FDA and vaping – ridiculous part 3

I just thought I would post this to ensure anyone reading this blog is up to speed. For any of my fellow vapers in the USA, you need to get active on this before big brother and big tobacco take your vaping away from you. For those of us in Canada, we need to keep a very close eye on Canadian regulations, as it is quite typical for Canada to follow the USA’s lead

WASHINGTON, April 28, 2014 /PRNewswire-USNewswire/ — Last week, the U.S. Food and Drug Administration (FDA) released its long-awaited draft regulations for electronic cigarettes (e-cigarettes) and other low-risk alternatives to smoking. The regulations offer little benefit, according to The Consumer Advocates for Smoke-free Alternatives Association (CASAA), the leading advocate for the current and future consumers of low-risk alternatives to smoking. However, CASAA believes that should the FDA finalize the rule in its current form, it will inflict devastating harm on consumers.

“This is a classic case of government imposing a ‘solution’ and then looking for a problem,” said CASAA President Julie Woessner, J.D. “The regulations do nothing to address real concerns, and instead are a slow-motion ban of the high quality e-cigarettes that have helped so many smokers quit. The rules would mostly require busy-work filings that impose huge costs with little apparent benefit.”

The proposed regulations are based on a faulty understanding of the science, reports CASAA Scientific Director, Dr. Carl V. Phillips. “FDA has cherry-picked the available evidence,” says Phillips, “blindly accepting any assertion that favors aggressive regulation and ignoring the overwhelming evidence about the harms that these regulations would cause.”

Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them. Such registrations offer minimal benefits, but ensure that only a few large companies who mass-produce small and disposable products would be able to afford the necessary filings. Additionally, while the regulations do not immediately ban the variety of popular flavors for e-cigarette liquid, they signal an intention to do so in the future.
“Our research and others’ shows that higher-quality hardware and appealing flavors are important for smoking cessation,” says Phillips. “Many former smokers report that they were always tempted to go back to smoking while using the smaller devices with imitation tobacco flavoring, but they quit smoking for good when they found better hardware and flavors that no longer reminded them of smoking.”

It is estimated that as many as a million American smokers have quit or substantially reduced their smoking thanks to e-cigarettes, and many are already making plans for a black market if these regulations take effect. Those smokers who are using e-cigarettes in a transition stage could easily return to smoking–and future potential switchers may never be able to make the transition–if the restrictions on high-quality products are imposed. Woessner, who quit smoking thanks to e-cigarettes, fears such impacts. “If I had been limited to only those products that would exist under this regulation, I would probably still be smoking.”

CASAA is preparing a response that will point out the flaws in the proposed regulations and is organizing its members and hundreds of thousand of other e-cigarette users in an attempt to persuade FDA about the harms this regulation would cause. Should that fail, it plans to fight the regulations in court.

CASAA is a 501(c)(4) nonprofit, public health, membership NGO. It does not represent the interests of industry. Donations are not tax-deductible as a charitable contribution.
Contact: Carl V Phillips, CASAA Scientific Director, 651-503-6746, cphillips@casaa.org.

FDA and vaping – ridiculous part 2

This is important to me as vaping has allowed me to give up cigarettes. Rather than my pack a day habit, I am now simply vaping. I haven’t had a cigarette since October, and all of my prior efforts to quit had been unsuccessful.

The proposed FDA regulations are going to insist that any vaping products, such  liquids must be reviewed and prior to  being allowed to be sold. The application fee is $2500 just to start, Then they also have to pay an additional $1500 per ingredient. Now some nicotine juice only contains as few as 4 or 5 ingredients, which means that the combined cost for the PMTA would be about $10,000 dollars. But that is misleading. That is for each juice, so if you manufacture 25 juices at 4 levels of nicotine, that is 100 applications, so a total of a million.

The exact rules are

1. Products that were already on the market as of February 2007 are grandfathered in and allowed to be sold without review, although the FDA could hypothetically order them off the market.

2. Products introduced between February 2007 and March 2011 are allowed on the market while under provisional review. Producers have had to submit applications, but they are allowed to continue selling while the FDA reviews them.

