FDA Bans 19 Ingredients from Hand Soaps

Antibacterial soaps will soon be gone from store shelves, according to a new rule from the US Food and Drug Administration (FDA).

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including triclosan and triclocarban. Triclosan used in 93 percent of liquid products labeled "antibacterial" or "antimicrobial" - at least 2,000 different products, according to the FDA.

Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that they are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

Some manufacturers have already started removing these ingredients from their products. They will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

The FDA issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as bacterial resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection. They did not provide the necessary data. For these ingredients, either no additional data were submitted 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 (GRAS/GRAE).

In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.