Structure/function claim notice for similar products "needs clarification" -- Lederle exec.
This article was originally published in The Tan Sheet
Executive Summary
STRUCTURE/FUNCTION CLAIM NOTICE REQUIREMENT FOR SIMILAR PRODUCTS "needs clarification," Lederle Consumer Associate Director of Regulatory Affairs Norma Skolnik said at a May 22-24 Functional Foods for Health retreat in Itasca, Ill. Skolnik noted that the 30-day notice requirement for structure/function claims "is a post-marketing notice and covers claims being made for the first time, and it is not clear whether marketing subsequent brands with [similar] formulations with the same claims would require additional notices to FDA."