Understanding the Difference Between a GRAS Notice and Self-Affirmed GRAS
Learn the difference between a GRAS Notice and self-affirmed GRAS, including risks, benefits, and how to prepare for regulatory changes.
... Read more December 13, 2025
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[blog_list]
Understanding GRAS Notice Delays in the FDA Review Process
Navigating the U.S. Food and Drug Administration (FDA) review process can be challenging for food and ingredient companies, especially when timelines do
... Read more December 8, 2025
Understanding GRAS Compliance in Pet Food Formulations
Pet food companies are under growing pressure to ensure that every ingredient in their formulas meets safety expectations, and GRAS compliance
... Read more December 3, 2025
How Combining Ingredients For A GRAS Conclusion Affects Product Safety
Introduction When working toward a GRAS conclusion for an ingredient, a common question is whether it is possible to combine
... Read more December 2, 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
... Read more 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
... Read more November 26, 2025
EFSA’s Novel Foods Transparency Rules Explained for EU Compliance
EFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
... Read more November 19, 2025
How to Get Your Novel Food Approved by FSANZ
Learn the key steps to getting a novel food approved by FSANZ. Understand safety requirements and how to navigate Australia and New Zealand’s novel food pathway.
... Read more November 12, 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
... Read more November 5, 2025
Understanding the Differences When Importing Human and Animal Food into Canada
When it comes to importing human food and animal food into Canada, many businesses assume the process is similar. In
... Read more October 31, 2025
Getting an NPN for Sports Supplements: Health Canada Step-By-Step Guide
Getting an NPN for sports supplements is essential for businesses looking to market their products legally in Canada. The Natural
... Read more October 29, 2025
Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up
If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
... Read more October 23, 2025
Understanding CETA and How It Helps You Sell Food Supplements in Canada Tariff Free
When exporting food supplements to Canada, understanding trade agreements can make a huge difference in your profitability. The Comprehensive Economic
... Read more October 21, 2025
Expert Panel in GRAS Determinations: Why It Matters for Ingredient Safety
When it comes to ingredient safety, an expert panel plays one of the most critical roles in the GRAS (Generally
... Read more October 16, 2025
Your Guide to Achieving GRAS Approval for Enzymes
Getting GRAS status for an enzyme is one of the most important steps to ensure your ingredient is recognized as
... Read more October 12, 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.
... Read more October 11, 2025
Your Step-by-Step Guide to the EFSA Novel Food Application Process
If you’re planning to introduce an innovative ingredient or food product in the European Union, understanding how to submit an
... Read more October 9, 2025
FDA Declares Nicotinamide Mononucleotide Lawful in Dietary Supplements
After years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
... Read more October 3, 2025
Preparing Instructions for Use for FDA Submission
Preparing Instructions for Use (IFUs) for FDA Submission for Medical Devices Preparing Instructions for Use for FDA submission can feel
... Read more September 26, 2025
Top SR&ED Eligibility Myths and What Actually Qualifies
When it comes to SR&ED eligibility, many businesses assume their projects do not qualify. This misconception often leads to missed
... Read more September 25, 2025
What Is the SR&ED Program and How It Supports Innovation in Canada
The Scientific Research and Experimental Development (SR&ED) program is one of Canada’s most valuable federal tax incentives for businesses. If
... Read more September 24, 2025
Best Practices for Achieving GRAS Status for Manufacturers
Reaching GRAS status is an important step if you want your Generally Recognized as Safe ingredient accepted for use in
... Read more September 23, 2025
The 7 Key Sections of a GRAS Dossier Every Business Should Understand
Preparing a GRAS dossier is one of the most important steps when seeking FDA recognition for a new substance in
... Read more September 22, 2025
What You Need to Know About GMP Training
What is GMP training, and why does it matter? If your company makes, packages, labels, or imports health products, this
... Read more August 29, 2025
How to Register Your Private Label Medical Device in Canada
Planning to sell a medical device under your brand in Canada? You might assume that using a licensed manufacturer means
... Read more August 6, 2025
Are you meeting Health Canada’s site license renewal requirements?
Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in
... Read more July 11, 2025
What Is Changing Under CFIA’s Feed Regulatory Modernization?
