What Health Canada’s New Prebiotic Monograph Means for Your NHP
Health Canada has published its first prebiotic monograph, and if you manufacture or plan to bring a prebiotic natural health
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May 1, 2026
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[blog_list]
Toothpaste Classification Under Health Canada: OTC Drug, NHP, or Cosmetic?
Toothpaste sounds simple. It sits on store shelves next to shampoo and soap, and most consumers never think twice about
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April 21, 2026
Whole Ingredient vs Extract GRAS Requirements: What Changes and Why It Matters
The question of whole ingredient vs extract GRAS requirements comes up constantly when companies formulate with botanicals, functional ingredients, or
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April 19, 2026
Health Canada’s Regulatory Enrolment Process Is Now Mandatory for Medical Device Licence Applications
As of January 2026, Health Canada’s Regulatory Enrolment Process (REP) is mandatory for all Class II, III, and IV medical device licence (MDL)
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March 30, 2026
What Health Canada’s Revised Fragrance Allergen Requirements Mean for Your CNF
When Health Canada amended the Cosmetic Regulations to introduce fragrance allergen disclosure requirements, the industry pushed back fast. The fragrance
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March 24, 2026
Veterinary Health Product or Drug Classification in Canada and Why It Matters
Determining whether your product is a veterinary health product or drug in Canada is one of the first and most consequential decisions you
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March 24, 2026
GMP, GPP and GACP Standards That Strengthen Your Cannabis Business
If you are preparing a new cannabis product for market or expanding into a new jurisdiction, understanding GMP, GPP, and GACP
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March 17, 2026
Your MDEL Renewal Is Due April 1. Here Is What to Do Before the Deadline
Missing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device
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February 18, 2026
FDA Releases Human Food Program 2026 Priorities For Food Businesses
The U.S. Food and Drug Administration (FDA) has released its priority deliverables for 2026 under the Human Food Program, outlining
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January 27, 2026
Achieving GRAS Status for a Probiotic: A Step-by-Step Approach
When you are trying to bring a probiotic ingredient to the U.S. market, one of the first questions you will
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January 18, 2026
FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real-world evidence in regulatory reviews. In a
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December 17, 2025
FDA Proposal Signals Major Changes for Sunscreen Active Ingredients
Recent regulatory activity in the United States is drawing renewed attention to sunscreen compliance. In a new announcement, the FDA
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December 17, 2025
FDA Strengthens Infant Formula Recall Oversight After Botulism Case
The U.S. Food and Drug Administration (FDA) has announced new actions aimed at improving recall effectiveness following an investigation into
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December 17, 2025
Understanding the Difference Between a GRAS Notice and Self-Affirmed GRAS
Companies introducing new food ingredients into the United States must demonstrate that those ingredients are safe under their intended conditions of use.
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December 13, 2025
Understanding GRAS and FEMA GRAS for Food and Flavor Compliance
The difference between GRAS and FEMA GRAS is a common point of confusion for companies working with food and flavor ingredients. When
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November 30, 2025
How to Reduce Costs Throughout Your FDA GRAS Project
FDA GRAS projects can feel overwhelming, especially when you are trying to balance timelines, research needs, and budget pressures at
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November 26, 2025
A Guide to Toxicological Studies for GRAS Conclusion
Building your safety narrative for a GRAS notice begins with toxicological studies for GRAS conclusion, and this foundation is one of the
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November 5, 2025
Clinical Studies for EFSA Novel Food Applications: How to Ensure Success
Introduction: Why EFSA Novel Food Clinical Studies Matter Bringing a novel food to the European market requires more than innovation.
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October 11, 2025
SupplySide Global Las Vegas 2025
Event Dates: October 27–30, 2025Location: Mandalay Bay, Las Vegas, USA SupplySide Connect Las Vegas 2025 is the leading event for
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September 12, 2025
Pets Canada 2025
Event Dates: September 17–18, 2025 Location: International Center, Hall 2, Mississauga, ON Join Quality Smart Solutions at Pets Canada 2025, Canada’s
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September 11, 2025
CHFA NOW 2025
Event Dates: September 19–21, 2025 Location: Enercare Center at Exhibition Place, Toronto, Canada Join Quality Smart Solutions at CHFA NOW Toronto
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September 11, 2025
De Minimis Rule Ending: What Businesses Must Know
The de minimis rule has long been a key part of U.S. customs policy. It allowed companies to import low-value
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August 30, 2025
FDA Chemical Screening: What The New EDT Tool Means For Food Safety
The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety
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July 31, 2025
Struggling With GRAS Compliance? Here’s What to Do
If you’re finding it difficult to navigate the GRAS process, you’re not alone. Whether you’re introducing a new food ingredient
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May 15, 2025
FDA Approves Natural Food Colors for Safer Use
The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to
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May 12, 2025
FDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
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May 12, 2025
Navigating FDA and Health Canada Rules for Eczema Products
The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without
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May 6, 2025
FDA announces ESG NextGen launch for industry submissions
FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now
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April 17, 2025
The Role of Natural Product Numbers (NPNs) in Canada
If you plan to sell a natural health product in Canada, you’ve probably asked what an NPN is and why
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April 6, 2025
Food and Supplement Labeling: Canada vs US Requirements
If you’re trying to bring a food or supplement product to both the Canadian and US markets, you’ve probably already
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March 31, 2025
Health Canada Releases Consultation on Co-Packaged Drug Products
Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation. The guidance explains
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March 29, 2025
Why a Canadian Agent Is Now Required for Cosmetic Notifications
Selling cosmetics in Canada? If you’re a brand outside of Canada, there’s an important update you need to know about.
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March 23, 2025
Health Canada Proposes Changes to Caffeine as a Supplemental Ingredient
Changes are on the horizon for caffeine as a supplemental ingredient, and they could directly impact your business. Whether you
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March 13, 2025
Health Canada’s Latest Updates to the Supplemental Ingredients List
Are Your Supplemental Ingredients Compliant? Canada’s New Rules Explained If your business sells supplemented foods in Canada, major regulatory updates
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March 3, 2025
NHP Labelling: Ministerial Exemption Order Announced
The regulatory landscape for NHP labelling is evolving, with businesses facing increasing pressure to comply with Health Canada’s updated regulations. Initially
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February 28, 2025
Bill 96 Explained: What It Means for Bilingual Labelling
The introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes
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January 29, 2025
A Practical Compliance Guide to Shilajit and FDA Rules
Navigating the FDA compliance process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit
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January 24, 2025
What Are Health Canada’s Rules for Probiotic Health Claims?
Navigating Health Canada’s rules for probiotic health claims can feel overwhelming, especially with the growing demand for these products. Businesses
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January 13, 2025
FDA Updates Guidance on Genome-Edited Foods
The U.S. Food and Drug Administration (FDA) has published an update to its guidance for voluntary premarket engagement regarding foods
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December 16, 2024
How to Ensure Compliance with Canada’s Infant Formula Registration
Are you looking to bring your infant formula to the Canadian market? Successfully navigating Canada infant formula registration is essential
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November 5, 2024
Navigating GRAS Panels: A Guide to Best Practices
When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The
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November 6, 2023
How to Sell on Amazon Canada: Step-by-Step Guide
If you’re looking to grow your e-commerce business, learning how to sell on Amazon Canada is a smart move. With
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July 28, 2023
GRAS vs NDI: A Simple Guide to Ingredient Compliance
Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the
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December 6, 2022
NHPID and NPN: 6 Key Things Businesses Should Know
If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine
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August 29, 2022