Antibacterial soaps, body washes containing triclosan banned by the US FDA
Many companies that sell antibacterial soaps and body washes market their products as something that helps keep you and your family safe by helping prevent the spread of germs and bacteria and lowering the risk of getting infected by illnesses and diseases.
But according to the US Food and Drug Administration (FDA), there is not enough scientific evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. Manufacturers have not been able to demonstrate that their products and ingredients are both effective and safe for long-term daily use.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
“In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The FDA has recently issued a final rule on consumer antiseptic wash products containing certain active ingredients. These products can no longer be marketed and companies will no longer be able to market products with the active ingredients.
The final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water and are rinsed off after use.
This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
In 2013, the agency issued a proposed rule after some data suggested that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.
Manufacturers are required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes under the proposed rule 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.
Manufacturers were not able to provide the necessary data to establish the safety and effectiveness of the 19 active ingredients included in the FDA’s final rule. Either no additional data were submitted or the data and information that were submitted for these ingredients were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE).
The FDA has not included benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) in the rule yet 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.
The agency establishes that washing with running water and plain soap remains one of the most important steps that can be taken to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the US Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60% alcohol.
Category: Features, Health alert
