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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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
dicentra Quarterly Newsletter – Q2 – 2012
May 10, 2012 By
May 10, 2012 Are You Making False Claims By Heather Van Blarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements If you don’t have “competent and reliable scientific evidence” […] 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 >>
Clinical Trials: Will the Wrong Trial Design Make Your Dietary Supplement or Functional Food an Unregistered Drug?
April 16, 2012 By
By Arwen Brooks Quality Assurance & Regulatory Affairs Assistant With the explosion of the natural health product and functional food industry, and the subsequent rules and regulations that have been […] 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 >>
FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet
October 3, 2011 By
Clara di Tella, BSc, Pharm QA Regulatory Affairs Specialist, Dicentra The United States Food and Drug Administration along with regulatory agencies from 80 other countries have completed the International Internet […] Read More >>
FDA Updates – Dealing with Natural Products in a Global Market
September 12, 2011 By
Manushvi Chadha, BPharm, RA Cert Regulatory Associate, Dicentra The FDA recognizes that the production of FDA-regulated products has gone international, with more globalization on the way. Not only wholly manufactured […] Read More >>
Drugs in Supplements? – New Site Keeps Industry Informed on Tainted Products Sold as Supplements
August 29, 2011 By
Drugs in Supplements? New Site Keeps Industry Informed on Tainted Products Sold as Supplements Lydia Hunziker, BComm Manager of Communications and Client Services, Dicentra When consumers purchase a natural health […] Read More >>
Natural Products Association – Regulatory Updates: Upcoming NDI Guidance May Clarify FDA’s Expectations – June 27, 2011
June 27, 2011 By
http://www.npainfo.org/index.php?src June 23, 2011 Upcoming NDI Guidance May Clarify FDA’s Expectations WASHINGTON, D.C. – Statement from Natural Products Association (NPA) Vice President of Scientific and Regulatory Affairs Cara Welch, Ph.D., [&hellip Read More >>
FDA – Regulatory Updates: FDA is Monitoring Certain Foods and Beverages Imported from Taiwan that May Contain Plasticizers – June 27, 2011
June 27, 2011 By
http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm June 22, 2011 The U.S. Food and Drug Administration (FDA) is notifying the public about the possible presence of a plasticizer called diethylhexyl-phthalate (DEHP) in certain food and beverages Read More >>
Regulatory Updates – June 15th 2011
June 15, 2011 By
  Health Canada http://www.hc-sc.gc.ca/index-eng.php Competition Bureau http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/h_00000.html CHFA http://www.chfa.ca Canadian Cosmetic Toiletry and Fragrance Association http://www.cctfa.ca/site/cctfa/ Read More >>

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