Canada Regulatory Status
Regulatory Agency
Health Canada. Click here to access the site.
Regulatory Category(ies)
Conventional Food
Natural Health Product
Veterinary Health Product
Prebiotic Types
Conventional Food
Acacia, Inulin, Resistant Starch, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Glucan, Isomaltooligosaccharides (IMO)
Natural Health Product
Inulin, Resistant Starch, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Glucan, Isomaltooligosaccharides (IMO)
Veterinary Health Product
Acacia, Inulin, Resistant Starch, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Xylooligosaccharides (XOS), Lactulose, Glucan, Pectin, Polyphenol
Fiber Definition
Conventional Food
- Carbohydrates with a degree of polymerization (or number of sacchride units) of 3 or more that naturally occur in foods of plant origin and that are not digested and absorbed by the small intestine; and
- Accepted novel fibres: Novel fibres are ingredients manufactured to be sources of dietary fibre and consist of carbohydrates with a degree of polymerization of 3 or more that are not digested and absorbed by the small intestine. They are synthetically produced or are obtained from natural sources which have no history of safe use as dietary fibre or which have been processed so as to modify the properties of the fibre contained therein. Accepted novel fibres have at least one physiological effect demonstrated by generally accepted scientific evidence.
- Accepted dietary fibre sources are permitted in all unstandardized foods, except infant formula unless stated otherwise
- Dietary fibres are not permitted in standardized foods, unless a provision for their addition is made in the Food and Drug Regulations
- List of non-novel determinations for food and food ingredients (see: https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/requesting-novelty-determination/list-non-novel-determinations.html)
- Completed safety assessment of novel foods, including genetically modified foods (see: https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products.html#table)
- For example, D-tagatose has been approved as a novel food for use as food and sweetening ingredient in order to fully or partially replace existing added sugars. Cross-referenced research shows that it provides a prebiotic effect
Natural Health Product
- No specific definition. See “Prebiotic Types”
Veterinary Health Product
Position on "Prebiotic Claim"
Conventional Food
- Considered an implied health claim. Traditional fibres and accepted novel fibres, as any other foods, can carry health claims that are truthful and not misleading. This means that a health claim made about a beneficial effect of a specific dietary fibre source requires substantiation specific to this fibre source.
- A novel fibre product with a demonstrated recognized fibre effect is primarily a source of nutrient (dietary fibre) and does not automatically qualify to carry a health claim. Thus, the demonstrated physiological effect should not be considered as a reviewed and accepted health claim.
- Dietary fibre claims do not require Health Canada assessment prior to sale, but certain health claims (i.e., therapeutic or disease-related) are subject to mandatory pre-market review by the Food Directorate of Health Canada
- Note that the term ‘prebiotic’ must not be made in conjunction with a fibre claim in such a way as to imply that all fibres are prebiotics
- Health claims that are not therapeutic or disease-related in nature (i.e., prebiotic) do not require pre-market approval, but are still subject to the same standard of evidence. Manufacturers are expected to have in-house evidence substantiating the health claim should they be questioned by enforcement agencies. Voluntary submission is encouraged.
Natural Health Product
- Acceptable and/or pre-cleared health claim, depending on the source and substantiating evidence
Veterinary Health Product
- Acceptable health claim, depending on the source and substantiating evidence
Rationale if not permitted (Include Reference / Regulation)
Not applicable
Facts Panel Declaration (per category)
Conventional Food
- The amount of dietary fibre is one of the 13 core nutrients that must be declared in the Nutrition Facts Table (NFT)
- The amount of dietary fibre naturally occurring in foods and the amount of dietary fibre from accepted novel fibre sources are both included as part of the total dietary fibre declaration
- The amount of both soluble and insoluble fibre may be separately declared as additional information
- The energy value of 2 kcal (8 kJ)/g must be included in the caloric declaration
Approved Health Claim(s)
Conventional Food
- Only content claims around dietary fibre are acceptable depending on dose. Health claims require pre-market submission
Natural Health Product
Pre-cleared Claims
- Source of fibre for the maintenance of good health– Helps support and maintain a healthy digestive system
- Helps stimulate the growth of healthy bacteria (such as Bifidobacteria) in the intestine/gut
- Prebiotic
Helps provide gentle relief of constipation and/or irregularity
(Inulin Monograph, 2013)
Novel, propreitary or ingredients/products which go beyond the pre-cleared information:
- Assessed on a case by case basis based on the risk level of claims and the evidence submitted.
