Substantial Evidence: Substantially Black and White

Those of us who work in the regulatory advertising and promotions field often describe the regulations under which we operate and the US Food and Drug Administration (FDA) interpretation of those regulations as "gray." We continuously scour FDA enforcement websites hoping to gain an inkling of what FDA's current thinking is on a wide range of advertising and promotion topics such as risk presentation and social media. We attend conferences and hang on each regulator's every word looking to be enlightened and move from gray to black and white.