Supplier qualification is a requirement of the regulations, as set out by 21 CFR part 111.75. Setting up a proper supplier qualification program is an essential step in maintaining dietary […] Read More >>
NHPD revises maximum daily limit of carvacrol for natural health products containing Oil of Oregano as a medicinal ingredient. Oil of oregano, derived from the species of Origanum spp., is […] Read More >>
Although rare the FTC and FDA have recently sent a joint warning letter to a company. An FDA warning letter can be scary enough, but a joint warning letter can […] Read More >>
The NHPD has Transitioned the Assessment of NHP Clinical Trial Applications (for primary indications inappropriate for self-care) and Adverse Reaction Reporting to the TPD. Health Canada informed the industry through […] Read More >>
B.I.G. is well coded and it will make it easy for you to get it SEO ready. B.I.G. is compatible with any plugins up to date and always will. With B.I.G. you can easily create Full Width Section with colored background, image background or even video backg Read More >>
FDA requires that all adverse and serious adverse events are tracked and reported, as required. Adverse event reporting is key area that inspectors focus on when inspecting a company. Tracking […] Read More >>
In December 2012, the Natural Health Products Directorate (NHPD) released two new guidance documents to provide clarity on the evidence for safety and efficacy of natural health products (NHPs) required […] Read More >>
By: Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Although many companies are aware of the need to have dietary supplement liability insurance, it is also important […] Read More >>
By: William Morkel, BSc Director of Quality & Compliance Recent closure of a testing laboratory in Mississauga, Ontario by Health Canada illustrates the need for companies to audit third party/contract […] Read More >>
Reprinted from Newhope 360 On Jan. 2, a new set of rules from Health Canada came into effect to limit allowable caffeine in food products. Single-serving beverages may now contain […] Read More >>
All domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register their facility with the FDA. Since 2003, […] Read More >>
2012 could have had a profound impact on the dietary supplement industry with the possibility of a new president, the resultant changes at FDA and FTC associated with a […] Read More >>
Tuesday, December 18, 2012 On August 4, 2010 the Natural Health Products Directorate (NHPD) of Health Canada informed the natural health products industry of new legislation – the Unprocessed Product […] Read More >>
Aromatherapy is defined by the NHPD as the branch of botanical medicine which uses essential oils and other volatile/aromatic plant extracts for therapeutic or medicinal effect1. While essential oils and […] Read More >>
Health Canada has approved the use of steviol glycosides in foods in Canada. Here are the links to the official announcement (November 30, 2012) and the Notice of Modification […] Read More >>
A nattokinase product (BXD Nattokinase Q) was recalled by Health Canada on October 29, 2012 (Health Canada 2012), citing a Section 7(d) Notice Of Refusal due to the possibility of […] Read More >>
Traditional medicine involves the use of herbal medicines, animal parts and minerals. Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, which contain as active ingredients parts […] Read More >>
It seems the outcry from the food industry and consumers to allow the use of stevia in food products in Canada is finally being heard by Health Canada. The public […] Read More >>
On October 22, 2012 the FDA announced that they are now ready to receive registration renewals for domestic and foreign manufacturers that process, pack or hold food for human or […] Read More >>
The Natural Health Products Directorate (NHPD) has recently released new monographs for consultation based on pre-cleared information. The consultation period is open from September 25, 2012 until October 24, 2012. […] Read More >>
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