Proving Antibacterial Soap Effectiveness Goal of New FDA Rules

Federal health regulators are proposing new rules that will require manufacturers of antibacterial soap to establish that their products actually work as advertised.  

On Monday, the FDA announced a proposed rule that would require antibacterial hand soap and body wash manufacturers to show that their products are effective and that they have been scientifically tested. The new regulation came following strong protests by the industry.

The FDA requirements would affect about 2,000 antibacterial soap products, which account for about half of the $900 million in liquid soap sold in 2012.

The proposed rule comes as the FDA faces a court-ordered deadline to regulate triclosan, the active ingredient in many antibacterial soaps, by 2016. The deadline was set following a lawsuit by the Natural Resources Defense Council, an environmental group. However, the rule will affect a number of chemicals; not just triclosan.

In recent years, concerns have arisen about the use of triclosan, which some studies say could cause muscle damage. Triclosan is added to many personal care products as an antibacterial agent. It is used in hand soap, deodorants, toothpaste and is added to other products like bedding, clothing and toys to reduce the risk of bacterial contamination.

The U.S. Environmental Protection Agency estimates that more than 1 million pounds of triclosan are produced annually in the U.S.

According to the consumer watchdog group Beyond Pesticides, formerly known as the National Coalition Against the Misuse of Pesticides, numerous common products are known to contain triclosan including Dial Liquid Soap, Clearasil Daily Face Wash, Colgate Total Toothpaste, Revlon ColorStay LipSHINE Lip color, Old Spice High Endurance Stick Deodorant and many others.

However, many companies are already phasing triclosan out of use, due to the concerns.

Other Antibacterial Soap Concerns

Regardless of concerns over triclosan, the FDA says there is little evidence that antibacterial soaps actually work any better than soap and water. Agency officials also say that in addition to triclosan’s health concerns, the widespread use of antibacterial soaps could cause other health risks, including bacterial resistance and hormonal effects.

“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,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the FDA press release. “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.”

The antibacterial soap industry disagrees with the FDA position, maintaining that it has proven the effectiveness of its products repeatedly.

“Over the past two decades, manufacturers of these products have provided significant data and information to the Agency about the safety and efficacy of this product category,” according to a statement released by the American Cleaning Institute and the Personal Care Products Council. “We are perplexed that the Agency would suggest that there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products.”

However, the groups also say that they applaud the FDA for the rulemaking overall, and believe the industry will be able to provide the agency with evidence proving the products’ effectiveness by submitting data already available.

The proposed rule making has a public comment period of six months, which will be followed by a 60-day rebuttal period. The regulations will go into effect one year after a final rule is published.