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Permitted vs. Not Permitted Pet Food Claims in Canada
SNI – February 10, 2026
Pet food claims in Canada follow a structured regulatory framework that ensures all statements on packaging, websites, and marketing materials are truthful, evidence based, and not misleading. Oversight is shared by the Competition Bureau, Canadian Food Inspection Agency (CFIA), and Health Canada, each of which plays a different role in evaluating...
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Health Canada Publishes 19 Updated NHP Monographs
SNI – February 5, 2026
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,...
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Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada
SNI – January 29, 2026
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...
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Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status
SNI – January 27, 2026
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...
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Health Canada vs. FDA: Regulatory Frameworks and Compliance
SNI – January 22, 2026
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....
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Creative Design for Regulated Products: Why It Is Different and Why It Matters
SNI – January 20, 2026
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...
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AAFCO Pet Food Standards Explained: U.S., Canada, and Europe
SNI – January 15, 2026
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...
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Health Canada Issues SOR/2025-248: A New Shortage Framework for Foods for a Special Dietary Purpose
SNI – January 13, 2026
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...
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Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements
SNI – January 8, 2026
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...
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January 2026: Health Canada Opens Consultation on Draft Guidance for Decentralized Clinical Trials
SNI – January 6, 2026
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...
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Selling Vitamins in Canada: In-Depth Review of Regulations and Licensing Considerations
SNI – January 6, 2026
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...
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Health Canada Proposes Changes to Medical Device Establishment Licensing (MDEL): What Importers, Distributors, and Manufacturers Need to Know
SNI – December 18, 2025
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...
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EU Cosmetic Labelling Requirements Under Regulation (EC) No. 1223/2009 | Regulatory Guide
SNI – December 16, 2025
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...
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How to Notify a Veterinary Health Product (VHP) in Canada: Avoiding Delays, Rejections, and Costly Mistakes
SNI – December 9, 2025
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,...
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Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know
SNI – December 4, 2025
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...
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Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase
SNI – December 2, 2025
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...
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CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance
SNI – November 27, 2025
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...
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Nutrition Facts Table Regulations in Canada: How to Meet the Requirements
SNI – November 25, 2025
General Overview of Nutrition Facts Table RegulationsMandatory Nutrients Declared in Nutrition Facts Tables (NFts)Rounding Rules for Nutrition Values in the Nutrition Facts TableReview of Key Nutrition Facts Table (NFt) ElementsThe Serving Size RequirementsServing Size for Single-Serving and Multi-Serving FoodsThe Role of Reference Amounts (RAs)Daily Value (DV) and Percent Daily Value...
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NHP Cost Recovery Paused: What NHP Companies Should Know
SNI – November 19, 2025
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...
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2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders
SNI – November 18, 2025
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...
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