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 noticed how complicated labeling can get. Maybe you’ve had a label approved in one country but rejected in the other, or you’ve found yourself buried in pages of inconsistent regulations. You’re not the only one
... Read moreHealth 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Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation.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 how these products and their individual components are regulated under the Food and Drugs Act and its regulations. If your business is involved in developing, packaging, distributing, importing or wholesaling co-packaged drug products, this is
... Read moreFDA Releases Cosmetic Facility & Product Registration Summary
On March 13, 2025, the U.S. Food and Drug Administration (FDA) released its first public summary data on the mandatory registration of cosmetic product facilities and the listing of cosmetic products, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). If you’re a manufacturer, processor, or brand owner distributing cosmetics in the
... Read moreWhy 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. As of March 1, 2025, Health Canada requires that all Cosmetic Notification Forms (CNFs) include a Canadian Agent. Whether you’re just starting to explore the Canadian cosmetics market or you’ve been selling here for years,
... Read moreFDA to Extend Food Traceability Rule: What You Need to Know
The FDA Food Traceability Rule compliance date could soon be pushed back. The U.S. Food and Drug Administration (FDA) is planning to give businesses an extra 30 months to fully comply with the final rule’s requirements. Why is this happening now, and what does it really mean for your business? While the extension isn’t official
... Read moreSupplySide Connect New Jersey 2025
April 7–9, 2025 Meadowlands Exposition Center | Secaucus, NJ Join Quality Smart Solutions at SupplySide Connect New Jersey 2025, where leading experts in health, nutrition, and dietary supplements will gather to shape the future of the industry. This key event brings together product innovators, suppliers, and service providers to foster collaboration and success. With regulatory
... Read moreVitafoods Europe 2025
May 20–22, 2025 Fira Barcelona Gran Via | Barcelona, Spain Join Quality Smart Solutions at Vitafoods Europe 2025, the premier global event for nutraceutical suppliers, manufacturers, and industry leaders. This event shapes the future of the functional food, beverage, and dietary supplement sectors with innovations and regulatory insights from across the globe. As regulations tighten
... Read moreYour 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 a small detail that derails the entire process, delaying market access by months. Medical device submission errors are more common than you might think, and they can cost you both time and money. The stakes
... Read moreHealth 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 impact licensed operations as well as current applicants. While some of these changes apply immediately, others have transition periods to give businesses time to adjust. Understanding these updates now can help you stay compliant, cut
... Read moreHealth Canada’s Latest Front-of-Package Labelling Updates
Introduction Recently, Health Canada announced interim policies affecting fresh coconut products and certain ready-to-eat breakfast cereals. The FOP labelling updates can impact your business, especially if you sell prepackaged foods. That’s why understanding these changes will help you stay compliant and avoid unnecessary disruptions to your business. In this blog, we’ll break down exactly what
... Read moreHealth 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 manufacture energy drinks, snack bars, or functional beverages, these updates will determine how you formulate and market your products moving forward. At the same time, Health Canada is tightening regulations to ensure consumers stay informed
... Read moreSelf-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 FDA to explore rulemaking to remove the option for companies to self-affirm that food ingredients are safe. If implemented, this shift will require all GRAS determinations to undergo FDA review, significantly altering the regulatory landscape
... Read moreHealth Canada Reviews CBD as an NHP in New Consultation
Health Canada is conducting a public consultation on CBD regulations for natural health products, exploring a pathway to allow non-prescription CBD products under the Natural Health Products Regulations (NHPR). This consultation opened on March 7, 2025, and will close on June 5, 2025. The proposed framework aims to expand access to non-prescription CBD products while
... Read moreFDA’s New AI Rules for Medical Devices: What’s Changing?
Artificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever. But with innovation comes regulation. The FDA’s new AI rules for medical devices introduce critical updates that manufacturers must understand to stay compliant and competitive. These guidances are part of a broader effort led by
... Read moreHealth Canada to Prioritize Canadian-Made Class III NHPs
The Natural and Non-prescription Health Products Directorate (NNHPD) has changed the review process for Class III Natural Health Product (NHP) applications. Due to a growing backlog and higher submission volume, Health Canada will now prioritize applications for products sold or manufactured in Canada within six months of licensing. Starting March 5, 2025, NNHPD will no
... Read moreHealth 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 are on the horizon. Health Canada has introduced new compliance rules for supplemental ingredients declared on product labels, with full enforcement set for December 31, 2025. These updates impact how your products are labelled and
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