Why is CFIA Updating its Feed Regulations? The Canadian Food Inspection Agency (CFIA) is in the process of modernizing its
... Read more July 11, 2025
Comparing FDA 510(k) and PMA Pathways for Medical Devices
When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make
... Read more June 23, 2025
Boosting Business Operations Through GMP Training
If you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part
... Read more June 20, 2025
The Role of Audits in Meeting Health Canada’s Compliance Standards
When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
... Read more June 19, 2025
Pet Supplements or Veterinary Health Products? Understanding the Difference
If you are planning to market animal health products, the question of pet supplements or veterinary health products will come
... Read more June 11, 2025
A Guide to Securing an NPN for Hydration Products in Canada
Thinking of selling hydration products in Canada? If your product makes a therapeutic claim, you may need a Natural Product
... Read more June 5, 2025
FY 2025 OMUFA Fees Due June 2: What You Need to Know
The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a
... Read more June 1, 2025
GRAS for Food vs. Feed: Understanding the Key Differences
When introducing a new substance into the market, one of the first questions you need to answer is whether it’s
... Read more May 31, 2025
Traditional Cosmetics vs. Cosmeceuticals: What’s the Difference?
Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in
... Read more May 28, 2025
A Guide to the SFCR Importer of Record Role
If you’re importing food into Canada, one of the key roles you’ll need to understand is that of the SFCR
... Read more May 24, 2025
MDL vs. MDEL: Understanding Canada’s Medical Device Licensing
If you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and
... Read more May 21, 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
... Read more May 15, 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
... Read more May 6, 2025
Comparing Cosmetic Compliance Standards: FDA and Health Canada
How FDA and Health Canada Regulate Cosmetics Differently Thinking about launching your cosmetic line in North America? Whether you’re a
... Read more May 1, 2025
Preparing a Successful Food Additive Submission in Canada
Learn how to prepare a food additive submission for Health Canada to ensure compliance and avoid costly delays.
... Read more April 25, 2025
Tips to Keep Cosmetics Compliant and Listed on Amazon Canada
Selling cosmetics on Amazon Canada can open up a world of opportunity, but it comes with strict compliance expectations. Recently,
... Read more April 22, 2025
What’s the Difference Between Functional Foods and NHPs?
If you’re planning to launch a product like a protein bar, electrolyte drink, or mushroom supplement in Canada, it’s important
... Read more April 8, 2025
The Role of Natural Product Numbers (NPNs) in Canada
What is NPN? Learn how to get approval for your natural health product and stay compliant with Canadian regulations.
... Read more April 6, 2025
Understanding the Importance of MDSAP Certification
If you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for
... Read more April 3, 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
... Read more March 31, 2025
Your Guide to Submitting a Medical Device to the FDA Without Errors
Submitting a medical device to the FDA can feel like navigating a maze. Even the most seasoned teams can overlook
... Read more March 18, 2025
Health Canada Announces Amendments to Cannabis Regulations
As of March 12, 2025 Health Canada has implemented changes to the Cannabis Act and its Regulations. These changes may
... Read more March 16, 2025
Self-Affirmed GRAS May End – What It Means for You
The self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the
... Read more March 12, 2025
Health Canada Reviews CBD as an NHP in New Consultation
Health Canada is conducting a public consultation on CBD regulations for NHPs, exploring a pathway to allow non-prescription CBD products under the NHPR. This consultation opened on March 7, 2025, and will close on June 5, 2025.
... Read more March 7, 2025
GRAS in Pet Food: A Guide to Ingredient Compliance
GRAS in pet food – these four words can make a big difference in your product’s regulatory status. Understanding what
... Read more February 5, 2025
Navigating the TGA Approval Process for New Substances
Bringing a new substance into Australia’s listed medicines market can be challenging. The TGA approval for new substances process involves
... Read more January 30, 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
... Read more 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
... Read more 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
... Read more January 13, 2025
FDA Sets 2028 Compliance Date for Food Labels
The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
... Read more January 10, 2025
MoCRA GMP Delayed Until October 2025: What You Need to Know
The U.S. Food and Drug Administration (FDA) has postponed the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) Good
... Read more December 18, 2024
What Are FDA Medical Device Classes?
Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
... Read more December 17, 2024
Understanding the Difference Between a VHP Representative and Importer of Record
If you’re planning to bring veterinary health products (VHPs) into Canada, you’ve probably come across the terms VHP Canadian representative
... Read more December 16, 2024
Health Canada Infant Formula Policy Transition
Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
... Read more December 12, 2024
How to Sell NHPs on Amazon Canada: A Complete Guide
Selling natural health products (NHPs) on Amazon Canada is a lucrative opportunity to expand your business and reach millions of
... Read more December 10, 2024
Health Canada Fees 2025 Guide
Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
... Read more December 5, 2024
Health Canada’s New Nicotine Rules: What’s Changing in 2024
If you’re in the business of nicotine products like pouches, gums, patches, sprays, or lozenges (collectively known as nicotine replacement
... Read more November 22, 2024
How to Prepare for an FDA 510(k) Pre-Submission
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new
... Read more November 15, 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
... Read more November 5, 2024
How to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide
Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing
... Read more November 1, 2024
Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?
If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a
... Read more November 1, 2024
Health Canada’s Drug vs Product Monograph: Key Differences
If you’re bringing a drug or health product to the Canadian market, you’ll need to understand Health Canada’s regulations. Two
... Read more October 30, 2024
New Modification to Buffer Zone Affects Food Manufacturers and Suppliers
Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special
... Read more October 28, 2024
Government of Canada Launches Consultation on Plant-Based Egg Alternative Labelling: What Businesses Need to Know
The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg
... Read more October 25, 2024
7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready
Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter
... Read more October 17, 2024
Breaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?
Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental
... Read more October 16, 2024
Understanding the Key Changes to Natural Health Product (NHP) Labeling in Canada
Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic
... Read more October 6, 2024
FDA Considerations Selling Foods in USA
Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires
... Read more August 29, 2024
Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)
Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,
... Read more August 21, 2024
How to Create Health Canada Compliant Food Labels
Designing a compliant food label is one of the most important steps when entering the Canadian market. The food labeling
... Read more August 17, 2024
Health Canada plans to share document about health products containing CBD this fall
This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been
... Read more August 8, 2024
FDA MoCRA Compliance Guide for Cosmetic Businesses
Are you struggling to keep up with changing cosmetic regulations? The FDA MoCRA (Modernization of Cosmetics Regulation Act), passed in
... Read more July 6, 2024
Health Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs
Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and
... Read more July 6, 2024
Health Canada 2024 Drug Establishment Licensing (DEL) Update
Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This
... Read more July 3, 2024
Launch Your Foods, Cosmetics, NHPs, & Pet Products on Amazon Canada: Compliance FAQs
We understand the impact of changing Amazon Canada regulations on your business – and how non-compliance can hurt you. Q:
... Read more May 3, 2024
FDA Regulates Lab-Developed Tests for Safety
FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical
... Read more May 3, 2024
How to get an NHP Licence for Nicotine Pouches in Canada?
Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid
... Read more January 7, 2024
FDA Updates Yogurt Standard: Key Changes for Manufacturers
Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard
... Read more January 2, 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
... Read more November 6, 2023
Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
The process of bringing medical devices to market in the United States involves stringent regulations imposed by the Food
... Read more November 2, 2023
Critical Control Points Explained: The Core of HACCP
https://youtu.be/dVbug89UHBA Introduction Ensuring food safety is crucial for businesses in the food industry. That’s where Hazard Analysis and Critical Control
... Read more November 2, 2023
Choosing Between GRAS Notice and Self-Affirmed GRAS
If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is
... Read more October 31, 2023
Understanding GRAS Substances and Their Role in Food Compliance
GRAS substances, or “Generally Recognized as Safe” substances, are essential to product development in the food, pharmaceutical, and cosmetic industries.
... Read more October 26, 2023
Everything businesses should know about the Supplemented Foods Facts Table (SFFT)
Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer
... Read more October 25, 2023
How Manufacturers Can Stay Compliant With Canadian Medical Device Rules
https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk
... Read more October 18, 2023
Selling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products
https://youtu.be/QABD-2XIRz0 Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in
... Read more October 12, 2023
A Guide to FDA 510(k) Clearance for Medical Devices
Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness.
... Read more October 11, 2023
How Drug Registration Works in the U.S. and What NDC Numbers Mean
Drug registration and NDC number might sound technical, but they play a big role in how medications make it to
... Read more October 4, 2023
Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy
... Read more September 29, 2023
A Clear Guide to FDA 510(k) Submission Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
... Read more September 28, 2023
Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers
Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for
... Read more September 27, 2023
Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
... Read more September 27, 2023
Everything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting
... Read more September 26, 2023
Selling Your Food Products in the USA: A Guide for Food Business Owners
https://youtu.be/x4c0LEPmJuM If you’re selling food products in the United States, understanding and complying with FDA regulations is non-negotiable. The Food
... Read more September 19, 2023