My Reply to the CBC VideoJournalist

[BlondieLocs]

HC's "advisory" is separate from HC's directive to ecig vendors and manufacturers.

I get that and have seen both. Was simply referring to Rachel's post regarding the timeline of HC's and FDA's advisories.

It's not about manufacturers not wanting to do this - they can't. It's impossible. New pharma's can only be submitted through a complex process that begins with academic research, proposed theories and laboratory studies, carried out by authorized university and research labs and headed by at least one PhD.

It's really the most authentic example of a catch 22 I've seen in my lifetime.

Just so I'm clear... What is the Catch 22, other than it being extremely time consuming and cost-prohibitive?

eliquid has market authorization in the UK. Same type of health authority, same level of product oversight. Many of the brands available are the exact same brands by the exact same manufacturers, containing the exact same ingredients as in Canada and the US.

The manufacturers have no problems applying for and receiving authorization. It's not complicated. It doesn't cost a fortune. New food and related products receive authorization each and every day.

My understanding, and I'll admit that I'm not that current on UK legislation, is that this was not a path that was without its bumps in the road either, nor is it over. I think what's going on in the UK is a "it's legal until we say otherwise, and we are revisiting the issue" kinda thing, no?

Major eliquid manu's already have authorization in every country that has permitted the application. They HAD it in Canada until March 2009, complete with customs authorization.

Between the time that HC first approved eliquids and the time they issued their advisory - nothing changed with the product - just the politics.

This I was not aware of. Thanks!

Blondie, I haven't seen HC refer to e-cigs or e-juice as "health products"...and respectfully, I don't think they view them as such. Health products make therapeutic claims; e-cigs & e-juice do not. In the absence of such claims...it would be a misclassification for HC to view them as such.

You didn't really think I would make such an unsubstantiated claim, did ya?

From their Advisory dated March 27, 2009: Health Canada Advises Canadians Not to Use Electronic Cigarettes - Health Canada Advisory 2009-03-27

"These products come as electronic cigarettes, cigars, cigarillos and pipes, as well as cartridges of nicotine solutions and related products. These products fall within the scope of the Food and Drugs Act, and under the Act, require market authorization before they can be imported, advertised or sold. The sale of these health products is currently not compliant with the Food and Drugs Act since no electronic smoking products have been granted a market authorization in Canada."​

and from the response letter I had previously posted in another thread: CITIZENS AGAINST GOVERNMENT ENCROACHMENT CITOYENS ANTI GOUVERNEMENT ENVAHISSANT: CORRESPONDENCE WITH HEALTH CANADA ON THE E-CIGARETTE BAN

"Electronic cigarettes contain nicotine, which is a highly addictive and toxic substance. Health products containing nicotine fall within the scope of the Food and Drugs Act. "
​

None of this is to say that I agree with HC's stance on the issue... just understand the freaking political red tape. Personally, I would like to see something similar to what's going on in the UK - it's legal until we can make it otherwise.

 

[BlondieLocs]

If they have not done any research, why do they feel compelled to advise us agaist it?

"We know nothing about the product, we've done zero research on it, but we are going to advise the public against it"

What they say they want is proof that it is safe before they give it market authorization. ("Health Canada is committed to protecting the health of Canadians by ensuring that health products meet requirement for safety, efficacy and quality.") HC is not going to incur the costs of research on every new drug/health product that a manufacturer wants to bring to market. We already have a large enough deficit.

Like I said earlier... it's a good form of CYA. If they grant authorization to a product that later becomes proven a health hazard it opens them up to frivolous lawsuits. If they can show they did due diligence before granting authorization, it somewhat negates that problem.

Maybe we are in a Monte Python skit?

I was thinking more along the lines of Abbott & Costello. Who's on first??

Red Bull and Vodka. There is a relatively new chemical concoction. Did some bar tender apply for “market authorization” from HC with research to back it up? Doubt it. I would imagine a certain dose over a certain duration would surely have negative consequences. Why does HC not feel compelled to issue an advisory on Red Bull and Vodka, and every other product on the market where an undefined amount of research has not been completed?

Funny you should mention that. They did do a study after reports of adverse reactions, and issued a statement: It's Your Health - Safe Use of Energy Drinks [Health Canada, 2010]

 

[Switched]

The latest MHRA decision although seems favourable in fact is a very well loaded gun, that of course favbours the governing body and not the community. Once you get through the smoke screen as interpreted by David Dorn and Andy Sutton (weeding through the frivolous chaff) they are very much intent on regulating to a level not dissimilar to NRTs, which we know is totally worthless. The good side of things is that they have decided on option 3 and do nothing until Apr 2013. That gives them 2 years to gets their ducks in a row. FWIW the chief cook and bottle washer is the WHO for the European Union.

 

[kanadiankat]

I get that and have seen both. Was simply referring to Rachel's post regarding the timeline of HC's and FDA's advisories.

Just so I'm clear... What is the Catch 22, other than it being extremely time consuming and cost-prohibitive?
....

My understanding, and I'll admit that I'm not that current on UK legislation, is that this was not a path that was without its bumps in the road either, nor is it over. I think what's going on in the UK is a "it's legal until we say otherwise, and we are revisiting the issue" kinda thing, no?

First - this is a great discussion! I learn a lot from your questions - so thank you for putting them out there.

The "catch 22" is not obvious in the wording of the "advisory" - only in the directive to manufacturers.

Food and Drug administration covers everything from milk to chemotherapy.

It is NOT cost prohibitive to obtain market authorization for food and related products - especially if you already own the manufacturing equipment. It's relatively easy.

So if you own a store and create some of your own products and want to mass produce and market them - you can do it (you might need a loan from the bank for compliant facilities - but it's reachable).

