Health Canada has announced a significant regulatory update affecting sports electrolyte products, formally transitioning them from the Natural Health Product (NHP) framework to the food regulatory framework. This change reflects […] Read More >>
Dietary Supplement cGMP Online Training | 21 CFR Part 111 | Early Registration Now Open There have been no major structural changes to 21 CFR Part 111 in recent years. […] Read More >>
State-level scrutiny of Generally Recognized as Safe (GRAS) substances is no longer limited to New York. While New York’s Food Safety and Chemical Disclosure Act has drawn significant attention because […] Read More >>
If you’ve been researching how to bring a food ingredient to market in the United States, you’ve likely come across the term “GRAS certification.” It’s a phrase that sounds official—but […] Read More >>
The U.S. Food and Drug Administration (FDA) has officially reversed its position on beta-nicotinamide mononucleotide (NMN), concluding that the ingredient is not excluded from the definition of a dietary supplement. […] Read More >>
AI is already part of your regulatory process AI isn’t coming to life sciences—it’s already here. It’s being used to screen ingredients, draft labels, monitor claims, summarize safety data, assemble […] Read More >>
What sponsors need to know today AI isn’t a future consideration in clinical research—it’s already embedded in how trials are designed, executed, and monitored. From protocol optimization and patient recruitment […] Read More >>
AI is entering the most failure-prone part of the lifecycle Pharmacovigilance has always been one of the most operationally complex—and failure-prone—areas of the regulatory lifecycle. It depends on the timely […] Read More >>
Dietary Supplement cGMP Online Training | 21 CFR Part 111 | Early Registration Now Open In the U.S. dietary supplement industry, product quality is not something that can be assumed. […] Read More >>
Blinding is a cornerstone of clinical trial design, but in probiotic and live biotherapeutic product (LBP) studies, it is uniquely fragile. Unlike conventional pharmaceuticals, probiotics and LBPs are living systems. […] Read More >>
Many companies entering the Canadian market ask the same question: does my product require an NPN? The answer depends on scope. In Canada, a product may require a Natural Product […] Read More >>
Nootropics in food and beverages: understanding GRAS requirements Nootropics—commonly described as “cognitive enhancers” or “brain health ingredients”—are increasingly being incorporated into functional foods and beverages. From botanical extra Read More >>
Health Canada has released an updated version of the Natural Health Products Management of Applications Policy (NHP MAP), replacing the previous guidance published in April 2019. The revised NHP MAP […] Read More >>
The Canadian Food Inspection Agency (CFIA) has announced important updates to the Safe Food for Canadians (SFC) licensing process, introducing additional information requirements, enhanced pre-issuance review procedures, and significantly longer […] Read More >>
Not every probiotic product requires a clinical trial. Many probiotic strains already have a body of published evidence, and regulatory frameworks for dietary supplements and foods do not always mandate […] Read More >>
Probiotic trials rarely fail for a single reason. More often, problems emerge from a series of early design decisions that were never fully aligned: the strain chosen doesn’t match the […] Read More >>
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 >>
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