On May 1, 2013 the CFIA announced that they will no longer be conducting food label reviews, as part of their mandatory pre-market registration, for certain meat and processed products. […] Read More >>
Don’t miss our next free Regulatory Update Webinar of the year on Tuesday, June 18th at 1:00 PM EST. You are invited to join hundreds of companies already tuning […] Read More >>
In today’s modern times dietary supplement marketing materials can come in a variety of forms, including blogs, Tweets, Facebook, StumbleUpon, Google+, reddit, Testimonials, Websites and Links. However, it is important […] Read More >>
The dicentra Team extends their condolences to the family of Willie Pelzer, President and CEO of Sunny Crunch Foods Ltd. Willie Pelzer (1934-2013) Withold “Willie” Pelzer, 79 years of age, […] 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 >>
In-process controls and specifications are a means of ensuring that a dietary supplement is manufactured, packaged, and labelled in a manner that will ensure that the quality of the dietary […] Read More >>
Some food-like NHPs were granted Temporary Marketing Authorizations with novel foods or food additives that have not yet been approved by Health Canada. It is the Food Directorate’s expectation that […] Read More >>
GMPs are a set of industry best practices to help ensure the safety, quality and efficacy of a natural health product. Natural health products (NHPs) are a valuable tool in […] 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 >>
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 >>
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