WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/150/Rev.1 
26 June 2007 
 (07-2718) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
Revision
 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Canadian Enquiry Point 
200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7  
Tel.: +(1) 613 238 3222 
Fax: +(1) 613 569 7808 E-mail:  info@scc.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. 
ICS numbers may be provided in  addition, where applicable):   Natural health products 
and certain drugs (ICS:  11.120) 
5. Title, number of pages and lang uage(s) of the notified document:    
Proposed Amendment to Certain Regulations Ma de under the Food and Drugs Act (Project 
1539) (23 pages; in English and French) 
Proposed Amendment to Schedule A to the F ood and Drugs Act and the Medical Devices 
Regulations (Project 1539) (3 pages; in English and French) 
6. Description of content:    
This regulatory Amendment proposes to amend the Food and Drug Regulations  (FDR) and 
the Natural Health Products Regulations  (NHPR)  
1. to revise the list of Schedule A diseases; and 
2. to exempt natural health products (NHPs)  and certain drugs from the prohibition on 
preventative claims for the remaining diseases listed in Schedule A. 
All other provisions of the Food and Drugs Act  (FDA), the Controlled Drugs and 
Substances Act  (CDSA), and their regulations would continue to apply.  G/TBT/N/CAN/150/Rev.1 
Page 2  
 
   
1. Revising the list of Schedule A diseases
 
 Schedule A to the FDA is a list of diseases, disorders or abnormal physical states (hereafter referred to as diseases) for which preventative, treatment, and cure claims are prohibited by 
subsections 3(1) and 3(2) of the FDA (hereafte r referred to as section 3) in the labelling and 
advertising to the general public of any f ood, drug, cosmetic, or medical device.  
 The regulatory proposal would revise Schedule A to list diseases which meet one or more criteria identified by a scientific advisory pa nel of experts. Criteria are a transparent 
mechanism to help ensure consistency in deci sions with respect to inclusion and exclusion 
of diseases in Schedule A. If a disease does not m eet any of the criteria, it will be removed 
from the Schedule A list. When a disease is re moved from Schedule A, all products covered 
by section 3 (food, drugs, cosmetics, and medical  devices) would no longer be subject to the 
preventative, treatment, and cure prohibitions for that disease. All these products would 
continue to be subject to all other provisions  in the FDA, the CDSA, and their regulations; 
therefore, any other restrictions on the labelli ng and advertising of cl aims or any conditions 
for market authorization of these products remain in place.   
2. Exempting NHPs and certain drugs from th e prohibition on preventative claims for 
the diseases remaining in Schedule A  
 Section 3 of the FDA contains the labelling and advertising prohibitions for Schedule A diseases. Section 3 prohibits the advertising of any food, drug, cosmetic, or medical device 
to the general public as a preventative, treatment , or cure for any of the diseases referred to 
in Schedule A. Section 3 also prohibits the sale of any food, drug, cosmetic, or medical 
device that is labelled or advertised to the general public as a preventative, treatment, or 
cure for any of the diseases referred to in Schedule A.   The regulatory proposal would exempt NHPs and certain drugs from the preventative components of the section 3 prohibition for di seases remaining in Schedule A (preventative 
prohibition).  
NHPs and drugs that are subject to this regulatory proposal would be permitted to carry 
preventative claims in labelling and advertis ing to the general public for diseases that 
remain in Schedule A. These products continue to  be subject to all other provisions in the 
FDA, the CDSA, and their regulations; therefor e, any other restrictions on the labelling and 
advertising of claims or any conditions for ma rket authorization of these products remain in 
place.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 16 June 2007 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months of publication 
in the Canada Gazette, Part I. 
On the date the measure is adopted 
10. Final date for comments:   30 August 2007  G/TBT/N/CAN/150/Rev.1 
 Page 3 
 
 
  11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
The electronic version of the regulatory text can be downloaded at:  
http://canadagazette.gc.ca/partI/2007/20070616/pdf/g1-14124.pdf