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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 >>
The FDA’s Updates for Sunscreen Products & the Sunscreen Innovation Act
March 21, 2016 By
In 2002, FDA first issued regulations on providing the process – The Time and Extent Application (TEA), to create a new Over the Counter (OTC) drug monograph, or amend an […] 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 >>
New FDA Guidance Liquid Supplement vs Beverage Covered by Webinar
January 17, 2014 By
 Thursday, January 16, 2014 Three Part Webinar Series  Provided by dicentra and Knowledge Bank Foods vs. Dietary Supplements:  Cross Dressing Products  Dear dicentra Subscriber, Jut in time for our upcoming […] 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 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’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 >>
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 >>
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 >>
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 >>
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 >>

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