Health Canada continues its progress in revising the monographs for natural health products (NHPs), with the release of Batch 4a for consultation. This is part of the ongoing effort by the Natural and Non-Prescription Health Products Directorate (NNHPD) to ensure the accuracy and relevance of these vital regulatory tools for stakeholders in the natural health product industry.

What’s Included in Batch 4a?

The consultation for Batch 4a includes the release of 6 Homeopathic-like monographs, alongside 3 new monographs:

• Capsicum annum (Topical Use) – This monograph covers the topical use of Capsicum annum (commonly known as chili pepper) for its traditional medicinal properties, often used in pain relief formulations.
• Calendula officinalis (Topical Use) – Calendula, or marigold, is known for its skin-soothing properties and is frequently used in topical applications to treat minor skin irritations and wounds.
• Hamamelis virginiana (Witch Hazel) (Topical Use) – This monograph covers the traditional topical use of witch hazel, commonly used for its anti-inflammatory and astringent properties, often found in skincare products.

These new entries cover specific medicinal ingredients and offer updated guidelines that could impact product formulation and compliance.

How Long Do I Have to Comment?

The consultation period for Batch 4a runs from September 5, 2024, until October 2, 2024. During this time, stakeholders are encouraged to provide feedback and suggestions to help refine these monographs. If you are proposing changes, ensure that you support your input with published evidence or rationale for consideration by NNHPD.

What’s Coming in Batch 4b?

Looking ahead, Batch 4b, which includes 17 single-ingredient topical and buccal monographs, will open for consultation on November 1, 2024. This batch will focus on traditional plants used for topical and buccal applications, and the NNHPD is specifically seeking input on establishing reasonable concentration limits based on traditional use. The consultation for Batch 4b will run for 75 days, concluding on January 14, 2025.

Here are the instructions Health Canada provided for commenting:

1. Double-click on the folder in the language of your choice
2. Double-click on the monograph you would like to view
3. Click on Download in the top right corner
4. Open the downloaded version on your computer
5. The document may have a banner at the top that reads “PROTECTED VIEW”. Please click on Enable Editing
6. Click the Review tab in Word
7. Add any comments you have using the New Comment function
8. Save this version with your comments and send it back to us at: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Input is due by October 2, 2024.

Get Expert Advice: Our consultants are here to assist you in reviewing your products and ingredients and provide you with a tailored compliance strategy to help you be prepared for the upcoming monograph revisions. Don’t hesitate to get in touch today, and together, we can ensure your readiness for these important changes.