Classifying pheromone-based products for companion animals: Notice to stakeholders
Effective date: November 3, 2023
Some pheromone-based products are used for cats and dogs to reduce stress or calm them. This notice clarifies the classification of these types of pheromone-based products.
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Background
An animal creates and secretes chemical substances known as pheromones. These pheromones act as a chemical signal to members of the same species.
Pheromones are odourless but are detected across the nasal tissue in much the same way that we detect scents. An animal's vomeronasal organ detects these odourless compounds, which then signals to other areas of the body.
Pheromones, natural or synthetic, are used to make products that are applied to an animal's skin or to the environment around the animal. They're used to induce feelings of calmness and reduce stress-related behaviours.
These products come in a variety of forms, such as diffusers, environmental sprays, collars and topical creams.
Regulatory classification
Pheromone-based products meet the definition of a drug in the Food and Drugs Act. They're extracted pheromone chemicals or manufactured synthetic versions that change an animal's organic function by manipulating their mood and behaviour. As the definition of a drug does not include how it's administered, products used to treat the environment or objects within the animal's environment are included.
Veterinary health products (VHPs) are low-risk veterinary drugs that are provided in dosage form. They're not sold or represented for use to diagnose, treat, mitigate or prevent diseases, disorders or abnormal physical states. Rather, they're used for general health and wellness, and to promote or maintain an animal's organic function or health.
Products that promote feelings of calmness and relaxation or reduce stress caused by external stressors fit within this general health and wellness definition. For this reason, they may be eligible for notification under the VHP pathway.
Pheromone-based products that calm or reduce stress for dogs and cats have been used safely in Canada for several decades. We know the risk to animals or humans is low. These products have not previously been authorized through the VHP pathway. However, their low-risk nature along with their general health and wellness purpose make them eligible for the pathway.
Adding these products to the VHP pathway will ensure these products can be regulated in a manner that's aligned with the appropriate regulatory definition and level of risk.
Pheromone-based products combined with other active substances, such as steroids or other pharmaceutical ingredients, are not eligible for notification as VHPs. They would be considered veterinary new drugs and regulated under Division 8 of the Food and Drug Regulations. The same goes for products that reference anxiety, reproductive performance or other diseases or disorders.
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Next steps
To be notified as a VHP, all ingredients from the candidate products must be included on the List of Permitted Substances (LPS). A substance application is required as a first step if:
- any active or inactive ingredients are not on the list or
- an existing LPS entry requires changes
- for example, to add a new route of administration
A notification form for a proposed VHP may be submitted after all ingredients have been appropriately added to the LPS.
Because these products are classified as VHPs, product manufacturers and distributors will need to notify their product using this regulatory pathway.
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This process will take time. We are providing a transition period of 12 months from the date of this notice for these products to come into compliance.
Contact us
For questions about the classification of products used in animals, email the Veterinary Drugs Directorate: classification-vet@hc-sc.gc.ca.
For questions about the VHP notification process, email the VHP program: vhp-psa@hc-sc.gc.ca.
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