Market Entry Support

18 Mar 2026

Entering the Canadian Market: Understanding the Roles of Brand Managers, Brokers, and Distributors

General Regulationsbrand manager vs broker vs distributor, Canada market entry, Canadian retail distribution, how to sell products in Canada

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…

22 Jan 2026

Health Canada vs. FDA: Regulatory Frameworks and Compliance

General RegulationsFDA, FDA vs Health Canada Regulations, health canada, regulatory frameworks

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.…

16 Sep 2025

New and Upcoming FDA Changes in 2025: GRAS Rules, FOP Labelling, and Supplement Ingredients – What You Need to Know

Food and Drug Administration (FDA) Regulations and Updatescanadian regulations, cross-border compliance, dietary supplements, DSHEA, FDA, FDA Unified Agenda, food labelling, FOP labelling, front-of-package labelling, GRAS, health canada, ingredient safety, NHP, nicotinamide mononucleotide, NMN, novel foods, Nutrition Labelling, Regulatory Affairs, self-affirmed GRAS, U.S. regulations

On September 4, 2025, the U.S. Food and Drug Administration (FDA) published its Unified Regulatory Agenda, a key planning document that outlines the Agency’s top priorities over the coming year. Among the many proposed and final rules, three initiatives stand out for their potential to significantly impact food and dietary…

06 May 2025

Health Canada’s April 2025 Update: Electronic Filing Requirements for Drug Product Submissions

General Regulations

As part of its continued digital modernization, Health Canada has reaffirmed the requirement that drug product submissions be filed electronically, using either the Electronic Common Technical Document (eCTD) format or the non-eCTD format. The appropriate format depends on the type of regulatory activity and the product category. Health Canada’s April…

14 Apr 2025

Guidelines for the Use of Maple Leaf and Canadian Flag on Products – Industry Insights

General RegulationsCanada's Coat of Arms, Canadian Flag, Made in Canada, Maple Leaf, Product Labelling, Product of Canada

In Canada, the maple leaf and the Canadian flag are more than just symbols—they're the essence of what it means to be Canadian. From evoking national pride to representing our values, these emblems carry immense weight. But, as with anything valuable, they come with a set of rules. If you're…

07 Apr 2025

“Product of Canada” vs. “Made in Canada” Differences and Conditions of Use

General Regulationscanadian regulations, Country of Origin Labelling, Made in Canada, Product of Canada

"Product of Canada" vs. "Made in Canada" Differences and Conditions of Use Product labelling in Canada requires a careful approach, as many claims that appear on products are subject to regulations and must meet specific requirements to ensure compliance. While some companies may see these requirements as additional hurdles, regulating…

24 Mar 2025

FDA ESG NextGen Launch: Key Dates, Features, and Transition Guide for Users

Food and Drug Administration (FDA) Regulations and UpdatesESG NextGen, FDA, NetGen, Regulatory Update, US Regulations

As part of its ongoing efforts to modernize and streamline the submission process, the FDA is transitioning from its legacy Electronic Submission Gateway (ESG) system to ESG NextGen. This new platform is designed to make regulatory submissions more efficient, secure, and user-friendly, all while enhancing the overall user experience. The…

03 Mar 2025

Importing Food from Europe to Canada: Review of Requirements

Food and Beverage, International TradeCFIA, European Commission, European Food Safety Authority, Food Regulations, health canada, importing foods, Safe Food for Canadians

As global trade continues to expand, the import of food products from Europe to Canada presents significant opportunities for businesses looking to reach new markets. However, ensuring compliance with both European and Canadian food regulations is crucial for a smooth and successful import process. The European Union (EU) enforces some…

18 Feb 2025

The FDA’s New “Healthy” Labeling Rules for Foods

Food and Beverage, Food and Drug Administration (FDA) Regulations and Updates"Healthy" Term on Foods, FDA regulations, FDA update, Food Regulations, USA Food Regulations

On December 19, 2024 , the U.S. Food and Drug Administration (FDA) unveiled an update to its Final Ruling on the use of the “healthy” label for food products—a refreshed tool that helps consumers identify health foods that reflect current nutrition science and Federal dietary guidance. This update is part…

04 Feb 2025

Canada’s tariffs on U.S. products: Impact on food, cosmetics, and health goods

International Trade2025 News, Canada tariffs, cosmetics, food, Government of Canada, NHPs, Trade news

On February 1, 2025, the Government of Canada formally responded to the U.S. tariffs on Canadian goods by announcing its own set of countermeasures. These tariffs on U.S. products are scheduled to take effect on February 4, 2025. As part of this response, the Department of Finance released a detailed…