Canada legalized recreational cannabis in 2018. However, nearly a decade later, one of the most natural extensions of that market,
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Few things set back a product launch more painfully than a rejection letter from the FDA. When your 510(k) submission
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Pursuing GRAS status for an extract is not the same as pursuing it for a whole botanical or a well-characterised food ingredient. The
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Sea moss has gone from niche wellness ingredient to mainstream market opportunity, and businesses across North America are taking notice. If you are
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Software that diagnoses, monitors, or treats a health condition carries a different kind of regulatory weight than a physical device. If
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Toothpaste sounds simple. It sits on store shelves next to shampoo and soap, and most consumers never think twice about
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The question of whole ingredient vs extract GRAS requirements comes up constantly when companies formulate with botanicals, functional ingredients, or
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When you submit a product licence application for a natural health product in Canada, your submission does not enter a
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Getting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market.
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Weight loss supplements are one of the most commercially attractive categories in the dietary supplement industry, and one of the
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You have a protein product ready to bring to market in Canada, and classifying it correctly is holding up your
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If you are bringing medical devices to the Canadian market, one of the first compliance questions to resolve is whether
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Cannabis edibles are one of the most tightly regulated product categories in Canada — and one of the most commercially
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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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If you hold a cannabis licence in Canada, you’ve likely come across the acronyms GMP, GPP, and GACP. They’re not
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If your organization sells finished medical devices in the United States, the structure of your medical device QMS is no
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Standard operating procedures for cannabis retail business operations are not optional extras. They are foundational documents that provincial regulators expect
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If you are preparing to launch a new ingredient or food product in Australia or New Zealand, one of the
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Thinking about launching a new food ingredient in the U.S. often raises an important question: how do you demonstrate safety to the
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If you manufacture or sell food ingredients in the United States, you have almost certainly come across the term GRAS. Yet many companies
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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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Bringing a new food ingredient to the European market often raises one critical question early in the process. Does the
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Introduction Bringing a new dietary ingredient to the U.S. market involves more than formulation and sourcing. If an ingredient does
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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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Navigating the U.S. Food and Drug Administration (FDA) review process can be challenging for food and ingredient companies, especially when timelines do
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Pet food companies are under growing pressure to ensure that every ingredient in their formulas meets safety expectations, and GRAS compliance
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Introduction When working toward a GRAS conclusion for an ingredient, a common question is whether it is possible to combine
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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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FDA GRAS projects can feel overwhelming, especially when you are trying to balance timelines, research needs, and budget pressures at
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EFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
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Introducing a new food ingredient into the Australian or New Zealand market means working within a regulatory system that takes
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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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When it comes to importing human food and animal food into Canada, many businesses assume the process is similar. In
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Getting an NPN for sports supplements is essential for businesses looking to market their products legally in Canada. The Natural
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If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
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When exporting food supplements to Canada, understanding trade agreements can make a huge difference in your profitability. The Comprehensive Economic
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When it comes to ingredient safety, an expert panel plays one of the most critical roles in the GRAS (Generally
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Getting GRAS status for an enzyme is one of the most important steps to ensure your ingredient is recognized as
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Introduction: Why EFSA Novel Food Clinical Studies Matter Bringing a novel food to the European market requires more than innovation.
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If you’re planning to introduce an innovative ingredient or food product in the European Union, understanding how to submit an
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After years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
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Preparing Instructions for Use (IFUs) for FDA Submission for Medical Devices Preparing Instructions for Use for FDA submission can feel
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When it comes to SR&ED eligibility, many businesses assume their projects do not qualify. This misconception often leads to missed
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The Scientific Research and Experimental Development (SR&ED) program is one of Canada’s most valuable federal tax incentives for businesses. If
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Reaching GRAS status is an important step if you want your Generally Recognized as Safe ingredient accepted for use in
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Preparing a GRAS dossier is one of the most important steps when seeking FDA recognition for a new substance in
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What is GMP training, and why does it matter? If your company makes, packages, labels, or imports health products, this
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Planning to sell a medical device under your brand in Canada? You might assume that using a licensed manufacturer means
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Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in
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Why is CFIA Updating its Feed Regulations? The Canadian Food Inspection Agency (CFIA) is in the process of modernizing its
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When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make
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If you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part
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When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
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If you are planning to market animal health products, the question of pet supplements or veterinary health products will come
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Thinking of selling hydration products in Canada? If your product makes a therapeutic claim, you may need a Natural Product
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The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a
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When introducing a new substance into the market, one of the first questions you need to answer is whether it’s
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Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in
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If you’re importing food into Canada, one of the key roles you’ll need to understand is that of the SFCR
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If you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and
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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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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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How FDA and Health Canada Regulate Cosmetics Differently Thinking about launching your cosmetic line in North America? Whether you’re a
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Food additive submission may not be the flashiest part of launching a new food product in Canada, but it’s one
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Selling cosmetics on Amazon Canada can open up a world of opportunity, but it comes with strict compliance expectations. Recently,
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If you’re planning to launch a product like a protein bar, electrolyte drink, or mushroom supplement in Canada, it’s important
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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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If you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for
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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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Submitting a medical device to the FDA can feel like navigating a maze. Even the most seasoned teams can overlook
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As of March 12, 2025 Health Canada has implemented changes to the Cannabis Act and its Regulations. These changes may
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The self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the
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Health Canada is conducting a public consultation on CBD regulations for natural health products, exploring a pathway to allow non-prescription
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GRAS in pet food – these four words can make a big difference in your product’s regulatory status. Understanding what
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Bringing a new substance into Australia’s listed medicines market can be challenging. The TGA approval for new substances process involves
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The introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes
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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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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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The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
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The U.S. Food and Drug Administration (FDA) has postponed the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) Good
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Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
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If you’re planning to bring veterinary health products (VHPs) into Canada, you’ve probably come across the terms VHP Canadian representative
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Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
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Selling natural health products (NHPs) on Amazon Canada is a lucrative opportunity to expand your business and reach millions of
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Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
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If you’re in the business of nicotine products like pouches, gums, patches, sprays, or lozenges (collectively known as nicotine replacement
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Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new
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Are you looking to bring your infant formula to the Canadian market? Successfully navigating Canada infant formula registration is essential
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Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing
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If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a
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If you’re bringing a drug or health product to the Canadian market, you’ll need to understand Health Canada’s regulations. Two
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Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special
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The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg
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Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter
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Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental
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Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic
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Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires
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Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,
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Designing a compliant food label is one of the most important steps when entering the Canadian market. The food labeling
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This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been
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