In Canada, Veterinary Health Product (VHP) claims must be supported by objective and credible evidence aligned with the product’s ingredients, conditions of use, and intended purpose. Claims should focus on maintaining or promoting animal health and must not represent the product as treating, diagnosing, mitigating, preventing, or curing disease.
Introduction
Introducing new products into the North American market requires careful planning across multiple disciplines, including product formulation, intended use, labelling, claims, and commercialization strategy. A successful launch depends on early alignment between the product’s market positioning and the regulatory requirements of each jurisdiction.
One of the most common challenges we see is that differences between regulatory frameworks are underestimated, particularly when companies are working under compressed timelines or responding to buyer pressure to enter a new market quickly. Veterinary Health Products (VHPs) are no exception.
Most companies understand that a notification number (NN) must be obtained before a VHP is sold in Canada. However, some are less prepared when Health Canada requests the information needed to support the product’s safety, efficacy, and claims.
Under the VHP framework, VHP claims should be supported by objective and credible evidence, and the evidence should be relevant to the product’s ingredients, conditions of use, target species, route of administration, and recommended dose. In other words, notification is only one part of compliance; companies should also be prepared to demonstrate that their product claims are appropriately substantiated.
At a Glance: VHP Claim Substantiation in Canada
VHP claims in Canada must remain within the scope of maintaining or promoting animal health and welfare. Claims that imply treatment, prevention, cure, mitigation, disease management, antimicrobial activity, parasite control, or other therapeutic effects may move the product outside the VHP pathway and trigger reassessment under a different regulatory framework.
Although substantiating evidence is not typically submitted to Health Canada at the time of VHP notification, companies should have objective and credible evidence available to support a reasonable expectation of effectiveness when the product is used as intended. This evidence should be relevant to the product’s active substances, List C conditions, target species, route of administration, recommended dose, conditions of use, and proposed claim wording.
For notifiers, the practical takeaway is that VHP notification is not a claim-free or evidence-free pathway. Before sale in Canada, companies should confirm that the product fits the VHP framework, the claims remain non-therapeutic, the evidence supports the product as formulated and represented, and the label, website, sell sheets, and other market-facing materials remain aligned with the notified VHP positioning.
- Understanding the Veterinary Health Product (VHP) Pathway in Canada
- What Claims Are Acceptable for Veterinary Health Products (VHPs) in Canada?
- What Evidence Is Needed to Substantiate VHP Claims?
- How Strong Does Evidence Need to Be?
- Why Species, Dose, and Route of Administration Matter for VHP Evidence
- Common Gaps in VHP Claim Substantiation
- How to Build a VHP Claim Substantiation File
- When a VHP Claim May Need Regulatory Reassessment
- How Source Nutraceutical, Inc. (SNI) Supports VHP Claim Substantiation in Canada
- FAQ: Health Canada Evidence Requirements for VHPs
Understanding the Veterinary Health Product (VHP) Pathway in Canada
Under Canadian regulations, VHPs are low-risk products sold in dosage form used to maintain or promote the health and wellness of companion and food-producing animals. They are regulated by Health Canada through the Veterinary Drugs Directorate (VDD) and are subject to the VHP Notification Program. Notifiers must note, VHPs are not intended to treat, prevent, or cure disease, which means their claims and overall product presentation must remain within the scope of general health support.
What Makes a Product a VHP?
A product’s eligibility for the VHP pathway depends on whether its active substance, conditions of use, and proposed claims align with Health Canada’s VHP framework. Health Canada’s List C, Veterinary Health Products, is central to this assessment because it identifies the substances permitted for use in VHPs and any applicable conditions, such as target species, route of administration, dose parameters, qualifiers, and mandatory label statements.
Substances or products that do not meet the VHP definition cannot be classified as VHPs and must either be reclassified under an appropriate product category or reformulated, relabelled, reclassified, or repositioned in a manner that realigns the product with the VHP pathway.