3. Since March 2011, all new products must receive FDA approval before being sold.

This will totally destroy the small vaping community, just leaving the big players (who are mostly owned by big tobacco companies now), as most, if not all current vaping products came into existance after the 2007 date, so that will put all of the current market under review.

If there was one shred of evidence that vaping was dangerous, I could look at this and say that it was for health reasons, but there isn’t. It is ludicrous that vaping is falling under the Tobacco Control Act. One interesting note is that the Tobacco Control Act was fully backed and negotiated by Philip Morris. They knew what they were doing. 

Not only that but the review process is a snail. It has been reviewing applications for four years on tobacco products, currently has more than 150 employees working on reviews, has received approximately 4,000 applications, and has managed to rule on only 34 of them. 


FDA and vaping – ridiculous

refillable vaporizer The FDA has come out with a draft regarding its position on vaping and it is now open to public commentary. I’m in Canada, so not directly affected, but where the US goes Canada seems to like to follow. The proposed FDA regulations are restrictive and very far-reaching and any vaper needs to take note and hopefully act.

The FDA seems to be grouping vaping under tobacco regulations, which is very silly, but I suppose as a lot of e-juice contains nicotine, there is a certain twisted logic. It is like grouping mouthwash under the liquor control board because they both contain alcohol. The draft regulations are a very long read, but there are three areas that stand out.

Age control – the FDA is looking to restrict vaping to 18 or older. To my mind, this is sensible and should move forward, although there is a great deal of evidence to support the position that banning something makes it even more attractive to those under the age of majority.

Warning labels – the FDA is proposing that e-liquids have warning labels on them. Again, this would seem sensible and I have even less objection to that than the age limits. Lets face it, a lot of e-liquid contains nicotine, which is addictive. That being said, so is caffeine and I don’t see coffee being similarly controlled.

The third area is the one that I have huge problems with. The FDA is proposing that all vaping gear and supplies needs approval before it is legal to sell them. This imposes a huge and probably unmanageable overhead on small manufacturers and sellers. This would hand the vaping world over to the large manufacturers, especially big tobacco, who already have to live under these restrictions. Most vaping gear consists of either batteries or units that contain coils to vaporize e-liquid. It is ridiculous to control these units – heck its like trying to control flashlights. As far as e-liquids are concerned, there is something to be said for a full statement of contents and potentially a ban on including certain products such as diacetyl which can be found in certain food flavorings, but approval – no – that is going way too far. That would mean that a small boutique e-liquid manufacturer would have to get approval for each and every liquid they create, for each mix of PG/VG, for each level of nicotine and for each flavor. That is something that would be completely unmanageable for a small outfit and would force them either underground or out of business.

Please watch this video – it does a good job of explaining what the FDA is proposing here

If there is any evidence that vaping is in any way dangerous to health, either to the vapers themselves or more specifically to those around them, then lets see that evidence and use that as the basis for sensible regulations. If I was suspicious, I would say that big corporate interests had significant input into these regulations with the intent of taking control of the vaping industry, and if these regulations proceed through as they are, then there is a pretty good chance that they will succeed.

For those of you that are vapers in the USA, or friends of people that have given up smoking by switching to vaping, you need to contact your congressman and tell them how much vaping has helped in your lives. This legislation must be stopped or heavily amended. It is just wrong that something that has helped me and thousands of others is going to be treated this way.


Buffy would not be proud

With the popularity of electronic smoking devices on the rise, the Sunnyvale City Council is taking an additional step to help regulate the generally unregulated gadget. Yes and before you comment, I know that this is Sunnyvale, not Sunnydale, and close only counts in horseshoes and dancing, but just like the TV series the council is ignoring science on behalf of a lobby of dark forces.

The city council voted unanimously March 18 to introduce an ordinance amending the city’s existing smoking ban in parks and on city property to include the use of electronic smoking devices. The existing ordinance prohibits smoking in various locations but does not specifically address the use of electronic smoking devices.

While state law prohibits the sale of electronic cigarettes to minors (ed. and so it should), it does not regulate the use of such devices, according to city staff.

