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29

Apr 2026

GRAS vs NDI: What Ingredient Manufacturers Need to Know
GRAS vs NDI: What Ingredient Manufacturers Need to Know
By
Why this distinction matters more than ever For companies developing ingredients for the U.S. market, one question comes up early—and often: Should this ingredient go the GRAS route, or require […] Read More >>

28

Apr 2026

Prebiotic vs Probiotic Claims: Regulatory Considerations
Prebiotic vs Probiotic Claims: Regulatory Considerations
By
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 >>

28

Apr 2026

Monitoring Safety in Probiotic Clinical Studies: Key Considerations
Monitoring Safety in Probiotic Clinical Studies: Key Considerations
By
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 >>

28

Apr 2026

Designing Placebo Controls for Probiotic Trials: Key Considerations
Designing Placebo Controls for Probiotic Trials: Key Considerations
By
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 >>

24

Apr 2026

Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
By
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 >>

24

Apr 2026

Dietary Supplement cGMPs 2026: FDA Enforcement Is Rising — and Most Companies Are Not Ready
Dietary Supplement cGMPs 2026: FDA Enforcement Is Rising — and Most Companies Are Not Ready
By
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 >>

23

Apr 2026

State-Level GRAS Disclosure Bills: What They Mean for Food Manufacturers
State-Level GRAS Disclosure Bills: What They Mean for Food Manufacturers
By
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 >>

21

Apr 2026

GRAS Certification: What It Really Means (and Why it Doesn’t Exist)
GRAS Certification: What It Really Means (and Why it Doesn’t Exist)
By
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 >>

21

Apr 2026

FDA Reverses Position on NMN: A New Pathway for Dietary Supplments
FDA Reverses Position on NMN: A New Pathway for Dietary Supplments
By
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 >>

20

Apr 2026

How AI is Regulated Across FDA, Health Canada, and the EU
How AI is Regulated Across FDA, Health Canada, and the EU
By
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 >>

20

Apr 2026

AI in Clinical Trials: Current Regulatory Expectations
AI in Clinical Trials: Current Regulatory Expectations
By
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 >>

17

Apr 2026

AI in Pharmacovigilance: Where Automation Meets Regulatory Accountability
AI in Pharmacovigilance: Where Automation Meets Regulatory Accountability
By
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 >>

31

Mar 2026

What are cGMPs and Why Do They Matter for Dietary Supplements?
What are cGMPs and Why Do They Matter for Dietary Supplements?
By
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 >>

31

Mar 2026

Maintaining Blinding Integrity in Probiotic and Live Biotherapeutic Trials
Maintaining Blinding Integrity in Probiotic and Live Biotherapeutic Trials
By
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 >>

27

Mar 2026

Does My Product Need an NPN in Canada
Does My Product Need an NPN in Canada
By
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 >>

26

Mar 2026

Nootropics and GRAS Status: What Ingredient Innovators Need to Know
Nootropics and GRAS Status: What Ingredient Innovators Need to Know
By
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 >>

18

Mar 2026

Health Canada Updates the NHP MAP: What Industry Needs to Know
Health Canada Updates the NHP MAP: What Industry Needs to Know
By
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 >>

12

Mar 2026

Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
By
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 >>

11

Mar 2026

When Does a Probiotic Need a Clinical Trial?
When Does a Probiotic Need a Clinical Trial?
By
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 >>

11

Mar 2026

Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
By
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 >>

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