December 16, 2013
FDA Proposes Putting Antibacterial Soaps Under Investigation
[ Watch the Video: Benefits Of Antibacterial Soap Under Scrutiny ]
On Monday, the Food and Drug Administration (FDA) announced it would be scrutinizing antibacterial soaps and body washes to determine their effectiveness compared to their traditional counterparts. The FDA said it would also be looking into the long-term effects of using antibacterial products.
The FDA is proposing makers of antibacterial cleaning products will have to show that the soaps and body washes are safe, effective, and prevent the spread of disease better than conventional soap and water. If manufacturers cannot prove a certain level of increased effectiveness, they must reformulate or re-label the particular product before continuing to sell it.
“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 Dr. Janet Woodcock, 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.”
“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” added Dr. Sandra Kweder, deputy director at the Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”
The FDA appears to be focusing on limiting the antibacterial use of triclosan in liquid soaps and triclocarban in bar soaps. In animals, exposure to these chemicals in high concentrations has been found to affect the levels of thyroid hormones and have estrogenic effects as well, such as early puberty in females and low fertility in males. These chemicals have also been found in human breast milk, urine and blood, fueling concerns over the widespread use of the two compounds.
“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney in for the Natural Resources Defense Council (NRDC). “FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.”
The FDA said its proposed rule does not necessitate the immediate removal of antibacterial soaps from the market. The proposed rule is currently being made available for a 180-day public comment period, which will be followed by a 60-day rebuttal comment period. Companies will also have a concurrent one year period to submit new data and information on their products.
In December 2012, the NRDC requested records for the FDA’s 1997 approval of Colgate Total, which includes triclosan. After releasing a redacted subset of the records sought, the FDA was sued by the NRDC for violating the Freedom of Information Act.
“Scientific studies have linked triclosan to multiple health hazards,” including the disruption of hormones, the complaint said.