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 >>
A Quality Management System (QMS) is a structured framework that organizations use to ensure their products or services consistently meet customer expectations and regulatory requirements. Its purpose is to ensure […] Read More >>
Achieving Generally Recognized as Safe (GRAS) status is a critical milestone in food and ingredient safety, assuring consumers, regulatory authorities, and industry stakeholders that a product or ingredient is safe […] Read More >>
On December 28, 2025, a new final rule from the FDA regarding medical gases will take effect. This rule aims to update and clarify the regulations surrounding current good manufacturing […] Read More >>
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule amending the regulations for in vitro diagnostics (IVDs) to include laboratory-developed tests (LDTs) explicitly. Effective […] Read More >>
Today, we bring crucial information regarding changes from the Federal Drug Administration (FDA) that impact cosmetic product facility registration and cosmetic product listing in the United States. These changes, outlined […] Read More >>
The FDA has issued a significant recall alert concerning Nutramigen, a product manufactured by Reckitt/Mead Johnson Nutrition. This product was positive for Cronobacter sakazakii, leading the FDA to inspect the […] Read More >>
Achieving Generally Recognized as Safe (GRAS) status is a critical milestone in food and ingredient safety. This status assures consumers, regulatory authorities, and industry stakeholders that a product or ingredient […] Read More >>
On August 7, 2023, the FDA issued draft guidance for Registration and Listing of Cosmetic Product Facilities and Products to assist cosmetics companies in submitting cosmetic product facility registrations and […] Read More >>
On July 17, 2023, the FDA announced the successful conclusion of its voluntary pilot program to evaluate the alignment of third-party food safety audit standards with relevant FDA regulations. The […] Read More >>
Definition of a Pregnancy Test A urine pregnancy test device is an In-Vitro Diagnostic (IVD) hormonal assay that measures the beta (β) subunit of Human Chorionic Gonadotrophin (hCG) levels in […] Read More >>
The FDA regulation of cosmetic products is designed to protect public health and ensure that consumers have access to safe and accurately labeled cosmetic products. In December 2022, Congress passed […] Read More >>
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