Electronic cigarettes–or e-cigarettes or personal vaporizers–are battery powered devices that simulate tobacco smoking, but use a heating element to vaporize a liquid solution. The solution can include nicotine or just liquid flavorings.

On April 3, 2012, the city council approved a ban on smoking in public parks, with the exception of golf courses, and designated city property as non-smoking.

That decision came after the council reviewed the city’s smoking regulations in March 2012, and considered whether to extend the ban on smoking to parks and all outdoor dining areas. The council declined a smoking ban in all outdoor dining areas. Instead, the city continued the existing regulation, which requires 60 percent of outdoor eating areas for all eating establishments to be reserved for non-smokers.

I can understand the ban on smoking in public places – there is second hand smoke and then there are cigarette butts that litter the area. Banning vaping is just plain silly and not supported by any evidence other than scientific hysteria. There isn’t a second hand smoke problem, the vapor usually doesn’t have any smell at all (except for my vanilla cupcake, which smells of cupcakes) and people are not going to be littering by dropping their vaporizers on the grass – believe you me – we take much better care of our gear than that.

If the intent is to stop teenagers vaping, then this is exactly the wrong way to go about it

A vaping comment that finally makes sense

Carl Phillips, an epidemiologist and former professor at the University of Alberta, where he researched tobacco harm-reduction, says there is plenty of evidence showing that e-cigarettes are “99% less harmful than smoking.”

At least 25 studies over the years examined the chemical effects of e-cigarettes, and “we do know enough to be confident that they are low risk,” he says.

“Where it ranks among hazards, it’s down in the range of eating french fries or eating dessert or not getting quite enough exercise,” says Mr. Phillips, who is based in New Hampshire and is the scientific director for the Consumer Advocates for Smoke-free Alternatives Association. “Not necessarily good for you, but in the range of everyday hazards that we accept without too much worry.”

E-cigarettes are cheaper than real cigarettes, too. The kits range in price from $30 to as much as $100.

He estimates that the device has helped millions of people to quit smoking worldwide, and thinks there is an “urgency” to Canada ending its ban on nicotine e-cigarettes. About 37,000 Canadians every year die from smoking tobacco, according to the Lung Association.

By prohibiting a smoker from switching, Mr. Phillips says, “you’ve done more harm in terms of putting that person at risk of dying prematurely, than could possibly done by the actual use of the product itself.”

I like this summary, it makes sense to me. The fog of war that is being thrown up by big tobacco, big pharma and anti tobacco lobbies tend to cloud out common sense and that is exactly what this is.

Smokescreen 3

E-cigarettes versus nicotine patches

E-cigarettes were just as effective as nicotine patches in helping smokers quit.

For their study, the team used adverts in local newspapers to recruit 657 adult smokers (aged 18 and over) who wanted to quit.

E-cigarettes show about the same rate of success in helping smokers quit as nicotine patches, according to the results of a trial that compared both methods against a placebo.

The findings were presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain, and were also published online in The Lancet. The researchers say theirs is only the second controlled study to evaluate the effectiveness of e-cigarettes but the first to compare them against nicotine patches.

Lead investigator Chris Bullen, professor and director of the National Institute for Health Innovation at the University of Auckland in New Zealand, says:

“Our study establishes a critical benchmark for e-cigarette performance compared to nicotine patches and placebo e-cigarettes, but there is still so much that is unknown about the effectiveness and long-term effects of e-cigarettes.”

The trial found that e-cigarettes and nicotine patches had comparable rates of success with few adverse events: roughly similar proportions of smokers were still not smoking 3 months after following a 13-week course using either e-cigarettes or nicotine patches.

However, the researchers caution that it is still too early to say where e-cigarettes fit into tobacco control and that more studies should be done to “establish their overall benefits and harms at both individual and population levels.”

Weasel words. Why couldn’t they simply stick to the facts. The facts are that vaping led to 7.3% quitting, the patch to 5.8%. Additionally, the study lasted 13 weeks and after that the volunteers were cut off cold and then reviewed after 3 months. No one bothered to ask how anyone who continued to vape did, or whether the people that were given vaping as an alternative were even allowed to continue.

