Pending regs promote pre-emption

Executive Summary

FDA has inserted pre-emption language into seven proposed rules that have yet to be finalized. FDA first mandated that its labeling pre-empts state requirements in the 2006 physician labeling rule. Similar language is included in a proposed rule on pregnancy and lactation labeling (1"The Pink Sheet" DAILY, May 28, 2008). It is also in proposed rules on skin bleaching drug products, labeling of OTC drugs, OTC analgesics, labeling on calcium claims, labels for sunscreens and a proposed rule on fatty acids. Three of these rules were proposed in 2006 and three in 2007. They must go into effect 60 days before President Bush leaves office