FDA considers dietary supplements that contain new dietary ingredients and that have not submitted new dietary ingredient Notifications to be adulterated. Any supplement that is considered to be adulterated can […] Read More >>
Until recently, the medicinal ingredient “vinpocetine” was considered an unacceptable ingredient for use in natural health products (NHPs) in Canada, according to the Natural Health Products Directorate (NHPD), and […] Read More >>
On September 14th, dicentra joined Genuine Health staff, Dr. Alan Logan, Sam Graci and Dr. Faisal Moola, of the David Suzuki Foundation for a tree planting afternoon at Canada’s first […] Read More >>
At the NBJ Summit this summer, Dr. Daniel Fabricant, Ph.D., director of the FDA’s Division of Dietary Supplement Programs, was asked his opinion on the status of the dietary […] Read More >>
To date there are 350 Product Licence Applications (PLAs) outstanding that should have Temporary Marketing Authorization (TMA) applications in queue at Health Canada. As of September 30, 2012 regulatory […] Read More >>
For those involved in the natural health products (NHP) industry there is a new compound of interest known as raspberry ketones, that is gathering a great deal of attention as […] Read More >>
Since the final good manufacturing practices (GMP) rule for dietary supplements was implemented in 2007, the Food and Drug Administration (FDA) has made it very clear that GMP inspections […] 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 >>
Aspartame, also known as E 951, is an artificial sweetener that has been approved for use in foods and beverages in the European Union (EU), and as a flavour […] Read More >>
On July 24, 2012 the FDA issued a Warning letter to United Nutrition Labs for continually failing to comply with current Good Manufacturing Practices (cGMPs) after a thorough on-site […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements At the NBJ Summit last week in Dana Point, CA, David C. Vladeck, the Director of the Federal […] Read More >>
By: Ashleigh Hampton, MSc Manager, Scientific Affairs Supporting evidence is required by both the Canadian and American regulatory bodies to substantiate marketed health claims. Health Canada reviews the evidence to […] Read More >>
By: William Morkel, BSc Director of Quality & Compliance It is standard practice amongst many countries to require an International Trade Certificate (ITC) to accompany any natural health product (NHP) […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York […] 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 >>
By Manushvi Chadha, BPharm, RA Cert NHP, Cosmetic and Drug Regulatory Affairs Associate As of June 2012 the Natural Health Product Directorate (NHPD) has released a document outlining their new […] Read More >>
By Heather VanBlarcom General Counsel and Senior Regulatory Specialist for Dietary Supplements It’s been no secret that obesity in the United States has been on the rise, largely due, in […] Read More >>
What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with […] Read More >>
Coconut oil has recently garnered significant attention in the natural health products industry for some very marketable uses such as weight loss. However, the use of coconut oil is not […] Read More >>
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