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Monday, September 1, 2025International

Canada's consultation on topical products containing human-derived exosomes

Consultation du Canada sur les produits topiques contenant des exosomes d’origine humaine

On August 14, 2025, Health Canada opened a 75-day consultation period on its approach to classifying topical products containing human-derived exosomes, human extracellular vesicles, or human cell-conditioned media as cosmetics and drugs.

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The purpose of the Health Canada’s communication “is to communicate Health Canada’s position on the classification and regulation of topical products at the cosmetic-drug interface that contain human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media to industry, practitioners, and the public”.
Thes Notice outlines the considerations applied in determining whether such a product is classified and regulated as a drug product or cosmetic product.

Health Canada recalls the definitions and regulations applicable to cosmetics and drugs.
The Agency also details the three criteria that determine the classification for this type of product.

Product representation
Health Canada is aware that some cosmetic companies are making representations on product labels, package inserts and/or advertisements that may create the impression that their topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media are drug products. And recalls that products for which therapeutic claims are made are classified as drugs.

Level of action
To be a classified as a cosmetic, the products must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the intended effect.
Indications of use that would facilitate percutaneous absorption or products administered through injection are not consistent …

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