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.
Effectiveness
Many studies have shown that the use of consumer antibacterial wash products is no betterat 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.