Health Canada’s ongoing efforts to update and revise its monographs continue with the release of Batch 2 for consultation. This marks another significant step in ensuring the accuracy and relevance […] 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 >>
A Natural Product Number (NPN) is an 8-digit number issued to a Natural Health Product (NHP), after an assessment, indicating its approval by Health Canada’s Natural and Non-Prescription Health Products […] 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 >>
The Canadian Food and Drug Regulations (FDR) have established regulations for Food for Special Dietary use (FSDU) as well as food for infants, covered under Divisions 24 and 25 of […] Read More >>
What is BRCGS The Brand Reputation Compliance Global Standard or BRCGS, is a set of requirements which are GFSI (Global Food Safety Institute) benchmarked for food safety, consumer products, packaging […] Read More >>
Introduction and Scope The Canadian Food Inspection Agency (CFIA) has published a final notice to industry for the final phase of implementation plan for nutrition labelling changes. Compliance comes into […] Read More >>
The Canadian Food and Drug Regulations (FDR) have previously set over 300 composition standards for food products being imported and traded within and between provinces of Canada. These compositional standards […] Read More >>
Health Canada’s Natural Non-Prescription Health Products Directorate (NNHPD) recently announced that beginning at the end of October, they will begin consulting on monograph revisions. This initiative is geared toward enhancing […] 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 >>
Attention all manufacturers, packagers, distributors, and sellers of Ready-to-Eat (RTE) foods in Canada, as of October 1, 2023, Health Canada’s updated policy on Listeria monocytogenes in RTE foods is now […] Read More >>
On Thursday, September 21, 2023, representatives from dicentra attended the CHFA Now’s Regulatory Forum in Toronto in order to stay informed and be able to provide our clients, prospects, and […] Read More >>
In the ever-evolving landscape of regulatory compliance for the natural health product (NHP) industry in Canada, recent developments such as Bill C-47 (refresher here) and the NHP GMP Inspection Program […] 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 >>
On June 22, 2023, Bill C-47 received Royal Assent, introducing amendments to the Food and Drugs Act (FDA) concerning Natural Health Products (NHPs). These amendments extend the enforcement power of […] 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 >>
On May 12, 2023, Health Canada alerted industry of a new proposal to introduce cost recovery fees for Natural Health Product (NHP) regulatory activities in Canada. The proposal, open for […] 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 >>
The Federal Trade Commission (FTC) announced On April 13, 2023, that it has sent notices to approximately 670 companies involved in the marketing of dietary supplements, functional foods, over-the-counter (OTC) […] Read More >>
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