In a final rule published this week, the U.S. Food and Drug Administration (FDA) determined that over-the-counter (OTC) antiseptics used in healthcare settings containing the ingredient Triclosan–the most commonly used active ingredient in OTC antiseptics–are not generally recognized as safe and effective for use in healthcare settings. The rule clarifies that the term “healthcare antiseptic” includes personnel hand washes, personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient antiseptic skin preparations.
The agency, which first proposed the rule in 2015, finalized it this week after companies that manufacture the antiseptics in question failed to respond with supporting data for the safety and effectiveness of their products.
In addition to the data gap, previous research of the ingredient showed an association between Triclosan and Triclocarban and reproductive and developmental harm in lab animals.
In addition to determining Triclosan unsafe and ineffective, the rule established 23 additional ingredients that are not generally recognized as safe and effective for OTC use. Triclosan was the only ingredient included in this list, however, found in OTC antiseptics marketed to healthcare settings.
OTC healthcare antiseptics containing one or more of the 24 active ingredients outlined in the rule will now be considered a new drug and will be subject to pre-market review. The FDA has given manufacturers of these products one year to comply with the new requirements or otherwise remove their product from the market.
The verdict is still out on the effectiveness and safety of six additional ingredients–ethanol, isopropyl alcohol, povidine-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol–and the FDA will hold off on making a decision on their safety and effectiveness pending data required from manufacturers due in one year.
Additional research suggests that the widespread use of antiseptics containing these newly banned ingredients may contribute to the development of antibiotic resistance.