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On August 7, 2023, the FDA issued draft guidance for Registration and Listing of Cosmetic Product Facilities and Products to assist cosmetics companies in submitting cosmetic product facility registrations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On February 22, 2023, the Food and Drug Administration (FDA), released draft guidance regarding the labeling of plant-based milk alternatives. The draft guidance, which provides industry with guidance on labeling […] Read More 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 >>
On December 20, 2022, the Federal Trade Commission (FTC) published “Health Products Compliance Guidance” for advertising and marketing health claims. The guidance document replaces “Dietary Supplements: An Advertising Guide for […] Read More >>
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] Read More >>
This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>