Blog

Bringing creatine products into Canada requires more than simply obtaining an NPN. From confirming whether the finished product fits the Natural Health Product pathway to selecting the fastest PLA route and avoiding common launch delays, early strategy is critical. This guide outlines how SNI helps international brands streamline creatine market...

Selecting the appropriate regulatory pathway for a medical device in Canada is a foundational market-access decision that shapes far more than initial licensing. It directly influences regulatory risk, evidence depth, quality system readiness, lifecycle change control, and cross-jurisdictional launch sequencing.  For quality, clinical, and product development teams, as well as technical manufacturers,...

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,...

Product classification is a critical determinant of regulatory strategy and market access in Canada. Whether a product is regulated as a cosmetic or a Natural Health Product (NHP) defines the applicable requirements under the Food and Drugs Act, including pre-market obligations, evidentiary expectations, labelling standards, and permissible claims.  For many product...

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...

Recognizing FHCP’s role as the national voice of Canada’s food, health, and consumer products industry  Source Nutraceutical Inc. (SNI) is pleased to announce its membership with Food, Health & Consumer Products of Canada (FHCP), the national industry association representing the manufacturers of food, health, and consumer products across Canada. SNI joins FHCP...

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...

For European and international brands, entering the Canadian market often presents a significant and unexpected barrier driven by uncertainty. It is not necessarily the product or its potential that limits progress, but rather a lack of understanding of how the Canadian system operates. In many European markets, manufacturers can approach retailers...

Product classification is often one of the most critical determinants of successful market entry, as it defines the applicable regulatory framework and, in turn, the pre-market requirements needed to demonstrate compliance. This principle applies equally to pet products. Early classification is essential to determine whether a product is a Veterinary Health Product (VHP) or a veterinary drug,...

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....