G/TBT/N/CAN/567  
 
18 October 2018  
(18-6518) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English/French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: CANADA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Department of Health  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Canada’s Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. I CS numbers may be provided in addition, where applicable): 
Prescription Drugs, Natural Health Products, Non -Prescription Drugs, Medical Devices 
(ICS: 11.120)  
5. Title, number of pages and language(s) of the notified document: Regulations 
Excluding Certain  Vaping Products Regulated Under the Food and Drugs Act from the 
Application of the Tobacco and Vaping Products Act Regulations Amending the Food and 
Drug Regulations and the Natural Health Products Regulations (Vaping Products) 
(22 pages, available in English and French)    
6. Description of content: Health Canada has put forward new regulations to exclude 
certain health products from the application of all or parts of the Tobacco and Vaping 
Products Act  (TVPA) when they are not associated with TVPA ris ks, such as inducement 
to smoking and nicotine addiction.  
The new regulations seek to ensure that the application of the TVPA and the Food and 
Drugs Act  (FDA) and their regulations on vaping products regulated under the FDA is 
representative of their asso ciated harms while achieving the purposes of the TVPA.  
The new regulations also extend existing requirements for child -resistant packaging under 
the Food and Drug Regulations  to any drug or  natural health product (NHP) that contains 
nicotine and to which the TVPA applies. The new regulations also require warning 
statements on the labels that the drug should be kept out of the reach of children and 
that there is enough nicotine in the package to seriously harm a child. These requirements 
do not extend to pr escription drugs, NHPs or non -prescription drugs, or medical devices 
that are excluded from the TVPA under the new regulations.  G/TBT/N/CAN/567  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: The objective of the Regulations Excludin g Certain Vaping Products 
Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping 
Products Act  (the Regulations) and the Regulations Amending the Food and Drug 
Regulations and the Natural Health Products Regulations (Vaping Pr oducts )  is to ensure 
that the application of the TVPA and the FDA and their regulations on vaping products 
regulated under the FDA is representative of their associated harms while achieving the 
purposes of the TVPA.  
8. Relevant documents:   
• Canada Gazette , Part II, 11 July 2018, pages 2433 -2454 (available in English and 
French)    
9. Proposed date of adoption: Not stated  
Proposed date of entry into force: The Regulations come into force upon registration, 
with the exception of the new child -resista nt packaging and labelling requirements for 
nicotine -containing vaping products. Those requirements will come into force six months 
after registration.  
10. Final date for comments: Not applicable (Published in Canada Gazette Part II on 
11 July 2018 with exemption from Pre -publication in Canada Gazette Part I)  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
The electronic version of the regulatory text can be downloaded at:  
http://www.gazette.gc.ca/rp -pr/p2/2018/2018 -07-11/html/sor -dors133 -eng.html  
http://www.gazette.gc.ca/rp -pr/p2/2018/2018 -07-11/html/sor -dors133 -fra.html  
http://www.gazette.gc.ca/rp -pr/p2/2018/2018 -07-11/html/sor -dors132 -eng.html  
http://www.gazette.gc.ca/rp -pr/p2/2018/2018 -07-11/html/sor -dors132 -fra.html