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New FDA Guidance Liquid Supplement vs Beverage Covered by Webinar
January 17, 2014 By
 Thursday, January 16, 2014 Three Part Webinar Series  Provided by dicentra and Knowledge Bank Foods vs. Dietary Supplements:  Cross Dressing Products  Dear dicentra Subscriber, Jut in time for our upcoming […] Read More >>
Dietary Supplement Marketing: Why it is Extremely Important to Keep an Eye on your Social Butterfly
June 3, 2013 By
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 >>

01

Apr 2013

GMP Compliance: The Benefits of Implementation
April 1, 2013 By
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 >>
A Double Whammy – Joint FTC and FDA Warning Letter
February 25, 2013 By
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 Importance of Tracking and Reporting Adverse and Serious Adverse Events to the FDA
February 11, 2013 By
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 >>
Food Facility Registration
October 11, 2012 By
On October 1st FDA announced food facility registration system is not yet ready for industry, despite requiring all foreign and domestic facilities that manufacture, process, pack, or hold food for […] Read More >>
The Dietary Supplement Industry: Are More Regulations on the Horizon?
September 14, 2012 By
  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 >>
GMP Procedures: Considerations for Manufacturers
September 4, 2012 By
  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 >>
Health Claim Substantiation
August 7, 2012 By
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 >>
cGMP Enforcement Actions Escalating in the United States
July 30, 2012 By
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 >>
Weight Loss Claims for Supplements – A Big Fat Problem
July 13, 2012 By
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 >>
Complying with FDA 21 CFR Part 111 – Understanding the Process of FDA Inspections, FDA Form 483 & FDA Warning Letter Responses
July 11, 2012 By
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 >>
The Failure of Dietary Supplement Manufactures to Comply with Current Good Manufacturing Practices (cGMPs) Continues to Make Headlines
July 6, 2012 By
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Over the weekend, the Chicago Tribune quoted Dr. Daniel Fabricant, head of the FDA’s Division of Dietary Supplement […] Read More >>
The Dietary Supplement Industry Can Breathe a Sigh of Relief, For Now
June 25, 2012 By
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements We can breathe a sigh of relief thanks to Senate supplement-industry champions Tom Harkin (D-IA) and Orrin Hatch […] Read More >>
dicentra is now a member of the Canadian Beverage Association
May 30, 2012 By
  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 […] Read More >>
An Interview with Heather Van Blarcom, General Counsel and Senior Regulatory Specialist for Dietary Supplements
May 22, 2012 By
By Sheldon Baker Nutraceuticals World Published May 18, 2012 Heather Van Blarcom recently joined dicentra and is a licensed attorney with more than 10 years of experience in the natural […] Read More >>
Common Violations in cGMP Compliance Inspections for Dietary Supplements
May 14, 2012 By
Current Good Manufacturing Practices (cGMPs) for Dietary Supplements have been in effect since June 2010 and the FDA has been increasing inspections each year since. In 2011, 145 FDA inspections […] Read More >>
GMP Training Makes Good Business Sense
December 21, 2011 By
William Morkel, BSc Director of Quality and Compliance, dicentra If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, […] Read More >>
FDA Targets Tainted Dietary Supplements
December 20, 2011 By
By Arwen Brooks Quality Assurance and Regulatory Affairs Assistant, dicentra Dec. 15, 2010 — The FDA today announced new steps to target harmful products marketed as dietary supplements, including the […] Read More >>
Happy Holidays from dicentra Inc.
December 14, 2011 By
  Then he slid down the chimney. A rather tight pinch, but if Santa could do it, then so could the Grinch. He thought to himself, I must address this […] Read More >>

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