The U.S. Food and Drug Administration (FDA) recently proposed rules governing hand sanitizer products and their ingredients. Specifically, the push is to require makers of antibacterial hand-sanitizing products to submit data on safety and effectiveness, if they want to stay on the market.

According to a recent Wall Street Journal article, the federal agency had previously issued such rules on antibacterial soaps used with water and on sanitizers used in hospitals. But this time, the FDA is focusing on gels, rubs, towelettes and other such over-the-counter products used to kill bacteria when soap and water aren’t available.

The FDA has opened the rule up for industry comment for 180 days. Also, sanitizer manufacturers have a year to submit evidence that their products are safe when absorbed into the bloodstream, and that they actually do reduce the bacterial count. Of particular interest is evidence concerning the safety of long-term, repeated exposure, especially in pregnant women and children.

The Wall Street Journal reports that about 90 percent of the products in question include ethyl alcohol, with the remainder generally featuring isopropyl alcohol or benzalkonium chloride. Makers of products will need to provide safety data for all three, but evidence on bacterial reduction only for the latter two.

In response to the proposed rule, Richard Sedlak, Executive Vice President, Technical & International Affairs at the American Cleaning Institute (ACI) issued the following statement:
“Hand sanitizers are a critical part of healthy hand hygiene routines for millions of consumers every single day. In fact, the Centers for Disease Control and Prevention (CDC) recommend using alcohol-based hand sanitizers if soap and water are unavailable.
 
“On behalf of our members who produce hand sanitizers and their ingredients, the American Cleaning Institute looks forward to providing in-depth comments to FDA on their proposed rules.
 
“We believe that the FDA has a wealth of data on hand sanitizers in their possession to judge them as generally recognized as safe and effective. However, we will work to provide additional data as necessary to ensure the agency has the most complete, useful, and up-to-date information on these beneficial products.
 
“Consumers can continue to use hand sanitizer products with confidence as this regulatory process moves forward. We will work to ensure that these products remain available to help people stay clean and healthy in homes, day care centers, restaurants, and offices across the United States.”