On July 25, 2025, Health Canada published six new Natural Health Product (NHP) monographs, along with minor revisions to five existing monographs. These updates form part of Health Canada’s ongoing effort to align the Natural Health Products Ingredients Database (NHPID) and related monographs with the latest scientific evidence, safety considerations, and regulatory requirements under the Natural Health Products Regulations.
For industry stakeholders, these changes are significant because they directly affect product formulation, labelling, evidence requirements, and market compliance. Companies with existing or pending product licences referencing these monographs should review the updates carefully to determine whether amendments to Product Licence Applications (PLAs) or product labelling will be necessary.
New Monographs
The following new monographs were published:
Green Tea Extract
Originally introduced in Batch 1 and subsequently revised after a second consultation in Batch 3, the updated Green Tea Extract monograph refines source material definitions, aligns permitted claims with current safety data, and clarifies quantity and potency ranges. These changes directly affect products containing Camellia sinensis preparations, particularly those making antioxidant or weight management claims.
Hydrocortisone – Topical
This new monograph establishes parameters for the safe and effective use of topical hydrocortisone in NHPs. It specifies maximum allowable concentrations, permitted uses, and cautionary statements. While hydrocortisone already has defined restrictions in Canada, this monograph standardises a compliance pathway for certain dermatological claims.
Serrapeptase
The Serrapeptase monograph defines source material requirements, permitted activity units, dosage ranges, and required risk statements, with an emphasis on enzyme activity standards and contraindications.
L-Carnitine
This dedicated monograph outlines permitted sources, dosage ranges, combination rules, and permissible claims. L-carnitine is also included in several of the revised monographs, meaning its regulatory framework has been comprehensively updated.
Ginkgo biloba
The updated Ginkgo biloba monograph clarifies extract standardisation requirements, removes certain extract ratio specifications to increase flexibility, and refines risk statements regarding drug interactions and bleeding risk. It also aligns with updates made to the Cognitive Function Products monograph.
Aromatherapy
This new monograph provides specifications for essential oils used in aromatherapy, including quality standards, permitted claims, and cautionary statements. Safety concerns addressed include dermal sensitisation, inhalation toxicity, and interactions with other therapies.
Revisions to Existing Monographs
Dandelion
The Dandelion monograph were updated to revise combination rules and clarify permitted ingredient pairings.
Workout Supplements
Revisions include:
- Addition of a combination rule when L-carnitine is combined with acetylcarnitine at Class II and III.
- Addition of L-carnitine as a source ingredient for L-carnitine.
- Exclusion of pregnancy-related uses or purposes from the Multi-vitamin/mineral Supplements monograph when marketed as workout supplements, as pregnancy caution statements are required.
- Inclusion of the missing minimum single dose for caffeine.
- Adjustment of duration of use statements for L-arginine to ensure proper validation.
L-Arginine
The L-Arginine monograph had its duration of use statements revised to ensure claims are supported by appropriate evidence.
Antioxidants
Revisions include adding L-carnitine as a permitted source ingredient, updating common names for green tea extract to align with the revised monograph and NHPID, and adjusting quantity information for green tea extract. Additional changes include:
- Addition of quantity parameters for Goji (Lycium barbatum) preparations and associated risk statements regarding drug interactions.
- Addition of a combination rule for alpha-lipoic acid to align with the single ingredient monograph.
- Addition of a combination rule when L-carnitine is combined with acetylcarnitine at Class II and III.
- Cross-referencing the single monograph for Haematococcus pluvialis in Tables 6 and 7.
Cognitive Function Products
Updates include adding synthetic source information for L-5-HTP and theobromine, removing the extract ratio for Ginkgo biloba to increase formulation flexibility, and adding a combination rule when acetylcarnitine is combined with L-carnitine at Class II and III.
Compliance Implications for Industry
These monograph updates have both compliance and commercial implications. Manufacturers should review product formulations to confirm that ingredient sources, dosages, and combinations meet updated specifications. Labelling may require changes to reflect new cautionary statements, revised duration of use limits, or updated risk information.
Claims should be reassessed to ensure they align with revised permitted purposes. Amendments to PLAs should be submitted where products currently reference outdated ingredient specifications or combination rules.
Proactively implementing these updates will help companies maintain compliance, avoid enforcement action, and preserve lawful market access under the Natural Health Products Regulations.
To learn how Source Nutraceutical Inc. can support your team with regulatory planning, product reformulation, or cross-border labelling compliance, contact us today. Our experts are here to help ensure your food products remain competitive, compliant, and market ready.
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