Sea moss has gone from niche wellness ingredient to mainstream market opportunity, and businesses across North America are taking notice. If you are
... Read moreSoftware that diagnoses, monitors, or treats a health condition carries a different kind of regulatory weight than a physical device. If
... Read moreToothpaste sounds simple. It sits on store shelves next to shampoo and soap, and most consumers never think twice about
... Read moreThe question of whole ingredient vs extract GRAS requirements comes up constantly when companies formulate with botanicals, functional ingredients, or
... Read moreWhen you submit a product licence application for a natural health product in Canada, your submission does not enter a
... Read moreGetting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market.
... Read moreWeight loss supplements are one of the most commercially attractive categories in the dietary supplement industry, and one of the
... Read moreYou have a protein product ready to bring to market in Canada, and classifying it correctly is holding up your
... Read moreIf you are bringing medical devices to the Canadian market, one of the first compliance questions to resolve is whether
... Read moreIf you want to sell edibles legally in Canada, you face a regulatory framework that demands precision at every step.
... Read moreDetermining 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 are preparing a new cannabis product for market or expanding into a new jurisdiction, understanding GMP, GPP, and GACP
... Read moreIf your organization sells finished medical devices in the United States, the structure of your medical device QMS is no
... Read moreStandard operating procedures for cannabis retail business operations are not optional extras. They are foundational documents that provincial regulators expect
... Read moreIf you are preparing to launch a new ingredient or food product in Australia or New Zealand, one of the
... Read moreThinking about launching a new food ingredient in the U.S. often raises an important question: how do you demonstrate safety to the
... Read moreIf you manufacture or sell food ingredients in the United States, you have almost certainly come across the term GRAS. Yet many companies
... Read moreWhen you are trying to bring a probiotic ingredient to the U.S. market, one of the first questions you will
... Read moreBringing a new food ingredient to the European market often raises one critical question early in the process. Does the
... Read moreIntroduction Bringing a new dietary ingredient to the U.S. market involves more than formulation and sourcing. If an ingredient does
... Read moreCompanies introducing new food ingredients into the United States must demonstrate that those ingredients are safe under their intended conditions of use.
... Read moreNavigating the U.S. Food and Drug Administration (FDA) review process can be challenging for food and ingredient companies, especially when timelines do
... Read morePet food companies are under growing pressure to ensure that every ingredient in their formulas meets safety expectations, and GRAS compliance
... Read moreIntroduction When working toward a GRAS conclusion for an ingredient, a common question is whether it is possible to combine
... Read moreThe difference between GRAS and FEMA GRAS is a common point of confusion for companies working with food and flavor ingredients. When
... Read moreFDA GRAS projects can feel overwhelming, especially when you are trying to balance timelines, research needs, and budget pressures at
... Read moreEFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
... Read moreIntroducing a new food ingredient into the Australian or New Zealand market means working within a regulatory system that takes
... Read moreBuilding your safety narrative for a GRAS notice begins with toxicological studies for GRAS conclusion, and this foundation is one of the
... Read moreWhen it comes to importing human food and animal food into Canada, many businesses assume the process is similar. In
... Read moreGetting an NPN for sports supplements is essential for businesses looking to market their products legally in Canada. The Natural
... Read moreIf your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
... Read moreWhen exporting food supplements to Canada, understanding trade agreements can make a huge difference in your profitability. The Comprehensive Economic
... Read moreWhen it comes to ingredient safety, an expert panel plays one of the most critical roles in the GRAS (Generally
... Read moreGetting GRAS status for an enzyme is one of the most important steps to ensure your ingredient is recognized as
... Read moreIntroduction: Why EFSA Novel Food Clinical Studies Matter Bringing a novel food to the European market requires more than innovation.
