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FDA Issues New Ruling on Antibacterial Soaps

SEP 07, 2016 | EINAV KEET
For years, consumers looking for a leg up on germs have purchased soaps and washes with labels touting their antibacterial properties. Now in a new ruling, the US Food and Drug Administration (FDA) has declared that companies selling over-the-counter antiseptic washes will no longer be allowed to market their products as such due to doubts over these products’ safety and effectiveness.

The FDA’s new ruling will affect the way manufacturers can label products that include a list of 19 active ingredients, the most commonly used of which are the antibacterial and antifungal agents triclosan and triclocarbon. In soaps, detergents, toothpastes, and mouthwashes, these ingredients act by targeting bacteria and inhibiting their ability to reproduce. This new ruling comes almost three years after the FDA proposed a rule requiring that manufacturers of over-the-counter antibacterial products demonstrate that those washes are more effective than plain hand soap in preventing illness and are safe for long-term use. In that proposal, the FDA called for data from clinical studies demonstrating that the products were superior to non-antibacterial washes in preventing human illness or reducing infection. It stated that if companies could not prove such safety and effectiveness, those products would need to be reformulated or relabeled to remain on the market.

After years of consumer use in the rigorous battle against pathogens such as Escherichia coli (E. coli) and norovirus, the antibacterial agents may actually pose health risks such as bacterial resistance and hormonal effects, according to the FDA. Public fears of antibiotic-resistant bacteria and the rise of “superbugs” have largely fueled the popularity of antibacterial household products. Although triclosan and similar agents have been used in medical settings for decades, health professionals and consumer advocates have argued that the use of these ingredients in everyday products only exacerbate the problem of antibiotic resistance.

“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 (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

After the FDA’s 2013 proposal, many household product manufacturers saw the move as a signal to the industry and began phasing out the labeling of soaps and washes as antibacterial. The new rules taking affect will not impact the way manufacturers label alcohol-based hand sanitizers, wipes, or the antibacterial products used in hospitals and healthcare settings. Due to industry comments, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride and chloroxylenol. During this time, consumer antibacterial products containing these specific ingredients may continue to be marketed while new data on their safety and effectiveness come in.

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