Notice: Classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media

August 14, 2025
Our file number: 25-104893-244

Classification is the first step in any regulatory process at Health Canada. The Food and Drugs Act (FDA) and its regulations serve as a basis for the classification of drugs, devices, food, and cosmetics. A product's classification is based on its function, purpose, and representation for use (explicit or implied) as outlined in the definitions of "drug," "device," "food" and "cosmetic" in section 2 of the FDA.

Detailed information on the classification of products at the cosmetic-drug interface is available in Health Canada's Guidance Document: Classification of Products at the Cosmetic-Drug Interface. Health Canada makes classification decisions based on available evidence at a point-in-time; classifications may be further influenced by the emergence of new scientific evidence or other pertinent information.

Purpose

The purpose of this Notice 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. This intended approach is based on available evidence to date.

This Notice outlines the considerations applied in determining whether a topical product containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media is classified and regulated as a drug product or cosmetic product. It is intended to provide information to regulated parties on compliance with the Food and Drugs Act and its regulations, and is intended to be used in conjunction with other existing guidance documents and policies.

Definitions

• cosmetic (Section 2 of the Food and Drugs Act):
  • includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.
• drug (Section 2 of the Food and Drugs Act):
  • includes any substance or mixture of substances manufactured, sold or represented for use in
    • (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
    • (b) restoring, correcting or modifying organic functions in human beings or animals, or
    • (c) disinfection in premises in which food is manufactured, prepared or kept.

Scope

Exosomes are membrane-bound extracellular vesicles that can be derived from human, animal, plant or synthetic sources. Conditioned media is prepared from cultured cells and can also contain extracellular vesicles or exosomes. This Notice applies to topical products that contain human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media.

Classification rationale

Health Canada recognizes that some ingredients are "inherent drugs", meaning that their intrinsic properties are such that they have no use other than as a drug. These substances are classified as drugs regardless of how they are represented. Tretinoin and corticosteroids are examples of inherent drugs. In contrast, some substances are not inherent drug, and instead have the potential to be used as ingredients in both drug products and cosmetic products. Salicylic acid and alpha-hydroxy acids are examples of ingredients used in both cosmetic and drug products.

Depending on the consideration of several factors including product representation, level of action, and composition, a topical product containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media could be regulated as a drug product under the Food and Drugs Act subject to the Food and Drug Regulations, or as a cosmetic product under the Food and Drugs Act subject to the Cosmetic Regulations.

Using the considerations outlined in this Notice, relevant parties including manufacturers and distributors of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media will be able to understand how Health Canada determines whether a product is a drug or a cosmetic. For more information on the factors that guide classification decisions by Health Canada in relation to products at the cosmetic-drug interface, refer to Health Canada's Guidance Document: Classification of Products at the Cosmetic-Drug Interface.

Product representation

Products sold, manufactured, or represented for use in treating, diagnosing, preventing, or mitigating a disease, disorder or abnormal physical state; or restoring, correcting or modifying organic functions in human beings are classified as drugs.

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. Products for which therapeutic claims are made (e.g., claiming therapeutic, pharmacological, or biological effects; claiming benefits comparable to the effects of cosmetical surgical procedures or drugs, etc.) are classified as drugs.

Level of action

To be a classified as a cosmetic under the Food and Drugs Act topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the intended effect. However, it is generally understood that cosmetics may exert a negligible organic effect which is local and transient.

Cosmetics are normally applied to an external part of the body and not absorbed below the skin to achieve the intended effect. Indications of use that would facilitate percutaneous absorption, (e.g. microneedling) are not consistent with cosmetics. Products administered through injection (intramuscular, subcutaneous, intravenous, etc.), with the sole exception of tattoo ink, are not considered to be cosmetics.

Composition

A product whose composition indicates that it is an agent for treating, diagnosing, preventing, or mitigating a disease, disorder or abnormal physical state; or restoring, correcting or modifying organic functions in human beings falls within the definition of a drug as per the Food and Drugs Act. Products that exhibit therapeutic or pharmacological activity are not considered cosmetics.

Exosomes from other sources

Similar to human-derived products, a given topical product containing exosomes, extracellular vesicles and/ or conditioned media from non-human sources could be classified as a drug or cosmetic under the Food and Drugs Act depending on several factors including product-specific representation, level of action and composition.

Canadian regulatory context

Products that are classified as drugs under the Food and Drugs Act require authorization under the Food and Drug Regulations prior to sale. A "No Objection Letter" (NOL) from Health Canada is evidence of appropriate authorization for clinical trial use, while a Notice of Compliance (NOC) and Drug Identification Number (DIN) are evidence of appropriate authorization for general market distribution.

Health professionals and patients should be aware that there remain potential risks associated with using unauthorized products, including those that contain human-derived exosomes, extracellular vesicles or cell conditioned media, for therapeutic purposes. These include the risks from unsubstantiated therapeutic claims and potential toxic effects, as well as the risks present with all materials of human origin, specifically, the transmission of infectious diseases and adventitious agents.

Regulated parties must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Submission of a cosmetic notification to Health Canada does not constitute an approval for sale, an agreement that the product is classified as a cosmetic, nor that the product complies with all legislative requirements. It is the responsibility of the regulated party to ensure that a cosmetic meets the requirements of the FDA and the Cosmetic Regulations.

Health Canada encourages Canadians to report the potential non-compliant sale or advertising of exosome-based therapies or any health product in Canada using the online complaint form. Additionally, consumers can report any health or safety incidents related to the use of cosmetic products by filling out the Consumer Product Incident Report Form.

Consultation

A 75 day consultation period begins with the posting of this Notice. During this period, manufacturers, distributors of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media, and other stakeholders may submit comments on this classification approach, along with any other relevant information for Health Canada's consideration.

Annex

Information that may further inform Health Canada's management of these substances could include:

1. Reports, data, or concerns related to topical products containing exosomes (e.g. adverse events, consumer complaints, patient complaints)
2. Relevant scientific publications or studies regarding topical products containing exosomes and their effect on the body/function, mechanism of action of the final product and/or individual ingredients
3. Substances that may be contained in exosomes in a final topical product, and their function
4. Directions for use that can accompany topical products containing exosomes, including any advice for pre-treatment prior to application
5. Any additional relevant information