canadian regulations

Health Canada Publishes 19 Updated NHP Monographs

05

Feb

NHPscanadian regulations, dosage updates, health canada, ingredient updates, monograph revisions, NHP compliance, NHP monographs, NHPID, Prebiotics

Health Canada Publishes 19 Updated NHP Monographs

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,…

Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

27

Jan

NHPscanadian regulations, health canada, natural health products, Natural Product Number, Nicotine Replacement Therapy, NPN, NRT

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…

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

23

Sep

NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

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…

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

18

Sep

NHPscanadian regulations, health canada, innovation, public health, Public Health Agency of Canada, red tape reduction, regulatory modernization, regulatory reform, risk-based regulation, trade barriers

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…

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

16

Sep

FDAcanadian 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

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…

Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

09

Sep

FoodCanadian food industry, canadian regulations, chewing gum, compliance, food labelling, free of sugars, health canada, low in energy, nutrient content claims, Regulatory Update

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…

Health Canada Adds New Ingredients to the Prescription Drug List

04

Sep

DINsartesunate, benzoyl peroxide, canadian regulations, crovalimab, health canada, osilodrostat, PDL update, Pharmaceutical compliance, Prescription Drug List, prescription drugs, quizartinib, Regulatory Affairs

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…

10

Jun

Product Packagingbilingual labelling, Canadian packaging compliance, canadian regulations, cost-effective compliance, food labelling Canada, label correction, natural health product labelling, overlabelling, packaging solutions Canada

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…

NHP Sampling Regulations for Tradeshows in Canada

23

Apr

NHPscanadian regulations, consumer safety, health canada, natural health products, NHP compliance, NHP Labelling, NHP sampling, NPN, product distribution, product licensing, tradeshow exhibitors, tradeshow regulations

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…

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

16

Apr

Foodcanadian regulations, food labelling, Food Regulations, FOP Requirement, Front Of Pack, Interim Policy, Nutrition 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…