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FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps

Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes

The FDA has issued a final rule establishing that consumer antiseptic wash products containing triclosan, triclocarban, and certain other active ingredients can no longer be sold as over-the-counter (OTC) products. 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. The affected 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 health care 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—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—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 OTC consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to nonantibacterial washes in preventing human illness or reducing infection.

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride, and chloroxylenol— to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

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. Hand sanitizers are an alternative if soap and water are not available. The Centers for Disease Control and Prevention recommends alcohol-based hand sanitizers that contain at least 60% alcohol.

Source: FDA; September 2, 2016.

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