US

Veterinary dietary supplements are regulated as animal food and do not require pre-market approval. They are regulated by the FDA’s Center for Veterinary Medicine (CVM) which requires that manufacturers ensure their products are safe and properly labeled. Product labeling cannot make disease prevention or therapeutic claims and cannot make false or misleading claims. Products must be labeled for supplementation only and not as a substitute for food daily rations.

CANADA

Veterinary Health Products (VHPs) are low-risk drugs intended to promote and maintain the health and well-being of animals and not claim to treat, prevent, or cure a disease. Examples include vitamins, minerals, botanicals, and probiotics.

VHPs are regulated by Health Canada’s Veterinary Drugs Directorate (VDD) under the mandatory VHP Notification Program. Manufacturers, importers, and distributors are required to notify Health Canada (prior to importing a VHP in Canada and at least 30 days before making any changes or selling a VHP in Canada) and to comply with Good Manufacturing Practices (GMPs) under the Natural Health Products Regulations.

The notification process has two phases: the Admin Screening Stage and the Info Verification Stage. In the Admin Stage, the application has all the required information and is formatted in accordance with the program guidelines. Two opportunities are given to corrects any missings, with each request allowing 10 days to respond. When the application is considered “administratively complete“, it moves to the Info Verification Stage which has a performance target of 30 days to issue a regulatory decision. In this step, there will be a review of the claims, ingredients, doses and other details of the product to ensure it meets the program requirements. If there are any questions at this stage, only one request for clarification will be sent with a 7 days allowance to respond. Upon completion of this notification process, a Notification Number (NN) is issued which serves as the product market authorization.

Notifications for VHPs are charged a licensing fee of CAD 578 (as of April 1, 2025) regardless of the success of the application. Small businesses (registered with Health Canada) are eligible for a reduced fee.

How can we help?

Our regulatory team provides comprehensive support to assist with preparation and submission of VHP applications, including:

• Preparing complete and compliant applications.

• Verification of ingredients inclusion to Health Canada’s “List of Permitted Substances“ and “List C: Veterinary Health Products“.

• Submission of VHP notifications files and handling of regulatory responses and updates.

• Labeling review and technical support to ensure bilingual and regulatory compliance.