Antibacterial Soap Faces Pressure to Perform From FDA

The Food & Drug Administration announced Monday that the makers of antimicrobial and antibacterial soaps and body washes will need to demonstrate the safety and effectiveness of their products, as well as prove that they prevent the spread of illness better than simple soap and water. Failing to do so, manufacturers must reformulate or re-label these products to continue selling them.

Targeting Troublemakers Triclosan and Triclocarban

The FDA is largely targeting triclosan, used in liquid soaps, and triclocarban, used in bar and some “deodorant” soaps. The use of these chemicals is associated with endocrine disruption and the rise of antibiotic-resistant bacteria. Animal studies reveal that exposure to high levels of triclosan also disrupts thyroid homeostasis and has an effect on estrogen levels, leading to low sperm count in males and premature puberty in females. More concerning to the millions of Americans using the myriad of products that contain triclosan and triclocarban, the chemicals have also been detected in human breast milk, urine and blood.

While the FDA is not requiring that producers of antibacterial soaps immediately take their products of the market, manufacturers do have to conduct clinical studies showing the long-term health effects of the use of their soaps. If the products prove unsafe, the active ingredients must be removed to remain on the market.

The Prevalence and Efficacy of Triclosan

According to the EPA, triclosan was first registered as a pesticide in 1969 and is still used as an antimicrobial pesticide in such commercial and industrial equipment uses, such as in fire hoses, ice-making machines and conveyer belts. In 1972, it was adopted for medical use, first in hospital and health care settings.

Today, the consumer market is saturated with products containing triclosan, including household cleaners, toothpaste, treated sponges, shower curtains and antibacterial cutting boards, in addition to hand sanitizers and antibacterial soaps. In Monday’s release, the FDA stated there is no evidence that consumer antibacterial soaps are any more effective at preventing disease than washing with 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

Antibacterial Soap Faces Pressure to Perform From FDA

The regulation of antibacterial and antimicrobial consumer products has been demanded for more than a decade. In 2000, the American Medical Association (AMA) began advising the FDA to closely monitor and possibly regulate the home use of antimicrobials. According to Natural Life Magazine, at the AMA annual meeting in 2000, Myron Genel, chair of the AMA Council on Scientific Affairs and a Yale University pediatrician, said, “There’s no evidence that they do any good, and there’s reason to suspect that they could contribute to a problem…[by helping to create antibiotic-resistant bacteria.]"

The FDA announced in 2005 that it was considering restricting antibacterial soaps after its panel of health experts overwhelmingly agreed that these products proved not to be any more effective than regular soap in preventing infections among consumers. In 2010, the FDA posted a summary of a health risk assessment for triclosan, including thyroid hormone and estrogen-related effects.

The FDA encourages the public to weigh in on the newly proposed rule during its 180-day comment period. Companies with have a concurrent one-year period to submit new data on their product. A 60-day rebuttal comment period will follow.

The FDA continues to stress the importance of hand washing to help prevent illness. In the absence of soap and water, hand sanitizer containing at least 60 percent alcohol is recommended. To learn more about best hand-washing practices, visit the CDC page on the topic here.

The FDA's proposed rule on antibiotic soap comes less than a week after the agency announced plans to phase out non-medical uses of antibiotics on farms to combat increasing human resistance to the critical bacteria-fighting drugs.

Renée Canada is an AADP-board certified holistic health coach for The Mind-Body Shift, with certification from the Institute for Integrative Nutrition and education from UConn's School of Public Health. In her practice, clients learn to improve their health and lifestyle through a holistic approach to wellness that encompasses the body, mind and spirit. Visit Renee’s website at http://themindbodyshift.wordpress.com to learn more about how you can create the healthy, rewarding and happy life you’ve always desired.