With FDA’s Tightening Stance on Food Claims, What Should Manufacturers Do?
In the past year, FDA has made considerable progress (in most cases), fine-tuning the regulations on foods and dietary supplements,...
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Burdock Group Consultants
- Dec 2, 2016
- 8 min
New FDA Dietary Supplement Guidance: Unnecessarily High Requirements for Safety Factors: Animal
The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1) contains answers to several...
Burdock Group Consultants
- Oct 1, 2016
- 5 min
The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure
FDA is mandating that all information relevant to the GRAS conclusion (including exposure information) should be publicly available.
Burdock Group Consultants
- Oct 1, 2016
- 10 min
The Strictest Regulation on Infant Formula in Chinese History: How does it compare to the U.S.?
On June 6th 2016, the China Food and Drug Administration (CFDA) published the final rule of Administrative Measures for Registration of...
Burdock Group Consultants
- Sep 1, 2016
- 4 min
New Draft Guidance on Allergy Assessment of Genetically Modified Plants from EFSA
The European Food Safety Authority (EFSA) has issued a new draft guidance on allergenicity testing of genetically modified (GM) plants...
Burdock Group
- Aug 31, 2016
- 7 min
Dietary Supplements in the U.S. and Abroad: Similarities and Differences
Demand for dietary and nutritional supplements worldwide continues to increase, with steady growth in the established markets and more rapid
Burdock Group Consultants
- Aug 1, 2016
- 4 min
The GRAS Process and Notifying FDA under the Final Rule (Part 1)
What makes for a successful Generally Recognized as Safe (GRAS) determination?
Burdock Group Consultants
- Aug 1, 2016
- 5 min
Some Speculation on Forthcoming Dietary Supplement Guidelines
If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011,...
Burdock Group Consultants
- Aug 1, 2016
- 3 min
The Elements for a Successful Generally Recognized as Safe (GRAS)
What makes for a successful Generally Recognized as Safe (GRAS) determination?
Burdock Group Consultants
- Jun 30, 2016
- 4 min
Safety Assessment Considerations When Testing Food Ingredients or Food Related Nanomaterials
Nanomaterials (NM) are substances that have at least one dimension in the nanoscale (1-100 nm). In the food industry, nanomaterials can...
Burdock Group Consultants
- Apr 30, 2016
- 4 min
Safety of Animal Feed Ingredients… More Than Just Maintaining Growth?
Within the last decade, there has been an increase in the level of concern for the moral and ethical treatment of animals. Pets are now...
Burdock Group Consultants
- Apr 1, 2016
- 12 min
International Regulations on Dietary Supplements: Challenges and Opportunities
An aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions.1 The...
Burdock Group Consultants
- Feb 29, 2016
- 1 min
Regulatory Update: FDA Issues a “Stay” For Parts of the Final Guidance for INDs
In September 2013, the FDA issued Guidance for Clinical Investigators, Sponsors and IRBs: Investigational New Drug Applications (INDs) –...
Burdock Group Consultants
- Jan 31, 2016
- 8 min
Five Questions to Consider Before Fortifying Foods
In November 2015, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) released new guidance on...
Burdock Group Consultants
- Jan 1, 2016
- 5 min
A Message from the President: What’s on the Horizon for 2016
The last two years initiated a trend on the food side of the Food and Drug Administration (FDA) to be more responsive to populist...
Burdock Group Consultants
- Dec 1, 2015
- 11 min
Limitations on GRAS Substances: Not All GRASes Created Equal
FDA has made it abundantly clear on several occasions that there is no “blank check” to use a GRAS substance in any food, at any level.
Burdock Group Consultants
- Aug 1, 2002
- 2 min
FDA Approves GRAS Status for Potassium Glucarate Ingredient
New ingredients are appearing in foods daily. Many of these new ingredients may provide an added health benefit, thus they serve as...
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