... Read moreIf you’re planning to introduce an innovative ingredient or food product in the European Union, understanding how to submit an
... Read moreAfter years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
... Read morePreparing Instructions for Use (IFUs) for FDA Submission for Medical Devices Preparing Instructions for Use for FDA submission can feel
... Read moreWhen it comes to SR&ED eligibility, many businesses assume their projects do not qualify. This misconception often leads to missed
... Read moreThe Scientific Research and Experimental Development (SR&ED) program is one of Canada’s most valuable federal tax incentives for businesses. If
... Read moreReaching GRAS status is an important step if you want your Generally Recognized as Safe ingredient accepted for use in
... Read morePreparing a GRAS dossier is one of the most important steps when seeking FDA recognition for a new substance in
... Read moreWhat is GMP training, and why does it matter? If your company makes, packages, labels, or imports health products, this
... Read morePlanning to sell a medical device under your brand in Canada? You might assume that using a licensed manufacturer means
... Read moreOver the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in
... Read moreWhy is CFIA Updating its Feed Regulations? The Canadian Food Inspection Agency (CFIA) is in the process of modernizing its
... Read moreWhen preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make
... Read moreIf you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part
... Read moreWhen it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list.
... Read more
If you are planning to market animal health products, the question of pet supplements or veterinary health products will come
... Read moreThinking of selling hydration products in Canada? If your product makes a therapeutic claim, you may need a Natural Product
... Read moreThe FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a
... Read moreWhen introducing a new substance into the market, one of the first questions you need to answer is whether it’s
... Read moreUnderstanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in
... Read more
If you’re importing food into Canada, one of the key roles you’ll need to understand is that of the SFCR
... Read moreIf you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and
... Read more
If you’re finding it difficult to navigate the GRAS process, you’re not alone. Whether you’re introducing a new food ingredient
... Read moreThe eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without
... Read moreHow 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,
... Read more
If you’re planning to launch a product like a protein bar, electrolyte drink, or mushroom supplement in Canada, it’s important
... Read moreIf you plan to sell a natural health product in Canada, you’ve probably asked what an NPN is and why
... Read moreIf you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for
... Read more
If you’re trying to bring a food or supplement product to both the Canadian and US markets, you’ve probably already
... Read moreSubmitting a medical device to the FDA can feel like navigating a maze. Even the most seasoned teams can overlook
... Read moreAs of March 12, 2025 Health Canada has implemented changes to the Cannabis Act and its Regulations. These changes may
... Read moreThe self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the
... Read moreHealth Canada is conducting a public consultation on CBD regulations for natural health products, exploring a pathway to allow non-prescription
... Read moreGRAS 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
... Read moreThe introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes
... Read moreNavigating the FDA compliance process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit
... Read more
Navigating Health Canada’s rules for probiotic health claims can feel overwhelming, especially with the growing demand for these products. Businesses
... Read moreThe U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
... Read moreThe U.S. Food and Drug Administration (FDA) has postponed the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) Good
... Read moreUnderstanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing
... Read moreIf you’re planning to bring veterinary health products (VHPs) into Canada, you’ve probably come across the terms VHP Canadian representative
... Read moreLearn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
... Read moreSelling natural health products (NHPs) on Amazon Canada is a lucrative opportunity to expand your business and reach millions of
... Read more
Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
... Read more
If you’re in the business of nicotine products like pouches, gums, patches, sprays, or lozenges (collectively known as nicotine replacement
... Read more
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 moreAre you looking to bring your infant formula to the Canadian market? Successfully navigating Canada infant formula registration is essential
... Read more
Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing
... Read moreIf you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a
... Read moreIf you’re bringing a drug or health product to the Canadian market, you’ll need to understand Health Canada’s regulations. Two
... Read moreSimplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special
... Read moreThe Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg
... Read moreAre your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter
... Read moreHealth Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental
... Read moreNatural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic
... Read moreRegulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires
... Read moreHealth Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health,
... Read moreDesigning a compliant food label is one of the most important steps when entering the Canadian market. The food labeling
... Read moreThis fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been
... Read more
Are you struggling to keep up with changing cosmetic regulations? The FDA MoCRA (Modernization of Cosmetics Regulation Act), passed in
... Read moreHealth Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and
... Read moreHealth Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This
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