March 2026: Health Canada Updates 11 NHP Monographs 

March 2026: Health Canada Updates 11 NHP Monographs 

Health Canada has published 11 updated natural health product (NHP) monographs effective March 27, 2026, continuing its modernization of the monograph framework under the Natural Health Products Regulations.  The latest publication includes updates to the monographs for cayenne (oral), cayenne (topical), cranberry, dried cranberry juice, devil’s claw, European pennyroyal, horseradish, Roman chamomile, stinging nettle,…
Read More
Health Canada Transitions NHP Site Licence Submissions from ePost Connect to LiquidFiles: What Companies Need to Do Now

Health Canada Transitions NHP Site Licence Submissions from ePost Connect to LiquidFiles: What Companies Need to Do Now

On March 30, 2026, Health Canada has introduced an important operational change for Natural Health Product (NHP) site licence submissions. Through Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 11, the Health Product Compliance Directorate confirmed that it is transitioning away from ePost Connect and moving…
Read More
Webinar Recap: Health Canada GMP (GUI-0158 v4.0) Update for NHPs

Webinar Recap: Health Canada GMP (GUI-0158 v4.0) Update for NHPs

In our recent webinar, our team provided a detailed overview of Health Canada’s updated Good Manufacturing Practices (GMP) Guide for Natural Health Products (GUI-0158 v4.0) and the practical implications for companies operating in the Canadian market. The session focused on how the revised guidance reshapes expectations for quality systems, importer accountability, and end-to-end supply chain…
Read More
Health Canada Ends the NHP FSRN Process in Canada 

Health Canada Ends the NHP FSRN Process in Canada 

On February 16, 2026, the Health Product Compliance Directorate released Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10, confirming the end of the Foreign Site Reference Number (FSRN) process and clarifying the regulatory treatment of foreign warehouses. This update marks a significant shift in how Good…
Read More
Health Canada Publishes 19 Updated NHP Monographs

Health Canada Publishes 19 Updated NHP Monographs

Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has officially published 19 updated Natural Health Product (NHP) monographs as part of the January 30, 2026 load. These updates affect a wide range of botanical ingredients, amino acids, and commonly used actives across the Canadian NHP market. For regulatory teams,…
Read More
Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 

Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 

Unexpected laboratory results are an unavoidable reality in natural health products (NHPs) manufacturing. A potency value that does not match historical performance, a microbial result that sits uncomfortably close to its limit, or a chromatographic profile that looks unfamiliar can all signal that something requires closer attention. These results do not automatically…
Read More
Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

Health Canada has officially updated the Prescription Drug List to clarify the non prescription status of nicotine buccal pouches containing 4 milligrams of nicotine or less per dosage unit. This change provides long awaited clarity for manufacturers, importers, and retailers entering the rapidly growing nicotine pouch category. The amendment, effective…
Read More
Health Canada vs. FDA: Regulatory Frameworks and Compliance 

Health Canada vs. FDA: Regulatory Frameworks and Compliance 

Regulatory compliance in Canada requires adherence to federal, provincial, and, in some cases, municipal legislation governing the safety, quality, and labelling of products placed on the Canadian market. Health Canada administers the regulation of a broad range of products primarily under the Food and Drugs Act and its associated Food and Drug Regulations.…
Read More
Health Canada Issues SOR/2025-248: A New Shortage Framework for Foods for a Special Dietary Purpose 

Health Canada Issues SOR/2025-248: A New Shortage Framework for Foods for a Special Dietary Purpose 

On December 17, 2025, Health Canada published SOR/2025-248, Exemption Order in Respect of Foods for a Special Dietary Purpose in the Canada Gazette, Part II. This Order creates a formal mechanism to help maintain access to medically important nutrition products when Canada faces a shortage or risk of shortage. It also supports continued market access for…
Read More
Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements 

Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements 

On November 25, 2025, Health Canada published a Notice of Modification updating the List of Permitted Supplemental Ingredients to expand the permitted use of caffeine and introduce a new mandatory cautionary statement for certain high-caffeine solid supplemented foods.  If you manufacture, import, or private label functional gummies, caffeinated candies, or other solid…
Read More