Tag Archives: FDA

The E-Cigarette Double Standard

Since the beginning of the e-cigarette debate over their safety and effectiveness to help smokers quit the habit, there have been those on both sides making claims. On one side there are many e-cigarette companies marketing the product as a “healthier way to smoke” and that they can help users quit smoking. And although the evidence is pointing to these conclusions, it is hard to deny that these claims may be premature. On the other hand, those against electronic cigarettes tout that e-cigarettes may be as, or more, harmful than tobacco cigarettes. They claim they are full of antifreeze and that they are marketed directly to children. These misleading statements about the potential dangers of electronic cigarettes do little to help smokers the actual difference between the two recreational products.

So here are the facts as we know them today: All surveys and studies done to date show evidence that e-cigarettes are at least as effective as NRTs in helping people quit smoking. However no one has completed the required clinical trials for the FDA to be able to make this claim. And no one likely will, since the e-cigarette has been deemed a tobacco product in the United States by the courts, rather than a NRT. As for the anti-freeze claim, the FDA did find trace levels of diethylene glycol in one companies e-cigarettes a few years ago. It was not found in any other companies products and wasn’t found in all samples. Yes, regulations to ensure only food grade ingredients are used are important, but to claim all e-cigarette users are inhaling toxins is absurd.

nicotine gumThe Guardian recently published an article entitled “Watch out, e-cigarette smokers – you’re inhaling the unknown“. And in the article the author, Tom Riddington, states.

With a little research, it is clear that we do not know the risks of using e-cigarettes long-term, and the potential for harm is significant. Until the same regulations as other nicotine replacements are imposed, e-cigarettes should be considered a snake-oil gimmick that could get a new generation hooked on nicotine before their first smoke.

This is where the double standard comes in. When a Nicotine Replacement Therapy product is introduced, the FDA looks at what is in it and whether or not it is effective in helping users quit smoking. They test it for 6 months to ensure no other problems arise. However 6 months is a far cry from knowing the long term effects. So why should e-cigarettes be held to a higher standard than FDA approved nicotine products? And e-cigarettes have been used in the US since 2007 with no major side effects reported.

As for getting kids hooked on the product, what about flavors of nicotine gum? Or just the fact that they put nicotine into gum, which is a kid favorite to begin with.

In conclusion, it is very much possible to also write, “With a little research, it is clear that we do not know the risks of using nicotine gum long-term, and the potential for harm is significant. Until different regulations are imposted, nicotine gum should be considered a snake-oil gimmick that could get a new generation hooked on nicotine before their first smoke.”

Canadian Lung Association: Are You Kidding Me?

In a press release put out by the Canadian Lung Association named “Don’t Be Fooled By E-Cigarettes!”, they make arguments against smokers in Canada trying electronic cigarettes.  Here is a look at what claims they make:

1. “People who use e-cigarettes inhale unknown, unregulated and potentially harmful substances into their lungs,”

First, let’s point out that tobacco smokers inhale known cancer causing agents.  It can be argued that since tobacco cigarettes can legally be sold in Canada that they are regulated.  Does that make them any safer?  But the biggest issue I have with this statement is that we do know what is in e-cigarettes.  There have been multiple studies done on the contents of e-cigs.  The ingredients in the e-cigarette vapor include propylene glycol, glycerin, water, and flavoring.  Some also come with nicotine in them.

2. “E-cigarettes may contain ingredients that are known to be toxic to humans including carcinogens and diethylene glycol, a toxic chemical used in antifreeze.”

This is a reference to a FDA test done in 2009.  This report was put out by the FDA in response to them being sued at the time by nJoy who claimed the FDA was unjustly seizing their stock.  nJoy was victorious in this battle.  Here is a thorough rebuttal of the FDA report.  Also, in Canada e-cigarettes do not contain nicotine so they do not have the TSNAs present as those with nicotine may.  As a side note, at the time the FDA knew so little about e-cigarettes that this was the picture they used when they released their “findings”:

fda e-cigarette testing

For those what don’t vape, here is the issue:  For the model of e-cigarette they show, you must take off the mouthpiece / cartridge before you plug it into the charger.  They way they show it, the e-cigarette would not ever charge.

