Business · 27/10/2009Updated: 10/17/2026 · 1 min read
FDA Withdraws Saccharomyces boulardii Eligibility for Over-the-Counter Antidiarrheal Monograph
Summary
The US Food and Drug Administration (FDA) has withdrawn its request for safety and effectiveness data on Saccharomyces boulardii, a probiotic strain previously considered for inclusion in the OTC monograph for antidiarrheal products, following a 2004 announcement.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →