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Three Part Webinar Series Provided by dicentra and Knowledge Bank – Foods vs. Dietary Supplements: Cross Dressing Products
December 3, 2013 By
Three Part Webinar Series Provided by dicentra and Knowledge Bank Foods vs. Dietary Supplements:  Cross Dressing Products  At SupplySide West this year Daniel Fabricant of the FDA stressed that the […] Read More >>
Dietary Supplement Labeling Act of 2013
November 24, 2013 By
The proposed Dietary Supplement Labeling Act of 2013 to amend the FFDCA and would require big changes to the industry, if the Act is passed.  On August 1, 2013 the […] Read More >>
The Importance of Supplier Qualification
August 19, 2013 By
Supplier qualification includes conducting regular audits on your vendors. Ensuring your supplier’s are qualified will help to ensure the quality of your products. Risk-assessment is the FDA’s main focus when […] Read More >>
Dietary Supplement Health Claim Substantiation: A Healthy Balance of Scientific Evidence and Risk Management Create a Winning Combination
July 2, 2013 By
A dietary supplement health claim substantiation assessment during product development may help to bring your product to market with ease. Dietary Supplement Health Claim Substantiation Health claim substantiation for your […] 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 >>
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 >>
Significance of Setting-up In-Process Controls and Specifications
May 6, 2013 By
In-process controls and specifications are a means of ensuring that a dietary supplement is manufactured, packaged, and labelled in a manner that will ensure that the quality of the dietary […] 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 >>
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 >>
FDA’s Increasing Enforcement Activities Highlight the Importance of Regulatory Compliance with respect to Dietary Supplement Liability Insurance
January 28, 2013 By
By: Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Although many companies are aware of the need to have dietary supplement liability insurance, it is also important […] 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 >>
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 >>
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 >>
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 >>
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 >>

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