3. E-cigarettes have candy-like flavours that appeal to kids

Kids and adults alike enjoy flavors.  As an example, vodka can be purchase with many, many flavors.  Should be ban it?

4. There are many proven ways to quit smoking

That statement is true provided you buy into Health Canada’s definition of “proven”.    Their list of ways to quit smoking includes Nicotine Replacement Therapies and prescription drugs.  Find out just how successful smokers are in quitting smoking using these methods.  They also fail to mention that NRTs do contain cancer cause substances known as TSNAs.

 

We only ask that smokers think for themselves, dig a little deeper into what they read, and make their own decisions about what is best for their health.

Will The FDA Rules For E-Cigarette Effect Canada?

If you follow the new in the electronic cigarette world, you know that the FDA has been hesitant, to put it nicely, about the e-cigarette. They have attempted to block it’s market categorization of a tobacco product, unsuccessfully.  They have attempted to deter smokers from using it using their own brand of science….with partial success.  But with the court cases over and their mandate handed down from Congress, they will soon be enacting rules and regulations regarding the use and sale of electronic cigarettes.  The specifics of these rules are not yet clear including the means by which they are available for sale, whether the regulations will encompass all parts of the e-cigarette (batteries, atomizers, cartomizers, e-liquid, bottles of e-liquid, etc), or even if they will be taxed similar to other tobacco products.  Some industry experts are skeptical about how the FDA will proceed.  As Bill Godshall of SmokeFree Pennsylvania states:

FDA issues notice of intent to propose “deeming” regulation by April of 2013 (to apply Chapter IX of FSPTCA to e-cigarettes, cigars, pipe tobacco, shisha/hookah and other tobacco products not currently subject to Chapter IX regulations) “and to specifiy additional restrictions.”
The question for Canadian vapers and current smokers looking for a change should be, “will this change the current situation  and stance of Health Canada regarding e-cigarettes in Canada?”  If history is a factor, then yes, it will.  US law often affects Canadian laws.  Our border is long and trade is free.  This creates a situation where adopting US laws is often easier and cheaper than creating our own from scratch.  Another factor are the companies involved is such products.  Since the e-cigarette will be officially a tobacco product in the US, US tobacco companies will be taking advantage of the situation (Lorillard and Reynolds already are).  These companies may push for entry into the Canadian market under the same regulations they operate under south of the border.
And our thoughts?  It is likely in the future Canada will classify and allow e-cigarettes with nicotine as a tobacco product.  We do hope they consider the science behind different tobacco products to allow the greatest possible exposure of electronic cigarettes to current smokers in Canada.  And remember, we’re all in this together. (Red Green)

The Biggest Misconceptions About Electronic Cigarettes

Here are the most quoted and wrong ideas about electronic cigarettes:e-cigarette misinformation

1.  It’s water vapour

No….it’s not.  Creating water vapour would mean boiling water, which e-cigs do not do.  The majority of the vapour is made up of propylene glycol lesser amounts of other compounds such as glycerin, nicotine (if nicotine e-liquid is vaporized) and the make up of the flavoring.  He is a study done on the second hand vapour produced from an electronic cigarette.

2.  The FDA found cancer causing chemicals in e-cigarettes.

They found trace amounts of smoke TSNAs in some samples.  They quantities they found pose no threat to human health.  Detectable levels of TSNAs can also be found in nicotine gum.  An analysis of the FDA testing on e-cigs can be found here.

3.  E-Cigarettes are banned in Canada.

No, only e-cigarettes with cartridges that contain nicotine are banned.  E-Cigarettes work just fine with no nicotine e-liquid.

4. Without nicotine, electronic cigarettes serve no purpose.

If smokers just wanted nicotine, then the nicotine gum would have 100% success rate helping smokers quit.  But they don’t.  So is it the action of smoking they want?  Is it the “break” they get when they smoke?  Whatever the answer is for each individual smoker; the e-cigarette does closely mimic the action of smoking…..with or without nicotine.

