Examining Supplemented Food Regulations in Canada

New Opportunities in the Supplementation of Foods

Supplemented Foods are prepackaged foods with one or more supplemental ingredients. Such ingredients include:

  • vitamins,
  • minerals,
  • amino acids and
  • caffeine

The Supplemented Foods regulations were published to prevent the health and safety of consumers and to provide clear and predictable regulatory environment for supplemented foods.

 Categories of Foods Eligible for Supplementation

Carbonated or non-carbonated water-based beverages

  1. Fruit Drinks (from concentrate), vegetable drinks (from vegetable concentrate), fruit and vegetable drinks (from concentrates), fruit nectars, fruit based smoothies, vegetable based smoothies or fruit and vegetable based smoothies
  2. Juices
  3. Single -serving prepackaged tea, coffee or herbal infusions
  4. Bards
  5. Hard, soft or semi-soft candies
  6. Chocolate confectioneries
  7. Chewing gum
  8. Ice Pops

III. Materials Used for Supplementation

  • Vitamins
  • Minerals
  • Amino Acids

The regulations prescribe mandatory minimum and maximum permitted levels of addition of these supplements.

  1. Labeling Requirements
  • List of Added Nutrients. Supplements added to foods must be listed by their common name in exactly the same manner as regular ingredient components.
  • Health Claims and Approvals

Supplemented food may make no health claims other than those already permitted in the Food & Drug Regulation and the Safe Foods for Canadians regulations. Supplemented foods with Caution labels may not make any claims, nor are they permitted for products are are intended to be consumed by a certain age group.

  • Supplement Facts Table
    • Instead of a Nutrition Facts Table (NFT), a Supplemented food must carry a Supplemented Food Table (SFT), which highlights the added supplements below the nutrition facts in both amount per mg or mcg, as well as the %DV.

Supplemented Food Facts Table

Supplemented Food Facts
  1. Required Warnings
  • Allergen Information – the same allergen labelling requirements exist for Supplemented foods as food regular foods.
  • Cautionary Statements for High Nutrient Levels – Certain Supplemented ingredients consumed by vulnerable people such as children, pregnant or breast feeding women may pose a risk to their health. When the declared amount of a Supplemented ingredient exceeds a certain threshold, the label must display a cautionary statement to inform the consumer of the potential risk
  • Food Caution Identifier

To ensure that consumers are aware that foods have been supplemented, a Supplemented food caution identifier must be placed on the principal display area of the supplemented food label. Specific regulations exist for the minimum size of this identifier and where it should be placed on the product label.

Supplemented Food Warning
  • Compliance and Safety
  • Manufacturer’s Compliance Obligations

As with all food manufacturing operations, the onus is on the producer or distributor to ensure that the food offered for sale in Canada complies with all the rules and regulations that apply to that food.

  • Health Canada’s Assessment Process

Stakeholders may request changes to the permitted substances and list of permitted food categories when they can specify are range of factors that will be used to assess the safety and justification for addition or expansion of these lists. Requests for changes will require:

  • Description of  the proposed change
  • Decription of the ingredient including its name
  • Source of the ingredient and method of manufacture
  • Information of hte physical and chemical properties of the ingredient
  • Information on the composition and specifications of the ingredient.
  • Proposed maximum amount of the ingredient per serving
  • Proposedd conditions of tuse of the ingredient
  • Data to establish safety of the ingredients under its proposed conditions of use.

VII. Conclusion

  • The Supplemented foods regulations are an effort by the Government of Canada to continuously modernize the regulations. In this particular case, it take a range of foods out of the scope of Natural Health Products, with its relatively onerous application and approval system, and permits for the safe supplementation of foods in Canada.
  • These regulations are empowering consumers for Informed Choices, and also create new opportunities for companies to expand their offerings to consumers in a controlled and measured way.


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