IF you're sitting around your kitchen and discover the cure for cancer though - forget about it. March your little idea to a pharmaceutical company or the local university and let them take it from there. You CAN'T get market authorization. YOU are not even allowed to apply.

By requesting that eliquid be submitted as a "new drug never tested on humans" - for research - they've essentially laughed in our faces. An eliquid manufacturer is not a pharmaceutical research center. Nothing to do with cost - it's simply impossible to submit a product - any product - as a new drug unless you are a drug company with all the licenses and laboratories.

So the catch 22?

22 a - The public are misled into believing that ecig companies are somehow refusing to become compliant (and if local farmers can do so with milk and eggs - why can't ecig companies do so as well - right?).

22b - On the other hand - ecig manufacturers are being told to submit their goods as pharmaceuticals and medical equipment - when there is no legal way they can do either.

My personal thoughts on this (and they are my personal opinions only) is that HC is basically saying that any pharma company in Canada can apply for authorization to market eliquid - but no one else is permitted.

UK Approvals:
It's perfectly normal for a health authority to maintain the right to re-visit how products are regulated. Right now, the UK is taking a wait and see attitude. There haven't found any reason to request additional standards yet - but it's open for the future.

That, in my opinion, is what a regulatory body is supposed to do. Fiddling with politics and laughing in the faces of citizens is not.

If I were a gambling girl - I'd put my money on the horse with the FDA banner. Yes, their press release was made a few months after HC's advisory - but that doesn't mean there is no connection. So far every country with trade-dependence on the US has taken the exact same stand as the FDA.

 

[rachelcoffe]

Touche, Blondie. HC is (bizarrely) calling e-cigs & e-juice "health products." I admit to being surprised...because it makes them look even stupider than usual, lol.

It's a clear-cut case of misclassification. E-cigs & e-juice are not health products. They do not make any therapeutic health claims. That is the very nature of a health product: it makes therapeutic claims in relation to your health. HC can call them that till they're blue in the face...won't make it true.

Down the road, when this issue is brought before a parliamentary committee specifically assembled to examine the related issues...it's going to look very favourable (for us) that HC has so obviously misclassified e-cigs (e-cigs making no therapeutic claims whatsoever) as "health products." By then, the FDA should also have exhausted every last option to misclassify e-cigs & e-juice down south (and lost). Even better. An excellent example of precedent we'll be able to point to.

We will win, people. It's inevitable. I don't know what the path between here & there will look like exactly, or what might happen in between. But I know we'll win.

Keep on vaping!

 

[nojoyet]

Originally Posted by kanadiankat
"Major eliquid manu's already have authorization in every country that has permitted the application. They HAD it in Canada until March 2009, complete with customs authorization.

Between the time that HC first approved eliquids and the time they issued their advisory - nothing changed with the product - just the politics."

Thanks. This is interesting; can you give us any details?

 

[Justice]

If HC needs a guinea pig here I am

 

[kanadiankat]

Originally Posted by kanadiankat
"Major eliquid manu's already have authorization in every country that has permitted the application. They HAD it in Canada until March 2009, complete with customs authorization.

Between the time that HC first approved eliquids and the time they issued their advisory - nothing changed with the product - just the politics."

Thanks. This is interesting; can you give us any details?

What type of details are you looking for?

 

[nojoyet]

What type of details are you looking for?

Hi
Anything that shows a timeline, the process and the person(s) behind the changes; just to have a clearer picture of what happened. Does it appear that these changes were already in progress or were they made in response to the appearance of e-cigs? Is there some "expert" behind the scenes we sould be sending an educational package to?

Sorry if all this has been discussed before and I've missed it.

Also the little devil inside me says give the person(s) responsible the negative exposure they deserve. Perhaps if someone said something outrageous enough, we could nominate them for a Cassie Award.

Sorry, can't make the link work; search for Cassie Award on ECF

Thanks again

 

[Can_supplier]

It comes from a faceless HC in March 2009 in the form of a advisory to users not to buy the product, and vendor to stop selling it because it doesn’t have market authorization.

Since then there has been some enforcement aimed at vendors nicotine e-juice in the form of a threatening letter.

Enforcement for the most part has been on the import of e-juice and hardware. Within the last year it seems HC has changed their position on hardware allowing it in. However overzealous and undertrained customs agents will still deny entry of hardware sometimes.

Not much more to it. Most of the options on law here are in preparation of a future battle with HC, rather than battles we’ve already had.

Guessing, HC is sitting back and watching how things turn out in the US before they make a move. Also right now the e-cigarette industry is nothing more than a drop in the bucket. HC can try to shut down one vendor but 5 more will pop up on Craigslist, so it is futile.

 

[kanadiankat]

Hi
Anything that shows a timeline, the process and the person(s) behind the changes; just to have a clearer picture of what happened. Does it appear that these changes were already in progress or were they made in response to the appearance of e-cigs? Is there some "expert" behind the scenes we sould be sending an educational package to?
....
Also the little devil inside me says give the person(s) responsible the negative exposure they deserve. Perhaps if someone said something outrageous enough, we could nominate them for a Cassie Award.
...Thanks again

I don't think we'll ever get access to that information. Whomever made the decision at HC made it without openly consulting anyone.

Those who held Canadian import/export licenses for eliquid were sent letter notifications informing them that they could no longer bring in, sell or promote the product in Canada.

HC's advisory failed to mention that the product had previously been legally imported and sold (openly with full disclosure), and failed to give any reason for the change in policy.

 

[nojoyet]

@ kanadianKat

Well no surprise eh! Thanks, that clears it up for me.