Classification of products under the Food and Drugs Act (F&DA)

Classification is the first step in any regulatory process at Health Canada. The Food and Drugs Act (F&DA) and its regulations serve as a basis for the classification of drugs, devices, food, and cosmetics. The definitions of "food," "drug," "cosmetic" and "device" in section 2 of the F&DA, and the definition of "natural health product" (NHP) in section 1 of the Natural Health Products Regulations, are fundamental to the classification of these products.
The four main sets of regulations that may apply to a product under the F&DA are:

The following diagram provides a visual overview of the regulations that apply to each product line:

As illustrated, the main subsets of drug products include NHPs, biologics, and pharmaceuticals. These subsets are important to distinguish, as NHPs fall under the Natural Health Products Regulations, and biologics, pharmaceuticals and hard surface disinfectants fall under the Food and Drug Regulations.

For certain novel drugs and devices for which the current regulations cannot appropriately accommodate, Health Canada's new framework for Advanced Therapeutic Products (ATPs) provides a pathway that is separate from the existing drug and device regulations. This pathway allows for more flexibility in the risk-based market authorization of these products.

How are products under the F&DA classified?

Most classification decisions are made by the appropriate program area upon submission of required information, or application for market authorization. However, there are instances where the classification of a product is not immediately apparent, or where a product meets multiple definitions. These products are known as 'interface products'. Examples of product interfaces include: the drug-medical device interface, cosmetic-drug interface, and the food-natural health product (NHP) interface.

Requests for the classification of products at the drug-medical device interface can be sent to the Office of Science (OoS) in the Bureau of Policy, Science and International Programs (BPSIP) within the Therapeutic Products Directorate of the Health Products and Food Branch (HPFB). The OoS primarily provides recommendations on the classification of products as drugs (i.e., pharmaceutical, biologic, or natural health products), medical devices, or drug-medical device combinations. When necessary, the OoS also provides advice on the classification of other products that are regulated by Health Canada. The in-house classification process involves rigorous research, analysis, and internal consultation with different areas within the Branch and Department. When needed, the OoS will engage the Therapeutic Products Classification Committee (TPCC) for guidance and/or concurrence on the classification recommendation. For questions on the classification of other products/interfaces, please see the contact information provided below.

Classification criteria

Relevant Acts and regulations are the central frameworks for product classification at Health Canada. For example, the definitions outlined in section 2 of the F&DA are the foundation of classification for drugs, devices, food, and cosmetics. In order to be classified as one of the four product types outlined in the F&DA, a product must meet one of these definitions. Classification is done on a case-by-case basis in accordance with a list of set criteria. The criteria used for classification vary depending on the interface or product type. Generally, four important criteria for classification include:

Representation (e.g., any written claims, pictures, symbols, indications, conditions of use, etc.)
Product purpose and intended use (i.e., the role of the product in fulfilling its claimed effect)
Composition (i.e., the ingredients, components, structure of the product, and their contribution to the claimed effect)
Format (e.g., products in conventional food formats such as prepackaged, ready-to-consume beverage products, bars, cereals, etc. versus dosage formats such as tablets or capsules)

More detailed information on the three interfaces and the criteria used for classification can be found in the following guidance documents:

The new ministerial schedule

In June of 2019, the Budget Implementation Act (BIA) received royal assent. Consequently, sub-section 2.4 and a new Schedule A of the F&DA were put in place to create new Ministerial authorities. These new authorities allow the Minister to determine a single set of regulations that would apply to a product that simultaneously meets more than one of the definitions outlined in the F&DA (i.e., drug, food, device, or cosmetic). Schedule A is intended to improve consistency, predictability, and transparency of classification decisions for industry stakeholders. Any change to Schedule A would be published in the Canada Gazette.