In its Final Notice published April 10, 2026, Health Canada confirmed that these substances are not considered “inherent drugs” based on the evidence currently available. This means they may potentially be used in either cosmetic or drug products. However, the decision does not give exosome-containing products an automatic cosmetic status. Classification remains dependent on the characteristics of the finished product.
For companies developing or marketing these products in Canada, the key factors are product representation, level of action and composition.
Exosomes are not automatically classified as drugs
Health Canada distinguishes between substances that are inherently drugs and ingredients that can potentially be used in both cosmetics and drugs.
“Inherent drugs” are substances whose intrinsic properties mean they have no use other than as a drug. Health Canada gives tretinoin and corticosteroids as examples.
Based on the evidence available today, human-derived exosomes, human EVs and human cell-conditioned media do not fall into this category. A topical product containing them may therefore be regulated either as a cosmetic under the Cosmetic Regulations or as a drug under the Food and Drug Regulations, depending on the finished product.
Health Canada also emphasizes that classifications are based on the evidence available at a particular point in time and may change if new scientific or other relevant information emerges.
Claims remain a major classification factor
The first consideration is how the product is represented to consumers.
Health Canada considers not only the wording on the package but also advertisements, package inserts, indications for use, images, symbols and explicit or implied claims.
A topical product may be considered a drug if it is represented for treating, diagnosing, preventing or mitigating a disease, disorder or abnormal physical state, or for restoring, correcting or modifying organic functions. Therapeutic, pharmacological or biological claims can therefore move a product into the drug framework.
For brands, this means that product names, websites, advertising and professional-use instructions should be reviewed together when determining regulatory status.
Absorption and method of use are critical
Health Canada gives particular importance to the level of action for topical products containing these human-derived materials.
To qualify as a cosmetic, the product must exhibit a lack of percutaneous absorption and should not need to be absorbed systemically to achieve its intended effect.
Products represented for administration in a way that facilitates skin penetration are not consistent with cosmetic classification. Health Canada specifically identifies microneedling as an example. Products administered by injection, including intramuscular, subcutaneous or intravenous administration, are not cosmetics, except for the statutory exception concerning tattoo ink.
This is particularly relevant to products marketed alongside aesthetic procedures or delivery techniques intended to increase skin penetration.
The complete formulation must also be assessed
Classification cannot be determined solely from the presence of an exosome or extracellular-vesicle ingredient.
Health Canada states that products exhibiting therapeutic or pharmacological activity are not considered cosmetics. The composition of the finished formulation must therefore be assessed together with its intended purpose and claims.
The same product-specific approach applies to topical products containing exosomes, EVs or conditioned media from non-human sources.
Human-origin ingredients bring additional obligations
Even when a product qualifies as a cosmetic, companies should separately examine Canada’s Cosmetic Ingredient Hotlist.
The Hotlist contains a restricted entry for “Human origin, substance of.” Manufacturers using substances of human origin must provide Health Canada with information concerning the source, production method, quality control—including microbial limits and viruses and the absence of estrogenic substances—and product labelling.
What should companies do?
The final notice provides useful direction, but it is not a blanket authorization for exosome cosmetics.
Before launching a product in Canada, manufacturers and brand owners should assess the finished formulation and review its claims, intended use, method of administration and potential absorption. Companies should also determine whether the human-origin requirements in the Cosmetic Ingredient Hotlist apply.
If the product is classified as a cosmetic, it remains subject to Canada’s cosmetic requirements, including notification to Health Canada within 10 days after the first sale. Importantly, submitting a cosmetic notification does not constitute approval or confirmation that Health Canada agrees with the product’s classification. Products classified as drugs require the appropriate Health Canada authorization before sale.
For the cosmetics industry, the main takeaway is clear: in Canada, the presence of exosomes does not determine the regulatory category by itself. The finished product, its claims, its mode of action and its composition must be assessed together.