What Claims Are Acceptable for Veterinary Health Products (VHPs) in Canada?
The most important distinction in VHP claim substantiation is the difference between general health support and therapeutic claim language. Understanding which claims are acceptable within the VHP framework is essential to maintaining the product’s classification and avoiding unintended movement into a different regulatory category.
However, keeping claims within the VHP scope is only one part of compliance. Brands must also ensure that appropriate evidence is available to substantiate the product and marketing claims, and that the evidence aligns with Health Canada’s expectations for objective and credible support.
Before assessing the evidence required to substantiate VHP claims, it is, therefore, important to first distinguish between non-therapeutic general health support and therapeutic claims.
General Health Claims for VHPs
Under Health Canada’s VHP framework, non-therapeutic claims are those that remain limited to maintaining or promoting the health and welfare of animals, rather than treating, preventing, curing, or mitigating disease. Acceptable VHP-style claims are generally framed as general health support claims, such as “supports joint health,” “helps maintain normal digestive function,” or “supports skin and coat health,” provided they align with the product’s ingredients (substances), target species, route of administration, dose, and applicable List C conditions.
Claims That May Trigger Veterinary Drug Classification
The VHP pathway is not appropriate for pet products with therapeutic claims because it is intended for low-risk pet products. High-risk claims, or claims that do not meet the VHP definition, such as “treats arthritis,” “controls parasites,” “prevents infection,” or “reduces inflammation associated with disease,” can move the product outside the scope of a VHP and trigger reclassification as a veterinary drug.
In such cases, the product must be reassessed under a different regulatory framework, such as the veterinary drug framework, which applies distinct requirements proportionate to the risks associated with therapeutic claims and must be met prior to market entry.
What Evidence Is Needed to Substantiate VHP Claims?
As discussed above, all VHP health claims must be substantiated with appropriate evidence. Health Canada expects VHP notifiers to have objective and credible evidence to support a reasonable expectation of product effectiveness when the product is used as intended. For claim substantiation purposes, this means the evidence should be relevant to the specific product, active substance or substances, target species, route of administration, recommended dose, conditions of use, and proposed claim wording.
Objective and Credible VHP Evidence
A VHP claim should not be substantiated solely by general ingredient history of use, supplier marketing materials, consumer testimonials, or evidence that is not relevant to the product as notified.
In practice, acceptable substantiating evidence may include a combination of the following:
- Peer-reviewed animal studies
- Published scientific literature on the active substance
- Authoritative references
- Traditional medicine references
- Supplier or ingredient-specific study reports
- Product-specific data
Animal clinical trials or target-species studies may provide stronger support, particularly for more specific, measurable, or outcome-oriented claims, but they are not always required for general health support claims.
Ingredient-Specific Evidence
Ingredient-specific evidence should support the role of each active substance in maintaining or promoting animal health and welfare. The evidence should be assessed against the substance form, dose, route of administration, target species, and any applicable List C conditions.
For example, if a VHP contains a probiotic and makes a claim to “help support normal digestive function in dogs,” the substantiating evidence should support the use of that specific probiotic strain, or a sufficiently comparable strain or preparation, for digestive health in dogs. The evidence should also be assessed against the dose delivered by the finished product, the oral route of administration, the recommended duration of use, and any applicable List C conditions. A general reference showing that “probiotics support gut health” would not be sufficient on its own if it does not align with the substance form, species, dose, and claim being made.
Product-Specific Evidence
Product-specific evidence assesses the finished product as a whole, which is particularly important where the claimed effect depends on the combined formulation rather than a single active substance. This may include product-level efficacy or safety data, target-species studies, structured observational data, tolerance data, palatability or intake data where relevant, and stability information.
This type of evidence is especially useful where the product contains multiple active substances, where ingredient interactions may affect the expected outcome, or where the claim is specific, measurable, or tied to product performance. It helps demonstrate that the finished product, as formulated and marketed, can reasonably be expected to support the stated health claim when used as directed.
