Final notice: Classification of topical products containing human-derived exosomes, human extracellular vesicles, or human cell-conditioned media

On this page

• Background
• Rationale for the classification approach
• Scope
• Classification considerations
• Canadian regulatory context
• Risks to health

Background

On August 14, 2025, Health Canada posted a notice to consult on how it intends to classify and regulate topical products at the cosmetic-drug interface that contain one or more of the following:

• human-derived exosomes
• human extracellular vesicles
• human cell-conditioned media

Health Canada received a total of 16 responses from:

• industry and industry associations
• health care professional associations and other health partners
• interested members of the public

We reviewed these responses and developed this final communication based on their feedback. We would like to thank everyone who provided comments.

Learn more:

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

Rationale for the classification approach

Classification is the first step in any regulatory process at Health Canada. The Food and Drugs Act 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). Details are outlined in the definitions of "drug," "device," "food" and "cosmetic" in section 2 of the Food and Drugs Act.

Learn more:

• Food and Drugs Act

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. Examples include tretinoin and corticosteroids.

In contrast, some substances are not inherent drugs, and can instead be used as ingredients in both drug products and cosmetic products. Examples include salicylic acid and alpha-hydroxy acids.

Based on available evidence to date, human-derived exosomes, human extracellular vesicles, and human cell-conditioned media are not inherent drugs. These ingredients have the potential to be used in both drug products and cosmetic products.

Several factors determine how a product is regulated, including product representation, level of action, and composition. A topical product containing human-derived exosomes, human extracellular vesicles, or human cell-conditioned media could be regulated as:

1. a drug product under the Food and Drugs Act, subject to the Food and Drug Regulations, or
2. a cosmetic product under the Food and Drugs Act, subject to the Cosmetic Regulations

Health Canada makes classification decisions based on available evidence at a point in time. Classifications may change if new scientific evidence or other pertinent information emerges.

Learn more:

• Guidance Document: Classification of Products at the Cosmetic-Drug Interface

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 one or more of the following:

• human-derived exosomes
• human extracellular vesicles
• human cell-conditioned media

Classification considerations

Product representation

"Representation" includes:

• indications of use
• package inserts
• advertisements
• claims on product labels presented as:
  • a word
  • a sentence
  • a picture
  • a symbol
  • a paragraph
  • an implication

Further, representations may be explicit or implied.

Products are classified as drugs if they are sold, manufactured, or represented for use in:

• treating, diagnosing, preventing, or mitigating a disease, disorder or abnormal physical state
• restoring, correcting or modifying organic functions in human beings

Products are also classified as drugs if they make therapeutic claims, such as:

• therapeutic, pharmacological or biological effects
• benefits comparable to the effects of cosmetical surgical procedures or drugs

Guidance on distinguishing between non-therapeutic/cosmetic claims and therapeutic/non-prescription drug & health product claims in advertising and labelling can be found in:

• Ad Standard's Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims

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, 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 when used according to manufacturer instructions

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.

Products are not consistent with cosmetics if they're represented to be administered in ways that would facilitate percutaneous absorption. For example, if product labels or package inserts indicate administration through microneedling or injection.

Products are not considered to be cosmetics if they're administered through injection (such as intramuscular, subcutaneous or intravenous). The only exception is tattoo ink.

Composition

A product falls within the definition of a drug as per the Food and Drugs Act if its 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

Products that exhibit therapeutic or pharmacological activity are not considered cosmetics.

Exosomes from other sources

A topical product containing exosomes, extracellular vesicles or conditioned media from non-human sources could be classified as either a drug or cosmetic under the Food and Drugs Act. This depends on several factors, including product-specific representation, level of action and composition.

Under the current Food and Drugs Act, natural health products are considered to be a subset of "drugs". Natural health products are regulated under the Natural Health Products Regulations. When applying the criteria for cosmetic vs. drug In this notice, the term "drug" includes natural health products.

This notice is not intended to assist in determining whether a drug is further sub-classified as a natural health product.

Canadian regulatory context

Drugs

Products classified as drugs under the Food and Drugs Act must be authorized by Health Canada before being sold under the Food and Drug Regulations.

Health Canada grants authorization for:

• clinical trial use with a "No Objection Letter" (NOL)
• general market distribution with a Notice of Compliance (NOC) and Drug Identification Number (DIN)

To verify the status of a drug product in Canada, read the product label to verify that Health Canada has authorized it for sale.

Authorized drugs have an 8-digit:

• Drug Identification Number (DIN)
• Natural Product Number (NPN), or
• Homeopathic Drug Number (DIN-HM)

You can also check if products have been authorized for sale by searching Health Canada's:

• Drug Product Database
• Licensed Natural Health Product Database

Learn more:

• Drug authorizing

Cosmetics

Regulated parties must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Submitting a cosmetic notification to Health Canada does not constitute:

• an approval for sale
• an agreement that the product is classified as a cosmetic
• an agreement that the product complies with all legislative requirements

The regulated party must ensure that a cosmetic meets the requirements of the Food and Drugs Act and the Cosmetic Regulations. Other requirements must be met where applicable, such as:

• legislation and guidance that may apply to cosmetics and cosmetic ingredients
• the Consumer Packaging and Labelling Act
• the Canadian Environmental Protection Act, 1999
• the Cannabis Act

To confirm if a cosmetic product has been notified to Health Canada, contact the manufacturer or use the contact information provided on the product.

Reporting

Health Canada classifies a product based on its function, purpose, and representation for use as established by the manufacturer. Any use by a health care professional outside the manufacturer's intended purpose falls outside Health Canada's jurisdiction. Report any concerns about a health care professional's activities to their professional licensing body.

Other reporting:

• Report potentially non-compliant sale or advertising of exosome-based health products.
• Report any health or safety incidents related to the use of cosmetic products.

Risks to health

Products containing human-derived exosomes, extracellular vesicles or conditioned media can pose risks to health in different ways. This includes:

• potential toxic effects
• the risk of unsubstantiated therapeutic claims for unapproved drug products
• the risks present with all materials of human origin
  • specifically, the transmission of infectious diseases and adventitious agents

Health Canada has risk-based regulatory frameworks to provide oversight of the drug and cosmetic products available for sale to people in Canada. This includes products with human materials. This lets Health Canada assess their safety, quality and efficacy to ensure they are acceptable for use according to the conditions of sale.