Cosmetic or Therapeutic? – The regulatory grey zone

For companies launching personal care products in Canada, the line between a cosmetic and a therapeutic product is not always as clear as it may seem. While most products may look and feel like conventional cosmetics, their composition, intended function, mode of action and claims can influence how Health Canada classifies them. 

Claims do matter, but this isn’t the whole picture. The formulation and how the product works are also important. A key consideration is how the product is represented to consumers…it’s overall representation. An ingredient commonly used in cosmetics does not automatically mean that a finished product will be classified as a cosmetic. There can be an important regulatory distinction between claims such as ‘brightens skin’ and ‘helps skin look brighter’. Classification is not simply a matter of changing a few words on a label. Health Canada can consider the overall representation of the product, including its name, packaging design, images and symbols used on the label, directions of use, implied claims, information on websites and social media posts.

The best strategy is to address classification early on during product development, rather than after the formula, packaging and marketing materials have been finalized.

Companies should consider:

• Reviewing the formulation
• Assessing the product’s intended mode of action
• Evaluating implied claims across all marketing channels
• Documenting the scientific and regulatory rationale for the proposed classification
• Engaging with Health Canada where the classification remains uncertain

Our team can help assess your product and develop the right regulatory strategy for you. Reach out to us to learn more.