Claim-Specific Evidence
Claim-specific evidence should demonstrate that the available support matches the claim being made. For a broad claim such as “supports digestive health,” the evidence should show a reasonable connection between the product (or specific ingredients in the product) and normal digestive function.
If the claim becomes more specific, such as referencing a narrower effect, timeframe, or measurable outcome, the supporting evidence should be tied directly to that specific representation. In practice, the claim should not be more specific than the evidence can support, remaining within the scope of the available evidence.
How Strong Does Evidence Need to Be?
Once the relevant evidence has been identified, the next step is to assess whether it is sufficiently strong to support the claim as worded. For VHPs, this assessment should be proportionate to the nature of the claim. A broad general health support claim will generally require less direct evidence than a claim that is specific, measurable, time-bound, or closely tied to a defined product outcome.
Strength of Product-Specific Studies
Product-specific studies generally provide the strongest level of support because they assess the finished product, or a formulation that is sufficiently comparable to the product being marketed. This type of evidence is particularly useful where the claimed benefit depends on the combined effect of multiple active substances, rather than the role of one ingredient in isolation.
Product-specific studies are not always necessary for general health support claims. In many cases, VHP claims may be substantiated using published evidence that supports the medicinal ingredients and their functions, provided the evidence is relevant to the product formula and the intended use.
Strength of Published Literature and Scientific References
Published literature and scientific references may provide appropriate support where they are sufficiently relevant to the product and the claim being made. The strength of this evidence depends on how closely it aligns with the substance used in the product, including its form, specifications, and intended conditions of use.
Evidence that closely reflects the product’s formulation and use conditions will generally carry more weight than evidence that requires significant extrapolation. Where extrapolation is necessary, the rationale should be clearly documented and scientifically justified, particularly where the evidence is drawn from another species, a different substance form, a different dose range, or materially different conditions of use.
Strength of Traditional Use, Supplier Data, and Other Supporting Evidence
Traditional use references, supplier data, ingredient-specific reports, and technical documentation may support the overall evidence package, but they should be reviewed based on their quality and relevance. These sources may be useful where they help establish known use, expected function, or supporting rationale for the substance.
However, they should not be treated as equivalent to well-matched product-specific or target-species evidence unless the underlying data supports that level of reliance or reflects the claim scope. Supplier documentation should be assessed for study design, test substance, species, dose, route of administration, measured outcomes, and applicability to the finished product.
Insufficient VHP Evidence
Certain types of information are generally too limited to support VHP claims on their own. This includes the following:
- Consumer testimonials
- Anecdotal reports
- Social media reviews
- General ingredient popularity
- Unsupported marketing materials
- Evidence that does not correspond to the claim being made
These materials may provide commercial insight, but they do not usually provide a sufficient basis for claim substantiation. Where the available evidence is limited or indirect, the claim should be revised so that it remains appropriately general and does not exceed the strength of the available support.
Why Species, Dose, and Route of Administration Matter for VHP Evidence
Species, dose, and route of administration are critical to determining whether the evidence relied upon is applicable to the product being notified. These factors affect how the product is used, how the active substance is delivered, and whether the claim remains aligned with the product’s conditions of use under the VHP framework.
VHP Evidence for the Target Species
Evidence should be relevant to the species for which the product is intended. Data generated in one species should not be automatically applied to another without a clear scientific rationale, particularly where there are differences in metabolism, physiology, diet, body size, or safety considerations.
For example, studies conducted in mice may not be directly applicable to dogs or cats due to inherent metabolic, physiological, and size-related differences. However, where a strong scientific rationale is provided as part of the evidence package, and the rationale clearly explains how those differences have been considered, the data may still play a supporting role in the overall substantiation file.
Dose and Duration of Use
The product should deliver an amount of active substance that is consistent with the evidence supporting the claim. If the finished product provides a lower dose than the evidence relied upon, the claim may need to be revised or further justified. Duration of use should also be considered, especially for claims that include a timeframe or imply an observable effect within a defined period.
