FDA At Antibacterial Soaps Product Potential Risks. Experts at the U.S. Food and Drug Administration (FDA) are taking a closer look at certain antibacterial products and say that these items do not necessarily reduce the likelihood of reducing illness or passing germs along to others. According to the agency, there should be clearly demonstrated benefits to balance these products’ potential risks.
The FDA states that no proof exists that over-the-counter (OTC) antibacterial soap products work any better at preventing illnesses than washing our hands with plain soap and water, according to lead FDA microbiologist, Colleen Rogers Ph.D. Also, these products contain chemicals, including triclosan and triclocarbon, which may carry risks. The benefits provided by these products have not been proven.
Triclosan and triclocarbon, in addition to being found in antibacterial soaps, are also found in toothpastes, liquid and bar soaps, mouthwash, fabrics, laundry detergent, and baby pacifiers, according to The New York Times. In fact, the U.S. Centers for Disease Control and Prevention (CDC) says the chemicals are found in the urine of most—three-quarters—Americans.
“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. Also, according to the agency, some of the ingredients in antibacterial OTC products may actually increase the likelihood of bacterial resistance to antibiotics and may also carry concerning hormonal reactions.
Safety And Efficacy of Antibacterial Soaps
Because of these issues, the agency issued a proposed rule on December 16th mandating manufacturers to provide more substantial data that demonstrates the safety and efficacy of antibacterial soaps. The proposed rule only covers consumer antibacterial soaps and body washes used with water and is not applicable to hand sanitizers, hand wipes, and antibacterial soaps used in health care settings, such as hospitals.
It seems that, the laboratory tests that have long been used to measure antibacterial soap efficacy do not directly test for how those soaps impact infection rates, Rogers explained. Under the FDA’s proposal, studies would be required that would directly test how an antibacterial soap provides a clinical benefit when compared to washing with non-antibacterial soap, says Rogers.
Triclosan is among the ingredients found in antibacterial soaps—sometimes called antimicrobial or antiseptic soaps—that is not found in plain soaps. Triclosan and other ingredients are added to an array of consumer products in efforts to prevent or minimize bacterial contamination. Because of its ubiquity, triclosan has caught the attention of many environmental groups, and animal studies have revealed that the chemical might affect the way in which hormones work in the body. Studies also show that triclosan is a contributing factor in antibiotic bacteria resistance, a growing and very significant public health issue.
New data suggests these active ingredients are present in larger amounts in these products than previously believed, raising issues over the risks potentially tied to regular, long-term use of these products, according to the FDA. Consumers, clinicians environmental groups, scientists, and industry reps are encouraged to weigh in on the proposed rule over its 180 days,
The FDA and the Environmental Protection Agency (EPA) are collaborating on science and regulatory issues concerning triclosan from two different perspectives. The EPA regulates Triclosan as a pesticide while the FDA is looking at the chemical’s effects when regularly used by consumers.
“It’s a big deal that they are taking this on,” Rolf Halden, director of the Center for Environmental Security at Arizona State University, told The New York Times. Halden has been following the issue for years. “These antimicrobials have taken on a life all of their own,” Dr. Halden said. “Their use has really proliferated.”
Senator Edward J. Markey, Democrat of Massachusetts, has long urged for increased control over antimicrobials, and told the New York Times that the chemicals had long “existed in a regulatory black hole, despite serious concerns about its impact on public health.”
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