For as long as many of us can remember, we have purchased antibacterial hand soap and body washes, believing that were beneficial to our overall health and cleanliness. However, recent research and an order by the FDA seems to show otherwise. It could also show that some of the ingredients in these products could be harmful with long-term use. The findings are causing many of us to rethink what we know about staying clean.
“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,” says the director of the FDA Center for Drug Evaluation and Research, Dr. Janet Woodcock. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The Food and Drug Administration recently issued a press release regarding some of the ingredients in common antibacterial hand soaps and body washes. In the statement, the FDA states that they are ordering manufacturers to remove certain ingredients that were originally believed to kill germs.
In the press release, the FDA states, “The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.”
The ruling is regarding an investigation that dates back to 2013 targeting certain ingredients that may be harmful to the public. The FDA had received pressure from environmental groups and law makers regarding these ingredients and the effects they had shown in lab animals. The new ruling applies to 19 different chemical agents found in common antibacterial soaps. The most common of these were triclosan and triclocarban.
“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” states the press release from the FDA. “Some manufacturers have already started removing these ingredients from their products.”
Soap manufacturers will have one year to remove these chemicals and are no longer allowed to market products containing them. This is because the chemicals were found to be either harmful or to provide no additional benefits as washing with regular soap.
Triclosan is used in over 96 percent of products that are labeled as “antibacterial” or “antimicrobial” that are available in the market today. According to the FDA, this amounts to a total of over 2,000 different products, many of which are common in average American households. It is so common, in fact, that most Americans already have at least a small amount in their systems at all times. The Center for Disease Control recently published a study in which over 75 percent of the individuals they tested had triclosan in their urine.
Companies negotiated for extra time regarding the additional ingredients that were listed in the original query. The FDA has agreed to give them another year to provide adequate research that they are beneficial when added to normal soap.
“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,” the FDA states. “This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.”
As far as the triclosan and triclocarban, the industry either provided no research or not enough to sway the FDA in its judgement. It appears as though they intend to spend their time on the other ingredients listed in the proposed rule. As to this judgement, the FDA states, “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.”
The final ruling does not include these ingredients. The companies plan to develop additional research into the effectiveness of them and present it to the FDA within the next year. While this data is being collected, companies are still allowed to market and sell soaps containing them, as long as they do not also include the banned substances.
The research institution that will provide this research is the American Cleaning Institute. Although it does not directly represent the soap companies, it probably has their best interests at heart. The ACI states they plan to give up the battle on triclosan and triclocarban and focus on researching the beneficial effects (if any) of the other “antibacterial” agents like benzethonium chloride and PCMX.
Regarding triclosan and triclocarban, the FDA states, “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).”
The original query was initiated when pressure was brought on by environmental groups regarding the possibly unsafe ingredients. This dates all the way back to 1978 when these groups– along with certain lawmakers– first began to ask questions about triclosan. The FDA was sued by the National Resource Defense Council (NRDC) in 2013, prompting the investigation.
Questions were initially raised when animal rights activists protested the use of the chemical on lab animals. Some testing had been performed using triclosan that had caused serious negative health reactions for the animals. Testing has shown that high doses of it seriously impacted hormonal productions and how the hormones worked in the body.
Although there is not yet proof that these chemicals have the same effects in humans, there was not enough evidence of their usefulness compared to regular soap and water for the FDA to allow their continued use. However, further testing is currently being performed and could possibly prompt further action. It is enough for many people to question whether they should continue to use the products. Especially when regular soap and water could be just as effective, the “antibacterial” types may not be worth the risk.
The current ruling only applies to hand soaps and body washes. Triclosan is still a common ingredient in many toothpastes. There is reliable research showing that it can be beneficial in killing germs that cause gum disease and other oral health problems. The ruling also does not apply to hand sanitizer.
“It is important to note that this FDA rule does not affect consumer hand sanitizers, antiseptic products used in healthcare settings, and antiseptics used in food handler settings,” said the ACI after the ruling was issued. “The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps. Manufacturers are continuing their work to provide even more science and research to fill data gaps identified by FDA.”
The ACI and the soap manufacturers will continue to fight, and understandably so. The removal of triclosan and triclocarban alone will cost the manufacturers between $106.3 million and $402.8 million, according to the estimates. If they are unable to provide sufficient research to convince the FDA that the other chemicals are beneficial, one can only imagine the costs.
“Consumer antibacterial soaps and washes continue to be safe and effective products for millions of people every single day,” the ACI went on to say. “Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection. Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”
While no one would disagree that hygiene is important to living a healthy life, this new information– or lack thereof– could change the way we think about it. Although these chemicals have not yet been proven to be necessarily harmful, this could really cause one to rethink what we use on ourselves and our children. Marketers have pushed the “antibacterial” line for longer than I can remember now, and it is unsettling to think that it may not mean much.
Although the cost for manufacturers to remove these chemicals may be high, it is nothing compared to the profits they make off of selling antibacterial soaps and washes. According to the National Resources Defense Council, Americans spend almost $1 billion dollars every year on these products.
Other ingredients in the products that are still being tested include triple dye, flurosalan, hexachlorophrene and several iodine complexes. Whatever those things are, they sound scary, and that is just a few of them. Whether they are harmful or not is still to be determined. However, there is no denying that regular soap and water still provide a safe and effective way to stay clean and healthy.
“Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others,” says the FDA. At least until new information is provided, maybe it’s best to stick to the regular stuff.