This seems to be typical of a lot of research, in that anything but abstinence is not acceptable, and that the researchers are coming in with in-built biases that they are incorporating into their findings.

Smokescreen 2

The demise of widespread cigarette use is one of the great public-health successes of the last century according to an editorial in the Seattle Times.

Since then-U.S. Surgeon General Luther Terry 50 years ago released a definitive report on the dreadful harm of cigarettes, national smoking rates plunged from 42 percent to 18 percent. For the demographic most coveted by Big Tobacco — teenagers — daily cigarette usage is one-third of the peak rate in 1976.

But a similar wake-up call is needed for nicotine’s sneaky new attack: E-cigarettes are suddenly the cool kid on campus, with candy flavors, low prices and the trendy nickname of “vaping.”

A Centers for Disease Control and Prevention survey found that e-cigarette use among high schoolers nationwide more than doubled 10 percent between 2011 and 2012, with many skipping right past traditional cigarettes. A King County Public Health survey found that 12 percent of high school seniors smoked cigarettes, while 5 percent smoked e-cigarettes.

A national prevention strategy is badly needed, to bat back marketing such as the sexy e-cigarette ad in Sports Illustrated’s swimsuit edition.

But acting locally first, a bill in the state Legislature is smartly proposing to extend existing tobacco sin taxes to e-cigarettes.

This idea, proposed by state Rep. Reuven Carlyle, D-Seattle, and Sen. Andy Hill, R-Redmond, is a no-brainer. Nicotine is equally addictive regardless of the delivery device. Tobacco taxes recognize the public cost of addiction.

No, No, No and No. Tobacco taxes are in recognition of the health care costs incurred by tobacco usage. They are also there to discourage the usage of tobacco or if you are really cynical they are just another tax grab.

Additionally, there is no identified causal link between vaping and tobacco use.

One would have thought that even the most brain dead anti tobacco campaigner would be applauding vaping (I won’t say e-cigarettes as they have nothing to do with a cigarette) as an effective alternative to tobacco use. For those of us that are not smoking anymore because we have switched to vaping, we certainly recognize this. Now dear old government is attempting to drive us back into the 20 a day habit. Yes, giving up is the best alternative, but at least for me, that wasn’t on the cards, so I am sickened and saddened by these latest steps.

Smokescreen 1

Another Tobacco Control Professional Declares that We Don’t Know if Smoking is any More Hazardous than Vaping
The misinformation in the tobacco control field is so widespread that hardly a day goes by that an anti-smoking advocate somewhere doesn’t publicly declare that smoking may be no more dangerous than vaping. This time it was the Sedgwick County Health Department (Wichita, KS), which wrote in an op-ed article in the Kansas City Star:

“It is not known how much nicotine or other potentially harmful chemicals are inhaled by users, nor is it known whether e-cigarette use may lead to use of other tobacco products. Neither are the benefits of using e-cigarettes over traditional products known.”

For goodness sake, this is twisting things a little wouldn’t you say? The implication here is that vaping is at least as bad for you as smoking. Duh, the truth is that the evidence shows this to be the complete and absolute opposite to the truth. With cigarettes you are inhaling hundreds, if not thousands of toxic chemicals. The only toxic chemical identified in vaping is nicotine, and in the quantities inhaled, the research that I have read says that it isn’t toxic. Addictive – yes – but not toxic.

Now I’m also addicted to chocolate, but that isn’t driving me to heroine. The logic simply doesn’t hold up.

Tobacco smoke is also known to be dangerous to non-smokers via second hand smoke. There is no evidence that I have been able to find that second hand vapor is in the slightest bit dangerous to people around a vaper.

Yet you read this article and that is certainly not the way I would interpret it.

This is like talking to a Catholic on birth control – abstinence is the only way, and the anti tobacco lobby sounds the same way. Shame on them!

Banning Vaping

I don’t get it.

