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Business · 23/08/2004Updated: 10/17/2026 · 1 min read

FDA Announces Call for Data on Saccharomyces boulardii as Antidiarrheal Ingredient for OTC Drug Products

The Food and Drug Administration (FDA) is seeking data on the safety and efficacy of Saccharomyces boulardii as an antidiarrheal ingredient in over-the-counter (OTC) drug products. The FDA will review the submitted information to determine if the ingredient can be generally recognized as safe and effective (GRAS/E) for its proposed use.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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