FDA Bans Chemicals Used In Antibacterial Soaps as Ineffective

The FDA has banned marketing of antibacterial soaps with certain ingredients such as triclosan that have not been proved safe and effective.

Published Sep 4, 2016

In September 2016, the U.S. Food and Drug Administration (FDA) announced that manufacturers of over-the-counter (OTC) consumer antiseptic wash products containing at least one of 19 specific active ingredients, including triclosan and triclocarban, will no longer be allowed to market those products.

The FDA stated that the companies offering such products had not been able to prove that the ingredients in question are safe or more effective than ordinary soap and water in preventing the spread of disease and infection:

According to the U.S. Food and Drug Administration (FDA), there isn’t enough science to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. To date, the benefits of using antibacterial hand soap haven’t been proven. In addition, the wide use of these products over a long time has raised the question of potential negative effects on your health.

After studying the issue, including reviewing available literature and hosting public meetings, in 2013 the FDA issued a proposed rule requiring safety and efficacy data from manufacturers, consumers, and others if they wanted to continue marketing antibacterial products containing those ingredients, but very little information has been provided. That’s why the FDA is issuing a final rule under which OTC consumer antiseptic wash products (including liquid, foam, gel hand soaps, bar soaps, and body washes) containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.

Why? Because the manufacturers haven’t proven that those ingredients are safe for daily use over a long period of time. Also, manufacturers haven’t shown that these ingredients are any more effective than plain soap and water in preventing illnesses and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products, ahead of the FDA’s final rule.

“Following simple handwashing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” says Theresa M. Michele, MD, of the FDA’s Division of Nonprescription Drug Products. “We can’t advise this enough. It’s simple, and it works.”

The FDA’s final rule covers only consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers or hand wipes. It also does not apply to antibacterial soaps that are used in health care settings, such as hospitals and nursing homes.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER) director, said that although consumers may believe antibacterial washes are effective at preventing the spread of disease-causing germs, no real scientific evidence backs up the claim that such products are better at such purpose than regular soap and water.

About 40% of antiseptic hand soaps (both bar and liquid form) contain the chemicals in question, with triclosan, the most common such ingredient, being found in 93% of liquid antibacterial/antimicrobial liquid products.

Triclosan was originally intended for use in hospitals when first marketed in the 1960s as a product that would kill microorganisms such as bacteria, rather than simply dislodging them from the skin as soap and water do. However, recent lab tests have shown that bacteria have become resistant to triclosan, and therefore its continued widespread use could worsen the problem of antibiotic resistance.

Additionally, animal studies have suggested that exposure to triclosan (and similar chemicals) may disrupt hormones in the body, trigger allergies, and be linked to some forms of cancer (although these studies have not yet definitively demonstrated such effects in humans):

Triclosan can be found in many places today. It has been added to many consumer products — including clothing, kitchenware, furniture, and toys — to prevent bacterial contamination. Because of that, people’s long-term exposure to triclosan is higher than previously thought, raising concerns about the potential risks associated with the use of this ingredient over a lifetime.

In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Some data shows this resistance may have a significant impact on the effectiveness of medical treatments, such as antibiotics.

David Mikkelson founded the site now known as back in 1994.

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