Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…
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Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

Cutting red tape is at the heart of Health Canada and the Public Health Agency of Canada’s new regulatory modernization plan. In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…
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New and Upcoming FDA Changes in 2025: GRAS Rules, FOP Labelling, and Supplement Ingredients – What You Need to Know

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

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…
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Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

On September 2, 2025, Health Canada updated the Table of Permitted Nutrient Content Statements and Claims, modifying the table to once again exempt chewing gum from the energy conditions set out under the “free of sugars” claim.  Learn more about this regulatory change and what it means for manufacturers and…
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Health Canada Adds New Ingredients to the Prescription Drug List

Health Canada Adds New Ingredients to the Prescription Drug List

Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as…
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A Cost-Effective Compliance Strategy: Over-labelling for Packaging in the Canadian Market 

A Cost-Effective Compliance Strategy: Over-labelling for Packaging in the Canadian Market 

Expanding into the Canadian food and natural health product market presents a unique set of regulatory challenges. From bilingual packaging requirements to specific nutrition facts and allergen declarations, manufacturers often face barriers that can delay product launches and increase operational costs. One practical and cost-effective solution to this issue is…
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NHP Sampling Regulations for Tradeshows in Canada 

NHP Sampling Regulations for Tradeshows in Canada 

Distributing Natural Health Product (NHP) samples at tradeshows in Canada is subject to clear regulatory requirements designed to protect consumer safety, ensure accurate labelling, and uphold Health Canada’s standards.  From proper packaging and compliant promotional claims to valid licensing and record-keeping obligations, all participants are responsible for operating in accordance…
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New Update to Health Canada’s Interim Policy on Front-of-Package Labelling

New Update to Health Canada’s Interim Policy on Front-of-Package Labelling

In the ever-evolving landscape of food labelling, it’s essential for businesses to stay up to date with regulatory changes. Recently, Health Canada released interim policy statements that address Front-of-Package (FOP) nutrition labelling for two specific categories of food: prepackaged fresh coconut and ready-to-eat breakfast cereals. These changes aim to clarify…
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“Product of Canada” vs. “Made in Canada” Differences and Conditions of Use

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

"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…
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Canada’s Animal Testing Ban and How To Ensure Compliance for Cosmetics

Canada’s Animal Testing Ban and How To Ensure Compliance for Cosmetics

Canada's 2023 ban on animal testing for cosmetics represents a pivotal moment in the global push for ethical practices within the beauty industry. This landmark regulation not only prohibits the testing of cosmetics and their ingredients on animals within the country but also aligns Canada with a growing number of…
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