Feds Seek Scientific Info About the Safety and Effectiveness of Antibacterial Soap

Earlier this month, the FDA revisited the issue of growing resistance of microbes to antibiotics by announcing a plan to minimize their use in livestock. Last week, the federal agency continued to raise awareness of antibiotic resistance by requiring manufacturers of nonprescription antibacterial soap to prove that their products are safe for long-term daily use and are more effective than plain soap in stopping the spread of infections.

The proposed rule doesn’t apply to hand sanitizers and wipes – which are alcohol-based and aren’t used with water – or to antibacterial products used in a health-care setting.

Soap that not only cleans but seems to protect against germs seems like a good idea, but as is often the case, more is not necessarily better. The consistent use of antibacterial agents that haven’t been thoroughly tested might cause harm, and using them for purposes other than preventing dire illness only makes the germy invaders stronger, as they evolve to resist the threat.

“New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available,” says the FDA document. “New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.” (See our blog, “Antibacterial Soaps Few Clear Benefits, Many Murky Questions About Safety.”)

As summarized on MedPageToday.com, the FDA wants to amend a 1994 declaration that nearly all antiseptic active ingredients currently in use are as “generally recognized as safe and effective” (GRAS/GRAE). The feds have been analyzing antibacterial active ingredients for several years.

Companies that fail to show that their soaps and body washes are safe and effective would have to remove the antiseptic ingredients from over-the-counter products, or they would have to eliminate antibacterial claims from product labels.

More than 2,200 antibacterial hand soaps and body washes are on the consumer market. And there’s no scientific evidence to prove that they are any more effective at preventing illness than plain soap and water.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement. “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

Among those potential risks is a hormonal effect. Some animal research has shown that daily exposure to ingredients such as triclosan in liquid soap and triclocarban in bar soap can affect estrogen, testosterone and thyroid hormones, although these effects on human safety have not been established.

That’s why manufacturers should conduct clinical trials to determine if they can be considered as generally recognized as effective, and safe.

It has not been proved that these ingredients promote microbial resistance to antibiotics, but it is known that triclosan is a long-lived chemical. Dr. Nicole Bouvier, an infectious disease specialist, told MedPageToday that it’s found in soil, water and human urine, where it has been associated, with elevated body mass index and with environmental and food allergies.

Until the FDA takes further action, which won’t happen before the end of next year, by which time manufacturers are expected to submit data, FDA officials say consumers should know what’s in their soap. Washing with plain soap and running water is a basic step to avoid getting sick and preventing the spread of germs. Hand sanitizers with at least 60% alcohol are a good choice if soap and water aren’t available.

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