Companies say there’s no cause for alarm, but studies suggest they may be dangerous. Now the FDA is preparing to rule.
Is the quest for clean doing more harm than good?
That’s the question at the heart of a debate between cleaning-products makers, researchers and environmental advocates. The outcome could affect millions of Americans who use antibacterial soaps, body washes and shower gels to fight germs as well as the companies that supply the $5.5 billion market for soap, bath and shower products.
In September, the Food and Drug Administration will announce a decision on whether companies that make and market antibacterial soaps containing certain ingredients have demonstrated they are safe and more effective than plain soap and water in preventing illness. If the FDA decides against them, the companies must reformulate the products a step a number of big manufacturers have already taken, citing public concerns and may need to remove claims from their labels.
The proposed new rules are part of a more sweeping review of virtually all antiseptic products used in the war against germs that are rinsed off or left on, including those used in hospitals to fight the rise in virulent bacteria and protect patients from infection. The FDA also plans to review hand sanitizers, including those based on alcohol, and it’s weighing separate rules for food-processing workers.
The chemicals used in antibacterial cleaners have been around for decades and are used in a wide range of other products. There is a lack of hard data linking them to human health outcomes. The FDA first judged some chemicals were safe and effective in 1994. But the most commonly used chemical, triclosan, was always under separate scrutiny, and while the FDA never took formal action, since then studies have suggested it can interfere with hormones and cause changes in thyroid, reproductive-growth and developmental systems. And some research indicates that the booming use of antibacterials is contributing to the creation of superbugs that are resistant to the antibiotics long used to fight them.
With new evidence that exposure is higher than previously thought and advances in technology to detect chemicals in the body, new data is needed to assess long-term effects, says Theresa M. Michele, director of the Division of Non-prescription Drug Products in the FDA’s Center for Drug Evaluation and Research.
We now know we can measure small amounts of ingredients in blood and that things you put on your skin can potentially be absorbed into the body, Dr. Michele says. Her advice: At this point, wash your hands with plain soap and water, because we don’t have enough data demonstrating these antibacterial soaps are any better in fighting disease.
A sweeping review
The FDA review, which includes 22 chemicals, has pitted the $30 billion cleaning-products industry, which maintains the products are safe and more effective than regular soap, against environmental groups and some scientists who charge they are not only no more effective than regular soap, but are dangerous to health and should be banned or restricted to fighting dangerous outbreaks in hospitals.
Both sides in the debate have submitted reams of evidence to the FDA supporting their stance, offering up conflicting studies that make it a challenge for the average consumer to make informed decisions.
Most of the controversy focuses on triclosan and a related chemical, triclocarban, first introduced in the 1950s and 1960s, respectively. Triclosan is an antibacterial chemical agent widely used in liquid hand soaps, other personal-care products such as body and face washes, cosmetics, school supplies and kitchenware. It works by killing or weakening bacteria, similar to the way antibiotic drugs prevent or treat infections. But while antibiotics are prescribed to cure disease, antibacterials are aimed at preventing the spread of disease-causing bacteria to people who aren’t infected, including by handling contaminated food and objects, or skin-to-skin contact.
Resistant bacteria In the case of antibiotics, because the drugs have been used so widely for so long, many types of bacteria have adapted. The FDA and some scientists are now concerned that antibacterial chemicals like triclosan, which linger in the environment and can be absorbed in the body, are also contributing to antibiotic resistance. A new Minnesota law will prohibit some cleaning products like hand soap and body wash containing triclosan after Jan. 1, 2017.
The American Cleaning Institute, which represents about 140 companies, is moving to satisfy the FDA’s data requirements for the safety and effectiveness of antibacterial ingredients, says Richard Sedlak, executive vice president, technical and international affairs. The institute and others have asked the FDA to defer rule making on three other ingredients companies are using as an alternative to triclosan, benzalkonium chloride, benzethonium chloride and chloroxylenol to allow time to submit new safety and effectiveness data. The FDA’s Dr. Michele says it is considering the request.
But the cleaning institute takes the position that the FDA has neglected a substantial amount of existing safety data showing the chemicals are effective in reducing the level of bacteria on the skin and more effective than soap that’s not antibacterial.
Along with another organization, the Personal Care Products Council, it has submitted extensive data to support its view that triclosan has been used safely for decades and has been extensively reviewed and permitted around the world, with no data directly linking it to human harm. Makers of antibacterial bath products also dispute that they are contributing to the creation of superbugs, noting that studies have shown that overuse of prescription antibiotics in humans and livestock is the driving force behind antibiotic resistance.
And the organizations warn that banning antibacterial products would increase the level of risk and exposure of the general population to bacteria, leading to increased infection and disease, including 7.5 million cases of food-borne illness and $38 billion in health-care costs annually. An FDA spokeswoman says the agency has no comment on that estimate.
By LAURA LANDRO WSJ Updated Feb. 15, 2016 11:01 p.m. ET