Oral, Topical, In-Water, and In-Feed Products
Route of administration affects delivery, exposure, and product performance. Evidence generated for one route should not be assumed to support another unless scientifically justified. Oral, topical, in-water, and in-feed products each present different considerations, including daily intake, site of application, consumption variability, feed processing, palatability, and consistency of use.
Common Gaps in VHP Claim Substantiation
Claims That Are More Specific Than the Evidence Supports
One of the most common gaps is using general evidence to support a more specific claim. For example, evidence that supports a broad digestive health benefit may not be sufficient to support a time-bound, measurable, or outcome-specific claim. Where the evidence does not directly support the level of specificity used in the claim, the wording should be revised to remain within the scope of the available support.
Human or Natural Health Product (NHP) Evidence Used Without Justification
Evidence from human natural health products (NHPs) may be useful as part of a broader scientific rationale, but it should not be applied to a VHP claim without justification. Differences in species, metabolism, dose, route of administration, and intended use can affect whether the evidence is relevant. Where human or non-animal data is used, the rationale for applying it to the target animal species should be clearly documented and scientifically justified.
Missing Dose, Species, or Route Relevance
A substantiation file may include credible evidence but still fall short if it does not align with the product’s dose, target species, or route of administration. Evidence based on a different species, materially different intake level, or different route of administration may require additional justification or may support only a more limited claim. These gaps should be identified early, as they often affect both claim wording and product directions for use.
Marketing Claims That Go Beyond the Notification
Another common gap occurs when the notified claim is appropriately framed, but the product is later promoted using stronger language in marketing materials. Websites, product listings, social media posts, sell sheets, and retailer materials can all influence how the product is represented and perceived once in the market. If these materials introduce therapeutic, disease-related, comparative, or unsupported performance claims, the product may move outside the scope of the original VHP positioning and require reassessment.
How to Build a VHP Claim Substantiation File
The purpose of a VHP substation file is to create a clear internal record showing why the claim is appropriate for the product and how it is supported.
Ingredient and VHP Formula Rationale
The evidence portfolio should include a rationale for each active substance and its role in the finished product. This should address why the substance is included and how it relates to the proposed claim. Where the formula contains multiple active substances, the rationale should also explain whether the claim is supported by individual ingredient evidence, the combined formulation, or both.
Evidence Summary for Each VHP Claim
Each claim should have a corresponding evidence summary that identifies the supporting references or data and explains how they apply to the claim. The summary should not simply list studies; it should briefly explain how the evidence supports the proposed wording, including any limitations, extrapolations, or assumptions that affect the strength of support, and how they are accounted for with the presented evidence.
Label and Marketing Claim Review
The substantiation portfolio should include a review of the claims used on the product label and related marketing materials. This helps confirm that the product’s market representation remains consistent across consumer-facing materials and does not introduce unsupported, therapeutic, comparative, or otherwise higher-risk claims beyond the intended VHP positioning.
Internal Regulatory Justification
An internal regulatory justification should document why the product and its claims are considered appropriate for the VHP pathway. This justification should summarize the classification rationale, relevant List C considerations, claim boundaries, evidence support, and any conditions or limitations that should be maintained throughout the product’s lifecycle.
When a VHP Claim May Need Regulatory Reassessment
A VHP claim may need regulatory reassessment when the product’s market representation changes in a way that affects its classification, claim scope, or conditions of use. This may occur when new claims are added, existing claims are strengthened, the target species or route of administration changes, or marketing materials begin to imply a therapeutic purpose beyond the notified VHP positioning.
Disease, Treatment, Prevention, or Cure Claims
Claims that state or imply treatment, prevention, cure, or mitigation of a disease or abnormal physical state should be reassessed before use. Where a claim moves from general health support into disease management, the product may no longer be appropriate for the VHP pathway and may require re-assessment.