I vape. For me it was a replacement for smoking, which was a habit that I have been partaking in for over 40 years and I have been off the evil weed now for 5 months. I had tried to give up prior to that point but without any success, whereas with vaping I occasionally get the urge to pick up a cigarette but rarely. So for me, vaping has been a huge positive. I breath better, the car, house and I don’t reek like an ashtray, and I no longer can be accused of making people ill through second hand smoke. Where is the downside?

Well if you listen to the public debate, you would think that vaping is Darth Vader level evil and targeted at corrupting the young. I have never heard so much rubbish in my life.

Lets talk about the science. Now on this front, I will admit the actual long term evidence is a bit sketchy. There is a reason for that – vaping hasn’t existed for that long, so long term evidence is going to be a bit hard to find. That being said there is significant evidence that it is a lot better for you than smoking. Speaking for myself, I have noticed that I can taste things better and my breathing is much improved. I haven’t noticed any downsides, which is not to say there aren’t any, but smoking has well documented health concerns so what I’m trading is a little unknown against definite bad.

Lets talk about the politics. This is where it gets weird. You would have thought that anything that is a viable replacement for smoking with less health risks would be welcome, but you would be wrong. The debate isn’t about whether this will help smokers give up, and what controls need to be placed on it to ensure that minors don’t use it. No, the debate is about banning it.

The anti smoking lobby is against it, the EU bureaucrats are against it, government can’t figure out where it stands and the healthcare industry is split. Oh yes – big tobacco and big pharma are seeing it as a revenue stream that they would like to control and are trying their best to set the playing field up to their advantage. I can sort of understand the anti smoking lobby – they have written off smokers and just want us to die quietly while they try to ensure than no-one else starts.

The rest are a bit more difficult to follow. I suppose the gut reaction of any bureaucrat is to ban anything they don’t understand. The healthcare industry is the same, they won’t green light anything until they have studied it for 30 years. Big pharma and big tobacco will do/say anything to control the revenue stream and have a significant proportion of the bureaucrats bought and paid for. Governments are only really concerned about one thing and that is the revenue stream. They want to ensure that there aren’t significant health care costs, and they also want to figure out a way to make money off it.

Hmmm, maybe it isn’t that difficult to understand after all.

Clone wars

No – not the Star Wars trilogy, but in the context of Vaping.

If you are a vaper, you are very quickly introduced to knock-offs. There is an epidemic in the vaping community, that as soon as a new device gets introduced, the little copy elves in China get going and within literally days, there is a clone out there at a fraction of the price. In some cases, the copies are so good that you can’t tell the difference, in other cases they are completely inferior.

China is is a major center of vaping. A significant amount of your legit vaping gear comes from China – Innokin and Kanger to name just two of the major players are from China. A lot of the e-liquid comes from China, as does many, if not all of the cigarette lookalike PV’s, and who knows what else. What doesn’t tend to come from China is the small boutique gear. China seems to specialize in large quantity, low margin. What they also seem to specialize in is copying….

Now the debate around what is and isn’t counterfeiting can drag on for ever. I doubt very much if there is much in the vaping world that is really that blindingly original, as it is all based upon the concept of warming up e-liquid using a coil of some variety or other to produce vapor. After that it is simply the way that you execute it. Where vaping seems to be right now is the search for a better mousetrap, and there are some very nice products that have come out. One of these is the Kayfun atomizer by SvoeMesto. This is a company out of Germany making high end rebuildable atomizers and other assorted kit and it isnt cheap. The basic Kayfun lite atomizer is 75 euros plus shipping, plus import duty. You can get a clone of this for 25 dollars from China shipped free, and it is a complete copy right down to the laser engraved logo. Is the copy as good? Well, I don’t have one so I can’t comment directly, but the reviews indicate that the clone is somewhat inferior, but not significantly.

I don’t have any objection to a company taking a concept, improving upon it and then marketing their version under their name, but a complete rip-off isn’t acceptable to me.

What should we do about it? At least in the arena of vaping, the leading edge creators are small companies, and can’t get into the long, protracted legal battles that someone like an Apple can. This is for the vaping community to resolve. We, as vapers, need to buy from the originator and not from the clone manufacturers.