Blog

Stepping into the new year, we interviewed one of the freshest faces on our SNI Clinical Trials team: Meet Nidhi Thakkar, Junior Clinical Trials and Regulatory Affairs Specialist. You’ve just joined team SNI as our new Junior Clinical Trials and Regulatory Affairs Specialist! What sparked your interest in this field?...

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...

The U.S. Food and Drug Administration has released its Human Foods Program 2026 Priority Deliverables, outlining the agency’s operational and regulatory focus areas for the coming year. While these deliverables do not create immediate new legal requirements, they provide a clear signal of where enforcement emphasis, rulemaking, and policy development are headed in...

On February 5, 2026, the U.S. Food and Drug Administration announced a shift in how it will approach voluntary “no artificial colors” claims on food labels. The agency also granted two petitions expanding the availability of alternative colour additives derived from natural sources.  For manufacturers operating in the United States, this development...

All Natural Health Product (NHP) site licence holders in Canada must renew their licence in accordance with the Natural Health Products Regulations. Although the renewal term varies by licence and is assigned directly by Health Canada, the obligation remains consistent across all sites: confirm continued compliance with Part 3 Good Manufacturing Practices (GMP) and keep Health...

If you manufacture or import functional foods, fortified beverages, gummies, probiotics, botanicals, powders, or “wellness” products, you have likely run into the Canadian classification question: is this a food or a natural health product (NHP)?  In Canada, that decision is not exclusively linked to marketing preference. It is a regulatory classification that drives your allowed claims, label...

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...

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,...

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...

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...

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....

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...

Skincare is increasingly regulated, evidence-driven, and commercially competitive across both Canada and the United States. As brands push for stronger performance claims, broader market access, and greater scientific credibility, human clinical data has become the cornerstone of regulatory defensibility and market differentiation. Skincare clinical trials now sit at the intersection...