As the gut microbiome continues to gain attention across food, natural health products (NHPs), and dietary supplements, prebiotic and probiotic claims have become a central focus for product development and […] Read More >>
Probiotics are widely regarded as safe in healthy populations. However, as clinical research moves toward targeted, high-potency, and therapeutic outcomes, safety monitoring must evolve. Living organisms interact dynamically with the […] Read More >>
Placebo-controlled studies remain the gold standard for demonstrating efficacy in clinical research. However, in probiotic trials, designing an appropriate placebo is far from straightforward. Unlike conventional pharmaceuticals, probiotics are living [&he Read More >>
Register for Dietary Supplement cGMP Online Training | 21 CFR Part 111 There have been no major structural changes to 21 CFR Part 111 in recent years. However, focusing on […] 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 >>
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 >>
Register Now for Dietary Supplement cGMP Online Training | 21 CFR Part 111 In the U.S. dietary supplement industry, product quality is not something that can be assumed. It must […] 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 >>
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 >>
On March 6, 2023, the Food and Drug Administration (FDA) launched a new directory of ingredients used in dietary supplements. The directory will be a “one-stop shop” for ingredient information […] Read More >>
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>
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