Manufacturers may have to show instead of tell when it comes to the safety of their antibacterial hand soaps.
The U.S. Food and Drug Administration (FDA) has proposed all antibacterial soap manufacturers should be required to prove their product is safe for" long-term daily use" and trumps plain soap in preventing disease, an FDA news release reported.
If the soap manufacturers were not able to demonstrate the effectiveness of their product, they would be required to either "reformulate or relabeled."
The rule would not be applied to "hand sanitizers, wipes, or antibacterial products used in health care settings." The effort is part of a widespread review of antibacterial ingredients led by the FDA.
Millions of Americans regularly purchase antibacterial hand soap and body wash, but there is almost no evidence to prove the effectiveness of these products, or if they are a better choice than "plain soap and water."
To complicate things even further, soap ingredients such astriclosan and triclocarban could have health repercussions such as hormonal interference and bacterial resistance.
"Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER) said. "Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk."
The fact that antibacterial products have been gaining consumer popularity prompted the FDA to work towards more specific regulations in terms of what products are deemed "generally recognized as safe and effective" (GRASE).
The new rules would require soap manufacturers to provide data from clinical studies assuring the products effectiveness.
"While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use," Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER, said. "Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others."
For now, the FDA suggests using products that contain at least 60 percent alcohol to disinfect hands if soap and water are not available.
The FDA stated that almost all soaps labeled "antibacterial," "antimicrobial," or even "deodorant" contain the ingredients being called into question.
For hand washing tips from the Centers for Disease Control and Prevention Click Here.
