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...
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burdockgroupconsul
- Dec 2, 2016
- 6 min
Are AAFCO and the Official Publication Headed for Extinction?
The American Association of Feed Control Officials (AAFCO)[1] was formed in 1909 by officials from individual State governments at a time...
burdockgroupconsul
- Oct 31, 2016
- 4 min
Updated Health Food Registration and Notification Process in China
In China, the concept of “Health Food” encompasses both functional food and dietary supplement. It refers to any food with claimed health...
burdockgroupconsul
- Oct 1, 2016
- 5 min
The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure
The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary exposure is a factor that must...
burdockgroupconsul
- 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...
burdockgroupconsul
- 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New Draft Guidance on Allergy Assessment of Genetically Modified Plants from EFSA
The European Food Safety Authority (EFSA) has issued a new draft guidance on allergenicity testing of genetically modified (GM) plants...
burdockgroupconsul
- Sep 1, 2016
- 1 min
SupplySide West Speaking Engagement Teaser: Regulatory and Labeling Challenges of Natural Colors
Synthetic coloring agents used in foods have periodically come under fire for having potentially adverse effects, especially for children...
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...
burdockgroupconsul
- 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? In the recent past many questions have been posed about...
burdockgroupconsul
- 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If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011,...
burdockgroupconsul
- 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? In the recent past many questions have been posed about...
burdockgroupconsul
- 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...
burdockgroupconsul
- May 31, 2016
- 3 min
International Regulations on Genetically Modified Organisms in Food
Fifteen years ago, a survey conducted in college students compared consumer acceptance of genetically modified organisms (GMOs) in Japan,...
burdockgroupconsul
- 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...
burdockgroupconsul
- 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...
burdockgroupconsul
- Feb 29, 2016
- 6 min
Colors from Natural Sources: Are They Safe for New Uses?
With today’s focus on “clean” labels, food manufacturers are replacing artificial colors with colors from “natural” sources. Some of...
burdockgroupconsul
- 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) –...
burdockgroupconsul
- 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...
burdockgroupconsul
- 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...
burdockgroupconsul
- Jan 1, 2016
- 6 min
Bayer’s Court Battle with FTC: Implications for the Dietary Supplement Industry
A recent United States District Court (New Jersey) decision has scored a small but significant win in a battle between Bayer and the...
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