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18

Dec 2020

Stricter Documentation Now Required for Supplements Sold on Amazon
Stricter Documentation Now Required for Supplements Sold on Amazon
By
Dietary supplement marketers selling on Amazon are now being asked to provide testing results and other manufacturing information on their supplement products in order to remain on Amazon’s site for […] Read More >>
FDA Announces Enforcement Discretion Policy for Certain Food Safety Modernization Act (FSMA) Regulations
January 11, 2018 By
      On January 04, 2018, the United States Food and Drug Administration (FDA) announced their position on enforcement discretion for certain Food Safety Modernization Act (FSMA) Regulations. Specifically, […] Read More >>
DNA Barcode Testing and Dietary Supplements is it Right For You?
April 20, 2015 By
As of late DNA Barcode testing has been a subject of heated debate, which can be a valuable tool when used appropriately. However, the appropriateness of its use is up […] Read More >>

25

Nov 2013

Jon Benninger, Vice President of Health & Nutrition Network Discusses the Importance of GMP Training
Jon Benninger, Vice President of Health & Nutrition Network Discusses the Importance of GMP Training
By
GMP training doesn’t have to be complex, expensive and time-consuming. Dedicating time and resources to in-house training, or hiring costly outside consultants isn’t the only answer. Make it easy with […] Read More >>
dicentra’s Regulatory Webinar – Q1: March 26, 2013
March 26, 2013 By
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 your Supplier Qualified?
March 18, 2013 By
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 >>
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 >>
The Importance of an Effective, On-Going cGMP Training Program
August 13, 2012 By
  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 >>
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 >>
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 >>
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 >>
If You Think the FDA’s cGMPs Don’t Apply to You, Think Again!
April 30, 2012 By
By Heather Van Blarcom General Counsel & Senior Regulatory Specialist – USA If your name is on the label of a dietary supplement product that you market and distribute, you […] Read More >>

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