FDA’s GRAS Review Process for Foods May Be Tested by Litigious Public...
By Bruce Silverglade and Mark L. Itzkoff As reported in Politico this week, there has been a shake-up of sorts within the public interest advocacy community regarding the tactics used to pressure the...
View ArticleFDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year
By Richard L. Frank and Michael J. O’Flaherty While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling. The FDA, during...
View ArticleA Consumer Group Files Suit to Vacate FDA’s GRAS Notification Program
By Mark L. Itzkoff In a formal challenge to FDA’s GRAS Notification Program, a consumer group called the Center for Food Safety (CFS) filed a lawsuit on Thursday alleging that FDA’s operation of the...
View ArticleFDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated...
By Mark L. Itzkoff On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated...
View ArticleFDA Public Meeting Will Consider Fundamental Changes to, and Expansion of,...
By Mark L. Itzkoff In the October 30 Federal Register, FDA announced that it will hold a public meeting to receive public input on updating its Guidance for Industry “Toxicological Principles for the...
View ArticleFDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program
The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program. “GRAS” is an acronym for the phrase “generally...
View ArticlePartially Hydrogenated Oils – GMA Petition to Allow Limited Uses Clears a Hurdle
FDA today announced that it has filed a petition submitted by the Grocery Manufacturers Association (GMA) to amend the food additive regulations to provide for the safe use of partially hydrogenated...
View ArticleFDA’s Strategic Plan for Foods and Veterinary Medicine
The agency on July 14, 2016 published FDA Foods and Veterinary Medicine Program (FVM) – Strategic Plan — Fiscal Years 2016–2025. This FVM Program outlines goals and objectives for the next 10 years:...
View ArticleFDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program
The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program. “GRAS” is an acronym for the phrase “generally...
View ArticlePartially Hydrogenated Oils – GMA Petition to Allow Limited Uses Clears a Hurdle
FDA today announced that it has filed a petition submitted by the Grocery Manufacturers Association (GMA) to amend the food additive regulations to provide for the safe use of partially hydrogenated...
View ArticleFDA’s Strategic Plan for Foods and Veterinary Medicine
The agency on July 14, 2016 published FDA Foods and Veterinary Medicine Program (FVM) – Strategic Plan — Fiscal Years 2016–2025. This FVM Program outlines goals and objectives for the next 10 years:...
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