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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 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 >>
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 >>
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 >>
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 >>
  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 >>
  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 >>
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 >>
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 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 >>
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 >>
  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 >>
  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 >>