FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Washes; Defers Action on Three Active Ingredients

September 12, 2016

By Riëtte van Laack

Last week, FDA announced its final rule regarding over-the-counter (OTC) consumer antiseptic wash products.  As we reported in 2013, FDA issued a proposal to declare all antimicrobial consumer hand wash products as not generally recognized as safe and effective but invited comments to prove that they were.  Notably, the Agency questioned whether there was any benefit of using these products as compared to soap and water. 

Not surprisingly, FDA has concluded that antimicrobial hand wash products containing any one of 19 active ingredients are not generally recognized as safe and effective; “manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.”  Therefore, they may no longer be marketed.

FDA deferred action for three active ingredients, i.e., benzalkonium chloride, benzethonium chloride, and chloroxylenol (see FDA letters here, here, and here). In response to comments, FDA decided to “allow for the development and submission of new safety and effectiveness data to the record for these [three] ingredients”

In the final rule as well as in the press release, FDA clarifies that its determination applies only to consumer antiseptic wash products comprising a variety of personal care products intended to be used with water, which may be used by consumers for personal use in the home and in certain public settings on a frequent, even daily, basis.  This final rule does not apply to “leave-on” consumer hand sanitizers (rubs), health care antiseptics, first aid antiseptics, and antiseptics for food industry use.

Based on the comments, it appears that the proposed rule had created uncertainty as to the inclusion of antiseptic for use by the food industry. In the final rule, FDA in no uncertain terms confirms that it considers such products as a separate category:  “A separate category is warranted because of additional issues raised by the public health consequences of foodborne illness, differences in frequency and type of use, and contamination of the hands by grease and other oils.”  FDA will address these products in future rulemaking.

The final rule is effective 1 year after it was issued, i.e., September 6, 2017.