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 intended for human food or animal feed. This decision significantly impacts how the substance must be evaluated and documented under the GRAS (Generally Recognized as Safe) process. The regulatory pathway for GRAS differs depending on
... Read moreTraditional 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 North America. While both types of products may appear similar on store shelves, they follow different regulatory pathways, and that has a direct impact on your compliance obligations. Whether you’re selling moisturizers, anti-aging serums, or
... Read moreA 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 importer of record. To begin with, this designation comes with specific responsibilities under the Safe Food for Canadians Regulations (SFCR), and getting it right is essential for avoiding compliance headaches. However, the regulatory landscape is
... Read moreMDL 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 over again: MDL and MDEL. Understanding the difference between them is one of the first steps toward compliance with Health Canada’s medical device regulations. The two licences cover different parts of the process. One applies
... Read moreStruggling 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 or formulating a novel product, understanding what it takes to meet GRAS standards can feel overwhelming. The FDA has outlined specific requirements, but without a clear plan, your submission might face delays or even rejection.
... Read moreFDA 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 petroleum-based dyes in the U.S. food supply. The approval of these natural food colors marks a big step toward cleaner labeling and healthier food options. Moreover, this update supports the U.S. Department of Health and
... Read moreFDA 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 expansion of its unannounced inspection program to now include foreign manufacturing sites. This change will directly impact companies exporting pharmaceuticals and other regulated products into the U.S. If you rely on international partners or operate
... Read moreFDA Front-of-Package Labeling Deadline Extended
FDA Front-Of-Package Labeling Comment Period Extended The U.S. Food and Drug Administration has extended the comment period for its proposed rule on front-of-package labeling. Originally set to close earlier, the comment window is now open until July 15, 2025. This extension gives stakeholders additional time to evaluate the rule’s potential impact and provide meaningful feedback.
... Read moreHealth Canada electronic filing updates: Key changes in 2025
If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want to take a closer look at. As of April 1, 2025, new electronic filing rules are now in place for both eCTD and non-eCTD formats. These updates aim to make the submission process more streamlined
... Read moreNavigating 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 a plan. FDA and Health Canada rules for eczema products vary widely depending on the formulation and claims. Many companies risk product delays or enforcement action by misclassifying their product or using unapproved claims. If
... Read moreComparing 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 seasoned brand or just getting started, understanding FDA cosmetic compliance vs Health Canada requirements is a must. Each country has its own set of rules, and missing even one detail can cause delays, product holds,
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