FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think

Published on May 1, 2018

You would think any application of the GRAS1 process would be a legitimate pathway to federal…

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Modernization of Cosmetics Regulation Act of 2018

Published on April 3, 2018

The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic…

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FDA’s Hostile Take-Over of GRAS, Part II: FDA’s Assault on Legitimacy of GRAS Expert Panels

Published on March 6, 2018

The week of November 13, 2017, is notable because FDA released two documents relating to…

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“Self”-GRAS in AAFCO’s Official Publication a Win-Win

Published on February 6, 2018

A newsletter article published in the Burdock Advisor a year ago1 described an existential threat…

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Filing a Citizen Petition to FDA: How It Works and What It Can Accomplish

Published on January 9, 2018

Is there a regulation or order related to food that you would like the U.S….

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Is This FDA’s Hostile Take-Over of GRAS or Is It Simply Establishing Some Ground Rules?

Published on December 5, 2017

The week of November 13, 2017, is notable because FDA released two documents relating to…

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Consultancy Experience Key to Southeastern Reduction Company’s FDA GRAS for Pecan Shell Fiber as Food Ingredient in Amounts up to 10%

Published on October 10, 2017

When Southeastern Reduction Company (SRC) contracted with Burdock Group to submit a GRAS dossier to…

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Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination of Oxalate-Reducing Enzyme As Food Ingredient

Published on September 7, 2017

After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized…

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Don’t Build Me a Cadillac: All I Want Is a Ford

Published on August 1, 2017

The title is synonymous with the expression, “Why should I pay you tens of thousands…

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U.S. Ingredient Approval- Which is Best? A Food Additive Petition or Generally Recognized As Safe (GRAS)

Published on June 2, 2017

*This article will be published in the Summer issue of IngredientsOnline.com   Food ingredient regulation…

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Petfood Forum 2017: Speaking Engagement Teaser on ‘The FDA GRAS Final Rule: Impacts on Getting Safe Ingredients into Pet Food’

Published on March 21, 2017

To be compliant with federal law, an ingredient added to food (including pet food) must…

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New FDA Dietary Supplement Guidance: Unnecessarily High Requirements for Safety Factors Based on Animal Studies

Published on December 2, 2016

The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1)…

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Are AAFCO and the Official Publication Headed for Extinction?

Published on December 2, 2016

The American Association of Feed Control Officials (AAFCO)[1] was formed in 1909 by officials from…

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The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure

Published on October 1, 2016

The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary…

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The GRAS Process and Notifying FDA under the Final Rule (Part 1)

Published on August 1, 2016

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past…

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The Elements for a Successful Generally Recognized as Safe (GRAS)

Published on August 1, 2016

What makes for a successful Generally Recognized as Safe (GRAS) determination?  In the recent past…

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