Blog

If you have ever worked on a regulated product launch and assumed that packaging would be a relatively straightforward final step, the complexity likely became apparent very quickly. In regulated prepackaged consumer product categories, packaging is not a decorative layer added at the end of development. It is a regulated...

Pet food labels are dense with nutrition claims, life-stage statements, and references to Association of American Feed Control Officials (AAFCO), yet the meaning behind those references is often unclear. Misunderstandings around AAFCO’s role are common, particularly when its name is associated with concepts such as approval, certification, or regulatory oversight that it does...

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...

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...

In 2025, Health Canada has released a draft guidance on decentralized clinical trials, now opening a public consultation that runs until February 21, 2026. This update represents a key milestone in Canada’s ongoing clinical trials modernization initiative and provides long-awaited regulatory clarity for sponsors and investigators planning decentralized or hybrid...

Vitamins are among the most widely used consumer health products in Canada, yet their regulatory oversight is frequently underestimated. While often perceived as low-risk supplements, vitamins sold for health purposes are regulated as Natural Health Products (NHPs) and are subject to a comprehensive oversight framework administered by Health Canada. This framework governs every stage...

On November 8, 2025, Health Canada published proposed amendments to the medical device establishment licensing framework in the Canada Gazette, Part I. The consultation is open for stakeholder feedback until January 17, 2026. If you hold, or are planning to apply for, a Medical Device Establishment Licence (MDEL), these proposed changes...

Entering the European Union (EU) cosmetics market requires more than a strong formulation. It demands precise alignment with the EU’s labelling framework, where compliance expectations are centralized, highly technical, and actively enforced. Regulation (EC) No. 1223/2009 establishes harmonized requirements to protect consumers, support product traceability, and ensure transparent, consistent communication...

Veterinary Health Products, commonly referred to as VHPs, are regulated in Canada as low-risk drugs under the Food and Drugs Act and the Food and Drug Regulations. Within this framework, VHPs are finished, ready to use products sold in a "dose” format, such as tablets, capsules, liquids, powders, pastes, chews,...

Health Canada has begun a new consultation on proposed revisions to the Cosmetic Ingredient Hotlist, opening the door to significant changes in how cosmetic ingredients are reviewed, classified, and permitted for use in Canada. The consultation period runs from November 19th, 2025, to February 17th, 2026, marking a critical window for industry to...

On November 20th, 2025, Health Canada released a new proposal signalling its intention to authorize exo-inulinase from Trichoderma reesei strain AR 577 as a permitted food enzyme in Canada. If the proposal moves forward, the change would be implemented through an update to the List of Permitted Food Enzymes following a public consultation period that closes on February 3rd, 2026.  The List of...

Corrective and Preventive Actions (CAPA) sit at the centre of every strong and dependable quality system in the natural health product (NHP) space. Whether you manufacture, package, label, import, or distribute NHPs, in Canada or internationally, CAPA demonstrates that you can recognize issues early, correct them effectively, and establish controls that prevent them from recurring...

The natural health products (NHP) sector in Canada continues to evolve as Health Canada progresses toward a modernized, risk-based regulatory framework. Many industry stakeholders have been monitoring the proposed cost recovery initiative with a tentative target implementation date of December 1, 2025. Health Canada has confirmed that this implementation date...

When Health Canada released Version 4.0 of the Good manufacturing practices guide for natural health products (GUI-0158) on September 4, 2025, it marked the first major revision of good manufacturing practices (GMP) expectations in a decade. The new guide, which will become enforceable on March 4, 2026, following a six-month...

A product label is often the first interaction a consumer has with a brand. It captures attention, communicates purpose, and conveys trust within seconds. However, a label’s success depends on more than just good design; it must also comply with strict regulatory standards. In Canada, where bilingual labelling, standardized Nutrition...

Please note that Health Canada officially ended the Foreign Site Reference Number (FSRN) process on February 16, 2026. The Department determined that the mechanism was no longer necessary and has consolidated the review of foreign site Good Manufacturing Practices (GMP) evidence within the existing site licensing pathway. Any new FSRN...

Importing pet food into Canada demands rigorous oversight, meticulous documentation, and consistent traceability. Under the jurisdiction of the Canadian Food Inspection Agency (CFIA), finished pet food, treats, and chews destined for the Canadian market must satisfy admissibility criteria based on species, ingredient origin, processing standards, and disease-control safeguards.  These rules reflect Canada’s...

As part of the upcoming Plain Language Labelling (PLL) requirements for Natural Health Products (NHPs) sold in Canada, Health Canada has introduced several flexibilities to help manufacturers address the challenges of fitting standardized Product Facts Table (PFT) content on small or uniquely shaped packaging. These flexibilities provide alternative approaches for...

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously.  In Canada, MDSAP serves as the recognized mechanism...

On October 17th, Health Canada has confirmed it will implement the ICH E6(R3) Good Clinical Practice (GCP) guideline, a major international update to the way clinical trials are designed, managed, and documented. The goal is to strengthen participant safety, improve data quality, and modernize how clinical research is conducted in Canada. ...