Email Responses from HC and HSC

[Concat]

So I was searching around and found this:

Harmonized System Committee

It says that in March, the Harmonized System Committee met to discuss the "Classification of spare cartridges for electronic cigarettes."

I emailed them to get more information. Here is the brief exchange:

Hello,

I was hoping for some information regarding a specific item on the agenda for the 47thSession of the Harmonized System Committee, which was held in March. I am specifically interested in the outcome, or details concerning section VIII, subsection 9: "Classification of spare cartridges for electronic cigarettes."

Any information you could provide, especially concerning the importation of spare cartridges would be most appreciated. I understand that nictone related e cigarette products can not be imported, but a spare cartridge does not contain nicotine. Is it still okay to import them?

Thank you very much for taking the time to respond to my inquiry.

At its 47thsession, the Harmonized System Committee classified two spare cartridges for an electronic cigarette :

- an electronic cartridge containing nicotine
- an electronic cartridge containing no nicotine

Both of these electronic cartridges were classified in subheading 3824.90 by application of General Interpretative Rules 1, 3 (b) and 6.

With respect to your questions regarding the ability to import either the electronic cigarette itself or the spare cartridges in either of the above-mentioned configurations, I would advise you that you should contact Health Canada with these questions. To this end, the following two links should be helpful to you.

Regards

Leo Callaghan

To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada - Health Canada Notice 2009-03-27

Health Canada Advises Canadians Not to Use Electronic Cigarettes - Health Canada Advisory 2009-03-27

This means to me that they've classifed them as a Miscellenous Chemical product > binders made for foundry moulds or cores; chemical products and preparations, including residual products, of the chemical or allied industries, nesoi > Others

I replied to clarify that both empty and full cartridges were classifed the same, and got no reply.

This concerns me as to whether or not HC will have the authority to ban the import/sale of empty cartridges.

I also emailed HC:

Hello,

I’m hoping to clarify certain policies regarding the importation and sale of electronic cigarettes. As I understand, the sale and importation of “e-juice” which contains nicotine is banned. However this is not the reason I am sending this email. It has come to my attention that upon direction from Health Canada customs has begun denying importation of any and all electronic cigarette related products, regardless of whether or not there is any nicotine in the package being imported. These products include empty cartridges, atomizers, and even something as innocuous as an e-cig battery.

I am hoping an agent will be able to shed some light on this matter and perhaps debunk certain myths regarding what is okay to import, and what is not okay. It was my understanding that providing the package does not contain any nicotine, then it should not be denied entry into Canada. There's no information on the HC website other than the original advisory issued two years ago.. For what it's worth, I had heard rumors that Health Canada had a "new" study. Has this been published publicly, or rather, could you direct me to any related studies in which Health Canada has based their advisory on?

Thank you for taking the time to respond to my inquiry.

Good afternoon,
This email is in response to your inquiry regarding electronic smoking products. According to our regulations, electronic cigarette with nicotine is not approved for sale in Canada. The companies require to submit new drug submission .
Also non-filled e-cigarettes with a health claim need to have medical device license.
Please contact the Health Product and Food Branch Inspectorate for information:
E-mail: insp-dgo_bdg-insp@hc-sc.gc.ca
Telephone : 613-946-5095
Toll free: 1-800-267-9675

On March 27, 2009, Health Canada posted a Public Advisory and a Notice to Stakeholders about electronic smoking products which are available at the following URL addresses:

Public Advisory: Health Canada Advises Canadians Not to Use Electronic Cigarettes - Health Canada Advisory 2009-03-27

Notice to Stakeholders: To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada - Health Canada Notice 2009-03-27

As per this advisory/notice, electronic cigarettes fall within the scope of the Food and Drugs Act and Regulations. As such, market authorization must be granted by Health Canada prior the importation and sale of these products in Canada. Currently, no electronic smoking products have been granted market authorization in Canada.

The Therapeutic Products Directorate (TPD) of Health Canada is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must submit substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations. This is done through the filing of a drug submission to the TPD.

Here is some additional information to clarify the classification of electronic cigarettes under the Food and Drugs Act:

a non-refillable disposable electronic smoking product (e.g., e-cigarette) prefilled with nicotine (or any other drug or Natural Health Product [NHP]) is considered to be a drug (or NHP)/medical device combination product and requires a DIN (or NPN). In this case, its drug delivery system is to be reviewed for safety and efficacy but a medical device license is not required;

a refillable electronic smoking product (e.g., e-cigarette) with nicotine or intended to be used with nicotine (or any other drug or NHP) is considered to be a drug (or NHP) delivery system and, therefore, a Class II medical device, and its nicotine (or drug or NHP) component requires a DIN (or NPN). (Please note that no medical device licence is to be issued until the associated drug component has received a DIN [or NPN].);

an electronic smoking product (e.g., e-cigarette) associated with a health claim but not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is considered to be a Class I medical device.
Sincerely,
Health Canada | Santé Canada
Ottawa, Canada K1A 0K9
info@hc-sc.gc.ca
Telephone | Téléphone 613-957-2991 / Toll free | Sans frais 1 866-225-0709
Facsimile | Télécopieur 613-941-5366 / Teletypewriter | Téléimprimeur 1 800-267-1245
Government of Canada | Gouvernement du Canada

Curious how the response seems to dance around the conclusion that any ecig product that does not have nicotine and does not make any health claims is not a medical device and therefore can not be regulated by HC.

Also worrisome is that they include the terms "intended" to be used with nicotine. How they determine a manufacturers "intent" is anyone's guess. But if you're importing it from the States, the company very well might state that their e cig delivers nicotine, which could cause HC to ban the import.

 

[Pipeous]

so if the intentions were written on the packaging "not intended for use with a nicotine product" or the products contained herein are designed to be used with pg/vg/flavourings, no health or m0edical claims are to be made or insinuated. to be used as a novelty item only...

these labels will circumvent any intentions (also known as assuming)

 

[IanK1968]

you would think so wouldnt you Pipeous

 

[Pipeous]

a lot is in the presentation and interpretation I think. how things are marketed will determine what rules they have to follow. so now it's time for some good marketing people to handle the wording and target audience. remove the points of concern with proper labels (you know how canada is about proper labels... don't forget english and french as well).

as I see it these things are designed to be used with pg/vg and flavour. nicotine was something added after the fact... just like you can fill a watermellon with alcohol.

 

[TallGrass]

"For Educational Purposes Only"

 

[Melnik]

"For Educational Purposes Only"

+5 And they should also be marked as flashlight batteries and personal water heaters.

 

[labradorlost]

It would be nice to hear what some lawyers have to say, as the responses given sure smell like they were written by a lawyer. I'm amazed at how vague and encompassing their definition is, but not surprised in the least bit.