The FDA has issued a report establishing that over-the-counter consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
Companies will no longer be able to market antibacterial washes with these ingredients 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.
This final 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 Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data that suggests antibacterial ingredients may do more harm than good over the long term.”
According to the FDA, washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the CDC recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
Since the FDA’s proposed rulemaking in 2013, manufacturers have been phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients in) these products.