What makes a soap 'antibacterial' and are there any benefits conferred by such a product that are underpinned by evidence? Moreover, are the ingredients of such a product more of a health risk than the bugs they supposedly dispatch? Those are just a few of the questions the FDA is pondering regarding soaps marketed to consumers as 'antibacterial,' and as Rick and I discuss on PodMed this week, precipitated our first foray into discussing something not based on a study and completely lacking evidence. Hmmm. New trend, anyone?
Here's the story: this week the FDA announced a proposed rule that will require manufacturers to provide data that demonstrate both safety and efficacy in reducing harmful bacteria with products labeled as antibacterial. Right now there is no evidence at all that such products are superior to plain old soap and water in reducing bacterial load or specific harmful species. Moreover, the ingredients contained in these soaps and body washes available over the counter include triclosan and triclocarban, two chemicals that may have harmful effects on people, especially when they are used long-term. Triclosan has been shown in animal studies to alter hormonal regulation and may also promote the development of antibiotic resistant bacterial species. Triclocarban is also suspected of affecting the action of testosterone. Right now, both of these ingredients can be found in a range of consumer-directed products, including clothing, kitchenware, furniture, cosmetics and toothpaste, in addition to body washes and soaps. Thus the range of exposures could be vast and the time period prolonged.
What specifically is the FDA proposing to do? A new standard for laboratory testing that directly tests the ability of a product to reduce infection rates will be employed. The agency is also working with the EPA to gather and integrate research data relative to triclosan with regard to risks related to exposure, especially as they occur over time. The FDA is also encouraging consumers and anyone else with an interest in this issue, including clinicians and scientists, to weigh in during the comment period for the new rule, which extends for 180 days. Okay, what about the rest of the madding crowd?
Rick suggests that for now, consumers read the labels of products they buy or have on hand around the house and see if triclosan or triclocarban are among the ingredients, and then make a decision about whether the risks of exposure are acceptable. Certainly there seems to be no acute, immediate risk but if long term risks are a personal concern, dispose of the product. The FDA and Rick and I all advocate for the pronounced ability of handwashing to reduce infection and contamination risk, however, so replacing your antibacterial product is encouraged if it keeps you washing your hands. For anyone who reads the labels of produces used in hospitals or healthcare facilities, it's important to note that the proposed rule does not apply to products designed to be used in these settings.
Other topics this week include panning multivitamins in Annals of Internal Medicine, new recommendations for defining and managing high blood pressure from the 8th Joint National Committee, and calcium channels blockers and clarithromycin and acute kidney injury in JAMA. A very Merry Christmas to all, and y'all live well.