Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient

Samenvatting

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Saccharomyces boulardii (S. boulardii), 250 milligrams (mg) (4.5 x 10\9\ lyophilized, viable yeast cells) taken 1 to 2 times daily with a maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in capsule form as an antidiarrheal ingredient. FDA has reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/ E) for its proposed OTC use.