Procter & Gamble’s psyllium cholesterol-lowering claim

Executive Summary

Via a May 11 letter, FDA gives the go-ahead for use of a protocol for a 34-week, double-blind, placebo-controlled, multisite, parallel, clinical study of psyllium's effect on reducing cholestrol levels. P&G, marketer of the psyllium-containing laxative Metamucil, previously submitted data on psyllium which FDA determined was insufficient to support a cholesterol-lowering claim. FDA said that the study objectives "are clear and the protocol should provide adequate data for statistical analysis of end-point efficacy and safety variables." But FDA added that the study "is not intended to address the questions of dose response and mechanism of action" and the agency made suggestions for minor modifications.