Health Canada announcement

[markab]

Health Canada released an anticipated comment today which included, the rather gloomy -although anticipated response;

"Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately. Health Canada is providing information to interested stakeholders on how to apply for the appropriate market authorizations and establishment licences."

I can't seem to be able to get a link to the entire article to work but you can find it on the first page of results if you do a Google news search for "electronic cigarette" It's an article from Market Watch.

We're in for a rough ride folks...

Mark

 

[halopunker]

Health Canada Advises Canadians Not to Use Electronic Cigarettes | SYS-CON UK

 

[LuckySevens4U]

Ya but it didn't BAN them, it is allowing them to apply for proper licenses. At least that's what I took from what you wrote.

 

[ejfan1977]

You know, I love how they say that "nicotine is addictive"... Duh! What do they think? That we are idiots! We all became addicted to nicotine through smoking, the legal and lethal way we were ingesting it before. OMG, I really wish they would quit with that statement! That act as if it were a new discovery!

(sorry, emotional outburst)

 

[halopunker]

Wait these contain nicotine?!!?!?!?

 

[LuckySevens4U]

Wait these contain nicotine?!!?!?!?

Not the ones YOU smoke. LOL

 

[ejfan1977]

Wait these contain nicotine?!!?!?!?

You're too funny! I needed that...

 

[Nuck]

It doesn't apply to the hardware. I just checked the notice to stakeholders. They will just have to ship into Canada without the carts.

 

[b00stzx3]

Is Canada governed by lobbysits as well? I hope they have a better system than us, they seem to use reason more!

 

[Nuck]

Nah..there is no conspiracy or hidden power. They want the drug tested like any other drug before it can be sold. The devices are only illegal to sell when combined with nicotine so it's pretty much the expected course.

Thank God I stocked up on juice (and continue to do so) in advance. This could take a while.

 

[Wildsky]

You guys have lots of friends this side of the border - we'll ship you the goodies no problem!

 

[TropicalBob]

Are we all reading the same words?

OTTAWA, ONTARIO -- (Marketwire) -- 03/27/09 -- Health Canada is advising Canadians not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada.

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

Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately. Health Canada is providing information to interested stakeholders on how to apply for the appropriate market authorizations and establishment licences.

Where's the language allowing e-cigs but not liquid?

 

[Nuck]

You guys have lots of friends this side of the border - we'll ship you the goodies no problem!

You own Wildsky

 

[Nuck]

Are we all reading the same words?



And



Where's the language allowing e-cigs but not liquid?

"In the absence of evidence provided by the sponsor establishing otherwise, an electronic smoking product delivering nicotine is regulated as a New Drug under Division 8, Part C of the Food and Drug Regulations. In addition, the delivery system within an electronic smoking kit that contains nicotine must meet the requirements of the Medical Devices Regulations. Appropriate establishment licences issued by Health Canada are also needed prior to importing, and manufacturing electronic cigarettes."


Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada

 

[LaceyUnderall]

"an electronic smoking product delivering nicotine is regulated as a New Drug under Division 8, Part C of the Food and Drug Regulations. In addition, the delivery system within an electronic smoking kit that contains nicotine must meet the requirements of the Medical Devices Regulations. Appropriate establishment licences issued by Health Canada are also needed prior to importing, and manufacturing electronic cigarettes."

Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada

I read this to mean that if the device is delivering a product that does not include nicotine then it does not fall into the regulations as it does not deliver a drug.

But this brings up a serious misconception: Is everyone aware that there are people at the FDA and Congressman who are completely unaware that there are no nicotine solutions available? Goes to show that not much deep research is being done before statements are being made. They are assuming that these are only used for nicotine delivery, when they in fact are not. Again, I will state it again, all suppliers should always offer the no-nicotine options. But... I can always take that up in our Association meetings and plan to do so.

Edit: Sorry for the duplication on Nuck. He responded faster than me!

 

[TropicalBob]

Yeh, well here's the part that chokes:

Electronic smoking products (i.e., electronic products for the vaporization and administration of inhaled doses of nicotine including electronic cigarettes, cigars, cigarillos and pipes, as well as cartridges of nicotine solutions and related products) fall within the scope of the Food and Drugs Act. All of these products require market authorization prior to being imported, advertised or sold in Canada. Market authorization is granted by Health Canada following successful review of scientific evidence demonstrating safety, quality and efficacy with respect to the intended purpose of the health product. This evidence is provided by the sponsor seeking market authorization. To date, no electronic smoking product has been authorized for sale by Health Canada.

In the absence of evidence provided by the sponsor establishing otherwise, an electronic smoking product delivering nicotine is regulated as a New Drug under Division 8, Part C of the Food and Drug Regulations. In addition, the delivery system within an electronic smoking kit that contains nicotine must meet the requirements of the Medical Devices Regulations. Appropriate establishment licences issued by Health Canada are also needed prior to importing, and manufacturing electronic cigarettes.

Health Canada is aware that some electronic smoking products have been advertised and sold in Canada without market authorization from Health Canada. Persons who may be importing, advertising or selling electronic smoking products without the appropriate authorizations are asked to stop doing so immediately. Products that are found to pose a risk to health and/or are in violation of the Food and Drugs Act and related Regulations may be subject to compliance and enforcement actions in accordance with the Health Products and Food Branch Inspectorate's Compliance and Enforcement Policy (POL-0001).

This is very blunt language to me. You got a ban on your hands. Color Canada red.

 

[LaceyUnderall]

But, what if it doesn't deliver nicotine?

 

[TropicalBob]

That is not, as the FDA has written, the "essential purpose" of the devices. We know what they're for -- and it's not "pretending smoking" with vapor.

 

[Nuck]

I just got off the phone with Health Canada and the hardware has not been classified and is NOT included in the ban. I requested a callback from one of the classification experts to see if I can get an additional information.

I will post if I can get more information.

 

[dEFinitionofEPIC]

That is not, as the FDA has written, the "essential purpose" of the devices. We know what they're for -- and it's not "pretending smoking" with vapor.

WE (the user) know what we will be using the device for when we purchase it. The device itself is neutral. There is no way they can put a ban on the device if not sold with nicotine because the regulating agency cannot assume what an intended purpose of a neutral device will be.


Vaporizer - Herbal Vaporizers = LEGAL