Antimicrobial Data Support CTFA/SDA Performance Criteria - Petition

A comprehensive literature review of topical antimicrobial data "corroborates" the suitability of the product performance criteria advocated by industry, the Cosmetic, Toiletry & Fragrance Association and Soap & Detergent Association maintain in an Aug. 6 joint submission to FDA.

The submission includes data on the benefits and efficacy of topical antimicrobials from the 1960s to 2000. The information provides the basis for a comparison of industry-supported performance criteria with that included in the 1994 tentative final monograph on health care antiseptics. CTFA and SDA proposed performance criteria for six categories of antimicrobials in 1995 comments on the TFM.

The comparison, which was based on American Society for Testing Materials test methods, demon-strates the criteria proposed in the TFM are "overly stringent," CTFA and SDA state. The groups point out two Category I active ingredients (iodine and alcohol) and the NDA-approved OTC ingredient chlorhexidine gluconate do not meet the TFM standards but are consistent with the industry criteria.

The submission accompanies a citizen petition requesting the administrative record for the TFM be reopened to admit the information. "Inclusion of the attached materials in the body of evidence considered by FDA in the development of the final monograph...is essential if FDA is to base its decision on the most current scientific information," the groups state.

CTFA and SDA note "more than six years have passed since the record of the TFM closed, and, at public meetings since that event (e.g., a Nov. 3, 1999 FDA feedback meeting), FDA has indicated the need for further information regarding these products."

Noting the final monograph is expected to cover health care personnel hand products, health care professional products and pre-operative skin care preps, the petition further requests FDA state in the monograph that other antimicrobials, including consumer hand and body products and food handler products, will be considered separately at a later date.

The petition is the third filed by CTFA/SDA on antimicrobials in recent months, following petitions on children's label warnings and use of cross-monograph ingredients and indications for antibacterial-containing products (¹ (Also see "Health-Care Antiseptics OTC Labeling Amendments Proposed By CTFA/SDA" - Pink Sheet, 16 Apr, 2001.) and ² (Also see "Antibacterial Cross-Monograph Ingredients, Indications Urged By CTFA/SDA" - Pink Sheet, 11 Jun, 2001.)).