FDA: Over-the-counter antibacterials no better than soap, water
Wed, Sep 7, 2016
A ruling by the U.S. Food and Drug Administration means over-the-counter consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
That’s because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.
The rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in healthcare settings.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The agency issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. The manufacturers did not provide the data.
The FDA ruling is an opportunity to remind the public of the importance of handwashing with soap and water, said Dr. Ryan Murphy, an emergency medicine physician with BayCare Clinic in Green Bay, Wisconsin.
“Thorough handwashing with soap and water helps reduce the spread of diarrheal and respiratory illness,” he said. “If water is not immediately available, the Centers for Disease Control and Prevention advises us to use an alcohol-based hand sanitizer that contains at least 60 percent alcohol to clean our hands.”
How should you wash your hands?
- Wet your hands with clean, running water (warm or cold), turn off the tap, and apply soap.
- Lather your hands by rubbing them together with the soap. Be sure to lather the backs of your hands, between your fingers, and under your nails.
- Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice.
- Rinse your hands well under clean, running water.
- Dry your hands using a clean towel or air dry them.
About BayCare Clinic
BayCare Clinic, baycare.net, is the largest physician-owned specialty-care clinic in northeastern Wisconsin and Michigan’s Upper Peninsula. With its 100-plus physicians, BayCare Clinic offers expertise in more than 20 specialties, serving clinical locations in 13 regional communities. Based in Green Bay, Wis., BayCare Clinic is a joint partner in Aurora BayCare Medical Center.