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…
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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.…
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Creative Design for Regulated Products: Why It Is Different and Why It Matters 

Creative Design for Regulated Products: Why It Is Different and Why It Matters 

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  

AAFCO Pet Food Standards Explained: U.S., Canada, and Europe  

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 

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…
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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…
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January 2026: Health Canada Opens Consultation on Draft Guidance for Decentralized Clinical Trials

January 2026: Health Canada Opens Consultation on Draft Guidance for Decentralized Clinical Trials

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

Selling Vitamins in Canada: In-Depth Review of Regulations and Licensing Considerations

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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