: A letter sent by the very scientists whose research was cited by the EU Commission to draft legislation geared towards ecigarettes and their usage. The letter details the many ways in which their research was wrongly used and misinterpreted.
  • Ecigs Do Not Stiffen Arteries (PDF): Researchers from Onassis Cardiac Surgery Center in Greece have found that while smoking just 2 tobacco cigarettes caused significant stiffening of the aorta, no difference was observed after the use of an e-cigarette by smokers AND vapers. Published December 2013.
  • Smoking Kills, and So Might E-Cigarette Regulation: Gilbert Ross MD, is a medical and executive director of the American Council on Science and Health. In this special report on The American, he states “simple common sense would dictate that inhaling the fewer, less harmful ingredients of e-cigarettes as compared to inhaling the thousands of chemicals in the smoke from burnt tobacco, many of which have been shown to be carcinogenic, is highly likely to be healthier.” Published November, 2013.
  • Research on Safety of Electronic Cigarettes (PDF): Dr. Konstantinos Farsalinos’ comprehensive presentation on existing data relating to the safety of ecigarettes. Presented at The E-Cigarette Summit, Royal Society, London in November 2013.
  • Nicotine Safety in the Context of E-Cigarette Use (PDF): Contrary to popular belief, the fatal overdose level for nicotine may be far higher than the generally accepted 50 to 60 mg (adult) says Dr. Jacques Le Houezec. This research was presented at the The E-Cigarette Summit, Royal Society, London in November 2013.
  • E-Liquids Shown To Have Low Cytotoxicity (PDF): The results of testing of 20 e-liquids, has revealed the majority of the vapor samples were found to have no adverse effects on cardiac cells. Even on the several that did have some effect (two of which were tobacco derived), the worst was 3 times less toxic compared to cigarette smoke. Published October 2013 in the International Journal of Environmental Research And Public Health.
  • Nicotine Levels Selection and Patterns of Electronic Cigarette Use: Study from Dr. Konstantinos E. Farsalinos that concludes nicotine levels seem to play a crucial role in achieving and maintaining smoking cessation in a group of motivated subjects. The study involved 111 participants who completely substituted smoking with electronic cigarette use for at least 1 month. Published September 2013.
  • Vaping: coronary circulation and oxygen supply (PDF): Recent research indicates that electronic cigarette use does not affect the oxygenation of the heart. Lead by principle investigator Dr Konstantinos Farsalinos; results of the research were presented at the European Society of Cardiology annual congress in Amsterdam in August, 2013.
  • Eliquids: No Health Concerns: A study by Professor Igor Burstyn of Drexel University School of Public Health based on a review available data has confirmed chemicals generally found in ecig eliquids pose no health concerns. Published August 2013 (PDF).
  • MHRA Ecigarette Research: The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) carried out extensive research on ecigarettes, arriving at the conclusion there was little concern that e-cigarettes can harm users by delivering toxic nicotine levels and little evidence of non-smokers taking up electronic cigarettes. Published in June 2013.
  • Evaluation of Electronic Cigarette Use And Liquid Consumption: This 2013 study challenges an EU proposal that would result in eliquids containing more than 4 milligrams of nicotine per milliliter being banned unless approved as medicinal products.
  • Electronic Cigarettes Do Not Damage The Heart: Electronic cigarettes appear to have no acute adverse effects on cardiac function according to research by cardiologist Dr Konstantinos Farsalinos.  He says based on currently available data, ecigs are safer and that substituting tobacco with electronic cigarettes could be beneficial to health.
  • Principles to Guide AAPHP Tobacco Policy: The American Association of Public Health Physicians recommends electronic cigarettes as a safer smoke-free tobacco/nicotine product.
  • Athens University Ecig Study Challenged: Dr. Michael Siegel questions a University of Athens study claiming e-cigarettes can cause lung damage.
  • Regulation: When Less Is More (PDF): Presentation slides from Clive Bates (of the Counter-factual) concerning the dangers of over-regulating ecigarettes. Mr Bates urges positively about the vast potential about e cigs, to put the (minor) risks in perspective and regulate as though the 1 billion who are predicted to die from tobacco related illnesses in the 21st century matter most. Presented at The E-Cigarette Summit, Royal Society, London in November 2013.
  • Vaping profiles and preferences: 1,347 vapers were surveyed in an effort to characterize e-cigarette use, users and effects. Results generally showed respondents found ecigarettes to be satisfying to use; cause few side effects; considered healthier than smoking, resulted in improve cough/breathing and lowered levels of craving. The survey was hosted at the University of East London. Published March 2013.

Granted, a lot of this is speculation on my part. But looking at the way things are at the moment and the way corporate interests and government seem to work indicates to me that something is brewing behind the scenes. Even more so when you consider all this talk about banning every type of ecig except for cigalikes, which everybody knows SUCK.

Is this more corporatist manoeuvring from the US federal government and big tobacco, or am I just barking up the wrong tree entirely? I mean, I’m all for safe ejuice — even more so in light of recent events — but there has to be a better way of doing this type of thing, or, failing that getting tests done for cheaper?

I’d just hate to see all the good the vaping community has achieved get buried in a landslide of bureaucracy and regulation.

 

Filed Under: Advocacy, Features Tagged With: FDA Deeming Regulations

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