FDA Digging Up Dirt on Antibacterial Soap
by: Lynn A. Toops, Attorney
The FDA recently announced a proposed rule change to make manufacturers of antibacterial soap prove that these products work as advertised. This move comes after research studies have indicated that Triclosan, a common active ingredient in antibacterial products, is no more effective than soap and water at ridding of germs and it might be dangerous. A concern is that many of these antibacterial soap makers advertise that their products are more effective than soap and water.
What does Triclosan do?
Triclosan is a synthetic broad-spectrum antimicrobial agent used in a variety of products from soaps and deodorants to toothpastes and fabrics. It was originally used as a surgical scrub in the 1970’s because of its antibacterial properties, but it also offers some antifungal and antiviral benefits. Hospitals use Triclosan to help reduce the occurrence of healthcare facility-acquired infections.
A study was conducted in 2004 at Columbia School of Nursing by Dr. Larson et al., to examine the health benefits of Triclosan use in average households. That study of over 200 households found that antibacterial products did not reduce the risk for symptoms of infectious disease. Following this study, the Centers for Disease Control and Prevention stated that antibacterial soaps are not necessary in everyday use and that washing hands with ordinary soap and warm water is an effective way to ward off infections.
Concerns about Triclosan
Consumer safety groups have long questioned the use of Triclosan in antibacterial products. Recent studies focused on the possible health impacts of Triclosan have shown the chemical disrupts sex hormones like estrogen and testosterone, as well as thyroid function in lab animals. The FDA’s recent move to change the rule so that manufacturers are required to prove their claims will better protect consumer health and safety.
Class action lawsuits have been filed against makers of antibacterial soaps that incorporate Triclosan as an active ingredient. In January 2012, plaintiffs in ten different states filed a class action lawsuit against The Dial Corporation, the manufacturer of Dial Complete Foaming Antibacterial Hand Wash, for unfair and deceptive trade practices and breach of warranty related to the company’s claim that its antibacterial soap is more effective at washing off germs than regular soap and water. This lawsuit is currently pending.
In June 2013, a similar lawsuit was filed against Colgate-Palmolive, the manufacturer of Softsoap Antibacterial Handsoap. Plaintiffs across six states claim the maker of Softsoap Antibacterial Handsoap misrepresented its product as more effective at washing off germs than soap and water alone. This lawsuit is currently pending.
Sales of antibacterial products top $1 billion annually. This industry stands to lose considerable profits if this rule change takes place and the industry continues to argue a measureable benefit to its products that contain Triclosan. However, most studies indicate no additional benefit can be found by using products containing this antimicrobial. There is a six month time period in which the public is welcome to comment to the FDA regarding this proposed rule change. After that time, the agency will allow a rebuttal period before a final rule is published.