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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks
Johnson & Johnson Faces Medical Monitoring Lawsuit Over Future Baby Powder Cancer Risks (Posted yesterday)

Women who used Johnson's Baby Powder around their genitals for feminine hygiene purposes now live in fear of developing ovarian cancer, according to the class action lawsuit seeking medical monitoring for future diagnoses

More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing
More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing (Posted 2 days ago)

A bundled complaint of about 9,600 Suboxone lawsuits were filed in federal court on Friday, ahead of the two-year anniversary of the FDA requiring tooth decay label warnings on the opioid treatment film strips, which is also a deadline for filing a civil complaint in many states.