Health Canada has finalized its regulatory approach for topical products containing human-derived exosomes, extracellular vesicles, and cell-conditioned media. Rather than labeling these substances as “inherent drugs,” Health Canada has determined that they can be classified as either drugs or cosmetics depending on their specific use and representation. A product is classified as a drug if it is marketed with therapeutic claims—such as treating diseases or modifying organic functions—or if it is administered via methods that facilitate deep absorption, such as injection or microneedling. Conversely, a product may be regulated as a cosmetic if it is intended for external application, has a local and transient effect, and lacks systemic absorption.
Health Canada’s final decision on the regulatory approach for exosomes reflects our commentary to the consultation. If you have any questions or concerns please email regulatory@cosmeticsalliance.ca.
