FDA to Antibacterial Soap Manufacturers: “Prove It”

antibacterial-handsoapsThe Food and Drug Administration (FDA) keeps a close watch on consumer health.

Tasked with approving hundreds of thousands of food and health products, the FDA has strict standards for products that can impact public health.

On the top of their list this month is triclocarban and triclosan — chemicals used widely in antibacterial hand soaps and other products. On December 16th, the FDA released a statement saying that it would require proof of the safety and effectiveness of the chemicals. If manufacturers cannot satisfy the FDA, their products will be removed from the marketplace.

Are Antibacterial Soaps Effective?

The FDA has proposed a rule that will require manufacturers of antibacterial hand soap and other hygienic products to provide proof that their soap products are as safe and effective as plain hand soap and water when it comes to preventing the spread of infection and preventing illness. The rule also calls for manufacturers to prove that long-term use of their products is also safe.

In a statement released by the FDA, the agency said “Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.”

Health officials estimate that approximately 2,000 individual soap and hygiene products contain triclosan and triclocarban.

Cleaning Chemicals in Question

The chemicals triclocarban and triclosan were originally used by surgeons. Before operating on patients, they would disinfect their hands with the chemicals to help prevent instances of infection in the operating room. The chemicals were eventually adopted by manufacturers of soaps, mouthwashes, cleaning products, and some cosmetics.

Growing concerns over the effectiveness and safety of these chemicals, as well as their environmental impacts have led the FDA to demand proof from manufacturers within one year. Several studies have suggested that the chemicals can have negative effects on the development of reproductive systems in animals, including humans. If the FDA isn’t convinced, the chemicals will be banned from use.

A particularly revealing study conducted in 2008 by the University of California Davis found that both triclocarban and triclosan caused reproductive hormone activity disruption, interfering with the signaling of cells in both the heart and the brain. Dan Chang, a professor emeritus at the university who was involved with the study, says “Americans spend nearly one billion dollars a year on these products even though studies show that they are no better than regular soap and water at reducing the spread of illness.”

“As you can imagine, this decision will affect many industries,” says Stephen Ashkin, president of The Ashkin Group, a consulting and promotional organization for green cleaning. “However, the impact [of these chemicals] on the environment and health and their overall effectiveness has been questioned for years.” Ashkin goes on to say that “except where [these chemicals] are required for use by law or for health reasons, proper hand-washing is all we really need to protect our health.”

The Natural Resources Defense Council Takes Action

Attorney Mae Wu, a Natural Resources Defense Council (NRDC) attorney, said, “This is a good first step toward getting unsafe triclosan off the market. The FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.”

This isn’t the first time the FDA has questioned the use of triclosan. The agency first made a proposal to remove triclosan from many products as far back as 1978. No final action was taken on the proposal, however, and the chemical has been used with greater frequency in the decades since.

The issue was brought back into the spotlight in 2010 when the NRDC sued the FDA to bring the proposal to a final rule. The new rule is the result of a settlement between the FDA and the NRDC.

The FDA is allowing public comment on the rule for 180 days. A one year period has been established for companies to present data proving the chemicals are safe and effective and do not pose long-term health threats to people or the environment. The public comment period has a targeted deadline of June 2014, while companies have through December of 2014 to submit research and other data to make their case. The agency’s stated goal is to have the rule finalized and to have a determination as to whether triclosan and triclocarban are “generally recognized as safe and effective” in September of 2016.

Environmental Impacts

Because many of the products manufactured with the antibacterial chemicals are hygiene products, a large percentage of them is deposited into the environment through drains and sewer systems.

The risk of infection at home, where many of the hand soaps and body wash products are used, is relatively low, not justifying the use of the chemicals.

Additional Information

The rule does not affect hand sanitizers, antibacterial products, and wipes used in hospital and health care environments. Hand sanitizers generally contain at least 60 percent alcohol and are considered a safe alternative when soap and water aren’t an option for washing. Most health officials, including the Centers for Disease Control and Prevention (CDC), believe that hand washing with regular soap and water is the best and most effective method for hand hygiene.

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