FDA bans triclosan, 23 other antiseptic ingredients

FDA has finalized a rule banning the marketing of OTC healthcare antiseptic products containing triclosan or any of 23 other active ingredients, having found these ingredients are not generally recognized as safe and effective (GRASE).

FDA has finalized a rule banning the marketing of OTC healthcare antiseptic products containing triclosan or any of 23 other active ingredients, having found these ingredients are not generally recognized as safe and effective (GRASE). Affected products include hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin products, and are primarily used in medical settings such as hospitals, clinics, and doctors' offices. FDA is giving manufacturers 1 year to reformulate or remove these products from the market, although manufacturers have already stopped using most of these ingredients. Triclosan is the only non-GRASE active ingredient being used in healthcare antiseptic products on the market today, according to the agency. FDA has deferred final rule-making for 1 year on the six most commonly used active ingredients in OTC healthcare antiseptic products currently on the market, which will give manufacturers additional time to conduct safety and efficacy studies. FDA Commissioner Scott Gottlieb, MD, notes this does not mean products containing these ingredients are ineffective or unsafe, but the agency expects this information may help better inform them on antiseptic resistance and antibiotic cross-resistance in the health care setting.