by Brianna Crandall — September 26, 2016 — In a move that may affect the supplies purchased for washrooms and around the office, the U.S. Food and Drug Administration (FDA) issued a final rule earlier this month establishing that over-the-counter (OTC) consumer antibacterial soaps containing certain active ingredients can no longer be marketed since 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.
This final rule applies to consumer antiseptic hand and body 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.
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, antibacterial hand and body wash manufacturers were required to provide additional data if they wanted to continue marketing antibacterial soaps containing those ingredients, including data demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.
The manufacturers either did not submit additional data on the 19 active ingredients, or the data submitted was not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE).
In response 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 (PCMX) — to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial soaps 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, notes the FDA. If soap and water are not available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
After the FDA’s proposed rulemaking in 2013, some manufacturers already started 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 from) these products.
The FDA final rule is available on the Federal Register Web site.