The FDA initially proposed a rule in 2013 following some data that suggested long-term exposure to certain active ingredients in antibacterial products (eg, triclosan [liquid soaps], triclocarban [bar soaps]) could lead to bacterial resistance or hormonal effects.
Advertisement
Friday’s decision primarily targets two once-popular ingredients – triclosan (TRY’-kloh-san) used in liquid soaps, and triclocarban (TRY’-kloh-kar-ban) used in bar soaps – that some research suggests can interfere with hormone levels and spur drug-resistant bacteria.
Antibacterial soaps are most often sold in liquid form, but not all liquid soap is classified as antibacterial.
The Food and Drug Administration is halting the sale of antibacterial washes and soaps that contain one or more of 19 ingredients. At the time, it emphasized that it was not asking for any consumer hand sanitizer products to be removed from store shelves.
As the FDA allows for the development and submission of new safety and efficacy data for these ingredients, manufacturers may still market consumer antibacterial washes containing these ingredients.
“Either no additional data were submitted“, the FDA said Friday, “or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective”. Triclosan is often used in toothpaste and it’s been shown to help kill germs that cause gum disease. It also does not affect antiseptic products used in healthcare settings.
“Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection”.
They found it was no more effective, both experiments indicating that there is “no significant difference” between the effects of plain soap and antibacterial soap when used under “real life” conditions, they concluded.
Advertisement
Companies manufacturing consumer wash products with three other ingredients – benzalkonium chloride, benzethonium chloride, and chloroxylenol – were given 1 year to develop and submit new safety and effectiveness data; they can continue marketing products with these ingredients in the meantime. In the meantime, many manufacturers have already started phasing out triclosan and other antimicrobial compounds from their products.
