The Food and Drug Administration announced on Monday that it was requiring manufacturers of antibacterial soaps to demonstrate that their products are safe for long-term use or reformulate them.
The agency said that some data suggested that long-term use of certain ingredients in the soap that give it the antimicrobial qualities — triclosan in liquid soaps and triclocarban in bar soaps — could pose health risks, such as bacterial resistance or hormonal effects. Some soaps labeled “deodorant” may also contain these ingredients.
Millions of Americans use these products, and agency officials said that accumulated scientific evidence and “concerns raised by health care and consumer groups” had prompted the drug agency to re-evaluate these products and whether their active ingredients are safe.
The proposed rule does not require producers of the soap to take it off the market immediately. Producers will have to conduct clinical studies that show the long-term health effects. If the soaps are not safe, the active ingredients will need to be removed from the products.
The proposed rule will be open for public comment for 180 days, and producers will have a year after that to submit new data and information.
“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,” said Dr. Janet Woodcock, the director of the F.D.A.’s Center for Drug Evaluation and Research.
Scientists have raised concerns about triclosan for decades. Senator Edward J. Markey, Democrat of Massachusetts, who has pressed federal regulators to more closely control the substance, said on Monday in a statement that federal authorities “have acknowledged the potential for triclosan to interfere with the body’s thyroid hormone, which is important for brain development and function, particularly in children.” Other studies, he said, showed that it disrupted other hormone functions important for puberty and fertility.