Before we GRAS, Let’s Sharpen Our Axe
By George A. Burdock, Ph.D. and Mr. Johnel Lagabon Occasionally, a GRAS needs to be amended. Other than expanding the list of food...
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Burdock Group
- Sep 10, 2019
- 5 min
GRAS: Meeting the Burden of Persuasion
By: Johnel Lagabon and George A. Burdock, Ph.D. In the process of compiling a GRAS dossier, often so much emphasis is placed on...
Burdock Group
- Aug 3, 2019
- 3 min
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...
burdockgroupconsul
- Aug 6, 2018
- 6 min
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...
burdockgroupconsul
- Jun 5, 2018
- 8 min
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...
burdockgroupconsul
- May 1, 2018
- 10 min
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...
burdockgroupconsul
- Apr 3, 2018
- 11 min
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...
burdockgroupconsul
- Mar 6, 2018
- 6 min
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...
burdockgroupconsul
- Feb 6, 2018
- 5 min
“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...
burdockgroupconsul
- Jan 9, 2018
- 5 min
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?...
burdockgroupconsul
- Dec 5, 2017
- 10 min
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...
burdockgroupconsul
- Sep 7, 2017
- 3 min
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...
burdockgroupconsul
- Aug 1, 2017
- 5 min
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...
burdockgroupconsul
- Jun 2, 2017
- 7 min
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...
burdockgroupconsul
- Mar 21, 2017
- 1 min
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...
burdockgroupconsul
- 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...
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 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
- 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
- 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...
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