On November 21, 2022, the FDA’s Center for Food Safety and Applied Nutrition issued warning letters to five manufacturers of food and beverages containing cannabidiol (CBD). These letters mark the […] 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 >>
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. While appearing similar to smallpox, it is […] Read More >>
The definition of blood pressure and its associated guidelines have recently been updated in the United States. Previously, high blood pressure was defined by the threshold blood pressure […] Read More >>
Service(s) related to this article: Food & Beverages and Product Development & Label Compliance Health Canada has released a notice of proposal describing the regulation of prohibiting the use of […] Read More >>
Service(s) Related to Post: Clinical Trial Consulting Services On January 18, 2017, the U.S. Department of Health and Human Services (HHS) together with 15 other federal agencies, released a lengthy […] Read More >>
SPECIAL ALERT November 10, 2015 As part of its ongoing post-licencing audit program, Health Canada has raised concerns with products that contain both caffeine and any ingredients that could possibly […] Read More >>
November 8, 2013 Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013. Companies have been advised to ensure that they are familiar with and […] Read More >>
DR. MOHAMMAD KHALID, PH.D., B.SC.(HONS) Dr. Khalid is the leading GMP expert at dicentra. He helps dicentra’s clients reach compliance with the FDA GMP Rule for Dietary Supplements (21 CFR […] Read More >>
March 26, 2013: dicentra conducted its first webinar of 2013. Critical American and Canadian updates including FDA’s proposed rules to amend cGMPs for food facilities under FSMA, the FDA’s Draft […] Read More >>
August 28, 2012 A Quick Note…. There have been a number of significant developments on the regulatory front for dietary supplements in the United States lately. For example, dietary supplement […] Read More >>
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs.We can be reached at 1-866-647-3279 […] Read More >>
May 10, 2012 Are You Making False Claims By Heather Van Blarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements If you don’t have “competent and reliable scientific evidence” […] Read More >>
By: Rupika Malhotra, MSc Scientific and Regulatory Affairs Associate, dicentra Inc. A new study published in the Journal of the American Medical Association demonstrates findings which indicate that along with […] Read More >>
Schedule F Revisions Published The long-awaited Schedule F revisions have been published in Canada Gazette II. Amendments to the Food and Drug Regulations have been made to 10 naturally sourced […] Read More >>
John Holtmann was born on May 24th, 1950, the youngest of Heinrich and Johanna Holtmann’s eight children. He grew up on a dairy farm in Rosser, Manitoba, and would want […] Read More >>
By: Ashleigh Hampton, MSc December 5, 2011 Previous reports of resveratrol have suggested that resveratrol undergoes extensive metabolism, thus resulting in a low bioavailability of the parent compound (As reviewed […] Read More >>
GMP Training Makes Good Business Sense If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, lack of proper […] Read More >>
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