Artificial intelligence is no longer experimental in regulated industries. It is being used to monitor claims, scan clinical literature, validate labels, screen ingredient risks, predict quality trends, and surface early […] Read More >>
Probiotic trials are frequently underpowered—not because sponsors ignore statistics, but because they underestimate how different probiotics are from conventional nutraceuticals. Unlike single-molecule ingredients, probiotics are living systems. Their ef Read More >>
Probiotic trials don’t fail only because a strain “doesn’t work.” Many fail because the endpoint doesn’t match the claim, the population, or the biology of a living product—and the study […] Read More >>
Functional mushrooms are now common in coffees, drink mixes, gummies, bars, and functional beverages. Ingredients like lion’s mane, reishi, cordyceps, chaga, and turkey tail continue to gain traction across cognitive, […] Read More >>
Peptides are increasingly used in functional foods, beverages, and performance nutrition products. From protein hydrolysates to precision-designed bioactive peptides, these short chains of amino acids are gaining commercial traction across […] Read More >>
Health Canada is abolishing Foreign Site Reference Numbers (FSRNs). The details are outlined below, but the key takeaway is this: FSRNs are no longer available or accepted, and foreign site […] Read More >>
Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has launched a 15-business-day consultation on a new draft Prebiotics Monograph for Natural Health Products (NHPs). Stakeholders have until February 20, […] Read More >>
On November 18, 2025, the Natural and Non-prescription Health Products Directorate (NNHPD) introduced two important regulatory tools designed to bring greater clarity, predictability, and flexibility to Canada’s Natural Health Product […] Read More >>
Ethanol, commonly referred to as alcohol, is one of the oldest and most widely used substances in the food industry. From its role as a fermentation product in beverages to […] Read More >>
Health Canada has confirmed that implementation of the proposed cost recovery fees for Natural Health Products (NHPs) will not proceed on December 1, 2025, as originally planned. According to correspondence […] Read More >>
In October 2024, Health Canada launched a consultation to update the 2015 Good Manufacturing Practices (GMP) Guidance Document (Version 3.0). That draft focused on simplifying language, aligning with international quality […] Read More >>
dicentra published a new JALM article (Aug 2025) presenting a staged framework that integrates analytical validity, clinical validity, clinical utility, regulatory strategy, and integrated evidence generation. Regulatory Approved Point-of-Care Diagnostics Read More >>
If you plan to sell cosmetics in Canada, one of the first compliance steps is completing Health Canada’s Cosmetic Notification Form (CNF). This form is an essential regulatory requirement under […] Read More >>
Background On January 15, 2025, the FDA revoked authorization for FD&C Red No. 3 (erythrosine) for use in foods, including dietary supplements, and in ingested drugs. The agency followed a […] Read More >>
As Canada continues to engage in an ongoing global trade war, it is important that you ensure your products are properly classified, both from a regulatory and a commercial perspective. […] Read More >>
As Canadian businesses prepare to celebrate Canada Day, many are looking to highlight their national pride by adding “Made in Canada” or “Product of Canada” claims to their product labels. […] Read More >>
On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative AI tool designed to assist FDA staff with core functions such as reviewing clinical […] Read More >>
Selecting the right monitoring approach is a critical decision for sponsors designing a clinical trial. It impacts not only patient safety and data integrity but also regulatory compliance, cost, and […] Read More >>
Before a single participant is enrolled or a protocol is submitted for ethics approval, one critical document quietly shapes the course of a clinical trial: the Clinical Research Feasibility Assessment […] Read More >>
As part of a sweeping push toward transparency in the U.S. food system, HHS Secretary Robert F. Kennedy Jr. has proposed eliminating the self-affirmed Generally Recognized as Safe (GRAS) pathway. […] Read More >>
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