Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has launched a 15-business-day consultation on a new draft Prebiotics Monograph for Natural Health Products (NHPs). Stakeholders have until February 20, 2026 to submit feedback.

This proposed monograph is intended to provide a compendial pathway utilizing pre-cleared information (PCI) for certain prebiotic ingredients, establishing clear expectations for permitted ingredients, claims, dosing, labelling, and risk information for on product licence applications (PLAs) forms (that could allow for the Compendial pathway if it is the only NNHPD Monograph leveraged in the application).

Scope & Purpose

The draft monograph serves as a regulatory guide for single-ingredient prebiotic NHPs intended for oral use in adults (18+). It distinguishes clearly between:

• Prebiotic claims (e.g., stimulating growth of healthy gut bacteria), and
• Fibre claims (e.g., digestive regularity),

stating these are separate concepts that must not be conflated on labelling. Not all fibres qualify as prebiotics, and fibre effects cannot be implied as prebiotic effects (or vice versa).

What Ingredients Are Covered?

The monograph includes a defined list of accepted medicinal ingredients and sources, including:

• Inulin (e.g., from chicory or Jerusalem artichoke)
• Acacia gum
• Fructooligosaccharides (FOS)
• Transgalactooligosaccharides (GOS)
• Xylooligosaccharides (XOS)
• 2′-Fucosyllactose (2′-FL)
• Lacto-N-neotetraose (LNnT)

Both plant-derived and certain synthetic/biosynthetic sources are described.

Permitted Uses & Dosing

The monograph proposes standardized uses such as:

• “A source of prebiotic(s)”
• “Helps stimulate the growth of healthy bacteria (such as bifidobacteria) in the gut”
• Fibre-related digestive health claims
• Gentle relief of constipation (for inulin, at specified doses)

Daily dose ranges vary by ingredient, for example:

Separate fibre and constipation claims have their own dose frameworks.

Important Regulatory Conditions

Key compliance points include:

• Single-ingredient focus: The monograph generally supports single-ingredient products. Combinations of listed ingredients are expected to be reviewed as Class III applications, except for the specific 2′-FL + LNnT combination under defined conditions.
• Directions for use: Products are to be taken with at least 250 mL of liquid and separated from other medications by a few hours. Additional instructions apply for powders and certain ingredients.
• Duration limits: Higher doses of some ingredients (e.g., acacia, XOS) trigger “ask a health care practitioner” statements for longer-term use.
• Risk information: GI effects (e.g., gas, bloating) and certain cautions/contraindications are specified for particular ingredients and uses.

Why This Matters

If finalized, this monograph would:

• Create a clear compendial route for a defined group of prebiotic ingredients
• Standardize how prebiotic vs fibre claims are assessed and labelled
• Clarify when products fall outside the monograph and require Class III evidence
• Set expectations for dose justification, labelling language, and safety statements

For companies developing digestive health products, especially those positioned around microbiome support, this is a significant step toward more structured oversight of prebiotic NHPs in Canada.

How to Participate

Stakeholders can submit comments on the draft monograph to NNHPD by February 20, 2026 via email to: nnhpd.consultation-dpsnso@hc-sc.gc.ca.

This consultation does not change current regulatory requirements yet, but it is a key opportunity to shape how prebiotic ingredients and claims will be regulated going forward.

Need Support?

dicentra supports companies with NPN strategies, monograph-based submissions, Class III applications, and label compliance for digestive health and microbiome-related products. If you’d like help assessing how the proposed Prebiotics Monograph may affect your formulations or pipeline, our team can provide regulatory and scientific guidance.