The U.S. Food and Drug Administration recently dealt a blow to consumer soap companies by decreeing that washing hands with regular soap and water was sufficient to prevent illnesses.
On Friday, the FDA issued a statement that read, in part:
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. 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. Some manufacturers have already started removing these ingredients from their products.
This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The FDA also issued a press release and additional information to consumers. The release read, in part:
When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected?
According to the U.S. Food and Drug Administration (FDA), there isn’t enough science to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. To date, the benefits of using antibacterial hand soap haven’t been proven. In addition, the wide use of these products over a long time has raised the question of potential negative effects on your health.
Though the ruling doesn’t affect hand sanitizers or wipes—nor does it affect antibacterial products used in health care organizations—brand managers for a number of companies that carry “antibacterial” products have their work cut out for them.
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NPR listed the 19 ingredients recently banned by the FDA:
- Cloflucarban
Fluorosalan - Hexachlorophene
- Hexylresorcinol
- Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
- Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
- Nonylphenoxypoly (ethyleneoxy) ethanoliodine
- Poloxamer-iodine complex
- Povidone-iodine 5 to 10 percent
- Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol (greater than 1.5 percent)
- Phenol (less than 1.5 percent) 16
- Secondary amyltricresols
- Sodium oxychlorosene
- Tribromsalan
- Triclocarban
- Triclosan
- Triple dye
Forbes contributor Rita Ruban wrote that many companies anticipated the ingredient ban:
The ban did not exactly take manufacturers by surprise. In December 2013, the FDA issued a proposed rule spurred by data that suggested the now banned active ingredients could contribute to bacterial resistance or cause hormonal effects. The proposed rule required makers of antibacterial hand soaps and body washes to demonstrate that they were safe to use every day and more effective than plain soap and water in keeping people healthy by preventing the spread of certain infections. If companies didn’t comply, they’d have to re-formulate [Beki: Does this prefix express your meaning better? If not, take the prefix out.—Bill] their products or remove the “antibacterial” claim from their labels.
A stroll down the soap aisle at the supermarket or pharmacy shows that a number of manufacturers must have chosen the first option, because “antibacterial” still appears on many product labels. “To give our consumers peace of mind, and despite triclosan having a long and extensive history of safe use, we decided in 2012 to phase out triclosan in our beauty and baby care products,” Johnson & Johnson JNJ +0.20% said in a statement released in July 2014. And in an undated page on its website, Procter & Gamble PG -0.12% states, “We have eliminated triclosan from more than 99% of the products where it was used and have an exit plan for the few remaining uses.”
However, some consumer products still contain the ingredients, NPR reported:
On its website, Dial's “All Day Freshness" antibacterial soap, for one, lists triclocarban as an active ingredient.
The Henkels Co., which owns Dial, didn't respond to an email seeking comment.
Why the ban? Wired’s Megan Molteni wrote that it has to do with the prevention of “superbugs”:
… [T]riclosan and chemicals like it are rarely present in high enough concentrations in consumer products to kill all the bacteria on your skin. At these low concentrations, they instead exert selective pressure on bacteria, allowing them to quickly evolve adaptations—like one cellular mechanism that sucks in triclosan and pumps it right back out, almost like a gag reflex. Add up these adaptations and you get bacterial resistance, which gets passed down genetically, and eventually you get…our future superbug overlords. “You can contribute to sublethal exposure ,” says Aiello, “and then you’ve got a pretty dangerous situation on your hands in terms of changing antibiotic resistance.”
“Scientists are thanking the FDA for the push, even if soap manufacturers aren’t,” Molteni wrote.
How do you think the ruling will affect branding and marketing efforts, PR Daily readers?
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