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On August 7, 2023, the FDA issued draft guidance for Registration and Listing of Cosmetic Product Facilities and Products to assist cosmetics companies in submitting cosmetic product facility registrations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 >>
This is a reminder to all importers wishing to certify food products under the Voluntary Qualified Importer Program (VQIP) for fiscal year (FY) 2024 that the VQIP Application due date […] 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 >>
Food additives are subjected to premarket review by the FDA, although an exemption applies if a petitioner can demonstrate that an ingredient is Generally Recognized as Safe (GRAS) under its […] Read More >>
On February 22, 2023, the Food and Drug Administration (FDA), released draft guidance regarding the labeling of plant-based milk alternatives. The draft guidance, which provides industry with guidance on labeling […] Read More >>
Back in 2016, the FDA published new requirements for the Nutrition Facts Table (or NFT) on packaged foods. This update was made to reflect new scientific information, linking together diet […] Read More >>
On January 26, 2023, Principal Deputy Commissioner Janet Woodcock released a statement regarding the current state of cannabidiol (CBD) regulation by the FDA and a growing need for a “new […] Read More >>
On January 31, 2023, the Commissioner of the Food and Drug Administration, Dr. Robert Califf, announced a proposal to overhaul the human foods program to protect food safety. The statement, […] Read More >>
The FDA has recently announced a proposal to amend the current Investigational New Drug (IND) application regulations. The proposal involves 2 exemptions for clinical investigations involving lawfully marketed foods (including […] Read More >>
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