This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency’s FOIA b...read more

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown University partnership we feature Georgetown University Law...read more

This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction ...read more

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown University partnership we feature Georgetown University Law...read more

Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Framework, 69 Food and Drug Law Journal, 237-272 (2014)

Posted on April 2014 by Diane E. Hoffmann, Claire M. Fraser, Frank Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few yea...read more

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by th...read more

In 2010, the Institute of Medicine (IOM) recommended that the Food and Drug Administration modify the generally recognized as safe status of sodium by setting gradually decreasing limits on sodium ...read more

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in...read more

The Federal Food, Drug, and Cosmetic Act (“FDCA”), amended in 1990 by the Nutrition Education and Labeling Act (“NLEA”), established a national framework for the administrat...read more

Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising from obesity-related health harms. These laws continue to b...read more