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20

Aug 2026

How to Prepare a Self GRAS Dossier for FDA Review
How to Prepare a Self GRAS Dossier for FDA Review
By
At a Glance A well-prepared self-affirmed GRAS dossier may already contain much of the scientific information needed to support an FDA GRAS notice. However, converting an existing dossier for FDA […] Read More >>

19

Aug 2026

Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
By
At a Glance Live Biotherapeutic Products (LBPs) are transforming therapeutic development, with clinical programs expanding across gastrointestinal disorders, metabolic disorders, immunology, oncology, and rare conditions. Unlike conventional pharmaceutical Read More >>

14

Aug 2026

Postbiotics vs. Probiotics: Regulatory and Clinical Differences
Postbiotics vs. Probiotics: Regulatory and Clinical Differences
By
Abstract Probiotics and postbiotics are both increasingly used in microbiome-focused health products, but the regulatory and clinical considerations surrounding them can differ substantially. Probiotics depend on live microorganisms, making strain [&hellip Read More >>

06

Aug 2026

Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
By
At a Glance While many commercially available probiotics have a well-documented history of safe use in healthy populations, clinical trials evaluating live biotherapeutic products (LBPs) or probiotic dietary supplements are […] Read More >>

31

Jul 2026

Does a Proprietary Ingredient Blend Need Its Own GRAS Conclusion?
Does a Proprietary Ingredient Blend Need Its Own GRAS Conclusion?
By
Abstract Introduction Developing a proprietary blend can create an important regulatory question: if every component is already Generally Recognized as Safe (GRAS), can the ingredients be combined under one existing […] Read More >>

31

Jul 2026

IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
By
Abstract Live Biotherapeutic Products (LBPs) are biological products that contain live organisms, are applicable to the prevention, treatment, or cure of a human disease or condition, and are not vaccines. […] Read More >>

24

Jul 2026

FDA Front-of-Package Nutrition Labelling Is Still Moving Forward: What Food Manufacturers Need to Know
FDA Front-of-Package Nutrition Labelling Is Still Moving Forward: What Food Manufacturers Need to Know
By
Abstract Although the proposed rule has been quieter than many expected, recent FDA communications confirm that Front-of-Package (FOP) nutrition labelling remains very much on the agency’s agenda. Here’s what has […] Read More >>

21

Jul 2026

Can a U.S. GRAS Ingredient be Sold in the European Union?
Can a U.S. GRAS Ingredient be Sold in the European Union?
By
Abstract For ingredient manufacturers expanding internationally, achieving Generally Recognized as Safe (GRAS) status in the United States is often viewed as a significant regulatory milestone. However, GRAS does not authorize […] Read More >>

15

Jul 2026

Synbiotics: Regulatory Classification and Clinical Trial Considerations
Synbiotics: Regulatory Classification and Clinical Trial Considerations
By
Abstract Synbiotics represent an increasingly sophisticated approach to microbiome-focused products by combining live microorganisms with substrates designed to support beneficial microbial activity. However, regulatory classification and evidence requirem Read More >>

15

Jul 2026

Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
By
Abstract Postbiotics are emerging as a significant new category of microbiome-focused products, offering potential advantages over traditional probiotics through improved stability, simplified manufacturing, and greater formulation flexibility. However, de Read More >>

15

Jul 2026

Does GRAS Status Matter in Canada?
Does GRAS Status Matter in Canada?
By
Abstract U.S. GRAS status is an important safety milestone, but it does not authorize an ingredient for sale in Canada. Instead, Health Canada evaluates ingredients under its own regulatory framework, […] Read More >>

14

Jul 2026

cGMP vs GMP: Key Differences for Dietary Supplements and NHPs
cGMP vs GMP: Key Differences for Dietary Supplements and NHPs
By
Abstract Good Manufacturing Practices are fundamental to product quality in both the Canadian Natural Health Product and U.S. dietary supplement industries. However, the requirements are not interchangeable. In the United […] Read More >>

26

Jun 2026

AI Hallucinations: Why Regulators Are Paying Attention
AI Hallucinations: Why Regulators Are Paying Attention
By
Regulatory and oversight concern around AI hallucinations is not centered only on intentional misuse, but on the introduction of unverifiable, unsupported, or fabricated information into regulated workflows. As organizations increasingly […] Read More >>

26

Jun 2026

FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
By
On February 2, 2026, the FDA’s revised Quality Management System Regulation (QMSR) officially became effective, replacing the long-standing Quality System (QS) Regulation framework under 21 CFR Part 820. While the […] Read More >>

12

Jun 2026

AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
By
Artificial intelligence is changing the way regulators evaluate medical devices, particularly where software functionality influences clinical decision-making or adapts over time. While software regulation is not new, machine learning introduces […] Read More >>

31

May 2026

Is Collagen Generally Recognized as Safe (GRAS) in the United States?
Is Collagen Generally Recognized as Safe (GRAS) in the United States?
By
Collagen continues to dominate the functional ingredient market across foods, beverages, supplements, and beauty-from-within products. From protein powders and ready-to-drink beverages to gummies and nutrition bars, collagen ingredients are now […] Read More >>

29

May 2026

GRAS for GLP-1 Inspired Supplements: Regulatory Strategy & Ingredient Considerations
GRAS for GLP-1 Inspired Supplements: Regulatory Strategy & Ingredient Considerations
By
As GLP-1 receptor agonist drugs like Ozempic®, Wegovy®, and Mounjaro® continue to dominate conversations around weight management and metabolic health, supplement companies are increasingly exploring ingredients that may support the […] Read More >>

29

May 2026

What GRAS Means For Pet Foods in the United States
What GRAS Means For Pet Foods in the United States
By
Pet food innovation is moving quickly across the United States. From novel proteins and functional ingredients to fermentation-derived compounds and upcycled materials, manufacturers are continuing to develop increasingly sophisticated products […] Read More >>

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 >>

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