FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court’s analysis in Sackett v...read more
This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as under the provisions of the Food, Drug and Cosmetics Act (FDCA...read more
Honorable Mention, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011.
Obesity is one of the most contentious issues facing the United States today. Some researchers warn of an obesi...read more
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as ...read more
Reliable and defensible data quality underpins the value and validity of decisions made by dietary supplement manufacturers, consumers, and regulatory investigators. Over the past few years, ...read more
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance...read more
64 Food and Drug Law Journal 677-692 (2009).
The world market for functional foods, nutraceuticals, and dietetic products has been expanding and is driven by demographic, economic, and social trend...read more
64 Food and Drug Law Journal 503-514 (2009).
The Food and Drug Administration (FDA) works actively to ensure that all the dietary supplements currently in the market are safe for the public. Exist...read more
64 Food and Drug Law Journal 43-68 (2009).
Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients―rather ...read more
63 Food and Drug Law Journal 929-942 (2008).
The Food and Drug Administration’s (FDA’s) current good manufacturing practices (cGMP) regulations represent a substantial advance in ensuri...read more