Executive Summary

SODIUM PHOSPHATE LAXATIVES NEW WARNINGS, USE LIMITS for both oral and rectal products are expected to be discussed at an OTC "feedback" meeting at FDA tentatively scheduled for July 15. In response to objections by the laxative manufacturers Nutramax and C.B. Fleet, the agency has agreed to a meeting on the new requirements, which were part of a May 21 final rule on sodium phosphate laxatives ("The Tan Sheet" May 25, p. 9). Among the companies' objections is that the warnings and directions for both types of products required by the rule were not previously proposed by the agency and therefore not subject to prior notice and comment as required by the Administrative Procedures Act.