Canada Clarifies Classification of Topical Products Containing Human-derived Exosomes

On August 14, 2025, Health Canada released a notice seeking input on its proposed approach to the classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media. ¹ Stakeholders may submit suggestions or relevant information to [email protected] by October 28, 2025. Submissions may include:

• Reports or concerns on exosome-containing topical products (e.g., adverse events, consumer/patient complaints);

• Scientific studies on their effects, mechanisms of action, or ingredients;

• Information on substances present in exosomes and their functions;

• Directions for use, including pre-treatment recommendations.

Background

Exosomes are membrane-bound extracellular vesicles that may originate from human, animal, plant, or synthetic sources. Conditioned media is prepared from cultured cells and may contain extracellular vesicles or exosomes. The proposed approach sets out how Health Canada determines whether such products are regulated as drugs or cosmetics, based on product representation, level of action, and composition.

Key Classification Criteria

1. Product Representation