Comparatively Speaking: US FDA Categories of Hand Sanitizer Actives

September 23, 2009 | Contact Author | By: Anthony J. O'Lenick, Jr., Siltech
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Tony O’Lenick turns to David R. Macinga, PhD, and James W. Arbogast, PhD, to explain the differences between the US Food and Drug Administration (FDA) categories used to classify hand sanitizer actives.

Hand sanitizers are considered drugs and regulated by the FDA under the 1994 Tentative Final Monograph (TFM). Monographs specify the active ingredients that can be contained within OTC drug products as well as specify labeling, product testing and other general requirements. Hand sanitizers are included in the product category called Antiseptic Hand Washes or Healthcare Personnel Hand Washes, which are products “designed for frequent use” and intended to “reduce the number of transient micro-organisms on intact skin.” This category also includes antimicrobial hand washes, which serve the same purpose as hand sanitizers and differ only in that they require water for use.

The 1994 TFM lists topical antimicrobial ingredients based on scientific data submitted to an advisory review panel to determine their safety and efficacy. The ingredients were placed into 1 of 3 categories:

• Category I: GRASE (generally recognized as safe and effective)
• Category II: not GRASE
• Category III: cannot determine if safe and effective; more data needed

The 1994 TFM classifies only two active ingredients as Category I (GRASE) for hand antiseptics: alcohol 60–95% and povidone iodine 5–10%. Since povidone iodine typically is not used in hand sanitizers, alcohol is identified as the only active ingredient the FDA currently recognizes as GRASE for hand sanitizers.

Triclosan, triclocarban, benzalkonium chloride, benzethonium chloride and parachlorometaxylenol, all potential active ingredients for skin disinfectants, are placed into Category III because the FDA has concluded that each lacked either safety or efficacy data sufficient for GRASE classification in hand sanitizers.

Since the monograph currently is in a tentative state, manufacturers are able to market hand sanitizers based on Category III ingredients. However, they are required by the FDA to submit further safety and/or efficacy data to prevent these ingredients from being excluded in the Final Monograph as GRASE active ingredients.

No natural product active ingredients, such as thyme, etc., currently are listed in the Monograph. Thus, natural antimicrobials are precluded from legal use in the United States, unless an approved New Drug Application (NDA) is obtained. At present, none have been granted.