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...
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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
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
Dec 1, 201511 min read
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
Oct 1, 20158 min read
A New Millennium of Technology and Food Science: The Death of Common Use as a Basis for GRAS
The regulation and innovation responsible for the approximate 70% reduction in food spending since 1950[1] has come under fire with some...
Burdock Group Consultants
Apr 1, 20153 min read
Thank you for joining us at Society of Toxicology’s (SOT) ToxExpo 2015
Society of Toxicology’s (SOT) 54th annual meeting held March 22nd-26th in San Diego, California. ToxExpo 2015 hosted 6,900 attendees and...
Burdock Group Consultants
Aug 1, 20148 min read
What’s Next for the GRAS Process?
There is no disputing the fact that the Generally Recognized As Safe (GRAS) process is under attack: first, by the General Accountability...
Burdock Group Consultants
Jul 1, 20149 min read
Pet Food Ingredient Regulations: The Elephant in the Room
Time is running out for pet food ingredient suppliers to conform to Federal regulations for their ingredients. The choices are either a...
Burdock Group Consultants
May 31, 20137 min read
The High Cost of a “Cheap” GRAS
There is no requirement in the law or in the regulations that a generally recognized as safe determination (so-called “self-GRAS”).
Burdock Group Consultants
Feb 28, 20136 min read
Diacetyl: Inhalation of a GRAS Substance Not GRAS When It Came to Lung Disease
Nearly everyone knows how it feels to swallow a bite of food or sip of beverage that “goes down the wrong pipe”, what physicians call...
Burdock Group Consultants
Jul 1, 201210 min read
The GRAS Process: Does it Need an Overhaul?
The following is an adaptation of a recent article published by the Food and Drug Law Institute (FDLI) in their June 2012 newsletter....
Burdock Group Consultants
Jun 1, 20107 min read
CVM GRAS Notification Finally Arrives
On Friday, June 4, the FDA Center for Veterinary Medicine (CVM) published an announcement regarding a Generally Recognized as Safe (GRAS)...
Burdock Group Consultants
Mar 1, 20104 min read
The GAO Report on GRAS: “Déjà vu all over again”
On March 4, 2010, the General Accounting Office (GAO) released a report to the public titled, “FDA Should Strengthen Its Oversight of...
Burdock Group Consultants
Aug 1, 20022 min read
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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