Before we GRAS, Let’s Sharpen Our Axe
Occasionally, a GRAS needs to be amended.
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Dr. George Burdock
Sep 10, 20195 min read
GRAS: Meeting the Burden of Persuasion
In the process of compiling a GRAS dossier, often so much emphasis is placed on showcasing the safety data that communicating the...
Burdock Group
Aug 3, 20193 min read
GRAS Questions: Why Should I Invest in a GRAS when Everyone is Already Selling My Ingredient?
“Why should I invest in a GRAS when everyone is already selling my ingredient?” Well, to be frank – it’s the law. “Any substance that is...
Burdock Group Consultants
Aug 6, 20186 min read
Cell-Cultured Meat: Who Will Regulate, FDA or USDA?
Does the Food and Drug Administration (FDA) have the regulatory tools and experience necessary to regulate cell-cultured “meat”? In a...
Burdock Group Consultants
Jun 5, 20188 min read
Can a Food Be a Drug and a Supplement?
“Let food be thy medicine and medicine be thy food” — Hippocrates of Cos (ca.460 BC – ca. 370 BC) The Drug-Like Properties of Foods Many...
Burdock Group Consultants
May 1, 201810 min read
FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think
You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by...
Burdock Group
Apr 3, 201811 min read
Modernization of Cosmetics Regulation Act of 2018
The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed...
Burdock Group Consultants
Mar 6, 20186 min read
FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Pan
The week of November 13, 2017, is notable because FDA released two documents relating to guidance for conclusions of GRAS1 status and...
Burdock Group Consultants
Feb 6, 20185 min read
“Self”-GRAS in AAFCO’s Official Publication a Win-Win
A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed...
Burdock Group Consultants
Jan 9, 20185 min read
Filing a Citizen Petition to FDA: How It Works and What It Can Accomplish
Is there a regulation or order related to food that you would like the U.S. Food and Drug Administration (FDA) to issue, amend or revoke?...
Burdock Group Consultants
Dec 5, 201710 min read
Is This FDA’s Hostile Take-Over of GRAS or Is It Simply Establishing Some Ground Rules?
Quantity & Quality of Evidence The first, “Regulatory Framework,” brings up some interesting issues, if not in a slightly overbearing...
Burdock Group Consultants
Sep 7, 20173 min read
Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination o
After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for...
Burdock Group Consultants
Aug 1, 20175 min read
Don’t Build Me a Cadillac: All I Want Is a Ford
The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS...
Burdock Group Consultants
Jun 2, 20177 min read
U.S. Ingredient Approval- Which is Best? A Food Additive Petition or Generally Recognized As Safe
*This article will be published in the Summer issue of IngredientsOnline.com Food ingredient regulation in the United States (U.S.) is...
Burdock Group Consultants
Mar 21, 20171 min read
Petfood Forum 2017: Speaking Engagement Teaser on ‘The FDA GRAS Final Rule: Impacts on Getting
To be compliant with federal law, an ingredient added to food (including pet food) must be approved by FDA for its intended use as a food...
Burdock Group Consultants
Dec 2, 20168 min read
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
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 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
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, 20163 min read
The Elements for a Successful Generally Recognized as Safe (GRAS)
What makes for a successful Generally Recognized as Safe (GRAS) determination?
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