Saccharomyces boulardii Eligibility for Consideration To Be Added to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products; Request for Safety and Effectiveness Data; Withdrawal

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Withdrawal of notice of eligibility and request for data and information.

SUMMARY:

We (Food and Drug Administration (FDA)) are withdrawing a notice of eligibility and call-for-data for safety and effectiveness information. The original notice published in the Federal Register of August 23, 2004 (69 FR 51852). In that notice, we announced that Saccharomyces boulardii (S. boulardii) was eligible for consideration to be added to the over-the-counter (OTC) monograph for antidiarrheal drug products.

FOR FURTHER INFORMATION CONTACT:

Michael L. Koenig, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-796-2090.

SUPPLEMENTARY INFORMATION:

In 2004, we published a notice of eligibility for consideration of the yeast S. boulardii in the OTC drug monograph system. We announced our intention to evaluate S. boulardii for inclusion in the monograph for OTC antidiarrheal drug products (21 CFR part 335). The notice also requested submission of data and information on the safety and effectiveness of S. boulardii for us to determine whether it could be generally recognized as safe and effective (GRAS/E) and not misbranded for its proposed OTC drug use.

S. boulardii for antidiarrheal use meets the definition of a drug in the Federal Food, Drug, and Cosmetic Act. (See section 201(g)(1) (21 U.S.C. 321(g)(1).) S. boulardii is a yeast or unicellular fungus and, therefore, also meets the definition of a biological product in the Public Health Service Act for this use. (See section 351(i) (42 U.S.C. 262(i) and 21 CFR 600.3(h)(1).) We have determined that this yeast is more appropriately regulated as a biological product under the biologics license application system than as an OTC drug product under the monograph system. Because we have decided to regulate S. boulardii as a biological product, S. boulardii is not eligible for consideration to be included in an OTC drug monograph. Therefore, this document withdraws the 2004 notice of eligibility permitting consideration of S. boulardii for addition to the monograph for OTC antidiarrheal drug products. This document also withdraws our 2004 request for submission of safety and effectiveness data and information on S. boulardii for OTC antidiarrheal use. Any further consideration of the potential therapeutic use(s) of this yeast should be addressed under regulations and procedures governing biological products.