LOS ANGELES – The makers of antibacterial soaps and body washes will have to demonstrate that their products are safe, effective and prevent the spread of illness better than good old-fashioned soap and water, or they’ll have to conform to new rules, the Food and Drug Administration said Monday.
Just days after unveiling new proposals to limit the use of antibiotic medications in livestock raised for human consumption, the FDA’s new measure takes aim at soaps suspected of promoting the development of bacteria resistant to eradication and of exposing consumers to hormone-disrupting chemicals.
If the products are not shown to be safe, effective and superior to soap and water in preventing disease spread, the FDA said, manufacturers will be required to reformulate or relabel them as a condition of continued sale.
The new rule, which will be open for public comment for 180 days and then subject to a 60-day rebuttal period, would not affect such products as hand sanitizers, sanitizing wipes and antibacterial products used in health care settings.
In announcing its latest effort to limit the use of bacteria-fighting products, the FDA is focusing largely on triclosan (used in liquid soaps) and triclocarban (used in bar soaps, including many deodorant soaps). In animals, exposure to high concentrations of these compounds has been found to suppress thyroid hormone concentrations and to have estrogenic effects, including premature puberty in females and low sperm count in males.
As the chemicals have been found in human breast milk, urine and blood, there is growing concern that the product’s widespread use may affect human health as well.
Research has also suggested a link between the long-term use of bacteria-killing soaps and the rise of resistant bacteria, human allergies and other autoimmune diseases.
The new rule could put an end to the marketing of “antibacterial” and “antimicrobial” soaps that promise to stop the spread of cold and flu germs and illness.
In recent years, such products have become a staple of classrooms and homes with children.
The FDA emphasized that it continues to consider hand-washing – or the use of alcohol-based hand sanitizers – essential for limiting the spread of illness-causing microbes and urged consumers to continue to be diligent about washing their hands.
The American Cleaning Institute, which represents the $30 billion cleaning product industry, said Monday it has provided the FDA extensive information showing that antibacterial products are safe and kill germs more effectively than soap and water.
“What perplexes us is we’ve submitted a whole wealth of data on safety and effectiveness,” said Brian Sansoni, a spokesman for the group, citing a meeting with the agency in 2008. “We just want to make sure the FDA has that data in front of them. We believe there’s a lot of solid data there.”
Sansoni dismissed suggestions that antibacterial soaps are worsening the threat of antimicrobial resistance, saying the real problem is misuse and overuse of antibiotic drugs. “The activists have tried to make a ghost story out of this, but there’s no ghost,” he said.
– The Washington Post contributed to this report.