by Brianna Crandall — January 13, 2014—The U.S. Food and Drug Administration (FDA) issued a proposed rule on December 16 to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness within one year, these products would need to be reformulated or relabeled to remain on the market.
This action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The FDA notes that the proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in healthcare settings.
Originally, surgeons used triclocarban to wash their hands before operations, explains Stephen Ashkin, president of The Ashkin Group and known as the “father of green cleaning.” However, in recent years this chemical as well as triclosan, which is similar, have been used in a wide range of products from mouthwash, hand soap, and cosmetics, to some cleaning products used mostly by consumers.
Ashkin has long believed these chemicals are unnecessary and potentially dangerous to health and the environment. “As you can imagine, this decision will affect many industries,” says Ashkin. “However, the impact [of these chemicals] on the environment and health and their overall effectiveness has been questioned for years.”
Although millions of Americans use antibacterial hand soap and body wash products to help prevent the spread of germs, there is currently no evidence that the products are any more effective at preventing illness than washing with plain soap and water, says the FDA. Further, some data suggests that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.
Since antibacterial soaps and body washes are widely used, resulting in widespread exposure of the public to the chemicals in question, the FDA believes there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk, and is placing the burden for that demonstration on the manufacturers.
“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,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “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.”
Consumers should continue to be diligent about washing their hands, asserts the FDA. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. The U.S. Centers for Disease Control and Prevention (CDC) offers information on appropriate hand washing on its site.
The proposed rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
