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January 4, 2026
Approximately 5 minutes
Classification of Products under the Food and Drugs Act in Canada – Health Canada Guidance
Classification of Products under the Food and Drugs Act in Canada – Health Canada Guidance
Regulatory Framework Overview
The Food and Drugs Act (FDA) and its associated Regulations provide the legal basis for classifying products in Canada. Health Canada determines classification based on the product’s intended use, claims made by the manufacturer or seller, composition, mode of action, and how it is presented. Correct classification is essential as it dictates the applicable regulatory requirements, including licensing, safety standards, labelling, and post-market obligations. Misclassification can lead to enforcement actions, product removal, or legal consequences. Classification of Products under the Food and Drugs Act - Canada.ca
Key Classification Factors
Health Canada uses a risk-based approach considering multiple attributes:
- Intended use / purpose: The main reason the product is marketed (e.g., diagnosis, treatment, prevention, cosmetic enhancement).
- Claims: Explicit or implied statements about structure/function, disease mitigation, or effects on the body.
- Mechanism of action: Pharmacological, immunological, metabolic, or physical means.
- Presentation: Packaging, labelling, advertising, and overall impression created.
- Composition and dosage form: Ingredients, concentration, and delivery method.
Products may fall into one primary category or be considered combination products requiring multiple regulatory pathways.
Main Product Categories and Examples
Food
Products primarily providing nutrition or satisfying hunger, with no disease treatment/prevention claims. Examples: conventional foods, beverages, spices.
Drug
Substances or mixtures intended to diagnose, treat, mitigate, prevent disease, restore/modify body functions, or disinfect surfaces/objects. Includes prescription, non-prescription, and disinfectants.
Cosmetic
Articles intended to cleanse, improve, alter, or enhance appearance (skin, hair, teeth) without affecting body structure/function. Examples: shampoos, makeup, perfumes.
Natural Health Product (NHP)
Naturally occurring substances used to restore/maintain health, with traditional or modern evidence supporting use. Includes vitamins, minerals, herbal remedies, probiotics (requires product licence).
Medical Device
Instruments/apparatus intended for diagnosis, treatment, or prevention via physical means (not pharmacological). Classified I–IV based on risk (e.g., bandages = Class I, pacemakers = Class IV).
Combination Products
Products combining drug/device, drug/cosmetic, or other attributes. Classification depends on primary mode of action (e.g., drug-coated stent primarily device; medicated cream primarily drug).
Decision-Making Process
Health Canada applies a stepwise evaluation:
- Assess primary intended purpose and claims.
- Determine mode of action (pharmacological vs. physical).
- Consider risk level and presentation.
- Assign primary category; if multiple, identify leading pathway.
Borderline cases may require formal classification requests with supporting data.
Practical Implications
- Food vs. Drug/NHP: Nutrient claims may be allowed for food; disease claims trigger drug/NHP classification.
- Cosmetic vs. Drug: Anti-aging or acne treatment claims often shift to drug.
- Device vs. Drug: Delivery of medication via device may result in combination classification.
Manufacturers/sellers are responsible for correct classification; Health Canada may reclassify based on evidence.
This guidance promotes regulatory clarity, ensures appropriate oversight, and protects public health by aligning products with the correct framework. Detailed factors, examples, decision trees, and request procedures are available on the Health Canada classification page. Classification of Products under the Food and Drugs Act - Canada.ca
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