By Riette Van Laack –
On June 30, as required under the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA published the amended tentative final monograph for consumer antiseptic rubs, also referred to as consumer rubs, leave on products or hand sanitizers. This category of products includes antiseptic wipes.
As we previously reported here and here, FDA has published two other proposed rules pursuant to the consent decree: a proposal to classify all consumer antiseptic hand wash products non-GRASE and a proposal to reclassify the health care antiseptics as category III (i.e., additional data are needed for safety or effectiveness).
In the most recent action, FDA proposes to (re)classify alcohol (60-95 percent), isopropyl alcohol (70 to 91.3 percent) and benzalkonium chloride as category III because the Agency has determined that it currently has insufficient data to conclude that these active ingredients are Generally Recognized as Safe and Effective (GRASE) under FDA’s updated standards. Unless additional data are submitted to support GRASE under the updated standards, FDA will declare them non-monograph ingredients in the final monograph. FDA hastens to note that this proposal should not be interpreted as FDA’s determination that the consumer antiseptic rubs on the market are not safe or effective.
It likely will come as welcome news for industry that the Agency does not propose to require clinical outcome data to support Generally Recognized as Effective (GRAE) status for the consumer antiseptic rubs. FDA previously required such data for the consumer hand wash products in light of the easily available alternative of washing with soap and water. However, antiseptic rubs are intended to be used by consumers when soap and water are not available, and there is no readily available alternative for antiseptic rubs.
Studies needed to support GRAE status for consumer antiseptic rubs include in vitro testing and in vivo studies. The in vitro test consists of a determination of the antimicrobial activity against potential pathogens; including 25 representative clinical isolates and 25 reference strains of specified organisms.
The in vivo study consists of a clinical simulation test. FDA continues to propose a bacterial log reduction as evidence that a consumer antiseptic rub is GRAE. As with the health care antiseptics, FDA proposes a log reduction standard for one-time use application only; for an active ingredient to be GRAE, a single application must result in a 2.5 log reduction on each hand within 5 minutes after application.
FDA also is asking for data and information about the impact of product use factors, e.g., the impact of volume of product per application on the efficacy of the product. FDA plans to use this information when developing the requirements for final formulation testing and labeling for the final formulations.
All three ingredients included in this proposed regulation are also included in the proposed regulation for health care antiseptics, so the requirements for additional safety data should not come as a surprise, as FDA’s considerations are largely identical for both categories of products.
FDA’s proposal does not address labeling and testing of final formulations because, at this time, no active ingredients are considered GRASE. The Agency indicates that, if any of the three ingredients are determined to be GRASE, the final rule will address requirements for final formulations, including efficacy testing.
The proposed rule is open for comments for 180 days. In addition, companies will have one year to submit new data and information, and comments on any new data or information may then be submitted to the docket for an additional 60 days.