FDA issues final rule on safety and effectiveness of over-the-counter antibacterial soaps and washes


 Data suggests that long-term use of certain antibacterial ingredients are dangerous

Credit: Pixabay
Credit: Pixabay

Disease prevention and health maintenance are key to human survival, and this is possible only through good hygiene practices. Accordingly, we rely heavily on antibacterial soaps or other washing products in our day-to-day life. In a recent press release, the U.S. Food and Drug Administration (FDA) warns consumers by banning almost 19 harmful chemical ingredients that are used in antibacterial soaps.

FDA issued a strong guideline termed ‘final rule’ that removes over-the-counter (OTC) consumer antiseptics such as wash products containing certain active molecules, and will no longer be allowed to market in near future. If the manufacturers do not prove that the chemical ingredients they use are both safe for regular use, and more effective than normal soap in preventing the spread of infections, these companies will no longer be encouraged to market their antimicrobial products.

Dr. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) said, “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,”. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

According to FDA, this final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used triclosan and triclocarban. In fact, these products are intended for use with water, and are rinsed off after use. However, this rule does not affect several daily-used consumer products including hand “sanitizers” or sanitizing wipes, shaving creams, cosmetics and some toothpastes or antibacterial products that are extensively used in healthcare settings.

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In 2013, the agency proposed a rule after some data indicated that long-term exposure to antibacterial products such as triclosan used in liquid soaps and triclocarban in bar soaps could carry several health risks, including bacterial resistance or hormonal problems. Under this final rule, manufacturers were required to provide the agency with a strong supporting data on the safety and effectiveness of certain ingredients used in over-the-counter  (OTC) consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This also includes data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or in reducing infection.

Up until now, for these ingredients, either no additional data were submitted or the information that was reported were not sufficient enough for the agency to find that these ingredients fall under the category of GRAS/GRAE (Generally Recognized as Safe and Effective). In response to comments submitted by industries, the FDA has delayed rulemaking for one year on three additional ingredients used in consumer wash products such as benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) to allow for the development and submission of new safety and effectiveness data for these ingredients. Nevertheless, consumer antibacterial washes containing these specific ingredients may be promoted during this time while the research data are still being gathered.

Though it is a time-taking decision for consumers to trust on these products, some researchers started applauding this new federal rule. Since the FDA’s proposed rulemaking in the year 2013, manufacturers have already started reducing the use of certain active ingredients in antibacterial washes including triclosan and triclocarban. Additionally, manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) their products. Nevertheless, it is apparent that harmful antibacterial products will no longer be FDA approved, and thus we may not see thousands of these products in the market soon.

This news was extracted from FDA’s recent press release. For more information, please visit www.fda.gov