FDA Requests Additional Data on Hand Sanitizers (July 2016)

According to a recent press release issued by the FDA, the agency is requesting additional data to reinforce the safety and efficacy of “certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC).”

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. Instead, it requires manufacturers of topical antiseptics to provide FDA with additional information about the active ingredients in their products that are being produced and those they plan to continue producing.

Technology Sciences Group’s senior regulatory consultant
Robert Stewart and regulatory scientist Ian Van Trump specialize in OTC drugs and hand sanitizer compliance. They can assist manufacturers who are seeking to accommodate FDA’s requirements.