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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
In December 2024, the U.S. Food and Drug Administration (FDA) announced a significant update to its Final Ruling on the use of the claim “healthy” on food product labels. This […] Read More >>
A Generally Recognized as Safe (GRAS) or New Dietary Ingredient (NDI) notification is essential for novel food ingredient manufacturers and distributors to ensure that their product is recognized as safe […] Read More >>
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