FDA restricts the usage of common antimicrobial soaps

Proposed rules by the Food and Drug Administration (FDA) could remove antibacterial soaps and body washes from store shelves – and might lead to 7.5 million new cases of foodborne illness and more than $38 billion in healthcare costs annually.

The new rules require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Antibacterial handwash products containing the ingredients triclosan and chloroxylenol play “beneficial roles in the daily hygiene routines of millions of people throughout the U.S. and the world”, but some data suggest that long-term exposure to these active ingredients could pose health risks, such as bacterial resistance or hormonal effects.

The American Cleaning Institute (ACI) expressed concern FDA has not assessed a substantial amount of existing safety data that are available on both ingredients prior to proposing that additional safety data are necessary to support the safety of their use in antibacterial soaps. “The available toxicological information provides no evidence for data gaps or gives cause for concern under typical use conditions of triclosan in consumer antiseptic wash products,” writes Richard Sedlak, ACI Executive Vice President, Technical & International Affairs. “After a transparent and scientific evaluation of existing data in accordance with established principles, we expect FDA will find that the triclosan database, in association with more recently published information, is sufficient for demonstrating the safety and efficacy of triclosan.”

Similarly, in regard to chloroxylenol, Sedlak writes that the “available toxicological information provides no evidence for data gaps or gives cause for concern under typical use conditions for chloroxylenol in consumer antiseptic wash products.” “Efficacy against pathogenic bacteria has been demonstrated. We believe that existing data on chloroxylenol is sufficient for demonstrating its safety and efficacy. Evaluation of the data in accordance with established principles, utilizing a weight of evidence approach, should lead FDA to conclude chloroxylenol deserves the official status of generally recognized as safe and effective.”

Both sets of comments make clear that existing evidence clearly shows that triclosan and chloroxylenol are not causing hormonal effects in humans, are not contributing to antibiotic resistance related to daily use of antibacterial soaps, and that both ingredients are effective at killing germs that can make people sick.

“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,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER.