FDAAA § 912 – A Fundamental Shift in the Dividing Line Between Foods and Drugs

In a previous post we opined that § 912 of the FDA Amendments Act (“FDAAA”) could represent a fundamental shift in the dividing line between foods and drugs.  For our most recent thoughts on that subject, we refer you to the column we recently published in FDLI Insighter.  There, we examine the potential of § 912 not only to reduce the historic flexibility by which an article may be deemed a food or a drug, but more importantly to deter innovation in the research and development of new food ingredients.

By Diane B. McColl & Ricardo Carvajal