Triclosan Soap Manufacturers Must Prove Health Benefits

It’s been just under a year, but with one announcement, the future of antibacterial soaps and body washes was called into question. In December of 2013, the U.S. Food and Drug Administration (FDA) proposed a new rule for consumer antibacterial soaps and body washes, in which soap manufacturers would be required to demonstrate safety for long-term daily use and efficacy beyond plain soap and water.

“This is a very important issue. The survival of antibacterial soaps and body washes is at stake here,” says Brian Sansoni, vice president of communication for the American Cleaning Institute (ACI), formerly the Soap and Detergent Association, a Washington D.C. trade association. “We believe that the rules, enacted as we see them, could put an end to consumer access.”

Even though the FDA rule specifies consumer soaps, the only markets it excludes are healthcare and foodservice settings. So, distributors selling to offices, schools, hotels and other facilities may no longer have access to antibacterial soap.

The ingredient at the focus of controversy is triclosan, one of the most widely used and inexpensive antibacterial and antifungal agents in products including soaps, detergents, toothpaste and shampoo. Triclosan was initially used as a hospital scrub, and its commercial use expanded in the 1990s as it was added to a number of different products, including clothing, bedding, toys and utensils.

But triclosan isn’t the only ingredient being reviewed.

“Three ingredients that were thought in 1994 to have ‘generally recognized as safe’ (GRAS) status are now being called into question as not having enough data to determine that definitively — hexylresorcinol, iodophors (i.e., all iodine-containing ingredients) and triclocarban,” says Jeff Ventura, press officer in the Office of Media Affairs and Office of External Affairs for the FDA.

In addition, four ingredients — benzalkonium chloride, benzethonium chloride, chloroxylenol and triclosan — didn’t have sufficient data to determine a GRAS status in 1994 and new data supports that decision.

The new data has called triclosan’s safety into question and is prompting further review of that ingredient. This data includes scientific studies that have shown it alters hormone regulation in animals and may contribute to creating antibiotic-resistant bacteria.

Additionally, while the FDA acknowledges the benefit of triclosan in certain products, such as mouthwash, the administration maintains it does not have evidence that triclosan in antibacterial soaps and body washes are any more effective or beneficial to health than washing with regular soap and water. Therefore, it is putting the onus on manufacturers to prove that antibacterial soaps are, in fact, more beneficial than regular soaps.

Essentially, the consumer antiseptic wash active ingredients that were approved for use in 1994 are no longer considered GRAS by the FDA, nor are they ‘generally recognized as effective’ (GRAE). There is insufficient data available to permit those GRAS/GRAE classifications. The FDA, in its Tentative Final Monograph, stated it found significant safety data gaps with both triclosan and triclocarban.