The U.S. Food and Drug Administration (FDA) has issued a proposed rule to ban certain ingredients in antibacterial soaps, thereby amending the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, the FDA is proposing to establish conditions under which OTC consumer antiseptic products intended for use with water are generally recognized as safe and effective.
Manufacturers have six months to respond to the planned regulation, which was published in the Federal Register on December 17, 2013 and is available online.
Why It Matters
Some data suggests that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects. Almost all soaps labeled "antibacterial" contain at least one of the antibacterial active ingredients that the FDA is proposing to ban, for example; triclosan used in liquid soaps; and triclocarban in bar soaps.
The FDA is also proposing that all consumer antiseptic wash active ingredients have data that demonstrates a clinical benefit from the use of these consumer antiseptic wash products compared to non-antibacterial soap and water. This could force makers of personal hygiene products to reformulate all bar soaps, liquid soaps, body washes, and dishwashing liquids labeled as "antibacterial."
How UL Can Help
UL's laboratories perform analytical, microbiological, physical and performance testing for a wide range of personal care and beauty categories including cosmetics, hair and skin care, baby products, and dental care.
For more information click Contact UL at the top of the screen and a UL representative will follow up with you soon.