Health products (food supplements) in Canada are regulated under a multi-departmental collaborative supervision framework: ① Health Canada (HC): Responsible for formulating policies, regulations and standards concerning the safety and nutritional value of health products, and conducting health risk assessments for food products. ② Canadian Food Inspection Agency (CFIA): Responsible for verifying the compliance of imported health products with Canadian regulatory requirements, and issuing the Safe Food for Canadians (SFC) licence. ③ Canada Border Services Agency (CBSA): Enforces relevant acts and regulations to ensure compliant cross-border trade flow at the border.
Official Website of the Regulatory Authority:https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/natural-non-prescription-health-products-directorate.html
Database Portal: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/index-eng.php
Food and Drugs Act (FDA)
Consumer Packaging and Labelling Act
Food and Drug Regulations (FDR)
Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) (SOR/0169)
Core classification criteria: A product is deemed a supplemented food and shall comply with the Supplemented Food Regulations when it meets all of the following conditions: it is a pre-packaged food; contains added vitamins, minerals, amino acids and other relevant substances; is not produced for nutritional fortification purposes; is not food intended for special population groups; falls within the permitted categories of supplemented foods; and all added ingredients are included in the permitted list and conform to the corresponding limit requirements.
Hold a valid Safe Food for Canadians (SFC) licence
Provide the product name and clear intended use of the product
Submit a complete product ingredient list or formulation sheet
Provide compliant bilingual product labels (English + French)
Provide a valid quality system certificate for health products.
English + French (labels and product instructions must be presented in both languages)
Product formulation: A full list of all medicinal ingredients (including content and source) and non-medicinal ingredients
Safety certification: Documentation substantiating product safety (e.g. references to official monographs, scientific literature or toxicological reports)
Label draft: The final draft of label design to be affixed to the product container or outer packaging
Applicant information: Company name and address. For non-Canadian entities, a designated Canadian representative is required
Animal-derived ingredient certificate (required only when the product contains ingredients such as gelatin, whey, lanolin, etc.)
Safe Food for Canadians (SFC) licence
Pursuant to the Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR), importers must hold a valid SFC licence issued by the CFIA and make accurate declarations on the import declaration form. Goods that fail to meet import requirements will be refused entry, and non-compliance may result in administrative penalties or even prosecution.
1.Official Fees
Safe Food for Canadians (SFC) licence: CAD 287.22 per licence (2023-24 fiscal year, effective as of March 31, 2024), with a validity period of 2 years.
2.Filing Timeline
The specific processing timeline depends on the business scope applied for by the importer, the category of the health product, its ingredient composition and the content of health claims.
3.Filing Procedure
Standard registration procedure: Document preparation → Product information filing → Product classification review → Ingredient compliance review → Label compliance review → Official record filing for future reference → Import customs clearance