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Burdock Group Consultants
Dec 2, 20166 min read
Are AAFCO and the Official Publication Headed for Extinction?
Traditionally, feed ingredient regulation had been left up to the individual States, with AAFCO acting to coordinate state regulatory.
Burdock Group Consultants
Oct 31, 20164 min read
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...
Burdock Group Consultants
Oct 1, 20165 min read
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, 201610 min read
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, 20164 min read
New Draft Guidance on Allergy Assessment of Genetically Modified Plants from EFSA
The European Food Safety Authority (EFSA) has issued a new draft guidance on allergenicity testing of genetically modified (GM) plants...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 Consultants
Sep 1, 20161 min read
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, 20167 min read
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, 20164 min read
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, 20165 min read
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If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011,...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, 20163 min read
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, 20164 min read
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
May 31, 20163 min read
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,...
Burdock Group Consultants
Apr 30, 20164 min read
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, 201612 min read
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, 20166 min read
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...
Burdock Group Consultants
Feb 29, 20161 min read
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, 20168 min read
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, 20165 min read
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
Jan 1, 20166 min read
Bayer’s Court Battle with FTC: Implications for the Dietary Supplement Industry
This case illustrates that the government can be found to be unconvincing in its arguments against a manufacturer.
Burdock Group Consultants
Dec 1, 20152 min read
Burdock Group Welcomes Dr. Wendan Wang*, Associate Scientist
Burdock Group welcomed Wendan Wang, PhD, who joined our office last month, November 2015, as Associate Scientist. Dr. Wang joins the...
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