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Is Your Food Really “Natural”?
May 30, 2016 By
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 >>
Xylitol: Sugar Substitute that can Poison your Dog
May 24, 2016 By
An article taken from the FDA website concerning sugar substitutes – found in some human foods and dental products that can be poisonous to your dog. Original Article Found On: […] Read More >>
Final Guidance Q&A for Medical Foods Posted by FDA
May 24, 2016 By
Original Article Found On: www.fda.gov I. Introduction This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The […] Read More >>
FDA Standards for Making Health Claims for your Dietary Supplements
September 8, 2015 By
Companies marketing dietary supplements aim to make claims for their products in order to help successfully market their products/product lines. As such, claims being made for dietary supplements are a […] Read More >>
FDA Proposes Additional Revisions to the Nutrition Facts Panel
August 24, 2015 By
July 24, 2015 – FDA provides supplemental proposal for changes to the Nutrition Facts panel to require % DV for sugars. The U.S. Food and Drug Administration is proposing additional […] Read More >>
Long-Term Brand Building with Regulatory Help (Part 1 of 2)
August 11, 2014 By
Developing new ingredients for a large company like Pharmachem, we’ve had to be responsible and conservative at every turn, working within established guidelines and with excellent people. Safety is always […] Read More >>
dicentra Welcomes Our Newest Team Member
May 8, 2013 By
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 >>
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 >>
Deadline to Renew Food Facilities Registration with the FDA Extended Until January 31, 2013
January 3, 2013 By
  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 >>
The US Dietary Supplement Industry in 2013 – Will the New Year Bring Changes or More of the Same?
December 18, 2012 By
  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 >>
dicentra’s NHP Regulatory Update 2012 – Q3
September 18, 2012 By
Topics covered: Canada: Consultations & Regulatory Initiatives Food Safety & Initiatives United States: Proposition 37 – Genetically Engineered Foods, Labeling, Initiative Statute Energy Drink Controversey Status of Draft NDI Guidance [&helli 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 >>
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 >>
FTC Wants to Level the Playing Field
August 9, 2012 By
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements At the NBJ Summit last week in Dana Point, CA, David C. Vladeck, the Director of the Federal […] 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 >>

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