Pending regulations promote pre-emption
This article was originally published in The Tan Sheet
Executive Summary
FDA inserts pre-emption language into seven finalized proposed rules, the American Association for Justice reports in a list of the pending rules. In a report critical of the Bush administration's inclusion of such language in agency-wide regulations, AAJ says pre-emption provides a "get out of jail free" card to companies. FDA first mandated pre-emption in the 2006 physician labeling rule. Similar language is in proposed rules on pregnancy and lactation labeling, skin bleaching drug products, OTC drug labeling, OTC analgesics, labeling on calcium claims, sunscreen labels and a proposed fatty acid rule (1"The Tan Sheet" June 9, 2008, In Brief). FDA proposed three of the rules in 2006 and three in 2007. They go into effect 60 days before President Bush leaves office