Aside from washing one’s hands with water and soap, using hand sanitizer is one of the most common ways people try to maintain clean hands, reduce the spread of disease, and prevent the growth of bacteria. For this reason, along with new scientific information from an independent advisory committee, FDA would like additional information to demonstrate that the main active ingredients in antiseptic rubs (ethanol, ethyl alcohol, isopropyl alcohol, and benzalkonium chloride) do not present risks of repeated exposure and assure long-term safety when used correctly.
FDA states that since they began their review of “topical antiseptics in the 1970’s, many things have changed, including the frequency of use of some of these products, new technology that can detect low levels of antiseptics in the body, and the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use .” This request for additional data is simply to ensure that consumers, especially at-risk populations such as pregnant women, the elderly, and children, who use topical antiseptics, are using products that are as safe and effective as possible.
This proposed rule does not call for regularly used hand sanitizers to be pulled from the market, but instead requires those who manufacture these topical antiseptics to provide FDA with additional information about the active ingredients in the products they produce and plan on to continue producing.
