Back in 2013, the Food and Drug Administration (FDA) started the long process of placing the burden of proof on antibacterial soap manufacturers. At the time, the FDA said that manufacturers of antibacterial products must show that not only are antibacterial soaps better germ killers than plain soap and hot water, but they must also prove that their soaps are safe. Turns out, manufactures could do neither, because the FDA issued a final rule on September 2nd establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed, including those with triclosan and triclocarban. The FDA notes, “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.” The FDA ruling will not affect any antibacterial products used in healthcare settings and also does not apply to OTC alcohol handrubs or wipes. In the FDA press release, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), notes, “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. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.” Since the FDA first said that antibacterials may not be safe, some manufacturers have already phased out certain active ingredients in antibacterial washes. Manufacturers who have not already removed active antibacterial chemicals from their products have one year to comply with the new rule.

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+ FDA issues final rule on safety and effectiveness of antibacterial soaps

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