5. Flavored e-liquid and cartridges entice children to use e-cigarettes.

I suppose flavored vodka gets kids drinking?   I doubt it.  Kids don’t smoke or drink because it tastes good.

6.  We just don’t know what’s in an electronic cigarette.

Yes we do.  Many tests have been done.  Click here for some e-cig testing.  Or just know that e-liquid must contain a majority of propylene glycol and/or glycerin in order to work at all.  The rest of the ingredients are water and optionally flavoring and nicotine.

 

If you hear of other misconceptions, drop us a note or leave a comment here and we will try to further curb the mass amount of mis-information about electronic cigarettes.

Electronic Cigarette Article From The Winnipeg Regional Health Authority

We came across an article written in January, 18th, 2012 by Susie Stachan from the Winnipeg Regional Health Authority in Winnipeg, Manitoba, Canada.  The article, entitled “E-cigarettes not the answer to quitting smoking” (full article can be found here) is full of misleading and incorrect information.  And although we respect what the WRHA has done over the years, we also believe in facts and science so here are some corrections.  Below are excerpts from the article and our opinion on their factuality.

Proponents say e-cigarettes help them to cut down on the health risks, eliminate the odour of burning tobacco, and cut down on the amount of nicotine they get with each inhalation.

The issue here is the word proponents, or rather than missing word “users”.  The fact is, the internet is full of e-cigarette users praising the technology.  It should be important what e-cigarette users and current/former smokers have to say, but it appears it is not.

Yet e-cigarette kits are both sold online through Canadian websites, and in stores in Winnipeg, all of which contain nicotine.

Simply not true.  Some electronic cigarette retailers do sell e-cigs with nicotine, but many do not.  One example is this online e-cigarette retailer which carries a couple different brands, all without nicotine.

Health-care providers don’t know if they are a safe alternative to regular cigarettes, or if they are a bid by Big Tobacco to continue having people buying their product.

How can they not know?  Everyone in the industry and on the forums know the big players, and they aren’t tobacco companies.  In fact the first sign of the tobacco industry getting involved in electronic cigarettes was when the tobacco company Lorillard bought the established e-cig brand, Blu.  Most e-cigarette companies are small start-ups with some better funded companies slowly rising to the top.

As for the safer alternative, let’s compare.  Tobacco cigarettes contain 4000 chemicals and kill about half the long time users.  E-Cigarettes use propylene glycol, glycerin, water, flavoring, and optionally nicotine.  All ingredients (minus the nicotine) are approved for use in food.  Nicotine is found in all NRT products.  And there have been multiple tests of the electronic cigarette.

“There are concerns about second-hand smoke, too. There’s no clear evidence on what’s in that vapour, and whether this will have a second-hand smoke effect on other people,”

At the time of the article, there wasn’t.  But now there is testing showing that e-cig vapor is not dangerous to bystanders indoors.

In May 2009, the FDA’s Division of Pharmaceutical Analysis tested the contents of 18 varieties of electronic cigarette cartridges produced by two vendors: NJoy and Smoking Everywhere. They found known cancer-causing agents in a number of the cartridges, and also that the actual nicotine levels did not always correspond to the amount they purported to contain.

What the FDA found was trace amounts of TSNA (Tobacco-specific nitrosamines) and as Dr. Michael Siegel noted on his tobacco harm reduction blog: “The rest of the story is that an independent scientific expert report has now confirmed that – at least in the case of NJOY electronic cigarettes – there is no evidence that these products pose any increased health risks compared to FDA-approved nicotine replacement products and that they pose much less health risk than FDA-approved tobacco cigarettes.”

We do believe that nicotine content should be regulated to ensure accuracy.

The Winnipeg Health Region offers smoking cessation support and supplies patients with nicotine patches and gum while they are staying in region hospitals.

That is great.  But seems odd that they would recommend a patch or gum with nicotine rather than recommend an electronic cigarette with no nicotine.  Last time I checked, they don’t give alcoholics beer so they will stop drinking.

We hope all public health organizations in Canada will base their opinions and recommendations on facts and science and not blindly tow the company line.