The United States Food and Drug Administration (FDA) last week ruled to disallow the use of the more than a dozen antibacterial compounds in so-called “antibacterial” handwashes. Australia’s regulator is now assessing whether it will follow suit.*
Triclosan is one of the most common antibacterial ingredients in domestic and medical handwash products, toothpastes and cosmetics. It is also used as a pesticide in many plastic consumer goods such as toys, and textiles such as carpets.
The FDA ruling applies only to consumer antibacterial handwashes and soaps designed and marketed for use in general domestic settings in the US. It doesn’t apply to those formulated specifically for hospital and other medical settings.
Manufacturers have a year to comply with the ruling.
Companies promoting these products have until now been able to make exaggerated claims about their relative germ-killing ability. As a result, they have enjoyed almost four decades of unfettered sales in a US handwash market, which is estimated to be worth about US$1 billion.
In theory, in order to be allowed to market products with a claim of antibacterial activity, there must be evidence to prove the claim as well as data showing it’s safe to use, including in the long term. Without data proving effectiveness and safety, products are not supposed to be approved.
It turns out that for triclosan and consumer handwashes, there was neither.
Many studies have shown that the use of consumer antibacterial wash products is no better at removing germs than plain soap and water.
Any idea that these products were better than plain soap and water at cleaning hands was simply a carefully crafted, widely propagated illusion.
The absence of data showing that antibacterial handwash products are superior to plain soap and water is a glaring omission in the regulatory documentation. It also raises the question of how we were sold a lie for so long.
Safety and other issues
The burden of proving the safety of compounds such as triclosan rests with the companies that want to make and market the products. Government regulators are the gatekeepers who weigh up the evidence and make a ruling.
In the case of the FDA, after being afforded the opportunity to present data to comprehensively answer safety questions, the companies have elected not to do so. In fact, it’s the absence of data showing the safety of frequent, low-dose, chronic exposure to triclosan, that has contributed to its regulatory demise.
When triclosan was first introduced, few would have predicted how widely it would be used. More than 1,500 metric tonnes of triclosan are produced, used and released into the environment annually.
Issues such the ability of chemicals to disrupt human hormone systems were not routinely considered when triclosan was first developed. Triclosan may be able to mimic the action of the human hormone oestrogen and in doing so, could disrupt hormone systems in humans and many other animals.
The potential for this compound to negatively impact natural ecosystems was also underestimated.
It remains unclear whether triclosan is able to interfere with human hormones or to have detrimental effects on ecosystems. But if they do have these effects, the consequences are serious, raising the stakes if triclosan use is allowed to continue.
While the question of whether the widespread domestic use of products such as triclosan contributes to the rise of antibiotic resistance remains contentious, regulators have finally erred on the side of caution, albeit for other reasons.
The FDA’s ruling may mark the beginning of the end for triclosan and antiseptics like it in domestic settings, although their use in medical settings will still be permitted. Other triclosan products such as hand rubs, wipes, toothpastes and cosmetics are not affected by this ruling.
Jittery consumers, however, may balk at continuing to put triclosan in their mouths two or three times a day when brushing their teeth. Ultimately, if consumers stop buying their personal care products, companies will re-consider their use of triclosan.
The bottom line
Triclosan-laden and many other antibacterial handwashes will begin to disappear from supermarket and drug store shelves over the next 12 months, at least in the US. Meanwhile, be reassured that washing your hands with plain soap and water combined with an effective technique is the best and safest way to clean your hands.
*A statement from Australia’s regulator, the Therapeutic Goods Administration (TGA) said:
The Australian Government Department of Health is aware of the FDA recommendations related to antibacterial soaps and any substances involved, and will review the information to see whether any action is required in the Australian context.
Christine Carson receives funding from federal government funding agencies and from industry to conduct research.
Authors: Christine Carson, Research Associate at the University of Western Australia &, Harry Perkins Institute of Medical Research