GRAS, or generally recognized as safe, is an exemption that allows ingredients that are considered to be GRAS for their intended use to be exempt from FDA premarket review when added to food. The G...read more

E-cigarettes are an increasingly hot topic in the tobacco world, especially after the release of FDA’s proposed deeming regulations in April of 2014. The proposed regulations aim to bring pre...read more

FDLI Names New President and Chief Executive Officer

Posted on May 2014 by Michael Levin‐Epstein

FDLI Names New President and Chief Executive Officer Amy Comstock Rick to lead organization effective August 25th The Food and Drug Law Institute (FDLI) announces the selection of Amy Comstock Ric...read more

“Should Oral Contraceptives Be Available Over the Counter?” is the timely topic addressed by Britt Whalin, AM (Director of Development and Communications), Kate Grindlay, MSc (Senior Pr...read more

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President and Chief Executive Officer Susan C. Winckler will step down ...read more

FDA’s Social Media Draft Guidance Is Focus of New FDLI Food and Drug Law Policy Forum

Posted on February 2014 by Davina Rosen Marano, Editor, FDLI

“Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?” is the timely topic addressed by Daniel Kracov, Partner, ...read more

“Ravioli Trees and Tortellini Bushes: What Should Courts Expect from the Reasonable Consumer When it Comes to ‘Natural’ Claims?” is the timely topic addressed by John E. Vil...read more

“The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?” is the topic addressed by Karla L. Palmer...read more

FDA’s Postmarket Surveillance of Medical Devices Is Focus of New FDLI Food and Drug Law Policy Forum

Posted on December 2013 by Michael Levin-Epstein, Editor-in-Chief, FDLI

“Is FDA’s Decision to Ramp-up the Postmarket Surveillance of Medical Devices the Best Way to Make Devices Safe?” is the topic addressed by Thomas R. McLean, M.D., J.D., FACS and Alexander B. McLean...read more

The Harmonization of Cosmetics Standards Is Focus of New FDLI Food and Drug Law Policy Forum

Posted on December 2013 by Michael Levin-Epstein, Editor-in-Chief, FDLI

“Is It Time for Harmonized Cosmetics Standards? A Comparison of U.S. and E.U. Cosmetics Regulation” is the topic addressed by Kimberly K. Egan, Founder, Saltbox Consulting and Jennifer ...read more