Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA. The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.
In 2013, FDA published a proposed rule to amend the 1994 monograph. The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought. According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance. In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water). Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.
FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol. In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients. Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.
