. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/GEN/1170 
6 July 2012 
 (12-3624) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
TRANSITION PROCESS FOR FOODS MARKETED AS NATURAL HEALTH  
PRODUCTS TO THE FOOD REGULATORY FRAMEWORK 
 
Communication from Canada 
  
 The following communication, received on 6 July 2012, is being circulated at the request of 
the Delegation of Canada. 
 
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1. Some products with added vitamins , minerals or amino acids that  appear to be foods, as well 
as foods making certain health claims, have previous ly been able to gain market access as Natural 
Health Products (NHPs).  Canada is undertaking a transition process for food products marketed as 
NHPs to the food regulatory framework.  As such, these products will be required to meet all food-related requirements.  Examples of food products th at are currently marketed as NHPs include energy 
drinks, waters and juices with adde d vitamins and minerals, and yogurts  and bars with specific health 
claims.  These food products currently marketed as NHPs represent a very small portion (2 per cent) 
of the approximately 50,000 NHPs currently in the Canadian marketplace.  
2. The Department of Health has determined, b ased on consumption patterns, history of use, 
representation to consumers, and in accordance with its guidance document "Classification of 
Products at the Food-Natural Health Product Interface:  Products in Food Formats" (" http://www.hc-
sc.gc.ca/dhp-mps/prodnatur/legislation/do cs/food-nhp-aliments-psn-guide-eng.php "), that most of 
these food products currently marketed as NHPs fit th e definition of a food.  The Department of 
Health, therefore, intends to classify and transitio n most of these products to the food regulatory 
framework.  This is consistent with the policy inte nt of the NHPR, as outlined in the regulatory impact 
analysis statement ( http://www.gazette.gc.ca/archives /p2/2003/2003-06- 18/pdf/g2-13713.pdf ), as well 
as the outcomes of the Natural Health Product Regulatory review, conducted in 2007, which re-
iterated that foods are excluded from the scope of the NHP Regulations.   
3. As of 17 April 2012 Canada is no longer accep ting NHP applications for products that are 
represented, packaged and sold as foods.  For t hose products already on the market as NHPs, the 
Department of Health has put in place a transition process to minimize the disruption to market, as 
long as the products are safe to be consumed as foods .  Products that are captured under the transition 
are those where a Product Licence Application has b een received by the Department of Health's 
Natural Health Products Directorate (NHPD) and ha ve been issued either a natural product number, 
an exemption number or are considered an application in progress. 
4. The transition of eligible food products market ed as NHPs to the food regulatory framework 
will be facilitated through the issuance of a Te mporary Marketing Authorization Letter (TMAL) 
(http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php ).  
Submissions for a Temporary Marketing Authoriza tion (TMA) are only needed for new products for 
which there is a regulatory impediment to the lega l marketing of a safe food in Canada.  New products G/SPS/GEN/1170 
Page 2  
 
  that comply with the Food and Drug Regulations  are not subject to pre-market scrutiny and do not 
require TMAs. 
5. The end goal of this transition process is to en sure that products that look like foods and are 
consumed as foods are regulated as foods. 
6. This serves to inform Members of how Canada  is proceeding with the transition process.  
This information has also been provided in G/ TBT/N/CAN/25/Add.1.  When ready, Canada will 
notify the WTO to provide Members the opportunity to comment on the proposed regulatory changes to the Food and Drug Regulations  that would allow the sale of these products. 
 
More information on the transition process a nd other relevant documents can be found on 
Health Canada's website: 
http://www.hc-sc.gc.ca/fn-an/prodnatur/tr ansit-process-food-aliment-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/prodnatur/ transit-process-food-aliment-fra.php  (French) 
 
 
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