After more than 35 years of debate, the U.S. Food and Drug Administration is finally taking a look at whether the antibacterial soaps that millions of Americans use daily are effective and safe.
The agency proposed a rule Monday to require the makers of antibacterial soaps and body washes to show that their products are safe for long-term use and are more effective than regular soap and water in preventing illness and the spread of infections.
Under the proposal, if companies don’t demonstrate the safety and effectiveness of their products, they’d need to be reformulated or relabeled to continue to be sold.
The Natural Resources Defense Council, an environmental action group, said the FDA has dragged its feet on antibacterial hand soaps for decades. As a result of NRDC’s lawsuit on these delays, the FDA agreed to a series of deadlines pushing to finalization of its regulation of hand soaps.
The rule only applies to antibacterial products used with water. It doesn’t include hand sanitizers, wipes, or antibacterial products used in hospitals, doctor’s offices, and other health care settings. Most of these contain alcohol not antibacterial chemicals.
No evidence currently exists that antibacterial products are any more effective at preventing illness than washing with soap and water, according to the FDA. And, some research shows that long-term exposure to some of the 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.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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 FDA doesn’t want consumers to stop washing their hands just because it’s examining antibacterial products.
“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,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER.
Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. Some soaps labeled “deodorant” may also contain these ingredients.
The Environmental Protection Agency, which regulates triclosan as a pesticide, and has also been studying the effects of the chemical for years. For more information on EPA's most recent assessment of triclosan, see “Triclosan Facts.”
In addition to looking at endocrine effects of triclosan, the EPA is considering data on developmental and reproductive toxicity, chronic toxicity, and carcinogenicity.
Triclosan and triclocarban also are found in clothing, furniture, toys, toothpaste, kitchenware, cosmetics, and other products. Manufacturers say they add the chemicals to prevent bacteria from growing in or on their products.
Consumers can comment on the proposed FDA rule for 180 days from Dec. 17. Companies will have one year to submit information, followed by a 60-day rebuttal comment period.