Antimicrobial, Anti-Inflammatory, or Behavioural Claims
Claims related to antimicrobial activity, anti-inflammatory effects, pain relief, parasite control, sedation, tranquilization, or treatment of behavioural conditions should be reviewed carefully. These claim areas may suggest a therapeutic purpose or fall within categories that Health Canada excludes or limits under the VHP Notification Program. Lower-risk support language may be possible in some cases, but the wording, substance, species, route, dose, and List C conditions should be assessed before the claim is used.
Claims for Food-Producing Animals
Claims for food-producing animals may require additional considerations because of factors such as species eligibility, food safety, residues, withdrawal periods, feed-related use, and potential implications for production-related outcomes. Under the VHP framework, Health Canada expects VHP claims to remain limited to general health support. Claims are generally not appropriate where they relate to the treatment, prevention, or cure of disease, or where they imply production enhancement. Accordingly, claims for cattle, poultry, swine, or other food-producing animals should be reviewed carefully before market entry or expansion to confirm alignment with applicable VHP requirements and conditions of use.
How Source Nutraceutical, Inc. (SNI) Supports VHP Claim Substantiation in Canada
Source Nutraceutical, Inc. (SNI) supports companies with VHP claim substantiation by assessing whether proposed claims are appropriately classified, supported, and aligned with Health Canada’s VHP requirements.
VHP Eligibility and Claim Review
SNI can assess whether the product fits the VHP pathway and whether its claims remain limited to maintaining or promoting animal health and welfare.
VHP Evidence Gap Assessment
SNI can review the available evidence to identify gaps related to claim wording, evidence relevance, formula alignment, List C conditions, species, dose, route of administration, or missing technical documentation.
VHP Notification and Label Compliance Support
SNI can support VHP notification preparation and review product labels, websites, sell sheets, and other market-facing materials for alignment with the notified information and Canadian VHP requirements.
Book an introductory call using the following form:
FAQ: Health Canada Evidence Requirements for VHPs
What evidence is required to substantiate Veterinary Health Product (VHP) claims in Canada?
VHP claims in Canada should be supported by objective, credible, and relevant evidence demonstrating a reasonable expectation of effectiveness when the product is used according to its intended conditions of use. Supporting evidence should align with the product’s active substances, Health Canada List C conditions, target animal species, recommended dose, route of administration, product formulation, and proposed claim language.
Are animal clinical trials required to support Veterinary Health Product (VHP) claims in Canada?
Animal clinical trials or target-species studies can provide strong substantiation for VHP claims, especially when claims describe specific, measurable, or outcome-based health effects. However, clinical trials are not always required for general health maintenance or wellness claims if other reliable scientific evidence adequately supports the product’s intended use and claim scope.
Can human natural health product (NHP) evidence be used for Veterinary Health Product (VHP) claims?
Evidence from human natural health products (NHPs) may help support the scientific rationale for a VHP, but it should be carefully justified before being applied to animals. Differences in animal species, physiology, metabolism, dosage, route of administration, and intended use should be evaluated to determine whether human evidence is relevant for VHP claim substantiation.
What types of claims are allowed for Veterinary Health Products (VHPs) in Canada?
Permitted VHP claims in Canada are generally limited to supporting, maintaining, or promoting animal health and wellness. VHP claims should remain non-therapeutic and should not state or imply that the product treats, prevents, cures, mitigates, or manages a disease or medical condition.
What claims can cause a Veterinary Health Product (VHP) to be regulated as a veterinary drug?
Claims that suggest therapeutic effects, disease treatment, disease prevention, antimicrobial action, parasite control, or management of a medical condition may move a product outside the VHP pathway. Examples include claims such as “treats arthritis,” “controls parasites,” “prevents infection,” or “reduces inflammation associated with disease,” which may trigger reassessment under Canada’s veterinary drug regulatory framework.
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