Occasionally, a GRAS needs to be amended.

In the process of compiling a GRAS dossier, often so much emphasis is placed on showcasing the safety data that communicating the...

“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...

Does the Food and Drug Administration (FDA) have the regulatory tools and experience necessary to regulate cell-cultured “meat”? In a...

“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...

You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by...

The cosmetics industry has been largely self-regulating since passage of the Food, Drug, and Cosmetic Act of 1938; however, the proposed...

The week of November 13, 2017, is notable because FDA released two documents relating to guidance for conclusions of GRAS1 status and...

A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed...

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?...

Quantity & Quality of Evidence The first, “Regulatory Framework,” brings up some interesting issues, if not in a slightly overbearing...

After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for...

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...

*This article will be published in the Summer issue of IngredientsOnline.com Food ingredient regulation in the United States (U.S.) is...

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...

The FDA’s new guidance document on new dietary ingredient notifications (NDINs) and related issues (1) contains answers to several...

Traditionally, feed ingredient regulation had been left up to the individual States, with AAFCO acting to coordinate state regulatory.

FDA is mandating that all information relevant to the GRAS conclusion (including exposure information) should be publicly available.

What makes for a successful Generally Recognized as Safe (GRAS) determination? 

What makes for a successful Generally Recognized as Safe (GRAS) determination?