- The Licensed Natural Health Database (LNHPD) contains information (including approved claims) about NHPs that have been issued a product licence by Health Canada through pre-cleared information or substantiating evidence.
- A search on LNHPD for “prebiotic” as a recommended use yeilds various licensed products, the most recent being Bimuno GOS with 10 health claims.
Veterinary Health Product
- No pre-cleared claims
- Example of an approved claim: Fortified with prebiotics to support the growth and activity of the beneficial bacteria in your pet’s gut
- To access List of Notified Products and their recommended use: https://health-products.canada.ca/vhp-psa/en/product-list
Dose Specifics
Conventional Food
- 2 g per serving = Source of fibre
- 4 g per serving = High source of fibre
- 6 g per serving = Very high source of fibre
Natural Health Product
- Refer to monographs for pre-cleared health claim doses.
- Qualtity restriction for non-medicinal ingredients (500 mg/24 hours): Fermentable carbohydrates that are present in sufficient quantity or with the intention of selectively influencing endogenous host microflora are considered to be prebiotics and must be declared as medicinal ingredients. Fermentable carbohydrates may be considered non-medicinal in quantities exceeding the limits indicated in the NHP Ingredients Database in non-compendial submissions if accompanied by a suitable scientific justification.
Regulatory Submission
Conventional Food
- Exclusive to prebiotic type / generic approval, Health claim submission
Natural Health Product
- Exclusive to prebiotic type / generic approval, Finished Product approval, Concurrent review of health claims
Veterinary Health Product
- Exclusive to prebiotic type / generic approval, Finished Product approval
Claims Substantiation
Conventional Food
- Scientific evidence is required to substantiate a food health claim prior to its use (https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims.html)
- Guidance Documents for Preparing Health Claim Submissions (https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/guidance-documents-preparing-submission-food.html)
- Guidance Document for Preparing a Submission for Food Health Claims (https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-document-preparing-submission-food-health-claims-2009-1.html)
- Guidance Document for Preparing a Submission for Food Health Claims Using an Existing Systematic Review (https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-document-preparing-submission-food-health-claims-2011.html)
Natural Health Product
- A risk-based assessment approach is used to categorize evidence recommendations into threelevels of risk: low, medium, and high. These levels are proportionate to the standard of evidencenecessary to support safety and efficacy of a product.
- Pathway for Licensing Natural Health Products Making Modern Health Claims (https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html)
- Pathway for Licensing Natural Health Products used as Traditional Medicines (https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-traditional-medicines.html)
Veterinary Health Product
- VHPs are low risk drugs in dosage form. They are used to maintain or promote the health and welfare of companion and food-producing animals. They are not for use to treat, prevent or cure disease.
- Evidence should support the key aspects of validity and be appropriate for the recommended conditions of use. Companies should hold evidence in line with these guidelines before claiming an intended use or indication for the product. This evidence may be requested and evaluated by health Canada where a safety concern arises, claims appear to be misleading, or in response of a complaint
Regulatory Approval Process
Conventional Food
- Novelty Determination Information Form (NDIF), Novel Food Notification, Health Claim Submission, if/where applicable
Natural Health Product
- Natural Health Products Ingredients Database (NHPID) Issue Form (if not listed in the NHPID)
- Product Licence Application (PLA) (health claim submission and approval as part of this dossier)
Veterinary Health Product
- Addition to List C via New Substance Application form
- VHP Notification
Post-Approval Process (i.e., Amendment and Renewal)
Natural Health Product
- Amendment, Notification
Veterinary Health Product
- Must notify of intent to make changes to notified VHP at least 30 days before making the change. Depending on type of change, a new Notification Number may be generated
Enforcement Practice
Conventional Food
- Food Directorate of Health Canada and/or Canadian Food Inspection Agency (CFIA)
Natural Health Product
- Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada
- Regulatory, Operations and Enforcement Branch (ROEB)
- Marketed Health Products Directorate (MHPD)
Veterinary Health Product
- Veterinary Drugs Directorate (VDD)
Link to Reference Documents
If you have updated information for this page, please submit it to Regulatory Lead Tania John for review: tjohn@nutrasource.ca. Thank you.