The recent controversy over declarations by the Food and Drug Administration related to federal pre-emption of state product liability laws has brought into the crucible of high-stakes tort litigation a hitherto relatively obscure area of administrative procedure.

With the FDA taking a considerably more pro-pre-emption stance of late, questions regarding judicial deference to agency — and particularly FDA — interpretations of their organic statutes and regulations are becoming more important. In light of this fact, this article examines the core precedent applicable to determining the extent of judicial deference to FDA decision-making.