The Dietary Supplement Health and Education Act (DSHEA) formed a strong framework for the regulation of New Dietary Ingredient (NDI) notifications as a pre-market safety review process. NDI is defined […] Read More >>
On August 24, Health Canada’s Food Directorate issued a Notice of Modification to Enable the Use of Steviol Glycosides (the active ingredient in stevia leaf extract) as a Sweetener in […] Read More >>
The U.S. Food and Drug Administration (FDA) has finally formalized the new Nutritional Facts panel for packaged foods. There are six critical changes that the FDA has implemented to help […] Read More >>
August 08, 2016 Marketed Health Products Directorate provides Summary Safety Review for Alpha Lipoic Acid. In an effort to increase transparency and consumer safety, Health Canada’s Marketed Health Products Directorate […] Read More >>
It was only last October that the World Health Organization (WHO) announced, based on a report from the International Agency of Cancer Research (IACR), that processed meats and red meats […] Read More >>
As of May 20th 2016, the FDA has proposed to include a separate line for added sugars on the nutrition label on food packaging to help Americans make more informed […] Read More >>
June 13, 2016 Canadian Food Inspection Agency updates the Industry Labelling Tool on Allergen-Free, Gluten-Free and Precautionary Statements. With the rising popularity of Gluten-Free foods and the proposed increase in […] Read More >>
If you pulled a food product off the shelf at your local grocery store and the label text read, “natural”, what would be your understanding of that statement? Most people […] Read More >>
Food safety has become an important concern for government, with Canada’s Public Health Agency (PHAC) approximating 4 million cases of food borne illnesses annually. Although food safety is a shared […] Read More >>
In 2002, FDA first issued regulations on providing the process – The Time and Extent Application (TEA), to create a new Over the Counter (OTC) drug monograph, or amend an […] Read More >>
December 1, 2015, the Natural and Non-prescription Health Products Directorate (NNHPD) released their latest Site Licensing Guidance Document (Version 3). The most significant change to the guide involves the introduction […] Read More >>
Health Canada’s Non-Prescription Drug Monograph Attestation Pilot has just ended, low success rate will result in revisions to the process. Health Canada initiated a Non-prescription drug monograph attestation pilot in […] Read More >>
If you know what Temporary Market Authorization (TMA) means and your company sells Caffeinated Energy Drinks in Canada, get ready to be puzzled. Maybe grab an energy drink to fuel […] Read More >>
December 8, 2015 Health Canada releases Policy and Monograph on Medicated Vapour products. Health Canada’s Medicated Vapour Products Classification Decision In December, Health Canada published a notice to the industry […] Read More >>
We have received notice that the Natural and Non-prescription Health Products Directorate (NNHPD) will initiate a new policy with respect to post-licence audit failures. The NNHPD implemented a new […] Read More >>
Health Canada issues revised guidance and updated Homeopathic monograph for homeopathic medicines for cough, cold, flu for children under 12. Homeopathic Monograph Revisions: Homeopathic Immunity Misconceptions In late 2014, […] Read More >>
Health Canada requires that industry conduct due diligence on their consumer products through safety assessments and labelling to ensure that do not pose harm to consumers. Under Canada Consumer […] Read More >>
Health Canada lists proposed changes to Nutrition Facts Table in Canada Gazette I, if approved industry will have 5 years for compliance. The Government of Canada is helping to […] Read More >>
Health Canada’s New Advance Notice of Importation Process Pilot Offers More Convenience and Flexibility to Importers of Drugs, NHPs, and Cosmetics. As regulatory consultants for the U.S. and Canada, dicentra […] Read More >>
The NNHPD has released 2 new product monographs Antioxidants and Kelp, for consultation until the end of April. The Natural and Non-prescription Health Products Directorate is steadily continuing the development […] Read More >>
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