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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 >>
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 >>
FDA Food Facility Registration Renewal – Now Ready
October 24, 2012 By
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 >>
FDA New Dietary Ingredient Notifications
October 2, 2012 By
FDA considers dietary supplements that contain new dietary ingredients and that have not submitted new dietary ingredient Notifications to be adulterated. Any supplement that is considered to be adulterated can […] 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 >>
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 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 >>
Magnesium Stearate –Update
June 18, 2012 By
The deletion of “magnesium salts of fatty acids” from the Codex International Numbering System (INS) had been proposed at the 42nd Session of the Codex Committee on Food Additives, 2010. […] Read More >>
4-Methylimidazole – A Cause for Concern in Caramel Colouring?
June 13, 2012 By
4-Methylimidazole is a substance found in caramel colouring that is manufactured using ammonia or ammonia sulphate in the production process. In addition to its presence in some soft drinks, 4-methylimidazole […] Read More >>
Senator Durbin Continues To Pursue Overregulation of The Dietary Supplement Industry
May 31, 2012 By
By Heather Van Blarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements For the moment, the Dietary Supplement Health and Education Act of 1994 (DSHEA) remains intact. In his […] Read More >>
Regulatory Barriers to Trade for Consumer Health Products
May 28, 2012 By
By Dr. John Harrison, PhD, MSc, BSc Senior Government Relations Advisor So you want to import a consumer health product from the U.S.A. to Canada. Good luck! There are many […] Read More >>
BARELY KEEPING THE GAS TANK ABOVE EMPTY – The Switch from RDA to EAR
May 23, 2012 By
By Heather Van Blarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements If you’re like me, you don’t particularly like running on empty. However, if the FDA revises the […] 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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